Abstract
Advances in HIV prevention technologies such as the use of HIV treatments as prevention (TasP) offer new tools in the fight against AIDS. This chapter examines how biomedical devices have morphed into behavioral interventions over the past 30 years. Of particular interest are sterile syringes, condoms, and HIV antibody testing; medical technologies now thought of as behavioral interventions. These highly effective prevention tools have been stymied by politics, misguided policies, poor allocation of resources, and failure to invest in behavioral components to their use. These experiences offer important insights into how treatments could fail as prevention. The chapter concludes with recommendations for avoiding the pitfalls of past prevention technologies.
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By condoning and embracing the concept of giving free needles to drug addicts, President Clinton has raised the white flag of surrender. Instead of leadership on the issue, we get a deadhead president who supports a program that gives free needles to drug addicts.
US Congressman Tom Delay (1998)
It may not seem obvious, but behavioral interventions for HIV prevention have always hinged on medical technologies. Sterile syringes, condoms, and HIV testing are the tools of behavioral prevention. Overtime these medical devices have become fully integrated with practical skills to the point at which they are inseparable from behavior itself. We know that these tools are most effective when delivered through a broader array of services. For instance, placing a bowl of condoms in a bathhouse is less effective than social marketing strategies to promote their use. Even HIV antibody testing without risk reduction counseling is merely a medical diagnostic test with no evidence for risk reduction of its own. It is the human interphase that determines the preventive value of these technologies. As treatments become the next tool of prevention, their use will also be at the mercy of perceptions, motivations, desires, beliefs, and behaviors. Perhaps the lessons learned from biomedical HIV prevention technologies of the past can help bolster the success of TasP.
Needles and Syringes
In the USA, injection drug use is the source of 8% of men’s and 15% of women’s HIV infection. HIV rapidly spreads through injection drug using networks because infected blood is highly infectious and the virus directly enters a susceptible blood stream. Even when blood plasma viral load is undetectable HIV concentrations are sufficient for transmission. Similar to sexual relationships, injection equipment is often shared within intimate and trusted relationships, inhibiting partners from taking precautions. Reducing the risk for HIV among injection drug users therefore requires both access to sterile injection equipment and changing the social dynamics of injecting drugs.
Syringe Access
Needles and syringes are basic medical supplies and their access is a matter of social policy. It is well known that providing injection drug users with access to clean injection equipment prevents HIV infections. Evaluations of syringe exchange programs demonstrate 33% reductions in HIV incidence in New Haven, 50% in Amsterdam, and 70% in New York City [57–59]. Don Des Jarlais and his colleagues at the Albert Einstein School of Medicine in New York City offer compelling evidence for the impact of syringe access on HIV epidemics. The number of syringes exchanged in New York increased from under 500,000 in 1990 to over three million in 2002. HIV incidence decreased during that same period from nearly 4% per year to less than 1% (see Figs. 2.1 and 2.2). Hepatitis C virus (HCV) is ten times easier to transmit through blood than is HIV, and syringe exchange programs demonstrate significant impacts on this disease as well. In 1990 80% of HIV uninfected injection drug users in New York were infected with HCV. Following implementation of syringe access programs, HCV infection rates dropped off sharply to 59% in 2001. Among persons who had been injecting for less than 6 years, the HCV infection rate fell from 80 to 38%. These findings represent a fraction of the significant body of research that demonstrates the public health impact of syringe access. Because the distribution of sterile syringes is determined by public policies, legislators have been the primary impediment to scaling up this effective strategy.
Politics of Syringe Access
Few public health failures are as infuriating as the ban on US Federal funding for clean injection equipment. In 1988 the US Congress established a prohibition on using Federal funds to pay for clean needles and syringe access. The ban remained in place for over a decade when it seemed likely that President Clinton would correct this misguided policy. The debate over syringe access peaked in 1998 when the public health benefits of needle exchange programs became indisputable. Numerous scientists and public health experts were on the frontlines of the fight. David Vlahov, then at the New York Academy of Sciences, presented a wealth of evidence to the 1997 NIH Consensus Development Conference. He presented evaluations of needle exchange programs, many operating since 1986, that clearly saved countless lives. Vlahov relied on rigorous research conducted by Yale University’s Robert Heimer and Edward Kaplan showing the incidence of HIV infections had dropped by 33% in New Haven as a direct result of private and state funded needle exchange programs. The NIH panel was briefed on research that demonstrated protective effects of needle exchange on HIV incidence in New York City. The NIH panel also heard evidence for the long-term impact of needle exchange on HIV prevalence in Chicago, Tacoma, Sydney, Toronto, and Glasgow. Every concern that justified the Federal ban was put to rest. Needle exchange does not promote drug use; in fact these programs encourage entering drug treatment. And because needles are exchanged on a one-to-one basis, they could not increase the number of needles in circulation. Research from the CDC showed that the rate of new HIV infections decreased by as much as 80% as a direct result of these programs.
Chaired by David Reiss of George Washington University Medical Center, the NIH panel determined that syringe and needle exchange programs are effective at reducing HIV infections and should be implemented with adequate resources. The panel concluded:
Legislative restriction on needle exchange programs must be lifted because such legislation constitutes a major barrier to realizing the potential of a powerful approach and exposes millions of people to unnecessary risk .... . Of utmost importance is that HIV prevention policy be based, whenever possible, on scientific information. This occurs too little—the behavior placing the public health at greatest risk may be occurring in legislative and other decision making bodies. The Federal ban on funding for needle exchange programs as well as restrictions on selling injection equipment are absolutely contraindicated and erect formidable barriers to implementing what is known to be effective. Many thousands of unnecessary deaths will occur as a result.
The NIH recommendations led to even more policy positions issued by the American Medical Association, the American Bar Association, the American Public Health Association, The Association of State and Territorial Health Officials, National Academy of Sciences, American Academy of Pediatrics, American Nurses Association, and The US Conference of Mayors. Every leading public health institute in the world declared syringe exchange a cheap and accessible biomedical device effective in preventing HIV infections.
With evidence and pressure from public health lobbies, the US Congress again debated lifting the Federal ban on funds for needle exchange programs. California representative Nancy Pelosi echoed the call for lifting the ban, stating that “Sound science is an essential component of good public policy, and the scientific support for needle exchange could not be more clear.” Texas congresswoman Sheila Jackson Lee added, “Secretary of Health and Human Services, the Director of the NIH, and the National Institute on Drug Abuse issued a determination that scientific evidence indicates that needle exchange reduces HIV transmission and absolutely does not encourage the use of illegal drugs.”
But public policy is not necessarily persuaded by evidence. California representative Frank Riggs summarized the support for maintaining the Federal ban on needle exchange, stating “We do not want to be in a position where we use tax payer funding or other tax revenues to promote illegal drug use, to promote further drug addiction, and drug dependency.” Public health lost the debate when congress voted 287–140 to make the ban on Federal funding for needle exchange “permanent.”
The ban stayed in place until July 27, 2009 when congress voted 218–211 in favor of lifting the ban. Signed by President Obama more than 15 years after research had definitively proven the effectiveness of needle exchange in preventing HIV infections. Today, US cities with the most number of syringes exchanged are the cities with the least number of new injection drug use HIV infections. The Harm Reduction Coalition lists 7-syringe access programs in New York City and 5% of HIV infections in New York in 2009 were among injection drug users. In contrast, there is only one syringe access program in Washington, DC where 28% of new infections in 2009 occurred among injection drug users.
Even the most comprehensive and expensive needle exchange programs are cost saving, documenting a return of $4 saved in health care costs for every $1 invested in needle exchange. For example, harm reduction centers and supervised facilities provide safe injection places as well as linkages to drug treatment, HIV testing, and medical care. A cost evaluation of one supervised injection facility in Vancouver British Columbia showed that HIV infections are averted at one-tenth the cost of caring for a person with HIV [10]. A more recent economic evaluation by Steve Pinkerton at the Medical College of Wisconsin showed that at an annual cost of $3 million, a supervised injection facility prevents 83 new HIV infections a year, saving $17.6 million in medical expenses [52].
The US is not the only country slow to act on needle exchange. Russia, for example, has an HIV epidemic that is fueled by contaminated injection equipment. The first documented case of AIDS in Russia occurred in St. Petersburg in the mid-1980s. Following a substantial outbreak of HIV in nearby Kaliningrad, it seemed that St. Petersburg was on the brink of an AIDS disaster [60]. At first compartmentalized among opiate injectors, heterosexual transmissions soon followed, as did a significant epidemic among Russian men who have sex with men. Oppressive drug policies, police intimidation of harm reduction and outreach workers, and homophobia hampered efforts to prevent HIV infections. Russia and the Ukraine account for 90% of all new HIV infections in Eastern Europe [22, 32]. Similar tragedies are playing out in Asia as well. The failure of policy makers to act on simple proven means for preventing HIV epidemics have brought some of the darkest days in the AIDS pandemic.
We have known since the late 1980s that syringe access is most effective when implemented within broader services. The aims of syringe access are to replace contaminated needles/syringes with clean equipment, reduce the number of contaminated syringes circulating in drug using networks, and link injection drug users to prevention and treatment services. At the 2011 meeting of the International AIDS Society, Don Des Jarlais outlined six principles of best practices for syringe exchange programs:
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Programs should be started when HIV prevalence is low to keep infections low
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Programs should be large scale with no limits on syringes and no requirement for one-to-one exchange
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Services should be provided at convenient locations and hours of operation
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Programs should provide multiple services including HIV testing, condom distribution, etc.
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Involve drug injectors as peers and experts in the site operations
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Work to ensure cooperation of law enforcement
Syringe exchange programs are further bolstered by social network interventions, again illustrating the power of integrating biomedical and behavioral prevention strategies.
Social Interventions for Injection Drug Users
HIV is spread through sexual and drug sharing networks. Intervening at the network level offers some of the most effective interventions for reducing HIV transmission. In these programs, injectors are recruited through outreach. As part of their participation, peers recruit their friends into subsequent intervention waves. The genius of this approach is that the level of intervention is matched to the level of HIV transmission. Interventions targeting injection drug users have implicitly and explicitly infiltrated social networks through informal conversations, community-level education, and advocacy. Social network interventions have demonstrated irrefutable success in reducing injection associated HIV transmission risks and, to a lesser degree, sexual risks.
Carl Latkin at Johns Hopkins University is a pioneer in network-level interventions. Latkin and his colleagues developed the first intensive behavioral interventions aimed at injection drug using networks. These innovative programs focus on reducing injection drug use behaviors (i.e., Stop AIDS for Everybody, SAFE) and reducing sexual transmission risks (i.e., Self-Help in Eliminating Life-Threatening Diseases, SHIELD) [61–65]. In the SHIELD intervention, injection drug users meet in ten small group sessions for training in risk reduction strategies. The intervention was designed to impact the participant’s own injection drug use as well as the injection practices of their network members. The intervention was designed for use in drug treatment centers, homeless shelters, and other ongoing services. Drawing from Latkin and Tobin’s descriptions [66, 67], the intervention is grounded in cognitive-behavioral models of behavior change common in skills-training interventions. SHIELD provides opportunities to personalize and conceptualize the meaning of HIV-related risk behaviors. Group members are instructed in strategies for examining individual and social-level factors that influence their decisions and actions. As typically occurs in skills-based interventions, the training emphasizes interactive techniques including modeling, performance, behavioral rehearsal, feedback, and public goal setting. Role-playing and other safer sex exercises were a key strategy for increasing comfort in reducing sexual risks, especially condom use. The SHIELD intervention embraces a harm reduction orientation by providing an array of options for reducing risk behaviors.
An important feature of SHIELD is that participants make public commitments to improve their own health behaviors and promote HIV prevention within their networks. A central tenant of SHIELD is to enhance a sense of community among network members. This goal is achieved through activities that contextualize HIV within broader community concerns. SHIELD participants identified major concerns in their community and discussed how HIV impacts the people they know. Group participants were asked what they could do to reduce the spread of HIV and to address other issues in their community. Building self-determination and a sense of community, there was significant attention to the interrelatedness of individuals, risk partners, and network members. SHIELD was therefore designed to harness the power of social norms and exploit their influence on behaviors.
Group members were encouraged to carry forward HIV education within their networks and to advocate risk reduction among their sex and drug partners, family, and friends. Positive health-promoting actions were intended to replace risk behaviors, creating multiple waves of prevention within established social networks. The behavioral skills built on naturally occurring protective behaviors within existing relationships. Sam Friedman of the National Development Research Institute described these behaviors as intravention. He identified protective injection drug using networks where preventive behaviors are normative and HIV prevalence remains low [68, 69]. Freidman described individuals within protective networks engaged in altruistic actions aimed at reducing network member risks. Motivated by the relationships themselves, individuals advised their friends to avoid risk, take precautions, and support protective actions. SHIELD exploits pro-social behaviors to propagate and strengthen intravention. SHIELD participants were themselves trained in peer outreach strategies and provided with informational brochures, syringe sterilization kits, and condoms for distribution in their networks.
The outcomes from a randomized trial testing the SHIELD intervention demonstrated reductions in both injection and sexual risk behaviors. Participants in SHIELD decreased injecting drugs 6 months after the intervention; 48% of SHIELD group members had decreased injecting compared to 25% of the control participants. It was common for participants to completely cease injecting drugs, with 44% of SHIELD participants and 22% of control participants stopping their drug use. In all, 69% of SHIELD group members no longer used unhygienic needles compared to 30% of control participants. In a multivariate analysis that controlled for multiple confounding factors including age, gender, race, education, arrest history, HIV status, and mood, the SHIELD group was more than three times likely to report stopping injection drug use and reducing needle sharing.
With respect to sexual risk reduction, 16% of SHIELD group members increased their condom use during vaginal sex with casual partners compared to only 4% of those in the control group. The SHIELD participants were more than seven times as likely to report increased use of condoms with casual partners. In addition, 18% of persons in the SHIELD groups reduced their number of casual sex partners compared to 7% of controls. These findings dovetail with reductions in injection risks to demonstrate multiple preventive benefits of the SHIELD intervention.
SHIELD builds on the success of earlier network-level interventions for injection drug users that focused solely on needle sharing and other drug-related risks. The intervention was innovative in its integration of both drug use and sexual risk behavior change in a single model. In that sense, SHIELD foreshadows the integration of multiple combinations of interventions that forms the state of HIV prevention today.
Condoms
The first cases of AIDS rather quickly revealed that the cause was sexually transmitted. Condoms became the first line of defense against AIDS even before HIV was discovered. The biomedical principle behind barrier methods is simple; placing an impermeable membrane between the virus and vulnerable cells will prevent infection. Two barrier methods have proven successful for HIV prevention—male condoms and female condoms.
While condoms prevent HIV infections, getting people to use them has proven to be the great challenge in HIV prevention. A fundamental truth in HIV prevention is that people hold two desires—to feel safe and to not use condoms. When used correctly and consistently, condoms provide nearly perfect protection against HIV. Condoms rarely fail in preventing STI, but we have failed to exploit their preventive benefits. Thousands of studies throughout the world show that attitudes toward condoms offset the protection they offer. The new standard in HIV prevention is to all but dismiss condoms. Condoms have been replaced with partner selection strategies, negotiating safety, and avoiding certain sexual positions; choices that help people feel safer with little safety.
Male Condoms
Condoms are the least expensive and most widely available means of preventing HIV. An industry report estimates that by 2016 the global market will reach 27 billion condoms. In South Africa, the country with the world’s largest AIDS epidemic, condoms are ubiquitous. The South African Department of Health distributes more than 400 million condoms annually and millions of additional condoms are doled out by non-governmental organizations. The Treatment Action Campaign, for example, provides more than one million condoms each month in the Western Cape Province alone.
Unless they break, slip-off, or are not used at all, condoms offer nearly complete protection against the spread of HIV. Laboratory testing shows that latex condoms are not easily broken. Condoms can be pumped with air to the size of a watermelon without bursting. Air and water burst tests show that more than 99% of condoms do not leak. Even when condoms do leak, they reduce exposure to HIV by a factor of more than 10,000 times. In practice, condom breakage rates fall between 1 and 10%, with user errors caused by insufficient lubrication, improper lubrication with oil-based products, reuse, excessive strain, and slippage.
Condom failure can also occur from incorrect use, such as leaving an insufficient reservoir at the tip or leaving excessive air bubbles in the condom. In the USA, contraceptive condom failures are as high as 17% annually [70]. In one study of adolescents, Rick Crosby and his colleagues found that as many as one in three sexually active youth experience condom failures, which are associated with subsequent STI [71]. In a study of STI clinic patients in Cape Town, South Africa we found 37% of men and 41% of women report lifetime histories of condom failures. We also found that oil-based lubricants were a factor in 12% of persons experiencing condom failure [72]. But the real problem is not the condoms themselves, but rather getting people to use them.
Consistent condom use means using one every time a person has sex, from start to finish. In reality, intermittent condom use is far more common. Condom use generally increases after a rise in HIV prevalence. For example, condom use reported during last intercourse among men who have sex with men in China was 56% in 2003–2005, increasing to 61% between 2006 and 2008, paralleling increased HIV prevalence in the population [73]. Increases in condom use are understandably reactive to rising HIV prevalence, which of course is too late for primary prevention.
Attitudes, beliefs, and perceptions ultimately determine condom use. Most negative attitudes toward condoms center on their interference with sexual sensation, pleasure, and sexual intimacy. Condoms can also become associated with disease and distrust. Less studied are the physiological aspects of sexual response in relation to condoms. Jeff Kelly and I suggested in 1995 that condom use should be placed in the realm of emotion and sexual arousal rather than reasoning and rational decision-making [74].
Early efforts in HIV prevention focused on increasing condom use by directly addressing negative attitudes. In fact, the very first behavioral HIV prevention interventions were primarily aimed at eroticizing condoms. Ribbed surfaces, exotic scents, and vibrant colors were combined with a cornucopia of lubricants to accentuate sensuality. These products certainly brought variety and choice. Although met with initial enthusiasm, there is little evidence that these products have done much to sustain condom use.
To directly address the sensation problem, manufacturers started making condoms from materials other than latex. Most promising were condoms made of polyurethane, a thin, durable plastic. It seemed that a plastic condom could be marketed in direct response to the growing resistance against latex. My research team conducted a study aimed at testing the uptake of polyurethane male condoms. We designed a 3-h workshop to encourage men to use polyurethane condoms. Men were told, “everyone knows rubbers can ruin the moment, but new plastic condoms are different.” Polyurethane condoms are thinner and men were told that the plastic allowed heat to transfer in both directions. The fact that polyurethane condoms do not grip the penis was also talked-up as an advantage. Despite our best efforts, the intervention did not lead to men beating down the door for polyurethane condoms. Men did use the polyurethane condoms, but they used latex condoms less. The net result was little change in protection.
Many other efforts to increase condom use have failed. For example, there are devices that assist men in rolling condoms on. There is also a spray-on condom, where the penis is inserted in to a hard plastic tube with interior nozzles that spray liquid latex in all directions, like water jets in a car wash. Another innovation to get people to use condoms is a product called Futura—a condom laced with a vaso-dilating gel to boost penile blood flow and maintain erections. Dubbed a Viagra condom, the idea is to increase appeal of using condoms by making sex with condoms last longer. None of these products have shown evidence of overcoming the power of negative attitudes.
Politics of Condoms
In May of 1988 the US Surgeon General C. Everett Koop released his report on AIDS to America. The report remains the largest dissemination of public health information in US history, with 107 million copies mailed to US households. The Surgeon General provided facts, telling us what we could do to avoid AIDS and just as importantly, what we did not need to be concerned about. Upon reflection, Koop reveals, “Of all the things I said, only two words seemed to be remembered: sex education, and the next few days were spent fending off press questions about when sex education should begin, and all the questions that come to mind if your interest is in sex education. Many of the issues of AIDS in the report seemed eclipsed by this distraction” [75].
The problem is how we define “sex education.” Comprehensive approaches embrace sexuality in a developmental context and address all aspects of sexual health and behaviors. In contrast, narrow approaches to sex education typically focus on abstinence. Advocacy for abstinence only sex education is firmly grounded in religious and political ideologies. In the parallel universe that saw syringe access voted down in the US Congress, the debate regarding comprehensive versus abstinence only sex education is not settled by evidence.
In 1996, President Clinton signed the Public Health Service Act, Public Law 104-193 to award States block grants for programs targeting HIV prevention for adolescents. However, the designated funds could only be used for abstinence education. Even at that time there was evidence that abstinence programs don’t work. The NIH Consensus Conference showed that comprehensive sex education is our best means of protecting the sexual health of young people. The NIH Panel noted that the new Federal policies were not in synch with the science and concluded:
The single greatest increase in HIV prevention funding occurred with 1996 Federal legislation in the United States providing $50 million within block grant entitlements for programs teaching adolescents abstinence from sexual behavior. Among the criteria for programs funded through the block grant program are the following two requirements: (a) ‘has as its exclusive purpose, teaching the social psychological, and health gains to be realized by abstaining from sexual activity’ and (b) ‘teaches that a mutually faithful monogamous relationship in the context of marriage is the expected standard of human sexual activity’ (Public Health Service Act, Public Law 104-193, Sec. 912). Some programs based on an abstinence model propose that approaches such as the use of condoms are ineffective. This model places policy in direct conflict with science because it ignores overwhelming evidence that other programs are effective. Abstinence-only programs cannot be justified in the face of effective programs and given the fact that we face an international emergency in the AIDS epidemic (available at http://consensus.nih.gov/1997/1997PreventHIVRisk104PDF.pdf).
Today the research could not be any clearer. There is no evidence that abstinence only sex education programs achieve their goals. For example one study randomly assigned adolescents to one of four-abstinence programs or a control group [76]. The programs defined as abstinence-only had the following key characteristics:
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Have as its exclusive purpose teaching the social, psychological, and health gains to be realized by abstaining from sexual activity.
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Teach abstinence from sexual activity outside marriage as the expected standard for all school-age children.
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Teach that abstinence from sexual activity is the only certain way to avoid out-of-wedlock pregnancy, sexually transmitted diseases, and other associated health problems.
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Teach that a mutually faithful, monogamous relationship in the context of marriage is the expected standard of sexual activity.
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Teach that sexual activity outside the context of marriage is likely to have harmful psychological and physical effects.
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Teach that bearing children out of wedlock is likely to have harmful consequences for the child, the child’s parents, and society.
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Teach young people how to reject sexual advances and how alcohol and drug use increase vulnerability to sexual advances.
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Teach the importance of attaining self-sufficiency before engaging in sexual activity.
While teens that received the abstinence programs did acquire accurate information about STI and contraception, the improved knowledge did not lead to behavior change. There were no differences in sexual behaviors observed in this study. In the end, 56% of adolescents who received abstinence education remained abstinent after the program, as did 55% of those in the control group. As much as 78 months later, 49% were abstinent regardless of which program they received [77]. In another randomized controlled trial, John Jemmott and his colleagues tested three-structured and manual-based brief interventions for adolescents: (a) an evidence-based safer sex program called “Be Proud—Be Responsible,” (b) an abstinence only program, or (c) a time-matched non-sexual health program to serve as the control group. Importantly, the abstinence intervention had a similar tone as the safer sex program, to avoid portraying sex in a negative light or send any moralistic messages. The results were clear. One year after the program, 20% of the abstinence program participants had engaged in sex, as did 16.5% of the safer sex participants and 23% of the control group. Direct comparisons showed that the safer sex intervention resulted in significantly less unprotected sex than the other two programs.
Scientific evidence and public health aside, President George W. Bush further promoted abstinence only sex education. The official US policy was to promote an approach to HIV prevention known as the ABCs—Abstinence, Be faithful, and Condoms. However, the seeds of abstinence only prevention were shown more than a decade earlier during the Regan Administration. President Reagan’s Surgeon General Koop stated “I never mentioned the use of condoms as a preventive measure against AIDS without first stressing the much better—and much safer—alternatives of abstinence and/or monogamy” [75].
The ABC mantra became a congressional mandate for funding HIV prevention, both domestically and internationally [78]. Because all US HIV prevention activities were required to embrace the ABC approach, the CDC went so far as to require all of its evidence-based prevention packages to include a back-tab in the manual for a standard ABC curriculum guide. Ironically, none of the “evidence” based interventions were even remotely related to an ABC approach and there are no such interventions that have been demonstrated effective [79]. Once again, AIDS prevention science fell on deaf ears.
Condom Counseling
Behavioral interventions can concentrate on multiple avenues to HIV prevention including reducing numbers of partners, abstaining from high-risk practices, or reducing substance use in sexual contexts. But every behavioral risk reduction intervention of value has included increasing condom use. Increased condom use is typically greater in casual than committed relationships. Condoms are also used more with known HIV-infected partners than non-infected partners. Meta-analyses show that increased condom use is among the most consistent behavioral intervention outcomes. Interventions delivered in individual counseling, small groups, or at the community level have all demonstrated increases in condom use. While interventions vary widely, they share much in common when it comes to promoting condom use. Changing negative attitudes toward condoms is an explicit aim of risk reduction counseling. However, purely cognitive approaches to increasing condom use are criticized for ignoring the physiological, sensation, and emotional aspects of sexual experience. Eroticizing condoms usually takes a hands-on approach by touching and feeling lubricated latex, placing condoms on anatomic models, and planning to incorporate condom use in the heat of the moment.
One key feature of interactive activities is condom desensitization. An HIV prevention intervention is perhaps the only time that a person will handle a condom in the light. It may also be the only time they will discuss the pros and cons of condoms. The experience also offers the opportunity to self-reflect and to consider the trade-off between increased protections versus loss of sensation. Although we do not know exactly what behavior change mechanisms are at work in condom skills training, it is likely they go beyond the technical accuracies of proper condom use.
Condom Successes
Condoms are effective at preventing the spread of disease at the individual and population levels. Aside from clean needles and syringes, no other prevention technology has thus far demonstrated a direct correspondence between access, uptake, and disease prevention. For example, Fig. 2.3 shows the relationship between condom distribution and STI rates in one South African township. The data illustrate peaks in condom distribution that coincide with declining rates of STI. The rises and falls in condom distribution suggest variations in supply or demand. Condoms distributed by the City of Cape Town Health Department are more a function of restocking clinics than implementing any particular program.
Coordinated efforts to distribute and promote condoms have proven successful in reducing disease. The best-known example is Thailand’s 100% Condom Program discussed earlier. This program embedded a broad-based approach to achieving 100% condom use among Thai military conscripts [80, 81]. The program included chaplains and medics delivering STI and condom use education, including a series of mandatory weekly discussions. Information on STI prevention was distributed along with scaled-up access to condoms. Small group workshops were also implemented to deliver intensive communication skills, condom use skills, role-plays, social reinforcement, and other behavioral strategies. Condoms were distributed using social marketing techniques. The results were impressive, with military recruits assigned to the program demonstrating 75% fewer HIV infections and 85% reductions in other STI compared to men who did not receive the program.
Thailand instituted a broader social policy for condom distribution that targeted high-risk populations. These efforts are widely recognized for reversing what was clearly an emerging AIDS crisis in Thailand. Mike Merson, former Director of the World Health Organization’s Global AIDS Program, described the program as:
The best evaluated effort of a nationwide program in a developing country has been that of Thailand, and it demonstrates the value of combining intervention approaches. In that country, where the commercial sex industry is well established, a mass condom promotional campaign was begun in the late 1980s and a 100-percent condom use program was instituted in brothels in northern Thailand in 1989 and in the entire country early in 1992. Antibiotics are also readily available for treatment of STDs. These together resulted in a more than six-fold increase in the percentage of sex acts with commercial sex workers in which a condom was used, from 14 percent before 1989 to over 90 percent in December 1994, with a concomitant decrease of 85 percent in male STD cases nationwide seen at government clinics and a decline in HIV prevalence in pregnant women and military conscripts by the end of this period. This impact has been most vividly demonstrated in northern Thailand, where there has been a significant decrease in HIV prevalence among military conscripts from 12.5 percent in 1991 to 6.7 percent in 1995 [82].
HIV incidence in Thailand peaked in 1995 and has since declined. The country’s aggressive prevention policies extended beyond scaling-up condom promotion to include syringe access, testing, and treatment. But there is no question that the 100% condom program had an impact.
Condom Double Standards
The standard for success of condoms is that one be used every time a person has sex—complete and consistent use. Using condoms during less than every sex act is generally considered a failure. But only condoms are held to a standard of perfect protection. Other prevention technologies, including vaccines, microbicides, and TasP are deemed successful with 40% protection. Male circumcision is considered a success because it can permanently cut HIV transmission in half. We are elated when a vaginal microbicide reduces HIV infections by 35% and thrilled when PrEP reduced HIV infections by 45%. No one expects any HIV prevention technology other than condoms to completely protect against HIV. For example, the FDA has suggested that condom packages include the following statement, “when used correctly and every time you have sex, latex condoms greatly reduce, but do not eliminate the risk of catching or spreading HIV, the virus that causes AIDS.”
Interventions that demand 100% condom use are set up to fail. On the other hand, interventions that aspire to increase condom use beyond some critical level, say 50% protection, are realistic. Several behavioral interventions have demonstrated meaningful increases in condom use. In one trial, Gina Wingood and her colleagues at Emory University reported that more than twice as many women who received a group prevention intervention reported consistent condom use than women in a control condition 1 year later [83]. However considerable protection was afforded to women who did not use condoms every time they had sex; a mean of 76% of intercourse occasions were condom protected among women in the intervention group compared to a mean of 54% for the comparison group. Tom Patterson at the University of California at San Diego reported similar findings from an intervention for female sex workers in Mexico, with average condom use increasing from 56 to 83% of intercourse occasions protected and increased condom use coincided with a 40% decline in STI. Even when inconsistent or incomplete, condom use translates to greater protection, usually exceeding the typically aspired level of 35% risk reduction.
Where Have All the Condoms Gone?
Condoms are the frontline defense against HIV infection. In 1995 there were over 450 million condoms sold in the USA. In 2010, the global condom market was worth nearly $4 billion and is expected to exceed $6 billion by 2015. And yet the demand outpaces the supply. With 16 million sexually active men in South Africa, the 450 million condoms distributed each year amounts to about 28 condoms per man. Condom shortages are becoming frighteningly common in many developing countries, especially those with the greatest HIV prevalence. Non-governmental organizations in China started providing free condoms to men who have sex with men after homosexuality was decriminalized in 1997. Nevertheless, over 16% of men who have sex with men in China state that condoms are unavailable [73].
According to the United Nations Population Fund, condom supplies have not met demand in developing countries since 1996. In 2005, at least 13.1 billion condoms were needed to reduce the spread of HIV in developing countries and yet only 2.3 billion were donated in 2005 and 3.4 billion in 2007. On average, African countries receive about ten condoms per man each year, whereas developing countries outside of Africa receive as few as one condom per man. Throughout Africa, studies of venues where people meet sex partners show that fewer than half have condoms available [84].
Shortages of female condoms are also common. International shipments of female condoms grew from 1.1 million in 2003 to over 14 million in 2009. The USA is a major donor of female condoms to developing countries providing 40% of female condoms sent to developing countries. Yet, female condoms only account for 3% of US condom shipments. Although the demand for female condoms varies, news reports suggest shortages in high-HIV prevalence countries [85]. It is challenging enough to get people to use condoms and short supplies are not helping. Given the cost differentials, condom shortages paint a bleak picture for TasP with much more dire consequences.
Female Condoms
Gender-power differentials in sexual relationships place women at-risk for HIV and were at the core of developing the female condom. Often described as a vaginal liner, there are a variety of such products available. Some female condoms have an internal framework of sponges that help anchor the lining in place. Other variations use panties to hold a replaceable liner in place. Perhaps the most elaborate model consists of a polyurethane pouch that is packaged inside a film capsule inserted in the vagina. The capsule dissolves, leaving four small foam forms that serve as anchors on the outside of a pouch. The idea behind all female condoms is to shift the initiation and a great degree of control for condom use from men to women. Female condoms require a minimal amount of cooperation from male sex partners [86].
The Female Health Company produces the most familiar female condom. Indeed, this product has been branded “The Female Condom” and it has almost universally been the subject of research. First approved by the FDA in 1993 as a contraceptive, the female condom soon demonstrated efficacy for preventing STI, including HIV. Female condom effectiveness research mirrors that of male condoms. Studies testing the vagina for post-coital markers show traces of semen in 17% of female condom users compared to 14% for male condoms. Female condoms break and tear at lower rates than male condoms, failing approximately 1% of the time. Female condom use reduces the probability of HIV transmission by as much as 97% [87]. To help manage the cost of female condoms, there are instructions for cleaning and reuse up to five times. However, the female condom is not without complaints including cost, which is typically between 35¢ and 55¢, compared to the 3¢ for male condoms. Women also complain about insertion difficulties and crinkling noises during sex. To address these concerns, there is a second generation of less expensive and quieter synthetic latex female condoms. Released in 2009, the new female condom revitalized efforts to promote its use.
With high expectations that it would revolutionize contraception and STI prevention, female condoms have generated considerable interest and discussion. The female condom is mostly acceptable to both women and men. However, women often use female condoms with just one sex partner. There is also evidence that the female condom is used mostly out of curiosity. Women who are already infected with HIV demonstrate greater use than women at-risk for HIV infection. Negative attitudes toward female condoms are more common among women who have not yet used them [87]. For example, 82% of women living with HIV who have never used a female condom do not believe they feel better than male condoms and 54% say the female condom is difficult to use. Negative attitudes may be hard to change if they keep women from even trying female condoms.
Although the female condom is intended to shift power dynamics in sexual decisions, it does not appear that they have succeeded. A challenge to female condom use is once again resistance from male partners. Male partners’ reactions to the female condom predict their use [87]. Many women do not choose to use female condoms because they fear negative reactions and objections of their male partners. Women may also not want to diminish the sex roles of men. Women who initiate female condom use can experience the same risks for adverse reactions and violence that they have experienced when suggesting their partners use male condoms [88].
For women who do try female condoms, they may replace male condoms. Product substitution in this case would have no impact on protection given the nearly equal preventive value of male and female condoms. However, there is evidence that the female condom is used in situations where male condom use would not occur, and therefore yielding a net protective benefit [87]. Also, women are not the only ones using female condoms, with some men using the “female condom” with same sex anal intercourse partners [89].
With high-acceptability and appeal for the female condom, it is surprising they are not in greater demand. An FDA study in 2002, nearly a decade after the female condom was approved, showed less than 2% of women in the USA had ever used a female condom. In 2008, a British study found that only 1% of women had used a female condom. In a study of HIV positive women, my research team found that despite generally positive attitudes toward female condoms, only 16% of women had used one, and only 6% used them as much as they used male condoms [90]. Aggressive social marketing campaigns can increase female condom use. In Zimbabwe, for example, female condom use increased from 400,000 to more than two million in 2008. Zimbabwe had been the site of a multifaceted program aimed to increase female condom use across all sectors of women [91]. For context, UNAIDS reported in 2009 more than 50 million women used female condoms worldwide.
The low uptake of female condoms is likely the result of multiple factors, including a lack of interest in long-term use. Such was our experience in South African STI clinics, where nurses complained that they could not access the female condom because of their cost. We started bringing the clinic suitcases of female condoms, usually a thousand at a time. A few years later we noticed that the clinic had a stockpile of female condoms. Supplies ramped up and demand dropped off. Ultimately, the nurses asked us to stop bringing them. It turns out that women expressed interest in the female condom, took some with them and did not return for more. The female condom intrigued women, but their use was not sustained. It would seem that female condom uptake is driven by a novelty effect.
Interventions designed to promote female condoms typically train women in their use. However, these interventions have also had disappointing results. My research team tested the effects of a 3-h workshop designed to educate women about female condoms, motivate women to use them, and build behavioral skills for bringing female condoms into sexual relationships [92]. The results showed few women used female condoms after initially trying them. It was rare for women to request more free female condoms after the intervention. In a more recent study, Theresa Hoke and her colleagues tested an intervention for female sex workers in Madagascar [93]. A total of 901 women were randomized to either receive peer education only or peer education supplemented with individual clinic-based counseling to increase male and female condom use. Results showed that there were no significant differences between conditions in male or female condom use and there were no differences between groups in aggregated STI prevalence.
HIV Antibody Testing
HIV testing is a medical diagnostic test, not too different from cholesterol screening and mammography. In preventive medicine, diagnostic screening is aimed toward detecting disease and, when disease is detected, providing medical interventions. Just like other diagnostics, the goal of HIV testing is therefore to detect infection. Early detection increases access to medical care during critical periods of disease progression. There is also evidence that testing HIV positive has a preventive benefit. As many as half of HIV-infected people in the USA are believed to be unaware of their HIV status and are therefore unknowingly spreading the virus. The HIV transmission rate for individuals who know they are HIV positive is between 1.7 and 2.4%, whereas the rate for HIV positive persons unaware of their infection is 8.8–10.8%. HIV-infected persons who do not know their HIV status account for between 54 and 70% of new HIV infections; conversely persons who know they are infected accounted for 30–46% of infections [94]. A significant minority of HIV-infected people who transmit HIV to drug using and sex partners is the focus of TasP. In contrast, there is no apparent preventive value of HIV testing for uninfected persons, unless the testing is accompanied by a risk reduction intervention.
Diagnostic Testing Is Not a Prevention Strategy
HIV testing itself is not a prevention strategy for uninfected persons. Testing HIV negative does not signal the need for risk reduction any more than low cholesterol tests lead to dietary changes or negative mammograms increase breast self-examination. Nevertheless, policy makers have been led to believe that HIV testing is a prevention strategy. More than half of the CDC’s HIV prevention budget is dedicated to HIV testing, and that proportion is growing. Figure 2.4 shows the proportional allocation of CDC’s annual HIV prevention budget in 2007, illustrating the significant increase in resources dedicated to HIV testing. As shown in Fig. 2.5 the CDC increased its funding for HIV testing in 2010 from 31% of its annual budget to 53%, which included an expansion of $143 million for new testing initiatives. At the same time, CDC removed provisions for requiring risk reduction counseling with testing, essentially gutting its potential preventive benefits.
In the early years of the HIV epidemic, testing was coupled with risk reduction counseling. Beginning in 1985, the newly developed HIV antibody test was used to screen and protect blood supplies, which all but eliminated transfusion-related HIV infections. By 1987 HIV testing was recognized as an opportunity for risk reduction counseling. The CDC established standards of care for conducting client-centered counseling in conjunction with HIV testing. Client-centered counseling in the context of testing is efficient, requiring less than 30-min of pretest and posttest counseling. Historically, risk reduction counseling was an integral part of testing, but not anymore.
Remembering Project Respect
In 1998 the CDC conducted a study to definitively answer the question, “does HIV testing and counseling reduce risks for HIV infection?” At that time behavioral interventions were still held to a standard where impact on STI would be considered compelling evidence for efficacy. Project Respect is among the most rigorously controlled HIV prevention intervention trials ever conducted. There were three main conditions to which STI clinic patients were randomized. Heterosexual men and women were tested for HIV and either received (a) two 20-min sessions of risk reduction counseling, one before and one after HIV testing that assessed personal risks for HIV, identified barriers to behavior change, developed an achievable risk reduction plan, and support patients to reduce their risks, (b) four sessions of enhanced counseling that concentrated on skills for consistent condom use and refusing to have sex without condoms; or (c) didactic prevention messages such as “be sure to use a condom,” representing a minimal approach to HIV prevention. The didactic message condition included a subsample that was not assessed as often as other study conditions to examine whether the assessments themselves had an impact on behavior.
The results of Project Respect were clear. Examining the clinical records of the participating STI clinics over a year after counseling showed that 12% of patients who received the two-session counseling and 11.5% of those in the four-session counseling condition had contracted a new STI. These rates were not different from each other, but both were significantly lower than the 14.6% new infections observed in the didactic message condition (see Fig. 2.6). The greatest degree of reductions in STI were observed in the sixth month after counseling, where there were 30% fewer STI in the counseling condition than the didactic messages condition [21].
Project Respect established a new standard for HIV prevention. Many have considered the two-session counseling and testing intervention as the standard of care. David Holtgrave at Johns Hopkins University has pointed out that the CDC’s press release announcing the Project Respect outcomes set the stage for its brand of client-centered counseling to become the standard of care, stating:
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“This study showed that it’s not how much you talk to people about HIV prevention that matters most—but how you talk to them…”
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“According to CDC, the brief sessions used in this study…are feasible to implement in busy health care settings”
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“In this study, the approach was implemented with existing clinic staff, in not much more time than that required for didactic messages, and cost only eight additional dollars per client to implement”
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“Far too often, prevention programs found to be ideal in research are too difficult and expensive to implement in the real world, with this program, the ideal can be real, with few additional resources”
It seemed then that the CDC was convinced that HIV testing and counseling would prevent infections. Since 1998, new interventions are typically tested against the Project Respect testing and counseling protocol. And yet today, Project Respect is not the standard of care in practice. It is bizarre that the CDC, after great expense and effort to conduct the trial in the first place, removed requirements that HIV testing include risk reduction counseling. The CDC has reduced what may be the most effective HIV prevention intervention they had to a diagnostic test. This decision tells us much about how the highest levels of CDC policy makers view behavioral interventions. If you consider Project Respect a vision of the future, a true integration of a behavioral intervention (risk reduction counseling) with a biomedical technology (HIV testing), the implications of dismantling HIV counseling and testing does not bode well for the future of TasP.
The Death of Client-Centered Counseling
Table 2.1 shows the evolution of HIV testing and counseling in past generations of the CDC’s HIV testing guidelines [95]. In 2006 the CDC revised again its guidelines for HIV testing in health care settings, essentially delinking risk reduction counseling from testing. The new CDC guidelines have “acknowledged that prevention counseling is desirable for all persons at-risk for HIV but recognized that such counseling might not be appropriate or feasible in all settings.” The guidelines explicitly state that the new approach does not modify standards for nonclinical settings where risk reduction counseling is less likely, such as street outreach, bath houses, festivals, and malls. Rather than maintaining a policy to improve the feasibility of risk reduction counseling, the CDC abandoned prevention counseling in health care settings, removing the hope for a preventive benefit of HIV testing beyond detecting persons already infected. The new policy specifically states:
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HIV screening is recommended for patients in all health care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
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Persons at high risk for HIV infection should be screened for HIV at least annually.
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Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
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Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health care settings.
The CDC’s rationale behind the policy change was based on two flawed lines of reasoning. First, the 2006 Guidelines state “Prevention strategies that incorporate universal HIV screening have been highly effective.” However, the two cases offered to make this point are universal screening of the blood supply which has “nearly eliminated transfusion-associated HIV infection in the United States” and routine testing of pregnant women for preventing perinatal HIV transmission. Both examples speak to the value of testing as a diagnostic screening linked to broader prevention strategies—removing contaminated blood from the supply chain and administering antiretroviral medications to prevent mother-to-child transmission. In their guidelines, the CDC does not offer any evidence that universal HIV testing itself is an effective prevention strategy.
The second line of reasoning for abandoning prevention counseling with testing stems from what the CDC views as the questionable efficacy of risk reduction counseling. Specifically, the CDC states in their rationale for the new guidelines:
The benefit of providing prevention counseling in conjunction with HIV testing is less clear. HIV counseling with testing has been demonstrated to be an effective intervention for HIV-infected participants, who increased their safer behaviors and decreased their risk behaviors; HIV counseling and testing as implemented in the studies had little effect on HIV-negative participants. However, randomized controlled trials have demonstrated that the nature and duration of prevention counseling might influence its effectiveness. Carefully controlled, theory-based prevention counseling in STD clinics has helped HIV-negative participants reduce their risk behaviors compared with participants who received only a didactic prevention message from health-care providers. A more intensive intervention among HIV-negative MSM at high risk, consisting of ten theory-based individual counseling sessions followed by maintenance sessions every 3 months, resulted in reductions in unprotected sex with partners who were HIV infected or of unknown status, compared with MSM who received structured prevention counseling only twice yearly.
Thus, the CDC’s logic goes something like this: risk reduction counseling can be effective but has not been implemented according to standards and is therefore not effective. Concluding that counseling and testing failed to reduce risk was primarily based on a dated meta-analysis of HIV testing and counseling studies. Lance Weinhardt and his colleagues reviewed studies that had evaluated the impact of HIV testing and counseling on subsequent risk behavior. They found that people who test HIV positive do reduce their risk behaviors after receiving test results, but the reduction is not universal and is often not sustained. More to the point, people who test HIV negative show no evidence of reducing their risk. However, Weinhardt et al. never suggested that counseling and testing is ineffective for HIV prevention. To the contrary, they pointed to inadequate implementation and operations, all of which occurred prior to Project Respect, as the likely explanation of the poor outcomes. They concluded:
HIV-CT (counseling and testing), at least as it was implemented in the studies reviewed, does not appear to be an effective intervention for the primary prevention of HIV infection. HIV-negative individuals did not reduce their risk behavior relative to untested participants, after HIV-CT. However, because inadequate attention has been paid to the psychological and social contexts of testing, the theoretical grounding of counseling, and the type and amount of counseling provided, a closer examination of these factors may reveal that HIV-CT is effective with HIV negative individuals under some circumstances.
It is well established by the CDC itself through Project Respect that risk reduction can be effective when it adheres to the principles of client-centered counseling. But the CDC never seriously implemented client-centered counseling as a standard of care in public or private health services. Resources have never been adequately allocated for training, quality assurance, or monitoring of risk reduction counseling. The didactic message condition in Project Respect is more consistent with counseling people currently receive with HIV testing. In fact, today the CDC has de-emphasized counseling to the point where most testing does not include hardly any prevention measures for those who test HIV negative.
In the 2006 HIV Testing Guidelines, the CDC is also referring to Project Explore as offering limited evidence of efficacy for risk reduction counseling. The CDC does not, however, acknowledge that the ten sessions of Project Explore reduced HIV incidence by 38% over 12 months. Ironically, the control condition in Project Explore was Project Respect client-centered counseling delivered every 6 months for the duration of the study, effectively equalizing the two conditions over the long term.
The CDC’s failure to exploit the prevention opportunities offered by HIV testing has not gone unnoticed. Even within the CDC itself, the Division of STD Prevention’s 2006 Treatment Guidelines refute the clinical testing guidelines—which actually include public health clinics, community clinics, and primary care settings—the very places where STDs are treated! The 2006 STI Treatment Guidelines state the following about HIV prevention counseling:
Prevention counseling does not need to be explicitly linked to the HIV-testing process. However, some patients might be more likely to think about HIV and consider their risks when undergoing an HIV test. HIV testing might present an ideal opportunity to provide or arrange for prevention counseling to assist with behavior changes that can reduce risk for acquiring HIV infection. Prevention counseling should be offered and encouraged in all health-care facilities serving patients at high risk and in those (e.g., STD clinics) where information on HIV-risk behaviors is routinely elicited.
Delinking risk reduction counseling from HIV testing has also drawn criticism from leading prevention scientists. David Holtgrave has argued that the preventive value of HIV testing and counseling are intertwined. He notes that HIV testing creates a context for behavior change and counseling provides the tools for change. Holtgrave, a former Director of the Division of HIV/AIDS Prevention at the CDC, draws the following conclusion:
The CDC has recently expressed concern that quality of counseling typically associated with HIV testing may be substandard in some settings and that it is therefore of little value. However, this means that we have a choice of whether to dismiss counseling or—as many states and localities have done contractually and in program guidelines—to raise its quality to the standard of client-centered counseling, which, according to the CDC, is effective, efficient, and practical in clinical settings. Aspiring to a consistent, client-centered standard of counseling is to be preferred. To do less could be construed as a negligent or harmful act, because withholding an intervention that can reduce incident STDs by 20–30% appears to violate a basic principle of biomedical ethics.
The question of who in the health care system can help us meet client-centered counseling standards, particularly if clinicians do not have the time must be explored. We need to be creative. Non-clinicians in the health care system could provide such counseling. Also, there are opportunities for community-based organizations to have much more active roles in counseling and testing, perhaps even in partnership with clinic-based health care professionals to ensure the availability of client-centered counseling and testing. In some respects, these agencies may be in a better position than clinicians, who may be too busy or too inexperienced in behavioral counseling, to develop and deliver counseling services at a client-centered standard [96].
The kind of creative thinking that Holtgrave mentions will come from clinical service providers. In Arizona, for example, the Rio Community Health Center developed innovative patient support services that deliver a broad range of evidence-based prevention programs that are integrated with clinical care [97]. These services are not seen as an added burden but rather as part of usual care. In South Africa, STI clinics with significant patient loads under extremely limited resources utilize specialized counselors to deliver HIV testing and counseling. I know from personal experience that South Africans receive counseling with testing that is in keeping with Project Respect’s client-centered approach. Thus, delivering risk reduction counseling with HIV testing can occur when prevention policy makers are committed to prevention.
New Testing Technologies
Advances in HIV testing technologies have expanded services beyond traditional care settings. Rapid HIV tests deliver results in as little as 10 min. People no longer fall through the cracks between collecting a blood specimen and delivering test results. Rapid tests can be performed on saliva samples, making the test quick, noninvasive, and free of biohazards. Noninvasive rapid HIV tests open the door to point of contact HIV testing; bringing testing to emergency rooms, night clubs, festivals, bath houses, and street corners. The advent of rapid HIV tests raised immediate questions about whether effective risk reduction counseling could be delivered with results received within minutes.
To answer this question the CDC conducted Project Respect-2. The aim of this study was to test whether the potent effects of counseling and testing observed in Project Respect could be replicated in the rapid test context. The CDC’s Carol Metcalf and Tom Peterman headed up the trial [98]. They randomized patients in US STI clinics to either receive standard 2-week or rapid testing and counseling. The standard condition was essentially the same intervention protocol delivered in the Project Respect study, consisting of pretest counseling, specimen collection, a waiting period, test result notification, and 20-min of client-centered counseling. The rapid testing condition also delivered pretest counseling, but the notification and counseling results were delivered in less than an hour. The counseling content was essentially the same for the two groups, with only slight modifications to meet the formatting of rapid testing. In both conditions, the counseling was personalized and focused on developing a risk reduction plan. Achieving one goal of rapid testing, all of the patients in the rapid testing and counseling condition received risk reduction counseling, whereas only 69% of patients in the 2-week standard condition received their results and posttest counseling.
Results showed that after 1 year of follow-up there was little difference between conditions for incidence of new STI; between 17 and 19% of participants were diagnosed with a new STI, higher than in the original Project Respect, which demonstrated 12% incidence. There was also some evidence that rapid test counseling may be slightly less effective in reducing risk than the standard test. In particular, they found rapid testing and counseling less effective for men than standard testing and counseling, but not so for women. Nevertheless, Project Respect-2 showed equivalent risk reduction outcomes for conducting standard or rapid testing with HIV risk reduction counseling.
Rapid tests have also opened the door to home testing. In 1996 the FDA approved home HIV testing. However, these tests were not truly conducted at home in the same way as performing an early pregnancy test. Rather, individuals purchased a home HIV test kit, collected a drop of fingertip blood and mailed it to the home test company for analysis. Results were delivered a couple weeks later in a phone counseling session for people who tested HIV positive and in an audio message for those who tested HIV negative. Today, HIV tests have been approved for over the counter sale, bringing the entire testing process into the home without any counseling. Home testing has the advantages of privacy, anonymity, low cost, and convenience. Consistent with the CDC’s standards for HIV testing, counseling is simply not a consideration.
Home tests may also be used as an impromptu prevention strategy by bringing the test into the context of sexual decision-making. The test can be used to determine whether partners need to use condoms. Individuals who select sex partners based on their perceived or believed HIV status (serosorting) may be interested in this strategy. Ana Ventuneac and Alex Carballo-Dieguez examined whether using home tests to screen sex partners may reduce HIV risks. Mathematical modeling found that in places of higher HIV prevalence, home testing could lower the risk for HIV infection even when considering the uncertainty of unprotected sex during acute infection when the results can be false negative. As population HIV incidence increases, and therefore so too does the likelihood of a partner being acutely infected, the impact of home testing for screening sex partners decreases. Thus, when compared with inconsistent condom use, home testing in high-prevalence communities can reduce risks, but the converse is true in places with high-HIV incidence. Home screening sex partners can actually increase risks for HIV infection because testing will replace condoms in a context where users just won’t know the epidemiological dynamics in their community.
A thorn in the side of HIV testing is the period between infection and immune response, a time when antibody tests are vulnerable to false-negative results. It is also during this time when newly infected persons are highly infectious and likely engaging in high-risk behaviors. Although early discussions of acute infection suggested that a large proportion of HIV transmission events occur during these few weeks, those ideas have not been supported by research. However, there is no question that individuals who are told they are HIV negative but are actually acutely infected have the potential to infect multiple partners.
A public health approach to acute infection involves reanalyzing blood samples that have tested HIV antibody negative to determine whether the test was conducted during the window period before immune response. Specimens collected as part of routine screening are subjected to an algorithm that tests and retests the specimens using sensitive and less-sensitive HIV testing and RNA detection procedures. Positive results signal a systematic partitioning of the specimen pool until, ultimately, the positive case is detected. What follows is a visit from a public health worker to the infected person. Mike Cohen and his colleagues at the University of North Carolina demonstrated the potential impact of public health detection of acute HIV infection [99]. In a study of 109,250 persons at risk for HIV infection who had been tested, there were 606 HIV-positive results. Of those, 107 did not test HIV antibody positive and were identified with the use of sensitive–less-sensitive enzyme immunoassays. In addition, 23 persons were found acutely infected only with the use of RNA testing. Although a small number of positive persons were detected, the number of new infections potentially averted could be enormous given that these highly infectious individuals thought that they were uninfected.
An alternative approach to detecting acute infection relies on clinical care. In this case providers are trained to conduct risk assessments with patients presenting with symptoms of acute viral infection. The basis for a clinical approach to detecting acute infection lies in assuming that some number of people newly infected with HIV will seek clinical services for fever, swollen lymph glands, loss of appetite, fatigue, headache, malaise, and rash that can occur within the first few weeks of infection. Lisa Hightow-Weidman at the University of North Carolina found that 75% of persons with acute HIV infection experience symptoms consistent with acute retroviral syndrome [100]. Among those with symptoms, 83% sought medical care but only 15% were appropriately diagnosed at their initial medical visit. Recognizing the symptoms as potentially acute HIV infection can trigger a risk assessment and HIV testing. Current HIV tests that combine antibody and antigen assays improve the sensitivity and specificity of detecting acute infection.
Lessons (Hopefully) Learned
Recognizing that condoms, needles, and antibody tests are biomedical technologies that have morphed into behavioral interventions provides a history to consider when scaling-up TasP. It is impossible to know how many infections have been averted by these early HIV prevention technologies. Unfortunately, their full prevention potential has never been realized. Let’s consider some challenges and barriers that can serve as lessons to learn as we scale-up TasP.
Biomedical Technologies Morph into Behavioral Interventions
All technology ultimately depends on humans for use. In public health, consider vaccines. An efficacious vaccine is useless without access, acceptance, and uptake. The H1N1 flu vaccine in 2009 offers one example. Coverage in the US and Europe was far lower than needed to achieve community-level protection. Confusing communications, misinformation, and public perceptions kept H1N1 vaccine acceptance and uptake low. The same can be said for the scale-up of human papillomavirus (HPV) vaccination, which is safe and nearly 100% effective. In 2010 the CDC reported that only 25% of adolescents 13–17 years old received at least one dose of the vaccine and only 11% reported receiving all three recommended doses. Condoms, needles, HIV testing, and now HIV treatments will only be as effective in practice as their social, cultural, and behavioral dimensions allow. Planning the implementation of TasP should look back on successes and failures of preceding biomedical prevention technologies.
Shifting Prevention Away from Condoms Toward TasP Will Increase STI Risks
Offering any alternative will reduce condom use. People want to feel safe and they do not want to use condoms. TasP offers this alternative. It is foolish to think that a man who undergoes circumcision to reduce his risk for HIV will continue to use condoms at the same rate he had before he was circumcised. Risk compensation is not an aberration; it is a consequence of human decision-making. When it comes to TasP, contracting an STI increases infectiousness, countering the protective mechanism of TasP. Suggesting that people should continue to use condoms when employing TasP is a doomed message given that the motivation behind TasP is to do away with condoms. To succeed, TasP must include a routinized and aggressive approach to screening and treating STI.
Medication Adherence Will Be Different for Prevention than It Is for Therapeutics
Asymptomatic patients will not experience overt benefits of treatment. The long-term benefits of early treatment are preventive, and will therefore face the same challenges as other forms of preventive health care. Successful prevention means that something does not happen. We must be better at communicating the expected outcomes from the preventive use of treatments. We already tell patients that if they lapse in their use of antiretroviral medications they run the risk of treatment resistance. This same mindset needs to be part of TasP.
Social Support Will Bolster the Impact of TasP
A key to the success of TasP will be engagement and retention to care. Supportive networks have proven effective in bolstering prevention with injection drug users, men who have sex with men, and women. There are now established social network methodologies that should be exploited when implementing TasP. Jeff Kelly at the Medical College of Wisconsin, a pioneer in network driven prevention interventions [101–103], is working toward adapting his successful models for treatment engagement and retention. Carl Latkin at Johns Hopkins University is also adapting his network-level interventions for people living with HIV/AIDS. These approaches will be important to the long-term success of TasP.
TasP Should Not Be Linked to HIV Testing
HIV testing has an identity problem. Testing had been an instrument of prevention, but now testing is solely a diagnostic tool. Connecting TasP to testing in a so-called “test and treat” strategy may place it in politically charged currents that could doom treatments to the same prevention fate as client centered counseling.
Stigma Remains a Significant Barrier to Care and Will Undermine TasP
There is a socio-cultural AIDS epidemic that runs in parallel to the epidemics of HIV and AIDS. Stephen Morin of the University of California at San Francisco in 1988 first set forth this concept of parallel epidemics [104]. Morin described “the social, cultural, economic, and political reaction to the HIV and AIDS epidemics.” He observed, “This third epidemic of reaction, which is just beginning, is as much a part of the pathology of AIDS as the virus itself.” Despite our long knowing that AIDS stigma degrades all of our efforts to prevent, test, and treat HIV there is a virtual dearth of stigma interventions. Most AIDS stigma research still relies on the work of Erving Goffman from 1963. Our failure to attract stigma researchers into the field has created a vacuum of knowledge on what could be the single most important social aspect of AIDS.
A Harm Reduction Perspective Should Frame TasP
We cannot expect 100% protection from any prevention technology, including TasP. If we lead people to believe that TasP is any more protective than it can be, we will have set TasP up to fail. People who use condoms half the time are told that they are not protected. This absolutist message has undermined prevention. If you miss taking the pill, should you just as well consider not using TasP at all? Communicating partial protection is critical, and yet how best to do so is unknown.
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Kalichman, S.C. (2013). Reflecting on Prevention Technologies. In: HIV Treatments as Prevention (TasP). SpringerBriefs in Public Health. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5119-8_2
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