Dataset Information

Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial.

ABSTRACT:

Background

Community-Based Sociotherapy (CBS) is an approach that was introduced in Rwanda in 2005, with the aim of improving psychosocial well-being among its participants and facilitating reconciliation processes. Over the years, CBS has been adapted contextually and the effectiveness of the approach has been measured in different ways, using qualitative and quantitative study designs. This study specifically assesses the effectiveness of CBS in terms of fostering the social dignity of participants as the primary outcome.

Methods/design

A cluster randomized controlled trial design with person-level outcomes whereas the CBS treatment is delivered at the cluster level. A total of 1200 eligible participants will be randomly assigned to two groups in a 1:1 ratio. Participants in the intervention group will receive the CBS intervention, while the control group will be waitlisted. The primary outcome measure is a self-designed and psychometrically validated Social Dignity Scale. The secondary outcome measures will be the WHO (Five) Well-Being Index (WHO-5), the Multidimensional Scale of Perceived Social Support (MSPSS), the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), the Self-reporting Questionnaire (SRQ-20), and the perceived parental self-efficacy scale. The primary analysis will be performed following an intention to treat analysis, using generalized estimating equation modeling.

Discussion

We expect this cluster randomized controlled trial to provide insight into the effectiveness of CBS on social dignity and secondary psychosocial outcomes among its group participants, who have different socio-historical backgrounds including genocide survivors, perpetrators, bystanders and their descendants, people in conflicts (family/community), and local leaders. This study will inform CBS implementers, policymakers, practitioners, and other stakeholders on the role of social dignity in interventions that focus on psychosocial healing.

Trial registration

ISRCTN ISRCTN11199072. It was registered on 2 April 2022.

SUBMITTER: Jansen S

PROVIDER: S-EPMC9768903 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial.

Jansen Stefan S Niyonsenga Japhet J Ingabire Chantal Marie CM Jansen Angela A Nzabonimpa Emmanuel E Ingabire Noella N Kangabe Jeannette J Sarabwe Emmanuel E Richters Annemiek A Rutayisire Theoneste T Nsabimana Epaphrodite E

Trials 20221220 1

<h4>Background</h4>Community-Based Sociotherapy (CBS) is an approach that was introduced in Rwanda in 2005, with the aim of improving psychosocial well-being among its participants and facilitating reconciliation processes. Over the years, CBS has been adapted contextually and the effectiveness of the approach has been measured in different ways, using qualitative and quantitative study designs. This study specifically assesses the effectiveness of CBS in terms of fostering the social dignity of ...[more]

PMID: 36539840

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Project description:IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients' health behaviours and HBCPs' work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs' programme; (2) HBCPs' programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs' programme. Under each hospital, administrative areas implementing the HBCPs' programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs' programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

Project description:BackgroundRwandan adolescents have limited access to high-quality family planning and reproductive health (FP/RH) information and care to prevent unplanned pregnancy and HIV/STIs. In addition to the immediate implications for health and well-being, teenage pregnancy is a significant cause of school drop-out, limiting girls' future potential and employment opportunities. This study introduces a direct-to-consumer digital education program that uses storytelling to deliver age-appropriate FP/RH information and economic empowerment training to adolescents. It also facilitates access to high-quality, youth-friendly FP/RH care and products. We evaluate two different school-based models of its implementation to understand how to optimize the uptake of contraception and HIV testing among adolescents.MethodsThe study consists of two distinct phases. The first formative intervention design phase, conducted from 2016 to 2019, used a human-centered design methodology to develop the intervention alongside over 600 Rwandan adolescents, their parents, teachers, and healthcare providers. Through this methodology, we sought to maximize the fit between evidence-based practices (uptake of modern contraception and HIV testing) and the implementation context of adolescents in Rwanda. The second phase is an impact evaluation, in which we will use a Hybrid Trial Type 2 Effectiveness-Implementation study design to determine the overall effectiveness of this digital intervention as well as the relative effectiveness of the two different school-based implementation models. This takes the form of a 3-arm cluster-randomized non-inferiority trial, with a sample of 6000 youth aged 12-19 in 60 schools across 8 districts in Rwanda. Primary outcome measures include use of modern contraception, delayed initiation of childbearing, and uptake of HIV testing.DiscussionThis study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness. The methodologies used are broadly applicable to the design, implementation, and evaluation of other behavior-based health programs in low and middle-income countries.Trial registrationClinicalTrials.gov Identifier: NCT04198272 . Prospectively registered 13 December 2019.

Project description:IntroductionSocial prescribing enables healthcare professionals to use voluntary and community sector resources to improve support for people with long-term conditions. It is widely promoted in the UK as a way to address complex health, psychological and social issues presented in primary care, yet there is insufficient evidence of effectiveness or value for money. This study aims to evaluate the impact and costs of a link-worker social prescribing intervention on the health and healthcare use of adults aged 40-74 with type 2 diabetes, living in a multi-ethnic area of high socioeconomic deprivation.Methods and analysisMixed-methods approach combining (1) quantitative quasi-experimental methods to evaluate the effects of social prescribing on health and healthcare use and cost-effectiveness analysis and (2) qualitative ethnographic methods to observe how patients engage with social prescribing. Quantitative data comprise Secondary Uses Service data and Quality Outcomes Framework data. The primary outcome is glycated haemoglobin, and secondary outcomes are secondary care use, systolic blood pressure, weight/body mass index, cholesterol and smoking status; these data will be analysed longitudinally over 3 years using four different control conditions to estimate a range of treatment effects. The ranges where the intervention is cost-effective will be identified from the perspective of the healthcare provider. Qualitative data comprise participant observation and interviews with purposively sampled service users, and focus groups with link-workers (intervention providers). Analysis will involve identification of themes and synthesising and theorising the data. Finally, a coding matrix will identify convergence and divergence among all study components.Ethics and disseminationUK NHS Integrated Research Approval System Ethics approved the quantitative research (Reference no. 18/LO/0631). Durham University Research Ethics Committee approved the qualitative research. The authors will publish the findings in peer-reviewed journals and disseminate to practitioners, service users and commissioners via a number of channels including professional and patient networks, conferences and social media. Results will be disseminated via peer-reviewed journals.

Project description:BackgroundCommunity health clubs are multi-session village-level gatherings led by trained facilitators and designed to promote healthy behaviours mainly related to water, sanitation, and hygiene. They have been implemented in several African and Asian countries but have never been evaluated rigorously. We aimed to evaluate the effect of two versions of the community health club model on child health and nutrition outcomes.MethodsWe did a cluster-randomised trial in Rusizi district, western Rwanda. We defined villages as clusters. We assessed villages for eligibility then randomly selected 150 for the study using a simple random sampling routine in Stata. We stratified villages by wealth index and by the proportion of children younger than 2 years with caregiver-reported diarrhoea within the past 7 days. We randomly allocated these villages to three study groups: no intervention (control; n=50), eight community health club sessions (Lite intervention; n=50), or 20 community health club sessions (Classic intervention; n=50). Households in these villages were enrolled in 2013 for a baseline survey, then re-enrolled in 2015 for an endline survey. The primary outcome was caregiver-reported diarrhoea within the previous 7 days in children younger than 5 years. Analysis was by intention to treat and per protocol. This trial is registered with ClinicalTrials.gov, number NCT01836731.FindingsAt the baseline survey undertaken between May, 2013, and August, 2013, 8734 households with children younger than 5 years of age were enrolled. At the endline survey undertaken between Sept 21, 2015, and Dec 22, 2015, 7934 (91%) of the households were re-enrolled. Among children younger than 5 years, the prevalence of caregiver-reported diarrhoea in the previous 7 days was 514 (14%) of 3616 assigned the control, 453 (14%) of 3196 allocated the Lite intervention (prevalence ratio compared with control 0·97, 95% CI 0·81-1·16; p=0·74), and 495 (14%) of 3464 assigned the Classic intervention (prevalence ratio compared with control 0·99, 0·85-1·15; p=0·87).InterpretationCommunity health clubs, in this setting in western Rwanda, had no effect on caregiver-reported diarrhoea among children younger than 5 years. Our results question the value of implementing this intervention at scale for the aim of achieving health gains.FundingBill & Melinda Gates Foundation.

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Project description:BackgroundResearch on group antenatal care in low- and middle-income contexts suggests high acceptability and preliminary implementation success.MethodsWe studied the effect of group antenatal care on gestational age at birth among women in Rwanda, hypothesizing that participation would increase mean gestational length. For this unblinded cluster randomized trial, 36 health centers were pair-matched and randomized; half continued individual antenatal care (control), half implemented group antenatal care (intervention). Women who initiated antenatal care between May 2017 and December 2018 were invited to participate, and included in analyses if they presented before 24 weeks gestation, attended at least two visits, and their birth outcome was obtained. We used a generalized estimating equations model for analysis.FindingsIn total, 4091 women in 18 control clusters and 4752 women in 18 intervention clusters were included in the analysis. On average, women attended three total antenatal care visits. Gestational length was equivalent in the intervention and control groups (39.3 weeks (SD 1.6) and 39.3 weeks (SD 1.5)). There were no significant differences between groups in secondary outcomes except that more women in control sites attended postnatal care visits (40.1% versus 29.7%, p = 0.003) and more women in intervention sites attended at least three total antenatal care visits (80.7% versus 71.7%, p = 0.003). No harms were observed.InterpretationGroup antenatal care did not result in a difference in gestational length between groups. This may be due to the low intervention dose. We suggest studies of both the effectiveness and costs of higher doses of group antenatal care among women at higher risk of preterm birth. We observed threats to group care due to facility staff shortages; we recommend studies in which antenatal care providers are exclusively allocated to group antenatal care during visits.Trial registrationClinicalTrials.gov NCT03154177.

Project description:BackgroundThis 4-year research project focuses on 6 social community enterprises (SCEs) that operate in 5 neighborhoods in a Dutch city. Residents of these neighborhoods face problems such as poor average levels of physical and mental health, high unemployment rates, and weak social cohesion. SCEs offer residents social, cultural, and work-related activities and are therefore believed to help these persons develop themselves and strengthen the social ties in the community. Because of a lack of empirical evidence; however, it is unclear whether and how SCEs benefit the health and well-being of participants.ObjectiveThis paper outlines a protocol for an evaluation study on the impact of SCEs, aiming to determine (1) to what extent SCEs affect health and well-being of participating residents, (2) what underlying processes and mechanisms can explain such impact, and (3) what assets are available to SCEs and how they can successfully mobilize these assets.MethodsA mixed methods multiple-case study design including repeated measurements will be conducted. Six SCEs form the cases. An integrated model of SCE health intervention will be used as the theoretical basis. First, the impact of SCEs is measured on the individual and community level, using questionnaires and in-depth interviews conducted with participants. Second, the research focuses on the underlying processes and mechanisms and the organizational and sociopolitical factors that influence the success or failure of these enterprises in affecting the health and well-being of residents. At this organizational level, in-depth interviews are completed with SCE initiators and stakeholders, such as municipal district managers. Finally, structurally documented observations are made on the organizational and sociopolitical context of the SCEs.ResultsThis research project received funding from the Netherlands Organization for Health Research and Development in 2018. Data collection takes place from 2018 until 2022. Data analysis starts after the last round of data collection in 2022 and finalizes in 2024. Expected results will be published in 2023 and 2024.ConclusionsDespite the societal relevance of SCEs, little empirical research has been performed on their functioning and impact. This research applies a variety of methods and includes the perspectives of multiple stakeholders aiming to generate new empirical evidence. The results will enable us to describe how SCE activities influence intermediate and long-term health outcomes and how the organizational and sociopolitical context of SCEs may shape opportunities or barriers for health promotion. As the number of these initiatives in the Netherlands is increasing rapidly, this research can benefit many SCEs attempting to become more effective and increase their impact. The findings of this research will be shared directly with relevant stakeholders through local and national meetings and annual reports and disseminated among other researchers through scientific publications.International registered report identifier (irrid)DERR1-10.2196/37966.

Dataset Information

Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial.

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