- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497405
WHC+ (Women's Health CoOp PLUS)
Combination Prevention for Vulnerable Women in South Africa
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pretoria, South Africa, 0126
- Wesley Community Centre
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- RTI International - Headquarters
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Test, Treat, Retain(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.
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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.
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Experimental: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unprotected intercourse among women
Time Frame: 6 months
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Percentages of condom use at last sex
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6 months
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Unprotected intercourse among women
Time Frame: 12 months
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Percentages of condom use at last sex
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Medical evaluation initiation amongst HIV-positive
Time Frame: 6 months
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Percentages of HIV-positive women receiving medical evaluations.
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6 months
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Medical evaluation initiation amongst HIV-positive
Time Frame: 12 months
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Percentages of HIV-positive women receiving medical evaluations.
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12 months
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Treatment initiation and retention amongst HIV-positive women
Time Frame: 6 months
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Percentages of HIV-positive women starting and staying in treatment
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6 months
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Treatment initiation and retention amongst HIV-positive women
Time Frame: 12 months
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Percentages of HIV-positive women starting and staying in treatment
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12 months
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HIV viral load among HIV-positive women who meet criteria for antiretroviral treatment (ART) and who produce medical records with HIV viral loads
Time Frame: 6 months
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HIV viral load from medical record
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6 months
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HIV viral load among HIV-positive women who meet criteria for antiretroviral treatment (ART) and who produce medical records with HIV viral loads
Time Frame: 12 months
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HIV viral load from medical record
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12 months
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Alcohol use
Time Frame: 6 months post intervention
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Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test
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6 months post intervention
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Alcohol use
Time Frame: 12 months post intervention
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Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test
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12 months post intervention
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Victimization
Time Frame: 6 months post intervention
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Percentages of women who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days
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6 months post intervention
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Victimization
Time Frame: 12 months post intervention
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Percentages of women who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days
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12 months post intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendee M Wechsberg, PhD, RTI International
Publications and helpful links
General Publications
- Wechsberg WM, Deren S, Myers B, Kirtadze I, Zule WA, Howard B, El-Bassel N. Gender-Specific HIV Prevention Interventions for Women Who Use Alcohol and Other Drugs: The Evolution of the Science and Future Directions. J Acquir Immune Defic Syndr. 2015 Jun 1;69 Suppl 2(0 1):S128-39. doi: 10.1097/QAI.0000000000000627.
- Wechsberg WM, Peasant C, Kline T, Zule WA, Ndirangu J, Browne FA, Gabel C, van der Horst C. HIV Prevention Among Women Who Use Substances And Report Sex Work: Risk Groups Identified Among South African Women. AIDS Behav. 2017 Nov;21(Suppl 2):155-166. doi: 10.1007/s10461-017-1889-0.
- Wechsberg WM, van der Horst C, Ndirangu J, Doherty IA, Kline T, Browne FA, Belus JM, Nance R, Zule WA. Seek, test, treat: substance-using women in the HIV treatment cascade in South Africa. Addict Sci Clin Pract. 2017 Apr 26;12(1):12. doi: 10.1186/s13722-017-0077-x.
- Wechsberg WM, Zule WA, Ndirangu J, Kline TL, Rodman NF, Doherty IA, Novak SP, van der Horst CM. The biobehavioral Women's Health CoOp in Pretoria, South Africa: study protocol for a cluster-randomized design. BMC Public Health. 2014 Oct 15;14:1074. doi: 10.1186/1471-2458-14-1074.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DA032061-01 (U.S. NIH Grant/Contract)
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