Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
Condition: HIV
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effect of a combination intervention on long-term
      HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years
      of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest
      Uganda. Clinics will be randomly chosen to either continue to provide study participants
      standard care or to provide the study intervention, which consists of discussion and
      counseling on major issues or life events, flexible access to the clinic, and rapid
      turnaround of VL test results. Participants will take part in the study for at least 2 years.
    

Detailed description: 
      The randomized controlled trial (RCT) will evaluate the effect of the SEARCH Youth
      intervention on long-term HIV viral load suppression among HIV-infected adolescents/young
      adults. The study's intervention is based on the PRECEDE model of behavioral change that is
      targeted towards adolescent and young adult behavior. The study design is a
      cluster-randomized trial where the unit of randomization is the HIV clinic: 14 clinics
      randomized to the intervention and 14 to the optimized country standard of care
      (Differentiated ART care, standard clinic hours, routine VL monitoring, access to 2nd and 3rd
      line ART), balanced within country. The target enrollment for the intervention is
      approximately 2300 (50-100 adolescents/young adults with HIV in each clinic, plus family
      members, providers and others taking part in qualitative interviews).

      Community-tailored youth testing and linkage strategies for ART will be implemented to
      recruit youth for the SEARCH Youth combination intervention RCT. Strategies to reach youth at
      the highest risk of HIV infection will be implemented. Those individuals who test
      HIV-positive will be referred to the local clinic for HIV treatment services and, if they
      otherwise meet entry criteria, to the SEARCH Youth study for possible inclusion.

      The components of the SEARCH Youth intervention include:

        -  Administration of life-stage assessment tool at the beginning of each visit that links
           to life-stage specific actions and puts subsequent medical discussions into an
           appropriate context

        -  Structured choice clinic access which will provide a choice to schedule visits during or
           after routine clinic hours or in an alternate location, with some phone-only visits
           available between in-person visits

        -  Rapid feedback of VL results, by phone or in person, aiming to be provided within 72
           hours, to provide immediate feedback on HIV suppression and engage participants in their
           overall health

        -  Provider e-collaboratives that comprises of chat groups using WhatsApp or similar secure
           messaging applications to solicit input about challenging cases using de-identified
           information

      Participants will take part in the study for at least 2 years.

      Some participants, family members, providers, HIV-negative youth and key informants will also
      take part in qualitative interview guides. Costs of the SEARCH Youth intervention will be
      evaluated to assess its efficiency and cost-effectiveness including as cost per participant,
      cost per additional participant with viral suppression and cost per DALY gained.
    

Intervention name(s): SEARCH Youth combination intervention
Intervention type(s): Other
Intervention description(s): Administration of life-stage assessment tool
Structured choice clinic access
Rapid feedback of VL results
Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomized trial
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; Adolescent; Young Adult; Viral Load; Counseling; Costs and Cost Analysis