WHC+ (Women's Health CoOp PLUS)

Study Overview
=================
Brief 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.

Official Title
-----------------
Combination Prevention for Vulnerable Women in South Africa

Conditions
-----------------
HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization

Intervention / Treatment
-----------------
* Behavioral: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)
* Biological: Test, Treat, Retain(TTR) only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Black/African 15 years or older (if under 18, must be able to sign assent) Use at least one of the following drugs: alcohol, marijuana (dagga), methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), inhalants (glue and benzene) methylenedioxymethamphetamine (MDMA -ecstasy), lysergic acid diethylamide (LSD), or Kat/cat, Nyaope (a mixture of marijuana and heroin) - weekly in the past 90 days Have had unprotected vaginal sex with a male partner in the last six months Able to speak English, Sesotho, Tswana, or Zulu Consent to HIV rapid testing and drug testing Provide written verbal and assent/consent to participate Able to provide verifiable locator information for the Tshwane area and plan to stay there in the next 12 months Exclusion Criteria: Males Individuals who do not self-identify as Black/African

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test, Treat, Retain(TTR) only<br>Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation. | Biological: Test, Treat, Retain(TTR) only<br>* 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.<br>|
| Experimental: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)<br>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 intervention is an adaptation of the evidence-based Women's CoOp(PI: Dr. Wendee M. Wechsberg). | Behavioral: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprotected intercourse among women | Percentages of condom use at last sex | 6 months | 
| Unprotected intercourse among women | Percentages of condom use at last sex | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical evaluation initiation amongst HIV-positive | Percentages of HIV-positive women receiving medical evaluations. | 6 months | 
| Medical evaluation initiation amongst HIV-positive | Percentages of HIV-positive women receiving medical evaluations. | 12 months | 
| Treatment initiation and retention amongst HIV-positive women | Percentages of HIV-positive women starting and staying in treatment | 6 months | 
| Treatment initiation and retention amongst HIV-positive women | Percentages of HIV-positive women starting and staying in treatment | 12 months | 
| HIV viral load among HIV-positive women who meet criteria for antiretroviral treatment (ART) and who produce medical records with HIV viral loads | HIV viral load from medical record | 6 months | 
| HIV viral load among HIV-positive women who meet criteria for antiretroviral treatment (ART) and who produce medical records with HIV viral loads | HIV viral load from medical record | 12 months | 
| Alcohol use | Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test | 6 months post intervention | 
| Alcohol use | Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test | 12 months post intervention | 
| Victimization | Percentages of women who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days | 6 months post intervention | 
| Victimization | Percentages of women who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days | 12 months post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gender-based Violence, HIV, Randomized Controlled Trial, Sexually Transmitted Diseases, Substance Abuse Detection, Test, Treat and Retain