TY  - JOUR
AU  - Feldacker, Caryl
AU  - Pienaar, Jacqueline
AU  - Wasunna, Beatrice
AU  - Ndebele, Felex
AU  - Khumalo, Calsile
AU  - Day, Sarah
AU  - Tweya, Hannock
AU  - Oni, Femi
AU  - Sardini, Maria
AU  - Adhikary, Binod
AU  - Waweru, Evelyn
AU  - Wafula, Mourice Barasa
AU  - Dixon, Anna
AU  - Jafa, Krishna
AU  - Su, Yanfang
AU  - Sherr, Kenneth
AU  - Setswe, Geoffrey
PY  - 2023
DA  - 2023/5/9
TI  - 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
JO  - J Med Internet Res
SP  - e42111
VL  - 25
KW  - SMS text messaging–based telehealth
KW  - 2-way texting
KW  - voluntary medical male circumcision
KW  - South Africa
KW  - mobile health
KW  - mHealth for quality improvement
KW  - digital health innovation in low- and middle-income countries
KW  - male engagement in care
KW  - COVID-19
KW  - mobile phone
AB  - 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 
SN  - 1438-8871
UR  - https://www.jmir.org/2023/1/e42111
UR  - https://doi.org/10.2196/42111
UR  - http://www.ncbi.nlm.nih.gov/pubmed/37159245
DO  - 10.2196/42111
ID  - info:doi/10.2196/42111
ER  -