JMIR Publications

ABSTRACT

Background:

There is a dearth of high-quality evidence from digital health interventions in routine program settings in low- and middle-income countries (LMIC). We previously conducted a randomized control trial (RCT) in Zimbabwe demonstrating that two-way texting (2wT) was safe and effective for post-operative follow-up after adult voluntary medical male circumcision (VMMC). To demonstrate the replicability of 2wT for improving ascertainment of adverse events (AEs) while reducing healthcare worker (HCW) workload, we conducted a larger RCT in both urban and rural VMMC settings in South Africa.

Objective:

To determine if 2wT improves AE ascertainment and, therefore, the quality of post-MC follow-up while reducing HCW workload.

Methods:

A prospective, un-blinded, non-inferiority RCT of 1084 adult VMMC participants with cell phones were randomized 1:1 and distributed between rural and urban district facilities providing VMMC in North West and Gauteng provinces. Non-inferiority was prespecified with a margin of -0.25%. 2wT participants responded to a daily text with in-person follow-up only if desired or AE suspected. The control group (routine care) were requested to attend in-person visits on post-operative days 2 and 7 as per national VMMC guidelines. All men were asked to return on post-operative day 14 for study-specific review. Safety (cumulative AEs ≤ day 14 visit) and workload (# in-person follow-up visits) were compared. Differences in cumulative AEs were calculated. Manning score method was used to calculate 95% confidence intervals (CIs).

Results:

Recruitment started June 7, 2021. Follow-up concluded February 21, 2022. In total, 1084 men were enrolled with 547 randomized to 2wT and 537 to control 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 1.01% (95% CI: 0.4, 2.3) of control participants, meeting the criterion for non-inferiority (one-sided 95% CI: -0.09, ∞). Among 2wT men, 11 AEs (9 moderate, 2 severe) were identified as compared to 5 AEs (all moderate) among control group men, a non-significant difference in AE rates (P=0.13). 2wT men attended 0.22 visits and control group men attended 1.34 visits, a significant reduction in follow-up visit workload (P<0.001). 2wT reduced unnecessary post-operative visits by 84.8%. Daily response rates ranged from 86% on day 3 to 74% on day 13. Among 2wT men, 514/547 (94%) responded to ≥1 daily messages over 13 days.

Conclusions:

Across rural and urban contexts in South Africa, 2wT was found non-inferior to routine in-person visits for AE ascertainment, demonstrating safety for VMMC follow-up. 2wT also significantly reduced follow-up visit workload in both settings, improving efficiency. These results strongly suggest that 2wT provides quality VMMC follow-up and should be adopted at scale. Adaptation of this 2wT telehealth approach for other acute follow-up care contexts could extend these gains beyond VMMC. Clinical Trial: This trial, “Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision (VMMC) Participants in the Republic of South Africa,” is registered at ClinicalTrials.gov (ID: NCT04327271).