PMID- 31337414 OWN - NLM STAT- MEDLINE DCOM- 20200205 LR - 20200915 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 20 IP - 1 DP - 2019 Jul 23 TI - Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial. PG - 451 LID - 10.1186/s13063-019-3470-9 [doi] LID - 451 AB - BACKGROUND: Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident. To reach the 2016 global MC target of 20 million, productivity must double in countries plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care and has performed over 120,000 MCs. MC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. The ZAZIC program AE rate is 0.4%; therefore, overstretched clinic have staff conducted more than 200,000 unnecessary reviews of MC clients without complications. METHODS: Through an un-blinded, prospective, randomized, controlled trial in two high-volume MC facilities, we will compare two groups of adult MC clients with cell phones, randomized 1:1 into two groups: (1) routine care (control group, N = 361) and (2) clients who receive and respond to a daily text with in-person follow up only if desired or if a complication is suspected (intervention group, N = 361). If an intervention client responds affirmatively to any automated daily text with a suspected AE, an MC nurse will exchange manual, modifiable, scripted texts with the client to determine symptoms and severity, requesting an in-person visit if desired or warranted. Both arms will complete a study-specific, day 14, in-person, follow-up review for verification of self-reports (intervention) and comparison (control). Data collection includes extraction of routine client MC records, study-specific database reports, and participant usability surveys. Intent-to-treat (ITT) analysis will be used to explore differences between groups to determine if two-way texting (2wT) can safely reduce MC follow-up visits, estimate the cost savings associated with 2wT over routine MC follow up, and assess the acceptability and feasibility of 2wT for scale up. DISCUSSION: It is expected that this mobile health intervention will be as safe as routine care while providing distinct advantages in efficiency, costs, and reduced healthcare worker burden. The success of this intervention could lead to adaptation and adoption of this intervention at the national level, increasing the efficiency of MC scale up, and reducing burdens on providers and patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03119337 . Registered on 18 April 2017. FAU - Feldacker, Caryl AU - Feldacker C AUID- ORCID: 0000-0002-8152-6754 AD - International Training and Education Center for Health (I-TECH), 325 9th Avenue, HMC#359932, Seattle, WA, 98104-2499, USA. cfeld@uw.edu. AD - Department of Global Health, University of Washington, 325 9th Avenue, HMC# 359931, Seattle, WA, 98104, USA. cfeld@uw.edu. FAU - Murenje, Vernon AU - Murenje V AD - International Training and Education Center for Health (I-TECH)/Zimbabwe, Harare, Zimbabwe. FAU - Barnhart, Scott AU - Barnhart S AD - International Training and Education Center for Health (I-TECH), 325 9th Avenue, HMC#359932, Seattle, WA, 98104-2499, USA. AD - Department of Global Health, University of Washington, 325 9th Avenue, HMC# 359931, Seattle, WA, 98104, USA. AD - Department of Medicine, University of Washington, Box 356420, 1959 NE Pacific Street, Seattle, WA, 98195-6420, USA. FAU - Xaba, Sinokuthemba AU - Xaba S AD - Zimbabwe Ministry of Health and Child Care, Harare, Zimbabwe. FAU - Makunike-Chikwinya, Batsirai AU - Makunike-Chikwinya B AD - International Training and Education Center for Health (I-TECH)/Zimbabwe, Harare, Zimbabwe. FAU - Holeman, Isaac AU - Holeman I AD - Medic Mobile, 3254 19th Street, Floor Two, San Francisco, CA, 94110, USA. FAU - Tshimanga, Mufuta AU - Tshimanga M AD - Zimbabwe Community Health Intervention Project (ZiCHIRe), Harare, Zimbabwe. LA - eng SI - ClinicalTrials.gov/NCT03119337 GR - R21 TW010583/TW/FIC NIH HHS/United States GR - 1R21TW010583-01/TW/FIC NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20190723 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Adolescent MH - Adult MH - Aged MH - Attitude of Health Personnel MH - Circumcision, Male/adverse effects/*methods MH - Equivalence Trials as Topic MH - Health Knowledge, Attitudes, Practice MH - Health Personnel/*organization & administration MH - Humans MH - Male MH - Middle Aged MH - *Patient Acceptance of Health Care MH - Patient Safety MH - Prospective Studies MH - *Text Messaging MH - Time Factors MH - Treatment Outcome MH - Volition MH - *Workload MH - Young Adult MH - Zimbabwe PMC - PMC6651991 OTO - NOTNLM OT - Healthcare delivery innovations OT - Mobile health OT - Post-operative follow-up OT - Voluntary medical male circumcision OT - Zimbabwe COIS- The authors declare that they have no competing interests. EDAT- 2019/07/25 06:00 MHDA- 2020/02/06 06:00 PMCR- 2019/07/23 CRDT- 2019/07/25 06:00 PHST- 2019/01/11 00:00 [received] PHST- 2019/05/24 00:00 [accepted] PHST- 2019/07/25 06:00 [entrez] PHST- 2019/07/25 06:00 [pubmed] PHST- 2020/02/06 06:00 [medline] PHST- 2019/07/23 00:00 [pmc-release] AID - 10.1186/s13063-019-3470-9 [pii] AID - 3470 [pii] AID - 10.1186/s13063-019-3470-9 [doi] PST - epublish SO - Trials. 2019 Jul 23;20(1):451. doi: 10.1186/s13063-019-3470-9.