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A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men's use of violence in periurban South Africa: study protocol.

ABSTRACT: OBJECTIVE:This paper describes the design and methods of a cluster randomised controlled trial (C-RCT) to determine the effectiveness of a community mobilisation intervention that is designed to reduce the perpetration of violence against women (VAW). METHODS AND ANALYSIS:A C-RCT of nine intervention and nine control clusters is being carried out in a periurban, semiformal settlement near Johannesburg, South Africa, between 2016 and 2018. A community mobilisation and advocacy intervention, called Sonke CHANGE is being implemented over 18 months. It comprises local advocacy and group activities to engage community members to challenge harmful gender norms and reduce VAW. The intervention is hypothesised to improve equitable masculinities, reduce alcohol use and ultimately, to reduce VAW. Intervention effectiveness will be determined through an audio computer-assisted self-interview questionnaire with behavioural measures among 2600 men aged between 18 and 40 years at baseline, 12 months and 24 months. The primary trial outcome is men's use of physical and/or?sexual VAW. Secondary outcomes include harmful alcohol use, gender attitudes, controlling behaviours, transactional sex and social cohesion. The main analysis will be intention-to-treat based on the randomisation of clusters. A qualitative process evaluation is being conducted alongside the C-RCT. Implementers and men participating in the intervention will be interviewed longitudinally over the period of intervention implementation and observations of the workshops and other intervention activities are being carried out. ETHICS AND DISSEMINATION:Ethical approval was obtained from the University of the Witwatersrand Human Research Ethics Committee and procedures comply with ethical recommendations of the United Nations Multi-Country Study on Men and Violence. Dissemination of research findings will take place with local stakeholders and through peer-reviewed publications, with data available on request or after 5 years of trial completion. TRIAL REGISTRATION NUMBER:NCT02823288; Pre-result.

SUBMITTER: Christofides NJ

PROVIDER: S-EPMC5875651 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men's use of violence in periurban South Africa: study protocol.

Christofides Nicola J NJ Hatcher Abigail M AM Pino Angelica A Rebombo Dumisani D McBride Ruari Santiago RS Anderson Althea A Peacock Dean D

BMJ open 20180323 3

<h4>Objective</h4>This paper describes the design and methods of a cluster randomised controlled trial (C-RCT) to determine the effectiveness of a community mobilisation intervention that is designed to reduce the perpetration of violence against women (VAW).<h4>Methods and analysis</h4>A C-RCT of nine intervention and nine control clusters is being carried out in a periurban, semiformal settlement near Johannesburg, South Africa, between 2016 and 2018. A community mobilisation and advocacy inte ...[more]

PMID: 29574438

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Project description:BackgroundCommunity mobilisation, engaging communities in a process to collectively enact change, could improve HIV testing and care engagement. In South Africa, current rates fall below those needed for epidemic control. We assessed whether community mobilisation increased HIV testing, linkage to care, and retention in care over time in intervention relative to control communities.MethodsWe conducted a cluster-randomised controlled trial in villages in the Agincourt sub-district of the rural Mpumalanga Province in South Africa. 15 villages were randomly assigned to either a community mobilisation intervention engaging residents to address social barriers to HIV testing and treatment (intervention arm) or to a control arm using balanced randomisation. Villages were eligible if they had been fully enumerated in 2014, had not been included in previous mobilisation activities, and included over 500 permanent adult residents aged 18-49 years. Primary outcomes included quarterly rates of HIV testing, linkage to care, and retention in care documented from health facility records among residents of the intervention and control communities over the 3-year study period. Intention-to-treat analyses employed generalised estimating equations stratified by sex. This trial is registered with ClinicalTrials.gov, NCT02197793.FindingsBetween Aug 1, 2015, and July 31, 2018, residents in eight intervention communities (n=20 544 residents) and seven control communities (n=17 848) contributed data; 92 residents contributed to both arms. Among men, HIV testing increased quarterly by 12·1% (relative change [RC] 1·121, 95% CI 1·099 to 1·143, p<0·0001) in the intervention communities and 9·5% (1·095, 1·075 to 1·114, p=0·011) in the control communities; although increases in testing were greater in the intervention villages, differences did not reach significance (exponentiated interaction coefficient 1·024, 95% CI 0·997 to 1·052, p=0·078). Among women, HIV testing increased quarterly by 10·6% (RC 1·106, 95% CI 1·097 to 1·114, p<0·0001) in the intervention communities and 9·3% (1·093, 1·084 to 1·102, p=0·053) in the control communities; increases were greater in intervention communities (exponentiated interaction coefficient 1·012, 95% CI 1·001 to 1·023, p=0·043). Quarterly linkage increased significantly among women in the intervention communities (RC 1·013, 95% CI 1·002 to 1·023, p=0·018) only. Quarterly linkage fell among men in both arms, but decreased significantly among men in the control communities (0·977, 0·954 to 1·002, p=0·043). Quarterly retention fell among women in both arms; however, reductions were tempered among women in the intervention communities (exponentiated interaction coefficient 1·003, 95% CI <1·000 to 1·006, p=0·062). Retention fell significantly among men in both arms with difference in rates of decline.InterpretationCommunity mobilisation was associated with modest improvements in select trial outcomes. The sum of these incremental, quarterly improvements achieved by addressing social barriers to HIV care engagement can impact epidemic control. However, achieving optimal impacts will probably require integrated efforts addressing both social barriers through community mobilisation and provision of improved service delivery.FundingUS National Institutes of Health, National Institute of Mental Health, and United States President's Emergency Plan for AIDS Relief through Right to Care and Project SOAR.

Project description:BACKGROUND:Men's perpetration of intimate partner violence (IPV) limits gains in health and wellbeing for populations globally. Largely informal, rapidly expanding peri-urban settlements, with limited basic services such as electricity, have high prevalence rates of IPV. Evidence on how to reduce men's perpetration, change social norms and patriarchal attitudes within these settings is limited. Our cluster randomised controlled trial aimed to determine the effectiveness of the Sonke CHANGE intervention in reducing use of sexual and/or physical IPV and severity of perpetration by men aged 18-40?years over 2 years. METHODOLOGY:The theory-based intervention delivered activities to bolster community action, including door-to-door discussions, workshops, drawing on the CHANGE curriculum, and deploying community action teams over 18?months. In 2016 and 2018, we collected data from a cohort of men, recruited from 18 clusters; nine were randomised to receive the intervention, while the nine control clusters received no intervention. A self-administered questionnaire, using audio-computer assisted software, asked about sociodemographics, gender attitudes, mental health, and the use and severity of IPV. We conducted an intention-to-treat analysis at the cluster level comparing the expected risk to observed risk of using IPV while controlling for baseline characteristics. A secondary analysis used latent classes (LCA) of men to see whether there were differential effects of the intervention for subgroups of men. RESULTS:Of 2406 men recruited, 1458 (63%) were followed to 2 years. Overall, we saw a reduction in men's reports of physical, sexual and severe IPV from baseline to endpoint (40.2% to 25.4%, 31.8% to 15.8%, and 33.4% to 18.2%, respectively). Intention-to-treat analysis showed no measurable differences between intervention and control clusters for primary IPV outcomes. Difference in the cluster-level proportion of physical IPV perpetration was 0.002 (95% confidence interval [CI] -?0.07 to 0.08). Similarly, differences between arms for sexual IPV was 0.01 (95% CI -?0.04 to 0.06), while severe IPV followed a similar pattern (Diff?=?0.01; 95% CI -?0.05 to 0.07). A secondary analysis using LCA suggests that among the men living in intervention communities, there was a greater reduction in IPV among less violent and more law abiding men than among more highly violent men, although the differences did not reach statistical significance. CONCLUSION:The intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents. Further analysis showed it was unable to transform entrenched gender attitudes and use of IPV by those men who use the most violence, but the intervention showed promise for men who use violence less. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02823288. Registered on 30 June 2016.

Project description:ObjectiveTo determine whether advocacy targeted at local politicians leads to action to reduce the risk of pedestrian injury in deprived areas.DesignCluster randomised controlled trial.Setting239 electoral wards in 57 local authorities in England and Wales.Participants617 elected local politicians.InterventionsIntervention group politicians were provided with tailored information packs, including maps of casualty sites, numbers injured and a synopsis of effective interventions.Main outcome measures25-30 months post intervention, primary outcomes included: electoral ward level: percentage of road traffic calmed; proportion with new interventions; school level: percentage with 20 mph zones, Safe Routes to School, pedestrian training or road safety education; politician level: percentage lobbying for safety measures. Secondary outcomes included politicians' interest and involvement in injury prevention, and facilitators and barriers to implementation.ResultsPRIMARY OUTCOMES DID NOT SIGNIFICANTLY DIFFER: % difference in traffic calming (0.07, 95%CI: -0.07 to 0.20); proportion of schools with 20 mph zones (RR 1.47, 95%CI: 0.93 to 2.32), Safe Routes to School (RR 1.34, 95%CI: 0.83 to 2.17), pedestrian training (RR 1.23, 95%CI: 0.95 to 1.61) or other safety education (RR 1.16, 95%CI: 0.97 to 1.39). Intervention group politicians reported greater interest in child injury prevention (RR 1.09, 95%CI 1.03 to 1.16), belief in potential to help prevent injuries (RR 1.36, 95%CI 1.16 to 1.61), particularly pedestrian safety (RR 1.55, 95%CI 1.19 to 2.03). 63% of intervention politicians reported supporting new pedestrian safety schemes. The majority found the advocacy information surprising, interesting, effectively presented, and could identify suitable local interventions.ConclusionsThis study demonstrates the feasibility of an innovative approach to translational public health by targeting local politicians in a randomised controlled trial. The intervention package was positively viewed and raised interest but changes in interventions were not statistically significance. Longer term supported advocacy may be needed.Trial registrationCurrent Controlled Trials ISRCTN91381117.

Project description:BackgroundWith 7.7 million South Africans currently infected with human immunodeficiency virus (HIV) and 4.8 million currently receiving antiretroviral treatment (ART), the epidemic represents a considerable burden for the country's resource-limited health system. In response to the health and human resource shortages, task shifting to community health workers (CHWs) and empowering people living with HIV (PLWH) are integral parts of a sustainable ART strategy. Despite the success of the ART programme, South Africa still faces both prevention and treatment challenges. To tackle these challenges, future endeavours need to focus on the role played by the households of PLWH in mediating between the community and PLWH themselves. Building health-enabling "HIV competent" households with the capacity to actively stimulate lifestyles that foster health, offers a potential strategy to tackle South Africa's HIV-related challenges. The aim of the "Sinako: Households and HIV" study is to investigate to what extent and how an intervention can increase HIV competence in PLWH and their households, and subsequently optimise the impact of CHW support on individual ART outcomes.MethodsThe "Sinako" study is a cluster-randomised controlled trial with two arms. In the control arm, CHWs offer a standard package of support to PLWH during home visits, focused on the individual. The intervention arm includes both a focus on the individual and the household to enable the patient to self-manage their treatment within an HIV competent household. A longitudinal mixed methods design is adopted to analyse the data. For the quantitative data analysis, methods including latent cross-lagged modelling, multilevel modelling and logistic regression will be used. To assess the acceptability and feasibility of the intervention and to construct a comprehensive picture of the mechanisms underlying the impact on the household and the PLWH, qualitative data (in-depth interviews and focus group discussions) will be collected and analysed.DiscussionStimulating HIV competence in households could be a feasible and sustainable strategy to optimise the outcomes of CHW interventions and thus be important for HIV treatment interventions in resource-limited settings.Trial registrationPan African Clinical Trial Registry, PACTR201906476052236. Registered on 24 June 2019.

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A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men's use of violence in periurban South Africa: study protocol.

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A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men's use of violence in periurban South Africa: study protocol.

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