HIVPhase 2/3WC-WHCNCT00729391
Women-Focused HIV Prevention in the Western Cape
A Phase 2/3 study testing Woman-Focused Intervention (Women's Health CoOp) and VCT Only in people with HIV and Substance Abuse, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in South Africa.
Trial summary
The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention. Read more about this study
- Who is it for?
- Ages 18 to 33 years, women only
- Conditions the study is for
- HIV, Substance Abuse, Violence
- What is being tested?
- Woman-Focused Intervention (Women's Health CoOp) and VCT Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Sep 2008to Mar 2012
- Phase
- Phase 2/3
- 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 18 to 33 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for the study, participants must be: (a) female; (b) report use of at least two drugs-alcohol, marijuana, methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), glue, MDMA (ecstasy), or LSD-at least once a week in the past 90 days; (c) be sexually active within the past 30 days with a male partner; (d) be aged 18 to 33 years; (e) live in the communities around the airport; and (f) provide verbal consent to be screened for eligibility and written consent to participate in the study.
Who cannot join
- If participants do not meet all of the inclusion criteria, they will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention.
Read the detailed description
Surveillance data indicate that HIV risk and substance use is a serious problem among South African women. This study, funded by the National Institute on Child Health and Human Development (NICHD), builds on findings from a recently completed pilot study among women in less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The pilot study tested the effectiveness of an evidence-based woman-focused intervention in reducing drug use, sexual risk, and victimization by addressing the intersection of these factors among 100 poor, substance-using women of colour.
The primary aim of this study is to test the effectiveness, through a randomized controlled trial (RCT), of VCT plus a woman-focused intervention relative to VCT only to increase knowledge and skills to reduce substance abuse, sexual risk, and victimization, and to an equal-attention (nutrition) control group at 3-, 6-, 9-, and 12-month follow-ups. A secondary aim is to examine the moderating effect of victimization (i.e., sexual and physical) and the mediating effects of HIV risk knowledge, condom use skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups to decrease risk related to drug use, sexual risk, and sex-related-victimization relative to the rapid testing group and to the equal-attention control group.
- Conditions
- HIV, Substance Abuse, Violence
- Being tested
- Woman-Focused Intervention (Women's Health CoOp), Nutrition (Attention-Control), VCT Only
- Keywords
- HIV, Sexual Risk, Substance Abuse, Victimization, Violence, Voluntary Counseling and Testing (VCT)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woman-Focused Intervention (Women's Health CoOp)Behavioural
Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
Nutrition (Attention-Control)Behavioural
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
VCT OnlyBehavioural
Participants in this group will receive VCT only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women's CoOp Receives: Behavioral: Woman-Focused Intervention (Women's Health CoOp) |
| 2 | Active comparator | Nutrition (Attention-Control) Receives: Behavioral: Nutrition (Attention-Control) |
| 3 | Active comparator | Voluntary Counseling and Testing Receives: Behavioral: VCT Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in substance abuse, sexual risk behaviors and victimization.
Measured: Baseline, 3-month, 6-month, 9-month and 12-month
Secondary outcomes (1)
The moderating effect of victimization and the mediating effects of HIV risk knowledge, condom skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups.
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study start26 Sep 2008
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Principal investigator, Wendee Wechsberg, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729391
- Sponsor's protocol ID
- R01HD058320
- Acronym
- WC-WHC
- Status last verified
- May 2017
- First submitted
- 5 Aug 2008
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Browne FA, Wechsberg WM. The intersecting risks of substance use and HIV risk among substance-using South African men and women. Curr Opin Psychiatry. 2010 May;23(3):205-9. doi: 10.1097/YCO.0b013e32833864eb.
PubMed 20308902Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.
PubMed 21473554Jones HE, Browne FA, Myers BJ, Carney T, Ellerson RM, Kline TL, Poulton W, Zule WA, Wechsberg WM. Pregnant and nonpregnant women in cape town, South Africa: drug use, sexual behavior, and the need for comprehensive services. Int J Pediatr. 2011;2011:353410. doi: 10.1155/2011/353410. Epub 2011 Apr 6.
PubMed 21541067Zule W, Myers B, Carney T, Novak SP, McCormick K, Wechsberg WM. Alcohol and drug use outcomes among vulnerable women living with HIV: results from the Western Cape Women's Health CoOp. AIDS Care. 2014;26(12):1494-9. doi: 10.1080/09540121.2014.933769. Epub 2014 Jul 21.
PubMed 25040338Myers B, Kline TL, Doherty IA, Carney T, Wechsberg WM. Perceived need for substance use treatment among young women from disadvantaged communities in Cape Town, South Africa. BMC Psychiatry. 2014 Apr 4;14:100. doi: 10.1186/1471-244X-14-100.
PubMed 24708789Myers B, Kline TL, Browne FA, Carney T, Parry C, Johnson K, Wechsberg WM. Ethnic differences in alcohol and drug use and related sexual risks for HIV among vulnerable women in Cape Town, South Africa: implications for interventions. BMC Public Health. 2013 Feb 26;13:174. doi: 10.1186/1471-2458-13-174.
PubMed 23442318Wechsberg WM, Myers B, Kline TL, Carney T, Browne FA, Novak SP. The Relationship of Alcohol and Other Drug Use Typologies to Sex Risk Behaviors among Vulnerable Women in Cape Town, South Africa. J AIDS Clin Res. 2012 Jul 20;S1(15):015. doi: 10.4172/2155-6113.S1-015.
PubMed 23403403Reed E, Emanuel AN, Myers B, Johnson K, Wechsberg WM. The relevance of social contexts and social action in reducing substance use and victimization among women participating in an HIV prevention intervention in Cape Town, South Africa. Subst Abuse Rehabil. 2013 Jun 28;4:55-64. doi: 10.2147/SAR.S45961. eCollection 2013.
PubMed 24648788Johnson JE, Carney T, Kline T, Browne FA, Wechsberg WM. Incarceration history relative to health, substance use, and violence in a sample of vulnerable South African women: implications for health services in criminal justice settings. Subst Abuse Rehabil. 2012 Jan 28;3(Suppl 1):59-69. doi: 10.2147/SAR.S21351. eCollection 2012.
PubMed 24474876Reed E, Myers B, Novak SP, Browne FA, Wechsberg WM. Experiences of violence and association with decreased drug abstinence among women in Cape Town, South Africa. AIDS Behav. 2015 Jan;19(1):192-8. doi: 10.1007/s10461-014-0820-1.
PubMed 24934652Wechsberg WM, Jewkes R, Novak SP, Kline T, Myers B, Browne FA, Carney T, Morgan Lopez AA, Parry C. A brief intervention for drug use, sexual risk behaviours and violence prevention with vulnerable women in South Africa: a randomised trial of the Women's Health CoOp. BMJ Open. 2013 May 28;3(5):e002622. doi: 10.1136/bmjopen-2013-002622.
PubMed 23793683
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women-Focused HIV Prevention in the Western Cape
- ClinicalTrials.gov ID
- NCT00729391
- Acronym / sponsor ID
- WC-WHC / R01HD058320
- Conditions
- HIV, Substance Abuse, Violence
- Keywords
- HIV, Sexual Risk, Substance Abuse, Victimization, Violence, Voluntary Counseling and Testing (VCT)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Medical Research Council, South Africa
- Study start
- 26 Sep 2008 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Aug 2008 (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.
The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention.
Detailed description
Surveillance data indicate that HIV risk and substance use is a serious problem among South African women. This study, funded by the National Institute on Child Health and Human Development (NICHD), builds on findings from a recently completed pilot study among women in less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The pilot study tested the effectiveness of an evidence-based woman-focused intervention in reducing drug use, sexual risk, and victimization by addressing the intersection of these factors among 100 poor, substance-using women of colour.
The primary aim of this study is to test the effectiveness, through a randomized controlled trial (RCT), of VCT plus a woman-focused intervention relative to VCT only to increase knowledge and skills to reduce substance abuse, sexual risk, and victimization, and to an equal-attention (nutrition) control group at 3-, 6-, 9-, and 12-month follow-ups. A secondary aim is to examine the moderating effect of victimization (i.e., sexual and physical) and the mediating effects of HIV risk knowledge, condom use skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups to decrease risk related to drug use, sexual risk, and sex-related-victimization relative to the rapid testing group and to the equal-attention control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Woman-Focused Intervention (Women's Health CoOp)Women's CoOp |
| 2 | Active comparator | Behavioral: Nutrition (Attention-Control)Nutrition (Attention-Control) |
| 3 | Active comparator | Behavioral: VCT OnlyVoluntary Counseling and Testing |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be eligible for the study, participants must be: (a) female; (b) report use of at least two drugs-alcohol, marijuana, methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), glue, MDMA (ecstasy), or LSD-at least once a week in the past 90 days; (c) be sexually active within the past 30 days with a male partner; (d) be aged 18 to 33 years; (e) live in the communities around the airport; and (f) provide verbal consent to be screened for eligibility and written consent to participate in the study.
Key exclusion criteria (1 listed)
- If participants do not meet all of the inclusion criteria, they will be excluded from the study.
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 |
|---|---|---|
| Woman-Focused Intervention (Women's Health CoOp)Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention. | Behavioural | 1 |
| Nutrition (Attention-Control)Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention. | Behavioural | 2 |
| VCT OnlyParticipants in this group will receive VCT only. | Behavioural | 3 |
Primary outcome
Reduction in substance abuse, sexual risk behaviors and victimization.
Time frame: Baseline, 3-month, 6-month, 9-month and 12-month
1 secondary outcome
The moderating effect of victimization and the mediating effects of HIV risk knowledge, condom skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups.
Time frame: 6 and 12 month
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 18 May 2017.
- Background: PubMed 20308902Browne FA, Wechsberg WM. The intersecting risks of substance use and HIV risk among substance-using South African men and women. Curr Opin Psychiatry. 2010 May;23(3):205-9. doi: 10.1097/YCO.0b013e32833864eb.
- Background: PubMed 21473554Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. No abstract available.
- Background: PubMed 21541067Jones HE, Browne FA, Myers BJ, Carney T, Ellerson RM, Kline TL, Poulton W, Zule WA, Wechsberg WM. Pregnant and nonpregnant women in cape town, South Africa: drug use, sexual behavior, and the need for comprehensive services. Int J Pediatr. 2011;2011:353410. doi: 10.1155/2011/353410. Epub 2011 Apr 6.
- Background: PubMed 25040338Zule W, Myers B, Carney T, Novak SP, McCormick K, Wechsberg WM. Alcohol and drug use outcomes among vulnerable women living with HIV: results from the Western Cape Women's Health CoOp. AIDS Care. 2014;26(12):1494-9. doi: 10.1080/09540121.2014.933769. Epub 2014 Jul 21.
- Background: PubMed 24708789Myers B, Kline TL, Doherty IA, Carney T, Wechsberg WM. Perceived need for substance use treatment among young women from disadvantaged communities in Cape Town, South Africa. BMC Psychiatry. 2014 Apr 4;14:100. doi: 10.1186/1471-244X-14-100.
- Background: PubMed 23442318Myers B, Kline TL, Browne FA, Carney T, Parry C, Johnson K, Wechsberg WM. Ethnic differences in alcohol and drug use and related sexual risks for HIV among vulnerable women in Cape Town, South Africa: implications for interventions. BMC Public Health. 2013 Feb 26;13:174. doi: 10.1186/1471-2458-13-174.
- Background: PubMed 23403403Wechsberg WM, Myers B, Kline TL, Carney T, Browne FA, Novak SP. The Relationship of Alcohol and Other Drug Use Typologies to Sex Risk Behaviors among Vulnerable Women in Cape Town, South Africa. J AIDS Clin Res. 2012 Jul 20;S1(15):015. doi: 10.4172/2155-6113.S1-015.
- Background: PubMed 24648788Reed E, Emanuel AN, Myers B, Johnson K, Wechsberg WM. The relevance of social contexts and social action in reducing substance use and victimization among women participating in an HIV prevention intervention in Cape Town, South Africa. Subst Abuse Rehabil. 2013 Jun 28;4:55-64. doi: 10.2147/SAR.S45961. eCollection 2013.
- Background: PubMed 24474876Johnson JE, Carney T, Kline T, Browne FA, Wechsberg WM. Incarceration history relative to health, substance use, and violence in a sample of vulnerable South African women: implications for health services in criminal justice settings. Subst Abuse Rehabil. 2012 Jan 28;3(Suppl 1):59-69. doi: 10.2147/SAR.S21351. eCollection 2012.
- Background: PubMed 24934652Reed E, Myers B, Novak SP, Browne FA, Wechsberg WM. Experiences of violence and association with decreased drug abstinence among women in Cape Town, South Africa. AIDS Behav. 2015 Jan;19(1):192-8. doi: 10.1007/s10461-014-0820-1.
- Results publication: PubMed 23793683Wechsberg WM, Jewkes R, Novak SP, Kline T, Myers B, Browne FA, Carney T, Morgan Lopez AA, Parry C. A brief intervention for drug use, sexual risk behaviours and violence prevention with vulnerable women in South Africa: a randomised trial of the Women's Health CoOp. BMJ Open. 2013 May 28;3(5):e002622. doi: 10.1136/bmjopen-2013-002622.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Woman-Focused Intervention (Women's Health CoOp) and VCT Only in people with HIV and Substance Abuse, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in South Africa.
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 1 inclusion and 1 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction in substance abuse, sexual risk behaviors and victimization. (time frame: Baseline, 3-month, 6-month, 9-month and 12-month). 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 NCT00729391, which also lists 11 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 18 May 2017.