Directly Observed Therapy for HIV Infected Adolescents

For HIV infected people, control of HIV infection is best achieved by adhering to the highly active antiretroviral therapy (HAART) regimen prescribed by their doctors. Poor adherence to a HAART regimen leads to clinical failure and the development of resistance. Many HIV infected adolescents have difficulty adhering to their prescribed anti-HIV regimens or OI prophylaxis; often, they cite forgetting to take their medications as the reason for poor adherence. This is a pilot study of using DOT and assessing adherence during DOT in HIV infected adolescents who have had difficulty adhering to HAART regimens in the past. The purpose of this study is to evaluate the efficacy in increasing patient adherence and the feasibility of using DOT among HIV infected adolescents.

This study will last 24 weeks. For the first 2 weeks of the study, DOT will be provided 7 days a week at the study site; participants will visit the study site daily and will be observed taking their medication. For the next 6 weeks, the frequency of DOT will be reduced from 7 days a week to 5 days a week. Based on adherence from Weeks 4 to 8, each participant will be recommended to continue with a DOT strategy as follows:

• Adherence Level 1 (greater than 93%) - DOT 3 days a week
• Adherence Level 2 (86% to 93%) - DOT 5 days a week
• Adherence Level 3 (less than 86%) - DOT 7 days a week

Participants will decide whether to accept their DOT assignment and to continue in the study. At Week 12 and every 4 weeks thereafter, adherence will be assessed and DOT may be adjusted as follows:

• Adherence Level 1 - Reduce frequency of DOT. Those already receiving DOT 3 days a week stop DOT and start self-administered therapy.
• Adherence Level 2 - Keep same frequency of DOT as the past 4 weeks.
• Adherence Level 3 - Increase frequency of DOT by one level, as described in previous list.

HAART will not be provided by this study, so participants must have access to their HAART medications coordinated separately through the study site. Participants who are taking medication requiring twice-daily dosing will self-administer their second doses.

There will be 7 study visits; they will occur at study entry and every 4 weeks thereafter. Medical history will occur at study entry. At every visit, participants' adherence to their regimens will be assessed, and they will also be interviewed by a social worker about their use of support services. Participants will undergo several assessments at study entry and Weeks 12 and 24 to determine participant confidence, beliefs about medicine, severity of depression, feelings of hopelessness, coping responses, and emotional and behavioral problems. Blood collection will occur at study entry and Weeks 8, 12, and 24. When participants successfully complete their prescribed courses of DOT or elect to discontinue DOT, they will again be interviewed by study staff.

Inclusion criteria

• Infected with HIV after age 12
• Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
• Able and willing to swallow medication
• Have access to HAART
• Parent or guardian willing to provide informed consent, if applicable
• Willing to use acceptable forms of contraception

Exclusion criteria

• Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
• HAART regimens that include medications taken more often than twice-daily
• Investigational agents (HAART or other medications) administered as part of other clinical trials
• Pregnant or breastfeeding