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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Medical Research Council, South Africa |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00729391 |
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 |
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HIV Substance Abuse Violence |
Behavioral: Woman-Focused Intervention (Women's CoOp) Behavioral: Nutrition (Attention-Control) Behavioral: VCT Only |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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 |
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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.
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2: Active Comparator |
Behavioral: Nutrition (Attention-Control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
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3: Active Comparator |
Behavioral: VCT Only
Participants in this group will receive VCT only.
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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.
Ages Eligible for Study: | 18 Years to 33 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
HIV Sexual Risk Substance Abuse |
Victimization Violence Voluntary Counseling and Testing (VCT) |
Mental Disorders HIV Infections Acquired Immunodeficiency Syndrome Substance-Related Disorders Disorders of Environmental Origin |