scholarly journals A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Munyaradzi Madhombiro ◽  
Bazondlile Dube-Marimbe ◽  
Michelle Dube ◽  
Dixon Chibanda ◽  
Moleen Zunza ◽  
...  
BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e017579 ◽  
Author(s):  
Nicola J Christofides ◽  
Abigail M Hatcher ◽  
Angelica Pino ◽  
Dumisani Rebombo ◽  
Ruari Santiago McBride ◽  
...  

ObjectiveThis 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 analysisA 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 disseminationEthical 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 numberNCT02823288; Pre-result.


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