title: Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda.
abstract: OBJECTIVE
  We 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.
  
  
  METHODS
  Concepts 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.
  
  
  RESULTS
  Existing 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.
  
  
  CONCLUSIONS
  Studies 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.
authors.affiliation: University of California San Diego, School of Medicine, Division of Global Public Health, 9500 Gilman Drive, MC 0507, La Jolla, CA 92093-0507.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Wagman
authors.affiliation: Department of Health Policy and Management, The Berman Institute of Bioethics, Johns Hopkins Bloomberg School of Public Health, Deering Hall, 1809 Ashland Avenue, Baltimore, Maryland 21205, Tel: 410-614-5550.
authors.forename: Amy
authors.initials: A
authors.lastname: Paul
authors.affiliation: Department of Public Health and Clinical Medicine/Epidemiology and Global Health, Umeå University, SE-901 87 Umeå, Sweden, Tel: +46 90 786 58 77.
authors.forename: Fredinah
authors.initials: F
authors.lastname: Namatovu
authors.affiliation: Rakai Health Sciences Program, Uganda Virus Research Institute, Nakiwogo Road, P.O Box 49, Entebbe, Uganda, Tel: +256-414-321700.
authors.forename: Robert
authors.initials: R
authors.lastname: Ssekubugu
authors.affiliation: Rakai Health Sciences Program, Uganda Virus Research Institute, Nakiwogo Road, P.O Box 49, Entebbe, Uganda, Tel: +256-414-321700.
authors.forename: Fred
authors.initials: F
authors.lastname: Nalugoda