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Women-Focused HIV Prevention in the Western Cape (WC-WHC)

Primary Purpose

HIV, Substance Abuse, Violence

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Woman-Focused Intervention (Women's Health CoOp)
Nutrition (Attention-Control)
VCT Only
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Sexual Risk, Substance Abuse, Victimization, Violence, Voluntary Counseling and Testing (VCT)

Eligibility Criteria

18 Years - 33 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • If participants do not meet all of the inclusion criteria, they will be excluded from the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Women's CoOp

Nutrition (Attention-Control)

Voluntary Counseling and Testing

Outcomes

Primary Outcome Measures

Reduction in substance abuse, sexual risk behaviors and victimization.

Secondary Outcome Measures

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.

Full Information

First Posted
August 5, 2008
Last Updated
May 16, 2017
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT00729391
Brief Title
Women-Focused HIV Prevention in the Western Cape
Acronym
WC-WHC
Official Title
Women-Focused HIV Prevention in the Western Cape
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 26, 2008 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Medical Research Council, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance Abuse, Violence
Keywords
HIV, Sexual Risk, Substance Abuse, Victimization, Violence, Voluntary Counseling and Testing (VCT)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Women's CoOp
Arm Title
2
Arm Type
Active Comparator
Arm Description
Nutrition (Attention-Control)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Voluntary Counseling and Testing
Intervention Type
Behavioral
Intervention Name(s)
Woman-Focused Intervention (Women's Health CoOp)
Intervention Description
Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition (Attention-Control)
Intervention Description
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
Intervention Type
Behavioral
Intervention Name(s)
VCT Only
Intervention Description
Participants in this group will receive VCT only.
Primary Outcome Measure Information:
Title
Reduction in substance abuse, sexual risk behaviors and victimization.
Time Frame
Baseline, 3-month, 6-month, 9-month and 12-month
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: If participants do not meet all of the inclusion criteria, they will be excluded from the study.
Facility Information:
City
Cape Town
State/Province
Western Cape
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20308902
Citation
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.
Results Reference
background
PubMed Identifier
21473554
Citation
Wechsberg 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.
Results Reference
background
PubMed Identifier
21541067
Citation
Jones 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.
Results Reference
background
PubMed Identifier
25040338
Citation
Zule 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.
Results Reference
background
PubMed Identifier
24708789
Citation
Myers 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.
Results Reference
background
PubMed Identifier
23442318
Citation
Myers 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.
Results Reference
background
PubMed Identifier
23403403
Citation
Wechsberg 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.
Results Reference
background
PubMed Identifier
24648788
Citation
Reed 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.
Results Reference
background
PubMed Identifier
24474876
Citation
Johnson 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.
Results Reference
background
PubMed Identifier
24934652
Citation
Reed 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 Reference
background
PubMed Identifier
23793683
Citation
Wechsberg 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.
Results Reference
result

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Women-Focused HIV Prevention in the Western Cape

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