Dataset Information

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.

SUBMITTER: Feldacker C

PROVIDER: S-EPMC10206620 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

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.

Feldacker Caryl C Pienaar Jacqueline J Wasunna Beatrice B Ndebele Felex F Khumalo Calsile C Day Sarah S Tweya Hannock H Oni Femi F Sardini Maria M Adhikary Binod B Waweru Evelyn E Wafula Mourice Barasa MB Dixon Anna A Jafa Krishna K Su Yanfang Y Sherr Kenneth K Setswe Geoffrey G

Journal of medical Internet research 20230509

<h4>Background</h4>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).<h4>Objective</h4>To demonstrate the replicability of 2wT, we conducted a larger RCT in both urban and rural VMMC settings in South Afr ...[more]

PMID: 37159245

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Project description:BackgroundTelehealth is growing, especially in areas where access to health facilities is difficult. We previously used 2-way texting (2wT) via SMS to improve the quality of postoperative care after voluntary medical male circumcision in South Africa. In this study, we offered males aged 15 years and older WhatsApp or SMS as their message delivery and interaction platform to explore user preferences and behaviors.ObjectiveThe objectives of this process evaluation embedded within a larger 2wT expansion trial were to (1) explore 2wT client preferences, including client satisfaction, with WhatsApp or SMS; (2) examine response rates (participation) by SMS and WhatsApp; and (3) gather feedback from the 2wT implementation team on the WhatsApp approach.MethodsMales aged 15 years and older undergoing voluntary medical male circumcision in program sites could choose their follow-up approach, selecting 2wT via SMS or WhatsApp or routine care (in-person postoperative visits). The 2wT system provided 1-way educational messages and an open 2-way communication channel between providers and clients. We analyzed quantitative data from the 2wT database on message delivery platforms (WhatsApp vs SMS), response rates, and user behaviors using chi-square tests, z tests, and t tests. The team conducted short phone calls with WhatsApp and SMS clients about their perceptions of this 2wT platform using a short, structured interview guide. We consider informal reflections from the technical team members on the use of WhatsApp. We applied an implementation science lens using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to focus results on practice and policy improvement.ResultsOver a 2-month period-from August to October, 2023-337 males enrolled in 2wT and were offered WhatsApp or SMS and were included in the analysis. For 2wT reach, 177 (53%) participants chose WhatsApp as their platform (P=.38). Mean client age was 30 years, and 253 (75%) participants chose English for automated messages. From quality assurance calls, almost all respondents (87/89, 98%) were happy with the way they were followed up. For effectiveness, on average for the days on which responses were requested, 58 (33%) WhatsApp clients and 44 (28%) SMS clients responded (P=.50). All 2wT team members believed WhatsApp limited the automated message content, language choices, and inclusivity as compared with the SMS-based 2wT approach.ConclusionsWhen presented with a choice of 2wT communication platform, clients appear evenly split between SMS and WhatsApp. However, WhatsApp requires a smartphone and data plan, potentially reducing reach at scale. Clients using both platforms responded to 2wT interactive prompts, demonstrating similar effectiveness in engaging clients in follow-up. For telehealth interventions, digital health designers should maintain an SMS-based platform and carefully consider adding WhatsApp as an option for clients, using an implementation science approach to present evidence that guides the best implementation approach for their setting.

Project description:ObjectiveAlthough adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe.Materials and methodsWe developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses.Results2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis.Conclusions2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.

Project description:BackgroundVoluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up.MethodsThe RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively.ResultsClients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts.ConclusionResults strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.

Dataset Information

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.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

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.

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