Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
Condition: Health Behavior; HIV; Mental Health
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if a group-based mental health intervention called
      Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by
      adolescents in Tanzania is acceptable and feasible and if it improves mental health,
      antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents
      as compared to youth receiving treatment as usual. Mental health intervention sessions will
      take place three times a month for approximately four months in groups of eight to ten youth
      based on age and sex. Caregivers will attend two sessions to support the youth and provide
      the guardian perspective on caring for HIV-positive adolescents. The investigator
      hypothesizes the mental health intervention will be acceptable, feasible, and will improve
      mental health and ART adherence among participating youth and this improvement will be
      sustained over time.
    

Detailed description: 
      The study will enroll up to approximately 130 participants from the established Kilimanjaro
      Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to
      approximately eight to ten persons per group, based on age and sex. Groups will be matched in
      pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to
      Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before
      the start of mental health intervention for each wave. Individuals will be randomized at this
      time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization
      will occur by a coin flip for two individuals based on alphabetical order: heads will be
      intervention group (I) and tails the standard of care group (SOC).

      This feasibility study is longitudinal with up to 24 month follow-up after intervention.
      Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be
      obtained by blinded interviewers using a structured survey to inquire about mental health
      symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample,
      and HIV-1 viral load from a blood sample and will be collected by the same research
      assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3)
      post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6)
      24-months post-intervention.
    

Intervention name(s): Mental Health Intervention; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Includes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions.; Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: adolescent; adolescence; HIV/AIDS; mental health; cognitive behavioral therapy