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Title Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda.
Full text https://escholarship.org/uc/item/1wh6240h
Date 2016
Author(s) Wagman, Jennifer A; Paul, Amy; Namatovu, Fredinah; Ssekubugu, Robert; Nalugoda, Fred
Abstract ObjectiveWe identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.MethodsConcepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.ResultsExisting ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.ConclusionStudies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.
Subject(s) intimate partner violence; cluster randomized trial; research ethics; HIV; Rakai; Uganda; HIV/AIDS; Clinical Research; Violence Against Women; Prevention; Clinical Trials and Supportive Activities; Mental Health; Behavioral and Social Science; Violence Research; 8.4 Research design and methodologies (health services); 8.1 Organisation and delivery of services; Health and social care services research; Peace; Justice and Strong Institutions; Public Health and Health Services; Psychology
Coverage 442 - 451
Publisher eScholarship, University of California
Type of publication article
Format application/pdf
Source Psychology of violence, vol 6, iss 3
Rights public
Identifier qt1wh6240h
Repository Berkeley - University of California
Added to C-A: 2023-01-09;09:24:53