Directly Observed Therapy for HIV Infected Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV
      infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a
      strategy in which patients are observed while taking their medications, has been proven
      useful in increasing patient adherence. The purpose of this study is to determine the
      effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty
      adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in
      the past.
    

Detailed description: 
      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.
    

Intervention name(s): Directly observed therapy (DOT)
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Experienced; Adherence; Compliance; Directly Observed Therapy; DOT; Treatment Naive