A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam
Condition: Hiv; Stigma, Social
Study type: Interventional

Summary: 
      The overall goals of the study are to deepen understanding of the spectrum of stigma
      experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV
      delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary
      efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing,
      and treatment adherence.

      The project has the following Specific Aims:

        1. Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on
           cognitive-behavioral therapy principles and delivered by telephone, using input from
           youth during intervention development.

        2. Assess the feasibility, acceptability and preliminary efficacy of this innovative
           approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among
           YLHIV through a small pre-post study.

        3. Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their
           relationships with ART adherence and psychosocial wellbeing via quantitative surveys and
           electronic adherence monitoring.

      The study will assess the feasibility and acceptability of this approach among YLVIV in
      Vietnam, and generate preliminary evidence for the potential effect of the intervention on
      important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral
      load (VL).
    

Detailed description: 
      For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal
      stigma and implement a 12-week pre-post intervention study in which participants will receive
      the phone-based intervention developed in the first phase. YLHIV will use an electronic
      adherence monitoring device for their ART medications.

      In the pre-post intervention study, each of 40 patients will be followed for a total of 16
      weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be
      used to measure their adherence throughout the 16-week period. Study participation will
      involve two phases, with the following activities:

      I. Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the
      investigators will provide each subject with a WPC and instruction on correct use. The
      investigators will select one medication for each WPC. While subjects continue to receive
      care as usual, the investigators will collect their adherence data using the WPC.

      II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10
      weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to
      the adherence information generated by the devices, as will their care providers.
    

Intervention name(s): CBT-based supportive skills delivered by phone by lay coaches
Intervention type(s): Behavioral
Intervention description(s): 8-10 weekly coaching sessions delivered by telephone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV; Stigma; Vulnerable groups; Vietnam