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      The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

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          Abstract

          Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and test the impact of the intervention at scale on biological outcomes.

          Trial Registration

          ClinicalTrials.gov NCT02034214

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          Most cited references23

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          Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial.

          HIV infection and intimate-partner violence share a common risk environment in much of southern Africa. The aim of the Intervention with Microfinance for AIDS and Gender Equity (IMAGE) study was to assess a structural intervention that combined a microfinance programme with a gender and HIV training curriculum. Villages in the rural Limpopo province of South Africa were pair-matched and randomly allocated to receive the intervention at study onset (intervention group, n=4) or 3 years later (comparison group, n=4). Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks. Both arms of the trial were divided into three groups: direct programme participants or matched controls (cohort one), randomly selected 14-35-year-old household co-residents (cohort two), and randomly selected community members (cohort three). Primary outcomes were experience of intimate-partner violence--either physical or sexual--in the past 12 months by a spouse or other sexual intimate (cohort one), unprotected sexual intercourse at last occurrence with a non-spousal partner in the past 12 months (cohorts two and three), and HIV incidence (cohort three). Analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT00242957. In cohort one, experience of intimate-partner violence was reduced by 55% (adjusted risk ratio [aRR] 0.45, 95% CI 0.23-0.91; adjusted risk difference -7.3%, -16.2 to 1.5). The intervention did not affect the rate of unprotected sexual intercourse with a non-spousal partner in cohort two (aRR 1.02, 0.85-1.23), and there was no effect on the rate of unprotected sexual intercourse at last occurrence with a non-spousal partner (0.89, 0.66-1.19) or HIV incidence (1.06, 0.66-1.69) in cohort three. A combined microfinance and training intervention can lead to reductions in levels of intimate-partner violence in programme participants. Social and economic development interventions have the potential to alter risk environments for HIV and intimate-partner violence in southern Africa.
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            Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial.

            Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women. We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women. In this cluster randomised trial, never-married women aged 13-22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and randomly assigned with computer-generated random numbers by enumeration area (1:1) to receive cash payments (intervention group) or nothing (control group). Intervention enumeration areas were further randomly assigned with computer-generated random numbers to conditional (school attendance required to receive payment) and unconditional (no requirements to receive payment) groups. Participants in both intervention groups were randomly assigned by a lottery to receive monthly payments ranging from US$1 to $5, while their parents were independently assigned with computer-generated random numbers to receive $4-10. Behavioural risk assessments were done at baseline and 12 months; serology was tested at 18 months. Participants were not masked to treatment status but counsellors doing the serologic testing were. The primary outcomes were prevalence of HIV and herpes simplex virus 2 (HSV-2) at 18 months and were assessed by intention-to-treat analyses. The trial is registered, number NCT01333826. 88 enumeration areas were assigned to receive the intervention and 88 as controls. For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data, weighted HIV prevalence at 18 month follow-up was 1·2% (seven of 490 participants) in the combined intervention group versus 3·0% (17 of 799 participants) in the control group (adjusted odds ratio [OR] 0·36, 95% CI 0·14-0·91); weighted HSV-2 prevalence was 0·7% (five of 488 participants) versus 3·0% (27 of 796 participants; adjusted OR 0·24, 0·09-0·65). In the intervention group, we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence (3/235 [1%] vs 4/255 [2%]) or weighted HSV-2 prevalence (4/233 [1%] vs 1/255 [<1%]). For individuals who had already dropped out of school at baseline, we detected no significant difference between intervention and control groups for weighted HIV prevalence (23/210 [10%] vs 17/207 [8%]) or weighted HSV-2 prevalence (17/211 [8%] vs 17/208 [8%]). Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income settings. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies. Global Development Network, Bill & Melinda Gates Foundation, National Bureau of Economic Research Africa Project, World Bank's Research Support Budget, and several World Bank trust funds (Gender Action Plan, Knowledge for Change Program, and Spanish Impact Evaluation fund). Copyright © 2012 Elsevier Ltd. All rights reserved.
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              Understanding the impact of a microfinance-based intervention on women's empowerment and the reduction of intimate partner violence in South Africa.

              We sought to obtain evidence about the scope of women's empowerment and the mechanisms underlying the significant reduction in intimate partner violence documented by the Intervention With Microfinance for AIDS and Gender Equity (IMAGE) cluster-randomized trial in rural South Africa. The IMAGE intervention combined a microfinance program with participatory training on understanding HIV infection, gender norms, domestic violence, and sexuality. Outcome measures included past year's experience of intimate partner violence and 9 indicators of women's empowerment. Qualitative data about changes occurring within intimate relationships, loan groups, and the community were also collected. After 2 years, the risk of past-year physical or sexual violence by an intimate partner was reduced by more than half (adjusted risk ratio=0.45; 95% confidence interval=0.23, 0.91). Improvements in all 9 indicators of empowerment were observed. Reductions in violence resulted from a range of responses enabling women to challenge the acceptability of violence, expect and receive better treatment from partners, leave abusive relationships, and raise public awareness about intimate partner violence. Our findings, both qualitative and quantitative, indicate that economic and social empowerment of women can contribute to reductions in intimate partner violence.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2014
                21 November 2014
                : 9
                : 11
                : e113621
                Affiliations
                [1 ]Pangaea Global AIDS Foundation, Oakland, CA, United States of America
                [2 ]University of California San Francisco, Center for AIDS Prevention Studies, San Francisco, United States of America
                [3 ]University of California, School of Public Health, Berkeley, United States of America
                [4 ]Zimbabwe AIDS Prevention Program, Harare, Zimbabwe
                University of Ottawa, Canada
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: MD MKD NP. Performed the experiments: MD MKD IMM DN. Analyzed the data: MKD BL. Wrote the paper: MD MKD BL.

                Article
                PONE-D-13-49388
                10.1371/journal.pone.0113621
                4240618
                25415455
                187fb9c7-8d08-4f34-b3aa-e42ac2f6d471
                Copyright @ 2014

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 31 January 2014
                : 27 September 2014
                Page count
                Pages: 1
                Funding
                This research was funded by the National Institutes of Health ( www.nichd.nih.gov, Grant# 5 R01 HD04513-05) awarded to Megan S. Dunbar. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Biology and Life Sciences
                Microbiology
                Medical Microbiology
                Microbial Pathogens
                Viral Pathogens
                Immunodeficiency Viruses
                HIV
                Population Biology
                Medicine and health sciences
                Epidemiology
                Economic Epidemiology
                Health Care
                Socioeconomic Aspects of Health
                Infectious Diseases
                Sexually Transmitted Diseases
                Viral Diseases
                Public and occupational health
                Preventive medicine
                HIV prevention
                Social Sciences
                Sociology
                Sexual and Gender Issues

                Uncategorized
                Uncategorized

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