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The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

ABSTRACT: HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe.Thirty rural communities were randomized to early or deferred implementation of the intervention in 2003. Impact was assessed in a representative survey of 18-22-year-olds after 4 years. Participants self-completed a questionnaire and gave a dried blood spot sample for HIV and herpes simplex virus-2 (HSV-2) antibody testing. Young women had a urinary pregnancy test. Analyses were by intention-to-treat and were adjusted for clustering.Four thousand six hundred and eighty-four, 18-22-year-olds participated in the survey (97.1% of eligible candidates, 55.5% women). Just over 40% had been exposed to at least 10 intervention sessions. There were modest improvements in knowledge and attitudes among young men and women in intervention communities, but no impact on self-reported sexual behavior. There was no impact of the intervention on prevalence of HIV or HSV-2 or current pregnancy. Women in intervention communities were less likely to report ever having been pregnant.Despite an impact on knowledge, some attitudes, and reported pregnancy, there was no impact of this intervention on HIV or HSV-2 prevalence, further evidence that behavioral interventions alone are unlikely to be sufficient to reverse the HIV epidemic. The challenge remains to find effective HIV prevention approaches for young people in the face of continued and unacceptably high HIV incidence, particularly among young women.

SUBMITTER: Cowan FM

PROVIDER: S-EPMC3058934 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

Cowan Frances M FM Pascoe Sophie J S SJ Langhaug Lisa F LF Mavhu Webster W Chidiya Samson S Jaffar Shabbar S Mbizvo Michael T MT Stephenson Judith M JM Johnson Anne M AM Power Robert M RM Woelk Godfrey G Hayes Richard J RJ

AIDS (London, England) 20101001 16

<h4>Background</h4>HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe.<h4>Methods</h4>Thirty rural communities were randomized to early or deferred implementation of the interventio ...[more]

PMID: 20881473

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Project description:ImportanceThe incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group.ObjectiveTo determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years.Design, setting, and participantsRandomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach.InterventionsParticipants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time- and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.Main outcomes and measuresPrimary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits.ResultsOf the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001).Conclusions and relevanceAmong YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW.Trial registrationClinicalTrials.gov Identifier: NCT01575938.

Project description:UnlabelledAdolescent 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 registrationClinicalTrials.gov NCT02034214.

Project description:Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers.The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat.Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way mHealth programs have yet to be tested for HIV prevention in a community-based setting with this population.ClinicalTrials.gov NCT02437123 https://clinicaltrials.gov/show/NCT02437123 (registered 4 May 2015). Protocol version: 24 July 2015.

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The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

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The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

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