Enhanced Linkage to HIV Care Following Home-Based HIV Testing in Rural Uganda
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a linkage to care intervention
      at achieving HIV viral suppression and intermediate outcomes of linkage/time to care, time to
      /receipt of opportunistic infection prophylaxis, and antiretroviral therapy (ART) among
      people testing HIV positive during home-based HIV counseling and testing (HBHCT) in rural
      Uganda.
    

Detailed description: 
      Throughout sub-Saharan Africa there is a pressing need to facilitate early and easier entry
      into HIV care and treatment; up to two-thirds of patients are lost to follow up between
      testing HIV positive and initiation of antiretroviral (ARV) treatment. Home-based HIV testing
      and counseling (HBHCT), which identifies those who are HIV positive at earlier disease stages
      than other testing approaches, is becoming a large component of many sub-Saharan African
      countries' HIV prevention programs, including Uganda's. Paper-based referral to care,
      sometimes adding follow-up home visits, is the most common linkage-to-care approach with
      HBHCT. Linkage to care may be challenging with HBHCT since the testing occurs in the home at
      a distance from a health facility. The investigators propose to test an intervention which
      enhances a linkage to care intervention tested in an urban Ugandan provider-initiated HIV
      testing setting and found to improve linkage to care. The aims of the project are: (1) In a
      cluster randomized trial compare the effectiveness of the enhanced linkage to care
      intervention vs. standard-of-care (paper based referrals) at achieving HIV viral suppression
      and intermediate outcomes of linkage to care, receipt of opportunistic infection prophylaxis,
      and ART initiation among those eligible for antiretroviral therapy (ART). (2) Using the
      standard-of-care group as a natural history control, collect longitudinal data on barriers to
      and facilitators of linkage to and retention in care and treatment and HIV viral suppression.
      (3) Estimate the cost-effectiveness of the intervention, as compared to standard-of-care, in
      terms of major study outcomes.

      Participation in the full study will last 12 months. All participants will first undergo
      HBHCT, viral load and CD4 testing, and complete a brief questionnaire. Participants will then
      be randomly assigned to one of two study arms: the enhanced linkage to care intervention arm
      or the standard-of-care control arm. Participants in both study arms will participate in
      interviewer administered questionnaires at 6 months and 12 months follow-up, viral load and
      CD4 testing at 12 month follow-up, and will permit the research team to access their medical
      records to extract information about their health status and linkage to care. Participants in
      the intervention arm will also receive a series of counseling sessions with an HIV counselor
      taking place at the participant's home, clinic, and over the phone. These sessions will last
      approximately 30 minutes, and consist of counseling to help clients identify and reduce
      barriers to engagement in care, assistance disclosing and identifying a treatment supporter,
      and stigma reduction through increasing social support.
    

Intervention name(s): Enhanced linkage to care; Standard-of-care plus
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Intervention Studies; Access to Health Care; Social Stigma; Social Support