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Women-Focused HIV Prevention in the Western Cape
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), October 2008
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Medical Research Council, South Africa
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00729391
  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 III

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

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 ]

Estimated Enrollment: 900
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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.
2: Active Comparator Behavioral: Nutrition (Attention-Control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
3: Active Comparator 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; (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729391

Contacts
Contact: Wendee M Wechsberg, PhD 919-541-6422 wmw@rti.org
Contact: Bronwyn J Myers, PhD 27-21-938-0218 Bronwyn.Myers@mrc.ac.za

Locations
South Africa
Recruiting
Cape Town, South Africa
Contact: Wendee M Wechsberg, PhD     919-541-6422     wmw@rti.org    
Contact: Bronwyn J Myers, PhD     27-21-938-0218     Bronwyn.Myers@mrc.ac.za    
Sub-Investigator: Bronwyn Myers, PhD            
Sponsors and Collaborators
Medical Research Council, South Africa
  More Information

Publications:
Responsible Party: RTI International ( Wendee M. Wechsberg, Principal Investigator )
Study ID Numbers: R01HD058320
Study First Received: August 5, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00729391  
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)

Study placed in the following topic categories:
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 13, 2009