Of the 285 TST positive youths recruited into the trial, the mean age was 15.9 years (±1.2) (Table 1). Fifty percent were females and 49% had no health insurance. Forty-five percent were foreign born and 96% were Latino. The majority of the participants (90%) spoke two languages, Spanish and English, with Spanish being the primary language for about 85%. Sixty-two percent were considered to be bicultural using the Marin & Gamba acculturation scale .
The majority of parents who participated were female (86%), with most (80%) being the participant’s Mother (Table 1). The mean age of the participating parent was 42.5 years (±7.8) and 44.0 years (±7.8) for the other parent. The mean years of education for both parents was over nine years (participating parent: M = 9.5, ±3.6; other parent: M = 9.6, ±3.9). Ninety-six percent of both parents were Latinos, with 89% of the participating parents born in Mexico (93% were foreign born) and 87% of the other parents born in Mexico (90% were foreign born). Sixty-six percent of the participating parents spoke only one language with the primary language being Spanish for 83%, while 60% of the other parent spoke two languages, again with Spanish being the primary language for the majority, 89%. The median income for the previous year was $<10,000 for the participating parent and $20,000–29,000 for the other parent, with the median for the household being $20,000–29,000. Forty-five percent reported not having any medical insurance.
A diagnosis of LTBI involves a positive TST and a negative CXR. X-rays are required to rule out active TB. Participants were encouraged to obtain a CXR as soon as possible, and staff maintained constant contact to monitor their progress to this end. Participants were contacted four to five times a week for a month, and then weekly until they were on medications (isoniazid). Assistance was provided as necessary. Many participants required prompting and assistance to obtain baseline X-rays, initiate treatment, and maintain treatment. About 46% of participants required assistance in receiving a CXR, requiring a mean of 1.5 contacts (range 0–14) in the form of telephone calls and/or home visits by project staff. Almost 19% required a home visit(s) to schedule the initial medical visit to get started on isoniazid (mean of 0.7, range 0–23) and 58% required phone call(s) (mean of 3.2, range 0–39). Home visits and phone calls were used to provide additional patient/parent education and to facilitate compliance with clinic appointments to initiate isoniazid.
Once appointments were scheduled, compliance with these medical visits was also a problem. Thirty-four participants (12%) missed one or more initial clinic appointments (range 0–6), and 15 (5%) required transportation by project staff. Continuing care was also an issue, with ongoing prompting required to enhance compliance with the follow-up clinic appointments.
Participants reported a general lack of knowledge of LTBI and TB at the initial interview. Twenty-two percent did not know that TB could be detected by a skin test; 15% did not know that LTBI treatment reduces the risk of TB, and 32% did not know that TB could be cured.
In addition to the routine continuity visits, some participants reported symptoms compatible with isoniazid side effects to our staff during intervention and measures visits, which required study staff to facilitate getting participants to their medical providers for unforeseen visits. Although no true isoniazid side effects were detected by providers in this study, the expenses for these visits were outside of the routine LTBI care, and often involved blood tests, which lead to financial issues for the participants, and difficulty in enforcing compliance with these visits.
The baseline questionnaire revealed a lack of parental knowledge regarding LTBI and LTBI treatment. Twenty percent of the participating parents did not know that LTBI could be detected by a skin test and 13% did not know that completing LTBI treatment greatly reduces risk of TB. Thirty percent of parents did not feel that TB could be cured, and 26% were ‘not worried when they found out their child had a positive TST.’ Forty percent of parents did not think that positive TST reflected being ‘infected with TB bacteria at some time in the past,’ while 14% thought it was from ‘receiving BCG vaccine as a child,’ and 19% attributed it to ‘scratching the site.’
Parents’ work conflicts and lack of transportation contributed to the difficulties in scheduling appointments for the CXR and isoniazid. This barrier was solved for those adolescents with a means of independent transportation through obtaining parental consent forms that permitted LTBI treatment without their presence. Parents frequently attributed lack of attendance to medical visits to costs to see a provider, even the modest charges of community health centers.
One parent’s concerns about potential side effects in their child prompted cessation of LTBI treatment and dropping out of the study.
The providers in the participating San Diego health centers were given the opportunity to obtain 3 h of CME credit for attending on-site LTBI in-services. Eighty-five physicians and mid-level practitioners were offered CME. Of these, 24 (28%) participated, yet just 17 (20%) providers took the CME pre-test required to obtain CME credit. Only 13 (77%) of the 17 completed pre-tests received a passing grade (60% correct). The post-tests were completed by 9 of the 17 providers, with 78% receiving a passing grade. During the in-services, we also encountered resistance to the CDC recommendations for monthly visits to evaluate persons treated with isoniazid for side effects. Some providers stated that ‘their patients would not return monthly,’ and, for that reason, they planned to continue prescribing/dispensing 2–3 months or more of medication at a time.
Five of the participating health centers completed the survey to assess their LTBI standards of care. The survey results were compared with the CDC’s guidelines for LTBI treatment. Respondents for the participating health centers included one medical director (physician), one staff physician, one RN, one public health nurse, and one medical assistant. Four of the five clinics correctly identified the dosage of isoniazid for daily regimes, with four of the clinics correctly identifying 300 mg as the maximum dosage for daily regimes. Three of the clinics correctly cited 9 months of treatment as the correct length of treatment for daily treatment with isoniazid; three also had protocols to see patients monthly. The other two clinics saw patients at initial visit only (one) and initial visit and final visit (one).
Of the participants who were given only 1 month of isoniazid at a time, 120/156 (77%) came back for the 1 month follow up, and 140/156 (90%) came back for at least one more visit. However, of the participants who were given more than 1 month, only 9/19 (47%) came back before their prescription ran out, and 13/19 (68%) ever came back. For those participants whose charts did not indicate the number of pills given, only 17/48 (35%) ever had another visit.
Until 2004, the County of San Diego was able to provide public funded care for LTBI, either through direct services, or through subcontracts with the community health clinic (CHC) system. However, due to shrinking public health funds in general as well as those for TB control, CDC’s priorities narrowed to active tuberculosis treatment and contact tracing and care. The County is now only able to provide limited direct LTBI care, and does no subcontracting. Per parental reports, even the modest charges of the participating CHCs for LTBI treatment were prohibitive for some participants. Similarly, providing care at discounted rates that families could afford was prohibitive for many of the community clinics to afford.
Participant Feedback About Clinical Care
Participants provided study staff feedback on their contacts with physicians when attempting to get started on isoniazid, reflecting misinformation and mistreatment. This included inappropriate dosing, not scheduling monthly visits, inappropriate length of treatment regimens, and inappropriate staff and/or methods of obtaining medical histories of possible side effects of isoniazid. Some participants seeing providers in San Diego reported that they were told: “Adolescents don’t need treatment for LTBI”, “Only 6 months of treatment is needed,” “Isoniazid is too toxic to use in adolescents.” Several participants seeing providers in Tijuana heard: “The positive TST in Mexicans is from BCG, and your child doesn’t need treatment” and “Don’t take medicine, just get a CXR every year.” This type of misinformation contributed to refusal to enroll in the study by at least 16 potential participants.
Additional problems were reported by parents and participants regarding obtaining refills. In some cases, families were told that medication was ready, but when they arrived at the facility to pick it up, there was no prescription. Patients attending facilities using a mail system, where medication refills of isoniazid were mailed to the patient’s home, reported never receiving the refills. Patients reported sometimes being asked about side effects by a nurse, a medical assistant, a receptionist, or not at all. This questioning sometimes took place in person, and sometimes by phone.