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Trial record 20 of 27 for:    " July 30, 2008":" August 29, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729391
First Posted: August 7, 2008
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Council, South Africa
Information provided by (Responsible Party):
Wendee Wechsberg, RTI International
  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 Health CoOp) Behavioral: Nutrition (Attention-Control) Behavioral: VCT Only Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Wendee Wechsberg, RTI International:

Primary Outcome Measures:
  • Reduction in substance abuse, sexual risk behaviors and victimization. [ Time Frame: Baseline, 3-month, 6-month, 9-month and 12-month ]

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 ]

Enrollment: 720
Actual Study Start Date: September 26, 2008
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Women's CoOp
Behavioral: 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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 33 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729391


Locations
South Africa
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical Research Council, South Africa
  More Information

Publications:

Responsible Party: Wendee Wechsberg, Principal Investigator, RTI International
ClinicalTrials.gov Identifier: NCT00729391     History of Changes
Other Study ID Numbers: R01HD058320 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2008
First Posted: August 7, 2008
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wendee Wechsberg, RTI International:
HIV
Sexual Risk
Substance Abuse
Victimization
Violence
Voluntary Counseling and Testing (VCT)

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders