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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00729391
First received: August 5, 2008
Last updated: May 12, 2011
Last verified: April 2011

August 5, 2008
May 12, 2011
September 2008
March 2012   (final data collection date for primary outcome measure)
Reduction in substance abuse, sexual risk behaviors and victimization. [ Time Frame: Baseline, 3-month, 6-month, 9-month and 12-month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729391 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Women-Focused HIV Prevention in the Western Cape
Women-Focused HIV Prevention in the Western Cape

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Substance Abuse
  • Violence
  • Behavioral: Woman-Focused Intervention (Women's CoOp)
    Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.
  • Behavioral: Nutrition (Attention-Control)
    Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
  • Behavioral: VCT Only
    Participants in this group will receive VCT only.
  • Experimental: 1
    Women's CoOp
    Intervention: Behavioral: Woman-Focused Intervention (Women's CoOp)
  • Active Comparator: 2
    Nutrition (Attention-Control)
    Intervention: Behavioral: Nutrition (Attention-Control)
  • Active Comparator: 3
    Voluntary Counseling and Testing
    Intervention: Behavioral: VCT Only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
720
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 33 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00729391
R01HD058320
No
Wendee M. Wechsberg, Principal Investigator, RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical Research Council, South Africa
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP