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
  Purpose

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.


Condition Intervention Phase
HIV
Substance Abuse
Violence
Behavioral: Woman-Focused Intervention (Women's CoOp)
Behavioral: Nutrition (Attention-Control)
Behavioral: VCT Only
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Women-Focused HIV Prevention in the Western Cape

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

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. [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]

Enrollment: 720
Study Start Date: September 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Women's CoOp
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.
Active Comparator: 2
Nutrition (Attention-Control)
Behavioral: Nutrition (Attention-Control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
Active Comparator: 3
Voluntary Counseling and Testing
Behavioral: VCT Only
Participants in this group will receive VCT only.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 33 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729391

Locations
South Africa
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Medical Research Council, South Africa
  More Information

Publications:
Responsible Party: Wendee M. Wechsberg, Principal Investigator, RTI International
ClinicalTrials.gov Identifier: NCT00729391     History of Changes
Other Study ID Numbers: R01HD058320
Study First Received: August 5, 2008
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
Sexual Risk
Substance Abuse
Victimization
Violence
Voluntary Counseling and Testing (VCT)

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014