%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 25
%N 
%P e42111
%T Expanding the Evidence on the Safety and Efficiency of 2-Way Text Messaging–Based Telehealth for Voluntary Medical Male Circumcision Follow-up Compared With In-Person Reviews: Randomized Controlled Trial in Rural and Urban South Africa
%A Feldacker,Caryl
%A Pienaar,Jacqueline
%A Wasunna,Beatrice
%A Ndebele,Felex
%A Khumalo,Calsile
%A Day,Sarah
%A Tweya,Hannock
%A Oni,Femi
%A Sardini,Maria
%A Adhikary,Binod
%A Waweru,Evelyn
%A Wafula,Mourice Barasa
%A Dixon,Anna
%A Jafa,Krishna
%A Su,Yanfang
%A Sherr,Kenneth
%A Setswe,Geoffrey
%+ Department of Global Health, University of Washington, Hans Rosling Center, 3980 15th Ave NE, Seattle, WA, 98105, United States, 1 (206) 221 4970, cfeld@uw.edu
%K SMS text messaging–based telehealth
%K 2-way texting
%K voluntary medical male circumcision
%K South Africa
%K mobile health
%K mHealth for quality improvement
%K digital health innovation in low- and middle-income countries
%K male engagement in care
%K COVID-19
%K mobile phone
%D 2023
%7 9.5.2023
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries. We previously conducted a randomized controlled trial (RCT) in Zimbabwe, demonstrating that 2-way texting (2wT) was safe and effective for follow-up after adult voluntary medical male circumcision (VMMC). Objective: To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Africa to determine whether 2wT improves adverse event (AE) ascertainment and, therefore, the quality of follow-up after VMMC while reducing health care workers’ workload. Methods: A prospective, unblinded, noninferiority RCT was conducted among adult participants who underwent VMMC with cell phones randomized in a 1:1 ratio between 2wT and control (routine care) in North West and Gauteng provinces. The 2wT participants responded to a daily SMS text message with in-person follow-up only if desired or an AE was suspected. The control group was requested to make in-person visits on postoperative days 2 and 7 as per national VMMC guidelines. All participants were asked to return on postoperative day 14 for study-specific review. Safety (cumulative AEs ≤day 14 visit) and workload (number of in-person follow-up visits) were compared. Differences in cumulative AEs were calculated between groups. Noninferiority was prespecified with a margin of −0.25%. The Manning score method was used to calculate 95% CIs. Results: The study was conducted between June 7, 2021, and February 21, 2022. In total, 1084 men were enrolled (2wT: n=547, 50.5%, control: n=537, 49.5%), with near-equal proportions of rural and urban participants. Cumulative AEs were identified in 2.3% (95% CI 1.3-4.1) of 2wT participants and 1.0% (95% CI 0.4-2.3) of control participants, demonstrating noninferiority (1-sided 95% CI −0.09 to ∞). Among the 2wT participants, 11 AEs (9 moderate and 2 severe) were identified, compared with 5 AEs (all moderate) among the control participants—a nonsignificant difference in AE rates (P=.13). The 2wT participants attended 0.22 visits, and the control participants attended 1.34 visits—a significant reduction in follow-up visit workload (P<.001). The 2wT approach reduced unnecessary postoperative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among the 2wT participants, 94% (514/547) responded to ≥1 daily SMS text messages over 13 days. Conclusions: Across rural and urban contexts in South Africa, 2wT was noninferior to routine in-person visits for AE ascertainment, demonstrating 2wT safety. The 2wT approach also significantly reduced the follow-up visit workload, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of the 2wT telehealth approach to other acute follow-up care contexts could extend these gains beyond VMMC. Trial Registration: ClinicalTrials.gov NCT04327271; https://www.clinicaltrials.gov/ct2/show/NCT04327271 
%M 37159245
%R 10.2196/42111
%U https://www.jmir.org/2023/1/e42111
%U https://doi.org/10.2196/42111
%U http://www.ncbi.nlm.nih.gov/pubmed/37159245