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Objective To assess the impact of Stepping Stones, a HIV prevention programme, on incidence of HIV and herpes simplex type 2 (HSV-2) and sexual behaviour.Design Cluster randomised controlled trial.Setting 70 villages (clusters) in the Eastern Cape province of South Africa.Participants 1360 men and 1416 women aged 15-26 years, who were mostly attending schools.Intervention Stepping Stones, a 50 hour programme, aims to improve sexual health by using participatory learning approaches to build knowledge, risk awareness, and communication skills and to stimulate critical reflection. Villages were randomised to receive either this or a three hour intervention on HIV and safer sex. Interviewers administered questionnaires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2.Main outcome measures Primary outcome measure: incidence of HIV. Other outcomes: incidence of HSV-2, unwanted pregnancy, reported sexual practices, depression, and substance misuse.Results There was no evidence that Stepping Stones lowered the incidence of HIV (adjusted incidence rate ratio 0.95, 95% confidence interval 0.67 to 1.35). The programme was associated with a reduction of about 33% in the incidence of HSV-2 (0.67, 0.46 to 0.97; P=0.036)—that is, Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 (1.6 to 68.2) per 1000 people exposed. Stepping Stones significantly improved a number of reported risk behaviours in men, with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months. In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months.Conclusion Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV—notably, HSV-2 and perpetration of intimate partner violence.Trial Registration Clinical Trials NCT00332878.

Background Mobile Technology and Incentives (MOTIVES) is a randomized pilot study of a mobile technology-based and behavioral economics-supported HIV prevention intervention. Behavioral economics (BE) uses financial incentives in a way that departs from the traditional focus on large monetary payments. Instead, BE suggests that relatively small “nudges” can effectively initiate and sustain behavior change. This pilot study examines the feasibility and acceptability of an HIV prevention intervention that uses text messages in combination with BE incentives to improve retention of HIV prevention information and increase frequency of HIV testing among Latino/a men who have sex with men (MSM) and transgender women (TGW). The pilot will also estimate mission-critical design parameters with point and confidence interval estimates of the intervention to inform a future, fully powered effectiveness study. Methods The project will be conducted in collaboration with Bienestar Human Services, Inc. ( Bienestar ), a non-profit community-based service organization. The intervention is being tested in a small, randomized controlled trial to pilot the intervention’s feasibility and acceptability among 200 Latino/a MSM and TGW from Bienestar ’s HIV testing sites. Information on feasibility will include recruitment, refusal, and retention rates as well as message sending success rates; acceptability will include perceived appropriateness based on responses to the intervention. Participants will be randomized into either the “information only” control group (e.g. receiving text messages with HIV prevention information) or the “information plus” intervention group (e.g. additionally receiving quiz questions that provide the possibility of winning prizes). Participants will be followed for 12 months from enrollment. In addition to using data abstracted from Bienestar ’s routine data collection mechanisms, we will also collect survey data (blinded outcome assessment) from participants at 0, 6, and 12 months to provide an initial assessment of whether incentives affect their level of HIV knowledge and testing frequency. Discussion If shown to be acceptable, feasible, and resource-efficient, MOTIVES will provide an innovative way to communicate the latest HIV prevention information and support trimestral HIV screening among Latino/a MSM and TGW. Trial registration ClinicalTrials.gov, NCT03144336 . Registered on 5 May 2017.

Black women in community supervision programs (CSPs) are disproportionately affected by HIV and other sexually transmitted infections (STIs). A randomized controlled trial of a group intervention titled Empowering African-American Women on the Road to Health (E-WORTH) demonstrated effectiveness in reducing sexual risk behaviors and STI incidence among Black women in CSPs. This secondary analysis aimed to assess the moderating effects of housing status and food security on E-WORTH effectiveness in reducing sexual risk behaviors and cumulative incidence of STIs over a 12-month period which were found significant in the original trial among a sample of 351 Black women in CSPs in New York City who use drugs and/or engage in binge drinking who reported engaging in HIV risk behaviors or testing positive for HIV. We examined the moderating effects of housing stability, housing independence, and food insecurity on reducing cumulative STI incidence and number of unprotected sex acts using mixed-effects negative binomial regression and logistic regression models that controlled for age, high school education, employment status, and marital status. Findings indicate that the intervention effect was moderated by housing stability, but not housing independence or food security. Compared to the control group, E-WORTH participants who were housing insecure had 63% fewer acts of condomless sex. Our findings highlight the importance of interventions designed for women in CSPs that account for upstream determinants of health and include service linkages to basic needs provisions. Further research is needed to unpack the cumulative impacts of multiple experiences of poverty faced by this population.

Background This paper describes the study protocol of a hybrid type I randomized controlled trial that evaluates the effectiveness and cost-effectiveness of implementing Empowering African-American Women on the Road to Health (E-WORTH), an Afrocentric, group-based, computerized human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention intervention for controlled substance-using black women in community corrections settings in New York City. Methods/design We provide an overview of E-WORTH’s hybrid type I design, which is guided by the Consolidated Framework for Implementation Research (CFIR). E-WORTH combines HIV/STI and intimate partner violence (IPV) prevention components and tests the comparative effectiveness of E-WORTH and streamlined HIV testing versus streamlined HIV testing alone in decreasing biologically confirmed HIV and STI incidence, sexual risk, and IPV, as well as in improving access to HIV and STI prevention services and care. Discussion This paper provides an overview of E-WORTH’s intervention protocol and serves as a framework for using hybrid type I designs, guided by the CFIR conceptual framework, to evaluate HIV/STI and IPV prevention interventions in community corrections settings. We discuss how E-WORTH’s hybrid type I design advances implementation science through its effectiveness and cost-effectiveness aims as well as through a mixed-methods study that evaluates multilevel theory-driven factors (structural, organizational, staffing, and client) guided by the CFIR that influences the implementation of E-WORTH in a criminal justice setting. This study also addresses the novel challenges and opportunities of implementing an intervention that targets specific racial subgroup(s) in a community corrections setting that services all populations, implementing a group-based intervention with technological components in such settings, and employing community-based participatory research strategies to guide recruitment and retention efforts. Trial registration ClinicalTrials.gov, NCT02391233 . Registered on 17 March 2015.

The Global Burden of Diseases, Injuries, and Risk Factors Study 2015 provides an up-to-date synthesis of the evidence for risk factor exposure and the attributable burden of disease. By providing national and subnational assessments spanning the past 25 years, this study can inform debates on the importance of addressing risks in context. We used the comparative risk assessment framework developed for previous iterations of the Global Burden of Disease Study to estimate attributable deaths, disability-adjusted life-years (DALYs), and trends in exposure by age group, sex, year, and geography for 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks from 1990 to 2015. This study included 388 risk-outcome pairs that met World Cancer Research Fund-defined criteria for convincing or probable evidence. We extracted relative risk and exposure estimates from randomised controlled trials, cohorts, pooled cohorts, household surveys, census data, satellite data, and other sources. We used statistical models to pool data, adjust for bias, and incorporate covariates. We developed a metric that allows comparisons of exposure across risk factors—the summary exposure value. Using the counterfactual scenario of theoretical minimum risk level, we estimated the portion of deaths and DALYs that could be attributed to a given risk. We decomposed trends in attributable burden into contributions from population growth, population age structure, risk exposure, and risk-deleted cause-specific DALY rates. We characterised risk exposure in relation to a Socio-demographic Index (SDI). Between 1990 and 2015, global exposure to unsafe sanitation, household air pollution, childhood underweight, childhood stunting, and smoking each decreased by more than 25%. Global exposure for several occupational risks, high body-mass index (BMI), and drug use increased by more than 25% over the same period. All risks jointly evaluated in 2015 accounted for 57·8% (95% CI 56·6–58·8) of global deaths and 41·2% (39·8–42·8) of DALYs. In 2015, the ten largest contributors to global DALYs among Level 3 risks were high systolic blood pressure (211·8 million [192·7 million to 231·1 million] global DALYs), smoking (148·6 million [134·2 million to 163·1 million]), high fasting plasma glucose (143·1 million [125·1 million to 163·5 million]), high BMI (120·1 million [83·8 million to 158·4 million]), childhood undernutrition (113·3 million [103·9 million to 123·4 million]), ambient particulate matter (103·1 million [90·8 million to 115·1 million]), high total cholesterol (88·7 million [74·6 million to 105·7 million]), household air pollution (85·6 million [66·7 million to 106·1 million]), alcohol use (85·0 million [77·2 million to 93·0 million]), and diets high in sodium (83·0 million [49·3 million to 127·5 million]). From 1990 to 2015, attributable DALYs declined for micronutrient deficiencies, childhood undernutrition, unsafe sanitation and water, and household air pollution; reductions in risk-deleted DALY rates rather than reductions in exposure drove these declines. Rising exposure contributed to notable increases in attributable DALYs from high BMI, high fasting plasma glucose, occupational carcinogens, and drug use. Environmental risks and childhood undernutrition declined steadily with SDI; low physical activity, high BMI, and high fasting plasma glucose increased with SDI. In 119 countries, metabolic risks, such as high BMI and fasting plasma glucose, contributed the most attributable DALYs in 2015. Regionally, smoking still ranked among the leading five risk factors for attributable DALYs in 109 countries; childhood underweight and unsafe sex remained primary drivers of early death and disability in much of sub-Saharan Africa. Declines in some key environmental risks have contributed to declines in critical infectious diseases. Some risks appear to be invariant to SDI. Increasing risks, including high BMI, high fasting plasma glucose, drug use, and some occupational exposures, contribute to rising burden from some conditions, but also provide opportunities for intervention. Some highly preventable risks, such as smoking, remain major causes of attributable DALYs, even as exposure is declining. Public policy makers need to pay attention to the risks that are increasingly major contributors to global burden. Bill & Melinda Gates Foundation.

Fear appeal approach has been used in health promotion, but its effectiveness has been mixed. It has not been well applied to HIV prevention among men who have sex with men (MSM). The present study developed and evaluated the relative efficacy of three online interventions (SC: STD-related cognitive approach, SCFI: STD-related cognitive plus fear appeal imagery approach, Control: HIV-related information based approach) in reducing prevalence of unprotected anal intercourse (UAI) among 396 MSM using a randomized controlled trial design. Participants’ levels of fear-related emotions immediately after watching the assigned intervention materials were also assessed. Participants were evaluated at baseline and 3 months after the intervention. Results showed that participants in the SCFI scored significantly higher in the instrument assessing fear after the watching the intervention materials. However, no statistically significant differences were found across the three groups in terms of UAI at Month 3. Some significant within-group reductions in some measures of UAI were found in three groups. Further studies are warranted to test the role of fear appeal in HIV prevention.

Background Economic vulnerability, such as homelessness and unemployment, contributes to the HIV risk among racial minorities in the U.S., who are disproportionately infected. Yet, few economic-strengthening interventions have been adapted for HIV prevention in economically-vulnerable African-American young adults. Engaging Microenterprise for Resource Generation and Health Empowerment (EMERGE) is a feasibility randomized clinical trial of an HIV prevention microenterprise intervention with integrated text messages (“nudges”) that are informed by behavioral economic principles. The trial aims to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. Methods/design In total, 40 young adults who are African-American, aged 18–24, live in Baltimore City, have experienced at least one episode of homelessness in the last 12 months, are unemployed or underemployed (fewer than 10 h per week), are not enrolled in school, own a cell phone with text messaging, and report at least one episode of unprotected or unsafe sex in the prior 12 months will be recruited from two community-based organizations providing residential supportive services to urban youth. Participants will undergo a 3-week run-in period and thereafter be randomly assigned to one of two groups with active interventions for 20 weeks. The first group (“comparison”) will receive text messages with information on job openings. The second group (“experimental”) will receive text messages with information on job openings plus information on HIV prevention and business educational sessions, a mentored apprenticeship, and a start-up grant, and business and HIV prevention text messages based on principles from behavioral economics. The two primary outcomes relate to the feasibility of conducting a larger trial. Secondary outcomes relate to employment, sexual risk behaviors, and HIV preventive practices. All participants will be assessed using an in-person questionnaire at pre-intervention (prior to randomization) and at 3 weeks post-intervention. To obtain repeated, longitudinal measures, participants will be assessed weekly using text message surveys from pre-intervention up to 3 weeks post-intervention. Discussion This study will be one of the first U.S.-based feasibility randomized clinical trials of an HIV prevention microenterprise intervention for economically-vulnerable African-American young adults. The findings will inform whether and how to conduct a larger efficacy trial for HIV risk reduction in this population. Trial registration ClinicalTrials.gov, NCT03766165 . Registered on 4 December 2018.

This study examined longitudinal acculturation patterns, and their associations with family functioning and adolescent risk behaviors, in Hispanic immigrant families. A sample of 266 Hispanic adolescents (M age = 13.4) and their primary parents completed measures of acculturation, family functioning, and adolescent conduct problems, substance use, and sexual behavior at five timepoints. Mixture models yielded three trajectory classes apiece for adolescent and parent acculturation. Assimilated adolescents reported the poorest family functioning, but adolescent assimilation negatively predicted adolescent cigarette smoking, sexual activity, and unprotected sex indirectly through family functioning. Follow-up analyses indicated that discrepancies between adolescent and parent family functioning reports predicted these adolescent outcomes. Results are discussed regarding acculturation trajectories, adolescent risk behavior, and the mediating role of family functioning.

Alcohol use is a key risk factor for HIV infection among men who have sex with men (MSM). Past studies show that brief motivational interventions (BMI) can increase the use of prevention methods (e.g., condoms), reduce alcohol use, and can be adapted for web-based delivery. However, few studies have explored these interventions’ effects in MSM. Forty high-risk, heavy drinking MSM who sought rapid HIV testing were randomly assigned to receive either (1) standard post-test counseling (SPC) alone, or (2) SPC plus Game Plan (GP), a tablet tablet-based BMI for alcohol use and HIV risk. Over three months of follow-up, GP participants reported 24% fewer heavy drinking days, 17% fewer alcohol problems, and 50% fewer new anal sex partners than controls. GP participants also reported fewer high-risk condomless anal sex events than controls, but these differences were not significant. These initial results suggest that web-based BMIs may be promising tools to help MSM reduce health risk behaviors.

Black men who have sex with men (MSM) in the United States experience disproportionately high rates of HIV and other sexually transmitted infections (STIs); however, the number of evidence-based interventions for Black MSM is limited. This study evaluated the efficacy of Many Men, Many Voices (3MV), a small-group HIV/STI prevention intervention developed by Black MSM-serving community-based organizations and a university-based HIV/STI prevention and training program. The study sample included 338 Black MSM of HIV-negative or unknown HIV serostatus residing in New York city. Participants were randomly assigned to the 3MV intervention condition (n = 164) or wait-list comparison condition (n = 174). Relative to comparison participants, 3MV participants reported significantly greater reductions in any unprotected anal intercourse with casual male partners; a trend for consistent condom use during receptive anal intercourse with casual male partners; and significantly greater reductions in the number of male sex partners and greater increases in HIV testing. This study is the first randomized trial to demonstrate the efficacy of an HIV/STI prevention intervention for Black MSM.