Women-Focused HIV Prevention in the Western Cape

HIV Clinical Trial

— WC-WHC  

Official title:

Women-Focused HIV Prevention in the Western Cape

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729391
• Other study ID #: R01HD058320
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 5, 2008
• Last updated: May 16, 2017
• Start date: September 26, 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2017
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 33 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Substance Abuse
• Substance-Related Disorders
• Violence

Intervention

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.
• Nutrition (Attention-Control)
Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.
• VCT Only
Participants in this group will receive VCT only.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (11)

Browne FA, Wechsberg WM. The intersecting risks of substance use and HIV risk among substance-using South African men and women. Curr Opin Psychiatry. 2010 May;23(3):205-9. doi: 10.1097/YCO.0b013e32833864eb. Review. — View Citation

Johnson JE, Carney T, Kline T, Browne FA, Wechsberg WM. Incarceration history relative to health, substance use, and violence in a sample of vulnerable South African women: implications for health services in criminal justice settings. Subst Abuse Rehabil. 2012 Jan 28;3(Suppl 1):59-69. doi: 10.2147/SAR.S21351. eCollection 2012. — View Citation

Jones HE, Browne FA, Myers BJ, Carney T, Ellerson RM, Kline TL, Poulton W, Zule WA, Wechsberg WM. Pregnant and nonpregnant women in cape town, South Africa: drug use, sexual behavior, and the need for comprehensive services. Int J Pediatr. 2011;2011:353410. doi: 10.1155/2011/353410. Epub 2011 Apr 6. — View Citation

Myers B, Kline TL, Browne FA, Carney T, Parry C, Johnson K, Wechsberg WM. Ethnic differences in alcohol and drug use and related sexual risks for HIV among vulnerable women in Cape Town, South Africa: implications for interventions. BMC Public Health. 2013 Feb 26;13:174. doi: 10.1186/1471-2458-13-174. — View Citation

Myers B, Kline TL, Doherty IA, Carney T, Wechsberg WM. Perceived need for substance use treatment among young women from disadvantaged communities in Cape Town, South Africa. BMC Psychiatry. 2014 Apr 4;14:100. doi: 10.1186/1471-244X-14-100. — View Citation

Reed E, Emanuel AN, Myers B, Johnson K, Wechsberg WM. The relevance of social contexts and social action in reducing substance use and victimization among women participating in an HIV prevention intervention in Cape Town, South Africa. Subst Abuse Rehabil. 2013 Jun 28;4:55-64. doi: 10.2147/SAR.S45961. eCollection 2013. — View Citation

Reed E, Myers B, Novak SP, Browne FA, Wechsberg WM. Experiences of violence and association with decreased drug abstinence among women in Cape Town, South Africa. AIDS Behav. 2015 Jan;19(1):192-8. doi: 10.1007/s10461-014-0820-1. — View Citation

Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. — View Citation

Wechsberg WM, Jewkes R, Novak SP, Kline T, Myers B, Browne FA, Carney T, Morgan Lopez AA, Parry C. A brief intervention for drug use, sexual risk behaviours and violence prevention with vulnerable women in South Africa: a randomised trial of the Women's H — View Citation

Wechsberg WM, Myers B, Kline TL, Carney T, Browne FA, Novak SP. The Relationship of Alcohol and Other Drug Use Typologies to Sex Risk Behaviors among Vulnerable Women in Cape Town, South Africa. J AIDS Clin Res. 2012 Jul 20;S1(15). pii: 015. — View Citation

Zule W, Myers B, Carney T, Novak SP, McCormick K, Wechsberg WM. Alcohol and drug use outcomes among vulnerable women living with HIV: results from the Western Cape Women's Health CoOp. AIDS Care. 2014;26(12):1494-9. doi: 10.1080/09540121.2014.933769. Epub 2014 Jul 21. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in substance abuse, sexual risk behaviors and victimization.		Baseline, 3-month, 6-month, 9-month and 12-month
Secondary	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.		6 and 12 month