The biobehavioral Women's Health CoOp in Pretoria, South Africa: study protocol for a cluster-randomized design.

BACKGROUND: South Africa has 6.4 million adults over the age of 15 living with HIV. Gender inequality issues continue to drive the HIV epidemic in South Africa, where Black African women bear the greatest HIV burden. Limited access to services; little capacity to negotiate sex and condom use; and other legal, social, and economic inequities make women highly vulnerable to HIV infection. Behavioral interventions have been shown to decrease risk behaviors, but they have been less successful in reducing HIV incidence. Conversely, biomedical prevention strategies have proven to be successful in reducing HIV incidence, but require behavioral interventions to increase uptake and adherence. Consequently, there is a need for integrated approaches that combine biomedical and behavioral interventions. Effective combination prevention efforts should comprise biomedical, behavioral, and structural programming proven in randomized trials that focuses on the driving forces and key populations at higher risk of HIV infection and transmission. METHODS/DESIGN: This prospective, geographically clustered randomized field experiment is enrolling participants into two arms: a control arm that receives standard HIV testing and referral for treatment; and an intervention arm that receives an evidence-based, woman-focused behavioral intervention that emphasizes risk reduction and retention, the Women's Health CoOp. We divided the city of Pretoria into 14 mutually exclusive geographic zones and randomized these zones into either the control arm or the intervention arm. Outreach workers are recruiting drug-using women from each zone. At baseline, eligible participants complete a questionnaire and biological testing for HIV, recent drug use, and pregnancy. Follow-up interviews are completed at 6 and 12 months. DISCUSSION: The biobehavioral intervention in this study merges an efficacious behavioral HIV prevention intervention for women with biomedical prevention through HIV treatment as prevention using a Seek, Test, Treat and Retain strategy. This combination biobehavioral intervention is designed to (1) improve the quality of life and reduce HIV infectiousness among women who are HIV positive, and (2) reduce HIV risk behaviors among women regardless of their HIV status. If efficacious, this intervention could help control the HIV epidemic in South Africa. TRIAL REGISTRATION: Trial registration no: NCT01497405.

Addressing the nexus of risk: Biobehavioral outcomes from a cluster randomized trial of the Women's Health CoOp Plus in Pretoria, South Africa.

BACKGROUND: HIV prevalence has increased among South African women who use alcohol and other drugs (AOD). However, HIV prevention and treatment efforts have not focused on this population. This study presents the efficacy of the Women's Health CoOp Plus (WHC+) in a cluster-randomized trial to reduce AOD use, gender-based violence, and sexual risk and to increase linkage to HIV care among women who use AODs, compared with HIV counseling and testing alone. METHODS: Black African women (N = 641) were recruited from 14 geographic clusters in Pretoria, South Africa, and underwent either an evidence-based gender-focused HIV prevention intervention that included HIV counseling and testing (WHC+) or HIV counseling and testing alone. Participants were assessed at baseline, 6-months, and 12-months post enrollment. RESULTS: At 6-month follow-up, the WHC+ arm (vs. HCT) reported more condom use with a main partner and sexual negotiation, less physical and sexual abuse by a boyfriend, and less frequent heavy drinking (ps < 0.05). At 12-month follow-up, the WHC+ arm reported less emotional abuse (p < 0.05). Among a subsample of women, the WHC+ arm was significantly more likely to have a non-detectable viral load (measured by dried blood spots; p = 0.01). CONCLUSION: The findings demonstrate the WHC+'s efficacy to reduce HIV risk among women who use AODs in South Africa. Substance abuse rehabilitation centers and health centers that serve women may be ideal settings to address issues of gender-based violence and sexual risk as women engage in substance use treatment, HIV testing, or HIV care.