{"doi":"10.2196/42111","title":"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","abstract":"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.","journal":"Journal of Medical Internet Research","year":2023,"id":334352,"datarank":0.5183068768539183,"base_score":3.091042453358316,"endowment":3.091042453358316,"self_citation_contribution":0.4636563680037475,"citation_network_contribution":0.05465050885017076,"self_endowment_contribution":0.4636563680037475,"citer_contribution":0.05465050885017076,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":3,"citers_with_citation_signal":2,"citers_with_endowment":2,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9468,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04327271"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1062751,"name":"Jacqueline Pienaar","orcid":"0000-0002-6252-4534","position":1,"is_corresponding":false},{"id":1058573,"name":"Beatrice Wasunna","orcid":"0000-0003-4185-8399","position":2,"is_corresponding":false},{"id":1062752,"name":"Felex Ndebele","orcid":"0000-0002-7499-7486","position":3,"is_corresponding":false},{"id":1063224,"name":"Calsile Khumalo","orcid":null,"position":4,"is_corresponding":false},{"id":1062753,"name":"Sarah Day","orcid":"0000-0003-2165-3580","position":5,"is_corresponding":false},{"id":597212,"name":"Hannock Tweya","orcid":"0000-0002-8247-1273","position":6,"is_corresponding":false},{"id":1059103,"name":"Femi Oni","orcid":null,"position":7,"is_corresponding":false},{"id":1062754,"name":"Maria Sardini","orcid":"0009-0000-1170-6373","position":8,"is_corresponding":false},{"id":1062755,"name":"Binod Adhikary","orcid":"0009-0007-3115-2540","position":9,"is_corresponding":false},{"id":1058571,"name":"Evelyn Waweru","orcid":"0000-0002-4599-8973","position":10,"is_corresponding":false},{"id":1062756,"name":"Mourice Barasa Wafula","orcid":"0000-0001-8599-3168","position":11,"is_corresponding":false},{"id":1062757,"name":"Anna M. 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Dixon","orcid":"0000-0002-2482-4835","position":12,"is_corresponding":false},{"id":1062758,"name":"Krishna Jafa","orcid":"0009-0008-3663-8854","position":13,"is_corresponding":false},{"id":250834,"name":"Yanfang Su","orcid":"0000-0001-7557-8518","position":14,"is_corresponding":false},{"id":340478,"name":"Kenneth Sherr","orcid":"0000-0002-2963-0829","position":15,"is_corresponding":false},{"id":1062759,"name":"Geoffrey Setswe","orcid":"0000-0003-3646-0722","position":16,"is_corresponding":false},{"id":467848,"name":"Caryl Feldacker","orcid":"0000-0002-8152-6754","position":0,"is_corresponding":true}],"reference_count":67,"raw_metadata":null,"created_at":"2026-07-19T01:09:48.843291Z","pmid":"37159245","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}