HIVPhase 1NCT01497405
WHC+ (Women's Health CoOp PLUS)
A Phase 1 study testing Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) and Test, Treat, Retain(TTR) only in people with HIV and Sexual Risk, run by RTI International at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexual Risk, Sexually Transmitted Diseases
- What is being tested?
- Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) and Test, Treat, Retain(TTR) only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Males
- Individuals who do not self-identify as Black/African
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
RTI International - Headquarters
Research Triangle Park, North Carolina, 27709
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization
- Being tested
- Test, Treat, Retain(TTR) + Women's Health CoOp (WHC), Test, Treat, Retain(TTR) only
- Keywords
- Gender-based Violence, HIV, Randomized Controlled Trial, Sexually Transmitted Diseases, Substance Abuse Detection, Test, Treat and Retain
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)Behavioural
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).
Test, Treat, Retain(TTR) onlyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Test, Treat, Retain(TTR) only | Active comparator | Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation. Receives: Biological: Test, Treat, Retain(TTR) only |
| Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) | Experimental | 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). Receives: Behavioral: Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected intercourse among women
Percentages of condom use at last sex
Measured: 6 months
Unprotected intercourse among women
Percentages of condom use at last sex
Measured: 12 months
Secondary outcomes (10)
Medical evaluation initiation amongst HIV-positive
Percentages of HIV-positive women receiving medical evaluations.
Measured: 6 months
Medical evaluation initiation amongst HIV-positive
Percentages of HIV-positive women receiving medical evaluations.
Measured: 12 months
Treatment initiation and retention amongst HIV-positive women
Percentages of HIV-positive women starting and staying in treatment
Measured: 6 months
Treatment initiation and retention amongst HIV-positive women
Percentages of HIV-positive women starting and staying in treatment
Measured: 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
Measured: 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
Measured: 12 months
Alcohol use
Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test
Measured: 6 months post intervention
Alcohol use
Frequency of alcohol use in previous 30 days measured by Revised Risk Behavior Assessment (RRBA) and breath test
Measured: 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
Measured: 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
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Felicia Browne, ScD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497405
- Sponsor's protocol ID
- 1R01DA032061-01
- Status last verified
- Jan 2025
- First submitted
- 1 Dec 2011
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25978479Wechsberg 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.
PubMed 28887751Wechsberg 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.
PubMed 28441975Wechsberg 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.
PubMed 25318563
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Prevention for Vulnerable Women in South Africa
- ClinicalTrials.gov ID
- NCT01497405
- Acronym / sponsor ID
- 1R01DA032061-01
- Conditions
- HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization
- Keywords
- Gender-based Violence, HIV, Randomized Controlled Trial, Sexually Transmitted Diseases, Substance Abuse Detection, Test, Treat and Retain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test, Treat, Retain(TTR) only | Active comparator | Biological: Test, Treat, Retain(TTR) onlyParticipants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation. |
| Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) | Experimental | Behavioral: 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). |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Males
- Individuals who do not self-identify as Black/African
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 will also include case management sessions. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg). | Behavioural | Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) |
| Test, Treat, Retain(TTR) onlyTTR +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. | Biological | Test, Treat, Retain(TTR) only |
Primary outcome
Unprotected intercourse among women
Time frame: 6 months
Percentages of condom use at last sex
Unprotected intercourse among women
Time frame: 12 months
Percentages of condom use at last sex
10 secondary outcomes
Medical evaluation initiation amongst HIV-positive
Time frame: 6 months
Medical evaluation initiation amongst HIV-positive
Time frame: 12 months
Treatment initiation and retention amongst HIV-positive women
Time frame: 6 months
Treatment initiation and retention amongst HIV-positive women
Time frame: 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
Time frame: 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
Time frame: 12 months
Alcohol use
Time frame: 6 months post intervention
Alcohol use
Time frame: 12 months post intervention
Victimization
Time frame: 6 months post intervention
Victimization
Time frame: 12 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Background: PubMed 25978479Wechsberg 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.
- Derived from this study: PubMed 28887751Wechsberg 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.
- Derived from this study: PubMed 28441975Wechsberg 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.
- Derived from this study: PubMed 25318563Wechsberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicia Browne, ScD principal investigator
RTI International
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test, Treat, Retain(TTR) + Women's Health CoOp (WHC) and Test, Treat, Retain(TTR) only in people with HIV and Sexual Risk, run by RTI International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unprotected intercourse among women (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497405, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.