TY - JOUR T1 - Safety of Tubal Occlusion by Minilaparotomy Provided by Trained Clinical Officers Versus Assistant Medical Officers in Tanzania: A Randomized, Controlled, Noninferiority Trial JF - Global Health: Science and Practice JO - GLOB HEALTH SCI PRACT DO - 10.9745/GHSP-D-18-00108 SP - GHSP-D-18-00108 AU - Mark A. Barone AU - Zuhura Mbuguni AU - Japhet Ominde Achola AU - Annette Almeida AU - Carmela Cordero AU - Joseph Kanama AU - Adriana Marquina AU - Projestine Muganyizi AU - Jamilla Mwanga AU - Daniel Ouma AU - Caitlin Shannon AU - Leopold Tibyehabwa Y1 - 2018/08/16 UR - http://www.ghspjournal.org/content/early/2018/08/16/GHSP-D-18-00108.abstract N2 - Trained clinical officers—nonphysicians with 3 years of specialized training—conducted the procedure safely and effectively compared with procedures performed by more advanced assistant medical officers. This evidence supports policy change allowing properly trained and supported clinical officers to perform minilaparotomy.Background: Tubal occlusion by minilaparotomy is a safe, highly effective, and permanent way to limit childbearing. We aimed to establish whether the safety of the procedure provided by trained clinical officers (COs) was not inferior to the safety when provided by trained assistant medical officers (AMOs), as measured by major adverse event (AE) rates.Methods: In this randomized, controlled, open-label noninferiority trial, we enrolled participants at 7 health facilities in Arusha region, Tanzania, as well as during outreach activities conducted in Arusha and neighboring regions. Consenting, eligible participants were randomly allocated by a research assistant at each site to minilaparotomy performed by a trained CO or by a trained AMO, in a 1:1 ratio. We asked participants to return at 3, 7, and 42 days postsurgery. The primary outcome was the rate of major AEs following minilaparotomy performed by COs versus AMOs, during the procedure and through 42 days follow-up. The noninferiority margin was 2%. The trial is registered with ClinicalTrials.gov, Identifier NCT02944149.Results: We randomly allocated 1,970 participants between December 2016 and June 2017, 984 to the CO group and 986 to the AMO group. Most (87%) minilaparotomies were conducted during outreach services. In the intent-to-treat analysis, 0 of 978 participants had a major AE in the CO group compared with 1 (0.1%) of 984 in the AMO group (incidence rate difference: 0.001% [95% confidence interval: –0.003% to 0.001%]), meeting the criteria for noninferiority. We saw no evidence of differences in measures of procedure performance, participant satisfaction, or provider self-efficacy between the groups.Conclusions: Tubal occlusion by minilaparotomy performed by trained COs is safe, effective, and acceptable to women, and the procedure can be safely and effectively provided in outreach settings. Our results provide evidence to support policy change in resource-limited settings to allow task shifting of minilaparotomy to properly trained and supported COs, increasing access to female sterilization and helping to meet the rising demand for the procedure among women wanting to avoid pregnancy. They also suggest high demand for these services in Tanzania, given the large number of women recruited in a relatively short time period. ER -