Expanding the evidence: A randomized control trial of interactive, SMS-based telehealth to improve safety and efficiency of male circumcision follow-up instead of schedule in-person reviews in rural and urban South Africa (Preprint)

Abstract

There is a dearth of high-quality evidence from digital health innovations from routine program settings in low- and middle-income countries (LMIC). We previously conducted a successful randomized control trial (RCT) in Zimbabwe demonstrating that two-way texting (2wT) follow-up was a safe and effective alternative to routine in-person follow-up for post-operative male circumcision (MC) care. To demonstrate robustness of the 2wT approach and cement the evidence for support, we conducted a larger RCT in both urban and rural MC contexts in South Africa (SA).

To determine if 2wT improves ascertainment of adverse events (AEs) and, therefore, the quality of post-MC follow-up while reducing healthcare worker (HCW) workload.

A prospective, un-blinded, non-inferiority RCT of 1084 adult MC participants with cell phones were randomized 1:1 and distributed between rural and urban district facilities providing MC 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 an AE suspected. The control group (routine) were requested to attend in-person visits on post-operative days 2 and 7 as per national MC guidelines. All men were asked to return on post-operative day 14 for study-specific review. The safety outcome (cumulative AEs ≤ the day 14 visit) and the workload outcome (number of in-person visits) were compared. Differences in cumulative AEs were calculated and 95% confidence intervals (CIs) were calculated using Manning score method.

Study recruitment started June 7, 2021 and follow-up concluded February 21, 2022. In total, 1084 men were enrolled with 547 randomized to 2wT and 537 to routine care with near equal proportions of rural and urban participants across groups. Cumulative AEs were identified in 2.3% (95% CI: 1.3, 4.1) of 2wT participants as compared to 1.01% (95% CI: 0.4, 2.3) of routine patients, meeting a criterion for non-inferiority (one-sided 95% CI: -0.09, ∞). Among 2wT men, 11 AEs (9 moderate and 2 severe) were identified as compared to 5 AEs (all moderate) among routine men, a non-significant difference (p=0.13). 2wT men attended 0.22 visits as compared to 1.34 visits among routine men, a significant workload reduction (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; 514/547 (94%) 2wT arm men responded to a daily message at least once over 13 days.

2wT was found non-inferior to routine in-person visits for AE ascertainment, demonstrating safety for MC follow-up. 2wT also significantly reduced workload, improving care efficiency. These findings were similar in both rural and urban contexts. These results strongly suggest that 2wT provides quality MC follow-up and should be adopted for MC service provision at scale. Adaptation of this 2wT telehealth approach for other acute follow-up care contexts could extend these gains beyond MC

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).