WHC+ (Women's Health CoOp PLUS)
Condition: HIV; Sexual Risk; Sexually Transmitted Diseases; Substance Abuse; Violence; Victimization
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the effects of standard HIV test, treat and retain (TTR) practices with
      TTR plus a woman-focused enhanced strategy--Women's Health CoOp (WHC+) intervention)
      targeting hard-to-reach and vulnerable alcohol and other drug (AOD)-using women to determine
      if the WHC+ intervention is more efficacious than TTR alone in reducing HIV risk behavior.
      Additionally, the study will determine whether HIV positive women in the WHC+ arm are more
      likely to follow through with referrals for further medical evaluation and linkages to HIV
      treatment and other care than women in the TTR arm.
    

Detailed description: 
      There is growing recognition that no single strategy will be sufficient to eliminate
      transmission. In light of evidence that neither existing biomedical interventions nor any
      existing behavioral interventions will be sufficient to control the HIV epidemic in South
      Africa, the proposed study will combine a biomedical intervention with an evidence-based
      behavioral intervention (i.e., the Women's Health CoOp) to maximize the efficacy of both
      strategies. If this combination intervention proves efficacious, there is a high likelihood
      that it can be widely implemented, be sustainable and have a substantial public health impact
      by reducing the exceedingly high HIV incidence in South Africa.

      The overarching goal of the proposed research is to determine whether this enhanced
      combination prevention strategy targeting vulnerable AOD-using women is more efficacious than
      current standard practices. The specific aims of the proposed study are:

      Aim 1: To expand the WHC outreach strategies to reach more alcohol and other drug (AOD) -
      using vulnerable women in Pretoria, South Africa.

      Aim 2: To test whether adding WHC to standard Treat, Test, and Retain (TTR) practices results
      in more HIV-positive AOD-using women getting medical evaluations (e.g., cluster of
      differentiation 4 (CD4), viral load), starting treatment, staying in treatment and in greater
      reductions in risk behaviors (e.g., AOD use, condom use, victimization) among all
      women-positive or negative.

      The study uses a geographical cluster randomized design. Hotspots (i.e. places where sex
      workers and drug using women congregate) in the city of Pretoria and the surrounding areas
      were mapped using geographic information system (GIS) software. Fourteen hotspots were
      identified and geocoded. The entire area was divided into 14 zones, each of which included a
      hotspot. Seven matched pairs of zones were created based on socio-economic conditions and
      estimates of the numbers of sex workers and drug-using women residing in them. Zones within
      pairs were randomized to the TTR arm or the WHC+ arm. Participants are recruited by outreach
      workers and their intervention condition is based on the zone from which they were recruited.
      At study enrollment/baseline, eligible participants complete a questionnaire and baseline
      HIV, drug and pregnancy testing. Follow-up data collection will be conducted at 6-months and
      12-months post-baseline.
    

Intervention name(s): Test, Treat, Retain(TTR) + Women's Health CoOp (WHC); Test, Treat, Retain(TTR) only
Intervention type(s): Behavioral; Biological
Intervention description(s): TTR +WHC: Participants in this group will be screened for HIV. HIV positive women, will be given post-test counseling and referrals for prompt medical evaluation and assessment.Both HIV negative and positive participants in this group will participate in 2 individual behavioral counseling sessions focusing on reducing HIV risk behaviours, alcohol and other drug use, and risk of violent victimization. It also adds case management to increase follow through with referrals and risk reduction plans and activities.This will also include case management sessions. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).; TTR +only: Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gender-based Violence; HIV; Randomized Controlled Trial; Sexually Transmitted Diseases; Substance Abuse Detection; Test, Treat and Retain