FANMI: Community Cohort Care for HIV-Infected Adolescent Girls in Haiti
Condition: HIV
Study type: Interventional

Summary: 
      The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected
      adolescent girls age 16-23 years in Haiti (80 adolescents per arm). Group Care includes
      receiving integrated clinical and social support services in groups of 5-8 adolescents at a
      monthly visit. The primary outcome is retention in HIV care at 12 months after randomization.
    

Detailed description: 
      The investigators will conduct a randomized controlled trial of Group Care in the GHESKIO
      Community Center versus Individual Care in the GHESKIO Adolescent Clinic for 160 HIV-infected
      adolescent girls age 16-23 years in Haiti (80 per arm). Adolescents randomized to Group Care
      will receive HIV services including integrated clinical and social support care in groups of
      5-10. Adolescents randomized to Individual Care will continue to receive individual care at
      the GHESKIO Adolescent Clinic, which is the current standard of care (described below). If a
      subject declines to participate in the study they will continue to receive standard HIV care.
      Participants will be randomized to either Group Care or Individual Care in a 1:1 ratio using
      a computer generated random assignment.

      Individual Care (standard of care): Adolescents randomized to Individual Care will receive
      care in the GHESKIO Adolescent Clinic which cares for both males and females age 13-23 years.
      The Adolescent Clinic waiting room has a television showing educational videos. After seeing
      a triage peer counselor and having their vital signs taken, participants see a nurse
      practitioner (NP) one-on-one in a private room for a 10-15 minute clinic visit. The NP may
      also provide family support counseling including family visits per clinical judgment. Each NP
      sees approximately 20 HIV-infected adolescents per day. The adolescent then returns to the
      HIV positive peer counselor, who provides one-on-one counseling for 30 minutes on topics
      chosen by the adolescent and the counselor. Each counselor sees ~10 adolescents per day.

      Group Care (intervention): Adolescent girls randomized to Group Care will join a group within
      one week of study enrollment and receive care in the GHESKIO Community Center. The
      investigators estimate that it will take 4-6 weeks to constitute a full group of 5-10. During
      this enrollment phase, groups will meet weekly, adding new participants each week. The
      participants will then meet monthly with an NP and a HIV positive peer counselor. Each
      monthly group session will last ~2 hours. This is comparable to the time it takes for a
      patient to pass through the Adolescent HIV Clinic. It will start with a 30 minute
      unstructured discussion. This time is intentionally unstructured and responds to our previous
      research finding that adolescents want to talk about topics of their choosing with their
      peers. This will be followed by a 45 minute group counseling session following a structured
      curriculum, addressing topics such as social isolation, stigma, family support, sexual risk
      behavior, life goals, medication adherence, job skills, and transitions. This is followed by
      a 30 minute social activity led by two rotating group leaders who are elected by their peers.
      Social activities include crafts, playing cards, and charades. Participants will be seen one
      by one by the NP for ~10-15 minutes in a screened in clinical area during the unstructured
      discussion and the social activity. All HIV clinical services, including provision of
      antiretroviral therapy (ART) medications, CD4 T cell monitoring, screening for symptoms and
      OI, medication adherence monitoring, family planning, and general primary care will be
      provided by the NP. Girls who become eligible for ART will be provided with individual
      counseling and promptly initiated on ART by the NP. The primary hypothesis is that Group Care
      will improve retention at 12 months compared with standard Individual Care. The study has >
      90% power to detect a difference in retention from 60% to 85%. Participants in both study
      arms will complete a questionnaire with a research nurse at enrollment, 6, and 12 months
      collecting data on HIV knowledge, HIV-related stigma, HIV disclosure, social and family
      support, depression and alcohol use, problem solving skills, and food insecurity.
    

Intervention name(s): FANMI - Cohort Care
Intervention type(s): Behavioral
Intervention description(s): FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment