High Acceptability of a Vaginal Ring Intended as a Microbicide Delivery Method for HIV Prevention in African Women
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- van der Straten, A., Montgomery, E.T., Cheng, H. et al. AIDS Behav (2012) 16: 1775. doi:10.1007/s10461-012-0215-0
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Vaginal rings (VRs) are new methods for continuous delivery of microbicides. This is the first study to quantitatively and qualitatively explore the acceptability of rings in Africa: 157 HIV-negative, sexually active women aged 18–35 used a placebo silicone elastomer ring for 12 weeks. They completed product acceptability questionnaires every 4 weeks. We conducted 6 exit focus group discussions with a subset of 48 women and 19 in-depth interviews with male partners. Retention in the study was high (97 %). Initial insertion at the clinic was successful on first attempt for 81 % of participants. Most women were comfortable using the ring, and very few (≤2 %) could feel it during daily activities or had ring-related physical or emotional problems. In the qualitative interviews many participants reported that they initially had concerns about using the ring. However, only a minority of women actually reported concerns with the ring during the study. The most frequent concern was that the ring would get lost inside the body (20 %), and this was significantly correlated with study site, frequently thinking about the ring and reporting that the ring was not very easy to remove. Qualitative data suggest that informants grew to like the ring because it felt securely placed, was unnoticeable during daily activities, and felt “normal” during sex. The ring appeared to be highly acceptable for women and men. Initial concerns with this novel method suggest a need for enhanced product counseling when VRs are introduced.
KeywordsVaginal ringMicrobicideHIV/STI preventionAcceptabilityAfrica
As women continue to be disproportionately affected by HIV in Africa, the search for novel, simple, acceptable female-initiated methods remains an important research priority . Vaginal rings (VRs) are new methods for continuous delivery of microbicides for HIV prevention. Initial safety and pharmacokinetic studies have shown that rings are safe and efficient for the sustained delivery of antiretroviral drugs to the vaginal mucosa [2–4]. They offer several advantages over the applicator and gel approach, such as continuous use for one to several months , discreetness, and coital independence. Thus, rings could potentially solve some of the current problems with acceptability, adherence, and effectiveness of single dose, coitally dependent, or daily microbicidal gel [5, 6].
In preparation for the introduction of the ring, it is essential to understand user and sexual partner experiences, product characteristics that are liked and disliked, and user skills levels needed for correct and consistent use. Currently, VRs are primarily used for contraception and treatment of symptoms related to menopause. The NuvaRing®, a combined hormonal contraceptive ring, has regulatory approval Worldwide; however, its availability is limited or nonexistent in Africa . Acceptability studies from Europe and North America have reported high levels of user and partner acceptability for NuvaRing®, with acceptability increasing with duration of use [8–10]. In one study, continuation rates with the ring were higher than for oral contraceptives, and acceptability of the ring was linked to sexual satisfaction . In Latin America, a progesterone VR has been approved for lactating women and has also shown a high acceptability level for reasons such as comfort, ease of use, and female control .
Despite these encouraging results, we can expect some problems or challenges in using VRs for HIV prevention based on other studies of female-initiated vaginal devices and experience with the contraceptive ring. For example, in a three-methods comparison study among Brazilian couples, women preferred the VR over an applicator or a diaphragm for potential microbicide delivery; however, more male partners preferred the applicator over the ring, possibly because of the lubrication provided by the gel . In that same study, 14 % of women reported difficulties with insertion or removal of the ring, and 11 % reported incorrect use. In a comparative study between NuvaRing® and oral contraceptives in the United States, fewer women thought that the ring, compared with the pill, did not interfere with sex; and fewer partners liked the ring, although the ring’s overall acceptability was good (65 %) . In a European study, although sexual comfort was reportedly high, 15 % of women and 29 % of partners felt the ring during intercourse at least occasionally . In Kenya a hypothetical acceptability study of the ring was conducted among female sex workers and male clients. Overall, the ring was received enthusiastically; however, concerns were raised related to HIV-stigma, covert use, reproductive health safety, and vaginal hygiene linked to continuous use .
This study is the first to evaluate the safety, acceptability, and use of a placebo ring intended for microbicide delivery to women in an African setting [16, 17]. Here we examined quantitatively and qualitatively the acceptability of the ring used for 12 weeks, in Tanzania and South Africa.
Study Sample, Design, and Procedures
The IPM 011 study was a randomized trial of the safety and acceptability of a silicone elastomer VR (“the ring”) with no active ingredient (“placebo”). The trial was conducted from April 2007 to March 2010 in four research centers in two countries: Durban, Johannesburg, and Cape Town in South Africa, and Moshi, Tanzania . To be eligible for participation in the study, women must have been aged 18–35, HIV-negative, healthy, sexually active (at least one vaginal sexual act per month in the past 3 months), not pregnant and using an effective contraceptive method. Women were recruited from the communities surrounding the research centers, including public venues frequented by women as well as health service providers (e.g., family planning service locations, public health clinics).
In a cross-over design, 170 women were randomized to wear the ring for 12 weeks, followed by a period of 12 weeks of non-use, or the reverse-order regimen. In total, 158 women received the ring. For the acceptability analysis reported here, the sample includes the 157 women (93.5 %), who also provided follow-up acceptability data.
At either enrollment or the cross-over visit, depending on group assignment, participants were taught how to insert and remove the ring using a translucent pelvic model. They then inserted the ring themselves at the clinic, and a study nurse verified correct placement. During the ring-use phase, participants were seen for four visits: at enrollment, and 4, 8, and 12 weeks (final visit) post-ring insertion. At each visit they completed a face-to-face behavioral interview that included questions on acceptability and experiences using the ring; they received a pelvic exam and were asked to remove the ring, wash it, and reinsert it under direct observation by a clinician. Women who were unable to insert or remove the ring themselves after three attempts were assisted by the clinician.
Prior to study exit, participants were asked whether they would like to be contacted for further participation in a focus group discussion (FGD), and whether they granted permission for study staff to contact their male partners for an interview. Male partners were contacted for participation only if their female partner had granted permission. Different qualitative methodologies were used for women and men, based on the practical experience of the research team: we have noted that discussion groups typically generate more lively conversations among women, including discussion of personal experiences, compared to one-on-one interviews. On the other hand, with men, we selected individual interviews as previous experience has shown that it is challenging to convene male FGD, because of work schedule and low motivation to join a discussion group.
Measures and Analysis
Conceptual framework components
Example of measures
Concerns and problems with the ring
Do you have concerns about the vaginal ring getting lost inside of you? (yes/no)
Did you experience any physical problems with the ring? (yes/no)
Product use experiences
How comfortable is the vaginal ring? (very comfortable to very uncomfortable)
How easy or difficult was it for you to insert the vaginal ring the last time you tried? (very easy to very difficult)
Does your main sexual partner know you are joining/have joined the vaginal ring study? (Yes/no/don’t know)
Partner’s support and influence
How important is it to you that your main sexual partner accepts the vaginal ring and agrees that you use it? (important, a little, not important)
Do you believe your main sexual partner might become angry with you if you used the vaginal ring without telling him? (yes/no/maybe)
Sexual encounter attributes
Non-interference with sex
Is it important for you that your main sexual partner doesn’t notice the vaginal ring during sex? (yes/no/maybe)
Product; relationship and sexual encounter attributes
Favorability and ranking of 12 different product characteristics
Which characteristic do you find the most favorable/unfavorable about the vaginal ring? (continuous use, efficacy against HIV, ring esthetics, getting lost in the body, female-controlled, concurrent use with a condom, covert use, non-interference with sex, sexual experience change for the woman or for the man, feeling the ring during sex, dislodgement during sex)
Qualitative assessments of ring acceptability were elicited through: (1) six exit FGDs with a subset of 48 women (mean: 8 women; range 5–11) at all four study sites; and (2) nineteen In-depth Interviews (IDIs) with male partners of female participants in Johannesburg and Moshi. No male partners were interviewed at the Cape Town and Durban sites owing to resource constraints.
Contingency tables were used to present descriptive data (frequency for categorical data; mean and/or median for continuous data). Change in acceptability variables across visits was assessed by generalized estimating equation (GEE) logistic regression models, to adjust for repeated measures over time. Exploration of the correlates of women’s concerns examined baseline demographic and behavioral variables, as well as time-dependent variables (use experience variables), using GEE logistic regression models, 95 % confidence intervals and χ2p-values for the univariate association between predictors of interest and outcome. Predictors significant at the p < 0.05 level, were retained for consideration in a multivariate logistic regression model where adjusted odds ratios and associated significance levels and confidence intervals were computed.
Acceptability findings from the quantitative and qualitative data analyses are presented thematically in accordance with the conceptual framework. The original three dimensions of acceptability are presented first: product attributes, relationship attributes/disclosure, and sexual encounter attributes; followed by the additional attributes of perceived efficacy that together contribute to overall acceptability and willingness to use the ring in the future.
Demographic and Sample Characteristics
Baseline characteristics of IPM 011 participants in the acceptability study (N = 157)
Mean: 27 (range: 18–35)
Has a main sex partner
Number of sex partners in past 3 months
Coital frequency with main partner in past 7 days
1 sex episode
2 or more sex episodes
Ring insertion attempts
Always used condoms in past 7 days with main partner (among those who had sex)
Previously participated in microbicide study
A (ring → no ring)
B (no ring → ring)
Partner knew about study
Prior to start of ring use
After ring use was initiated
Use of any vaginal productsa
Two female FGDs and 9 male IDIs were conducted in Johannesburg; 2 female FGDs and 10 male IDIs were conducted in Moshi; and 1 female FGD was conducted at the Cape Town and at the Durban sites. The qualitative subsample was very similar to the total study sample, except that more qualitative participants came from the Moshi site. Only nine Indian/Cape Colored participants were in the overall sample, and none were represented in the qualitative subsample (see companion paper by Montgomery et al. ).
Concerns and Experiences with the Ring
Concerns, experiences, and feelings about the ring
Final product use visit
Concerns about coming out
n = 154
n = 152
Concerns about getting lost inside
n = 154
n = 152
Physical problems with ring
n = 154
n = 151
Emotional problems with ring
n = 154
n = 152
Have views changed about the ring
n = 154
n = 152
Better than first thought
Worse than first thought
How often think about ring in past 7 days
n = 154
n = 152
Can feel ring during normal activities
n = 154
n = 152
How comfortable is the ring
n = 154
n = 152
Less than very comfortable
How easy to insert last time you tried
n = 153
n = 151
Less than very easy
How easy to remove last time you tried
n = 152
n = 152
Less than very easy
How often do you check if ring in place
n = 154
n = 152
1× per day or more
1× per week or more (but <1×/day)
At first follow-up, 26 % of women thought often or sometimes about the ring in the previous 7 days (Table 3). This proportion significantly decreased to 17 % at the final product use visit (OR = 0.58; 95 % CI 0.36–0.94, χ2 = 4.89, df = 1; p = 0.03). Few women reported feeling the ring often or sometimes during normal activities: 4 % at week 4 follow-up and only 1 % at the final product use visit, and one woman only reported this at all visits. Most women said the ring was very comfortable (~95 % across all visits). Only two women reported that it was less than very comfortable at all follow-up visits. The majority of women said that the ring was very easy to insert the last time they had tried, and this proportion increased somewhat from 89 % at the week 4 visit to 95 % at week 12 (OR = 2.06; 95 % CI 0.94–4.50, χ2 = 3.28, df = 1; p = 0.07). Similarly, most women (90 % across all visits) said it was very easy to remove, and only six participants said it was less than very easy to remove at all follow-up visits. Per study protocol, women were not provided advice about checking (or not) if the ring was in place. When asked about it, about half the women across all visits said they never checked to ensure that the ring was in place; however, at the week 4 visit, 20 % said that they checked once a day or more, and this (non-significantly) decreased to 16 % at the final product use visit (OR = 0.77; 95 % CI 0.51–1.16, χ2 = 1.67, df = 1; p = 0.2).
Correlates of concerns of the ring getting lost inside the body, GEE analysis
Demographic and Sexual Behavior Characteristics (Baseline)
Ever used male condom
Condom use in past 7 days with main partner
Not every time
Use of any vaginal products
A (ring → no ring)
B (no ring → ring)
Use experiences (concurrent FU)
Ever experienced physical or emotional problems with ring
How often think about ring
How easy to insert
Less than very easy
How easy to remove
Less than very easy
How often check if ring is in place
1× day or more
1× per week or more
…if something is artificial in your body, that thing, automatically, your body would kick it out. So that was my concern…that this thing is artificial and it is in her body, then it will kick it out—if not, won’t she have some sort of infection? (Male, Johannesburg)
There were also initial concerns about the ring coming out during sex:
I was thinking that we were going to stay three months without having sex, because I was thinking [it] is going to come out. But I said to myself let’s try and see if it [the ring] comes out. And it didn’t come out. (Female, Johannesburg)
Sometimes I became worried that it can happen that the ring gets lost inside me because I did not understand how it is inside. (Female, Durban)
So after they show us how our vagina looks like there is nothing that can pass to the other place where it supposes to be there…. There is this thing like a plastic and it is a structure of womb so this ring it sit exactly right to the mouth of the womb and it (the womb) has small mouth. (Female, Johannesburg)
I was thinking to what may happen if we had sex with the ring in [the] vagina as it may get lost inside forever… (Male, Moshi)
A variety of other initial concerns were also mentioned by women in the FGD, including concerns about potential discomfort; cleanliness; that they might feel the ring during their everyday activities; and that their male partners might feel it while they were having sex. Men were concerned that the ring might reduce sexual pleasure or that it might hurt their partners, or themselves: “I just thought it might disturb us or hurt us when we have sex” (Male, Johannesburg). One man said he was worried that the ring might prevent pregnancy. Other men wondered if their partners were hiding something from them, such as having another sexual partner or being HIV positive.
Most- and Least-liked Product Characteristics
At the final product use visit, after 12 weeks of use, the three characteristics that women ranked most favorably about the ring were (in order) that: (1) it “might someday be used to prevent HIV”; (2) “it does not interfere with ‘normal’ or ‘natural’ sex”; and (3) “that you must use a condom with the VR during the study”. The three least-favored characteristics were (in order) that (1) “it might get lost in the body”; (2) “it might come out during sex”; and (3) “it might change the feeling of sex for the male partner”.
In the exit FGDs and interviews, several women stated that the vaginal ring’s potential for HIV/sexually transmitted infection (STI) prevention was what attracted them to the ring: “The fact that it might be used to prevent HIV infection and other STIs to women, is why I liked it the most.” (Female, Moshi)
What attracts me about the ring is that it does not bring any difference during sexual intercourse; I feel normal as before starting using the ring. (Male, Moshi)
Those who said they were concerned that the ring might hurt their partner or get lost inside stopped worrying about these issues once they had experience with the ring and found that this was not the case, and as exemplified by several of the preceding quotes, everything was “normal”. This growing acceptability of the ring was highlighted by the comments of a few women and men who said they could feel the ring when it was first inserted, but over time stopped feeling the ring, and some even forgot about it completely.
I think it is alright because it protects her like it is going to prevent HIV for her. More especially when I think about rape, you see, so if it is always in her, it’s safe. (Male, Johannesburg)
Women did not express concern about wearing the ring every day when they were not having sex. Similarly, most of the men did not mind their partners wearing a ring when they were not having sex every day.
Ring Disclosure and Partner Support
…there are some days you will [be] having sex with your partner and he might touch something strange…he will then ask you what is inside…you might end up being beaten, until you show him what is inside. (Female, Moshi)
I have my husband…, so if I use a ring it’s him I am protecting myself against. That’s why I explained to him everything, and when I joined the study I told him everything. I told him I have joined the study, and the day I wore the ring before we had sex I showed the ring to him. I told him that in future the ring will have a prevention drug against HIV in it. He agreed with me and I had sex with him with the ring on. (Female, Moshi)
I didn’t say anything, and I thought when I tell him he will say horrible things, like [if] I insert things in my vagina that means I want to witch him, so he didn’t feel anything. The thing I was praying is not to come out during sex because if it happens he will tell his friends. (Female, Johannesburg)
I thought she didn’t trust me and she think I got diseases. But when she explain that it is a process of study, so even now I must help her so she can complete the study. (Male, Johannesburg)
On my side, she decided [on] using it without informing me as she wanted to make it a surprise—that’s why I say I just laughed, but to some other people, imagine when having sex and accidentally it [the ring] comes out while partner is not aware, I think things will be a disaster. So I think [it] is good that they inform their partners. (Male, Moshi)
You might be beaten and sent back to your parents because of the ring. Honestly it is good to use the ring without informing the partner [because] some men are troublesome. (Female, Moshi)
Sexual Encounter Attributes
You feel like your mind is telling you that you are pushing that ring or maybe this ring will do something—you know, for the first week you are not free. Psychologically you are not free and you are not relaxed because your mind is telling you something …. (Male, Johannesburg)
It was like more enjoyable because when he penetrates his penis inside me I felt like he is touching the ring, so it was more enjoyable. (Female, Johannesburg)
Several men also described an increase in sexual pleasure that they attributed to the ring. One man said: “It increased pleasure as it was making me feel the [vagina] tighter, thus, increasing the pleasure (Male, Moshi). Another man reported that his partner’s vagina was wetter, as a result of wearing the ring, and this made sex more pleasurable for both partners.
Willingness to Use in the Future and Efficacy Perception
At the final product use visit, all women said that they would be willing to use the ring if it were found to be effective (95 % CI 98–100 %), and 81 % (95 % CI 74–87 %) said they would use both condoms and a ring for sex, if recommended.
I am happy about the condom but if in the future we have [a] better thing like a ring, I will prefer to use the ring because it will [let] me control the ring, because[it] is something that women can control …without the man knowing. Other men don’t want to use[a] condom so if you have the ring you will know that you are protected even if he doesn’t want to use a condom. I think [a] ring will be better and I will use it most of the time. (Female, Johannesburg)
I prefer condom; it will be right for me because I am use to condom for now. M’kay, maybe I was not use to it [the ring], you see. (Male, Johannesburg)
Personally I think it won’t be good, because if it is proved that ring work they have to be used alone. [If] it will require to use with condom then we will know that the ring is not able to prevent HIV. (Male, Moshi)
This mixed-method study examined the acceptability of a placebo ring in Africa, for future delivery of a microbicide for female-initiated HIV prevention. Overwhelmingly, women found the ring easy and convenient to use, and male partners were mostly supportive of ring use. Discreetness, preservation of the natural feeling of sex, and continuous use were viewed as favorable attributes of this product. Several women and their partners had initial concerns about the product, prior to or when they started using the ring, such as fears of the ring coming out spontaneously during sex or getting lost in their bodies. Participants were also concerned that the ring would alter the feeling of sex, and some expressed safety or side effect concerns with the ring. However, these concerns were generally overcome through education and counseling at the clinic and through direct experience using the ring. One concern seem to persist about the ring “getting lost” in the body. Multivariable analyses suggested that there might be local cultural differences, or variability in the education/counseling that participants received at the clinics, that could lead to differing concerns about the ring “getting lost” in the body. This issue may also merit further attention in that concerns about a lost ring may not simply result from popular anatomical misconceptions: there are at least two reports in the medical literature of inadvertent bladder placement of the NuvaRing®, and this should be considered a potential rare complication in patients who have “lost” the ring . Other anecdotal reports of a lost ring following intercourse have been noted .
As initial fears dissipated, study participants grew to like the ring, and reported few problems using it. They liked having a continuous-use product that they did not have to remember to use and that could hypothetically allow for disease protection in unplanned situations, such as being overtaken by sexual desire, or rape. For men, their support of the VR was based on the positive experience they had while their partners were enrolled in the study. Most did not feel the ring during intercourse, it did not impact their sexual pleasure, and they did not experience any negative side effects from the device.
Interestingly, although the method was experienced as extremely discreet for women who wore it and for their partner, the same issues of relationship trust and disclosure emerged with the ring as with other female-initiated HIV prevention methods [19, 24, 25]. In theory, women may have the choice of whether or not to disclose ring use to their partner, but whether they actually can exercise their choice may depend on the specifics of their relationship and of their cultural context [26, 27].
Although several aspects of product acceptability and use may be measured effectively through structured questionnaires, it is important to use qualitative methods to explore acceptability issues in more depth. This allowed for a richer and more nuanced understanding of the product characteristics, as well as the social and behavioral issues that shaped acceptability and can possibly influence uptake and use in the future, if a ring with an active product is found to be effective against HIV. The addition of qualitative research in this study also provided a direct in-depth exploration of male partners’ views. Although concurrent use of ring and condoms appeared acceptable through survey questionnaires, qualitative data highlighted men’s and women’s reluctance to use two methods for HIV prevention. These are important considerations for the future development of educational messages to optimize individual level of protection, in a rapidly changing HIV prevention landscape. Newly identified topical and oral pre-exposure prophylactic methods thus far have been reported to only confer partial protection, and a key challenge will be to underscore the importance of using these novel biomedical tools (when available), in the context of a “comprehensive package of prevention methods” [6, 28].
As with other studies based on self-reported data, one important limitation here may have been courtesy bias. This bias may be stronger in structured questionnaires than during open-ended qualitative approaches, where expression of personal opinion is encouraged and discussion between participants may highlight a diversity of points of views, as exemplified by the contrasting views elicited by these two methodologies regarding participants’ willingness to use the ring and condoms concurrently. Also, per protocol, the ring was inserted, removed, cleaned and reinserted at the study visits. Participants’ living physical environment and socio-economic factors were not probed about and did not emerge spontaneously in the qualitative interviews, although these could be important influences on ring use and acceptability in ‘real life’. While menses and vaginal practices related to menses were associated with ring removals and non-adherence [22, 29], they did not emerge as barriers to ring acceptability in qualitative interviews. However, these topics were not systematically explored, and given their potential for interference with ring use, future studies should examine the relationship between menses, vaginal practices and ring acceptability and use. Also, the acceptability of placebo versus active rings may be different. However, recent data indicate excellent safety and high acceptability in a 12-week trial of the ring with the antiretroviral drug Dapivirine, in African women . Long term adherence and acceptability of the ring will be monitored in ongoing and upcoming phase III trials.
As discussed above, worries about the ring getting lost in the body emerged as a major concern in both qualitative and quantitative components of the study. Previous studies have also noted widespread anatomical misconceptions across a range of cultures, and local views of the female body may shape beliefs regarding how contraceptives, barrier methods, microbicides and devices may work or interfere with normal bodily functions [30, 31]. More qualitative research may help elucidate reasons for this concern with the ring, and, in future ring studies, a counseling curriculum should specifically address this issue, whether it is linked to local cultural beliefs or to user skills, including difficulties with ring removal. Detailed counseling and guidance about ring insertion/removal and expulsion were helpful here and should be provided in future studies, coupled with information sheets containing instructional diagrams to depict the appearance of the ring and guidance for its correct physical placement. These information sheets could also provide clear explanation on cleanliness and mechanism of action.
In summary, the ring is a novel female-initiated method, which is easy and convenient to use and appears highly promising for continuous topical release of ARV-based microbicides in the African context, particularly in light of disappointing results from two trials with daily use of microbicide gel or oral PrEP (VOICE and FEMPrEP). Though the ring can be used secretly, involving the male partner may facilitate uptake and use of the method. As with any innovation, careful education and counseling should be provided initially, to dispel concerns and fears that future users may have.
We would like to acknowledge the women who participated in this study, the IPM 011 study team, and to extend special thanks to the research sites’ clinical and social science teams in Moshi, Johannesburg, Durban, and Cape Town. This work was supported by the International Partnership for Microbicides (IPM).