WHC+ (Women's Health CoOp PLUS)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 15 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | May 2012 |
| End Date: | December 2015 |
Combination Prevention for Vulnerable Women in South Africa
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.
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.
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.
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.
Inclusion Criteria:
1. Female
2. Black/African
3. 15 years or older (if under 18, must be able to sign assent)
4. 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
5. Have had unprotected vaginal sex with a male partner in the last six months
6. Able to speak English, Sesotho, Tswana, or Zulu
7. Consent to HIV rapid testing and drug testing
8. Provide written verbal and assent/consent to participate
9. Able to provide verifiable locator information for the Tshwane area and plan to stay
there in the next 12 months
Exclusion Criteria:
1. Males
2. Individuals who do not self-identify as Black/African
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