BACKGROUND: The methods and purposes of randomization are often poorly understood by participants in clinical trials. Individual misunderstandings can be compounded in community-based intervention trials, especially in research-naïve communities. Randomizing entire communities to intervention or control status risks creating the perception that control communities are being denied desirable services, ultimately undermining trust in the research process. PURPOSE: To develop a randomization scheme for an HIV prevention trial of a community-level intervention that would be credible to the communities involved while maintaining the scientific integrity of the intervention trial at a rural site in Zimbabwe. METHODS: Project staff developed strong partnerships with community stakeholders and embedded randomization into the trial's community preparedness processes. Local idioms were used to explain the concept, purpose, and mechanics of randomization. Actual allocation of communities to intervention or control status took place at a public lottery conducted by local chiefs. RESULTS: The Project obtained the endorsement of its randomization of eight rural communities by local political stakeholders and community members. LIMITATIONS: This case study may not generalize to other settings. CONCLUSIONS: By developing strong community partnerships, and communicating randomization through local idioms, community based intervention trials conducted in resource-poor environments can successfully mitigate risks inherent in randomizing communities to control status.
BACKGROUND: The methods and purposes of randomization are often poorly understood by participants in clinical trials. Individual misunderstandings can be compounded in community-based intervention trials, especially in research-naïve communities. Randomizing entire communities to intervention or control status risks creating the perception that control communities are being denied desirable services, ultimately undermining trust in the research process. PURPOSE: To develop a randomization scheme for an HIV prevention trial of a community-level intervention that would be credible to the communities involved while maintaining the scientific integrity of the intervention trial at a rural site in Zimbabwe. METHODS: Project staff developed strong partnerships with community stakeholders and embedded randomization into the trial's community preparedness processes. Local idioms were used to explain the concept, purpose, and mechanics of randomization. Actual allocation of communities to intervention or control status took place at a public lottery conducted by local chiefs. RESULTS: The Project obtained the endorsement of its randomization of eight rural communities by local political stakeholders and community members. LIMITATIONS: This case study may not generalize to other settings. CONCLUSIONS: By developing strong community partnerships, and communicating randomization through local idioms, community based intervention trials conducted in resource-poor environments can successfully mitigate risks inherent in randomizing communities to control status.
Authors: Thomas J Coates; Michal Kulich; David D Celentano; Carla E Zelaya; Suwat Chariyalertsak; Alfred Chingono; Glenda Gray; Jessie K K Mbwambo; Stephen F Morin; Linda Richter; Michael Sweat; Heidi van Rooyen; Nuala McGrath; Agnès Fiamma; Oliver Laeyendecker; Estelle Piwowar-Manning; Greg Szekeres; Deborah Donnell; Susan H Eshleman Journal: Lancet Glob Health Date: 2014-04-08 Impact factor: 26.763
Authors: Diane V Havlir; Laura B Balzer; Edwin D Charlebois; Tamara D Clark; Dalsone Kwarisiima; James Ayieko; Jane Kabami; Norton Sang; Teri Liegler; Gabriel Chamie; Carol S Camlin; Vivek Jain; Kevin Kadede; Mucunguzi Atukunda; Theodore Ruel; Starley B Shade; Emmanuel Ssemmondo; Dathan M Byonanebye; Florence Mwangwa; Asiphas Owaraganise; Winter Olilo; Douglas Black; Katherine Snyman; Rachel Burger; Monica Getahun; Jackson Achando; Benard Awuonda; Hellen Nakato; Joel Kironde; Samuel Okiror; Harsha Thirumurthy; Catherine Koss; Lillian Brown; Carina Marquez; Joshua Schwab; Geoff Lavoy; Albert Plenty; Erick Mugoma Wafula; Patrick Omanya; Yea-Hung Chen; James F Rooney; Melanie Bacon; Mark van der Laan; Craig R Cohen; Elizabeth Bukusi; Moses R Kamya; Maya Petersen Journal: N Engl J Med Date: 2019-07-18 Impact factor: 91.245
Authors: Estelle Piwowar-Manning; Agnes Fiamma; Oliver Laeyendecker; Michal Kulich; Deborah Donnell; Greg Szekeres; Laura Robins-Morris; Caroline E Mullis; Ana Vallari; John Hackett; Timothy D Mastro; Glenda Gray; Linda Richter; Michel W Alexandre; Suwat Chariyalertsak; Alfred Chingono; Michael Sweat; Thomas Coates; Susan H Eshleman Journal: BMC Infect Dis Date: 2011-09-24 Impact factor: 3.090
Authors: Daniel Mäusezahl; Andri Christen; Gonzalo Duran Pacheco; Fidel Alvarez Tellez; Mercedes Iriarte; Maria E Zapata; Myriam Cevallos; Jan Hattendorf; Monica Daigl Cattaneo; Benjamin Arnold; Thomas A Smith; John M Colford Journal: PLoS Med Date: 2009-08-18 Impact factor: 11.069