Two-way Texting for VMMC Follow-up in Republic of South Africa

NCT04327271 | Completed Results DMC

• 2 other identifiers: STUDY000097031R01NR019229-01
• Study Type: interventional
• Target: 1,093
• Locations: 1 country
• Sites: 9

Brief Summary

Voluntary medical male circumcision (alternatively abbreviated in the literature as VMMC or MC) is a critical HIV prevention intervention with global support for expansion across sub-Saharan Africa (SSA). MC is safe: routine programs in SSA report adverse event (AE) rates well under 2%. Nevertheless, global MC guidelines require one or more follow-up visits within 14 days for AE detection. Our prior research in Zimbabwe employed two-way texting (2wT) between patients and providers to focus follow-up on men with potential AEs, allowing men healing without complication to opt-out of routine post-operative visits. 2wT safely reduced client visits by 85%, suggesting that 2wT can make MC services dramatically more efficient while maintaining safety. In the Republic of South Africa (RSA), high-volume urban clinics, remote service delivery, and low AE identification threaten quality at scale. Across more than 500,000 annual MCs performed, up to 1 million multi-stage, unnecessary MC reviews are likely conducted. RSA pressure for MC expansion and severe health system constraints, combined with good cell coverage, suggest 2wT's impact would be significant for MC care quality and efficiency, especially in rural areas. A randomized control trial (RCT) will rigorously evaluate how 2wT improves AE ascertainment and follow-up efficiency in urban and rural clinics. We aim to conduct an RCT to determine how 2wT increases AE ascertainment while reducing workload in the RSA implementation context. While the overall protocol covers multiple components over a 5-year study, this registration is specific to the RCT, aim 1.

Conditions

Voluntary Medical Male Circumcision

Outcome Measures

Primary Outcomes (2)

• Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit

  AE rates are a global indicator of VMMC quality. This is a standard WHO and US PEPFAR government indicator as indicated in the attached reference material: PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations. Incidence of AEs before Day 14 will be extracted from routine VMMC data for both 2wT and control. Incident AEs on Day 14 will be identified, classified, and graded for severity using routine Ministry of Health protocols and recorded on routine VMMC AE forms. The investigators will compare cumulative rates of any moderate or severe AE on or before Day 14 between groups using Fisher's exact test as the expected number of AEs is low. The rates will be calculated per arm as: (num moderate plus severe AEs)/(total num VMMC clients who attend 2, 7 or 14 Day follow-up visit). Multivariate logistic regression models (any AE versus none) will quantify the magnitude of difference, adjusting for any potential confounders

  Any AE before, and including, up to 22 days post VMMC to allow for logistical issues delaying attendance of the Day 14 visit

• Number of Non-study In-person Visits

  To determine follow-up visit reduction, the investigators will compare the number of in- person visits for intervention and control using a t-test.

  Less than or equal to 42 days post-operative

Secondary Outcomes (2)

• Percent of Adverse Events (AE) Identified /on/ Day 14 Visit

  AEs identified during Day 14 visits that occurred only in the window between post-operative days 13-22

• Number VMMC-related Severe Adverse Events Over 22 Post-operative Days

  Within 22 days post operative

Study Arms (2)

Text-based VMMC follow-up

EXPERIMENTAL

Follow-up conducted via daily text not through mandatory in person visits. Men may elect to come to the clinic if concerned about any complications but have no routine, scheduled follow-up visits.

Behavioral: Text-based VMMC follow-up

Routine VMMC follow-up care

NO INTERVENTION

Routine VMMC follow up care with in person visits according to national guidelines.

Interventions

Text-based VMMC follow-up BEHAVIORAL

2wT clients will receive automated daily texts from days 1-13. If a 2wT VMMC client responds that he suspects an AE, a VMMC nurse will exchange modifiable, scripted texts with clients to determine symptoms, frequency, and severity. Then, if deemed necessary, the client will be asked to return to clinic the following day or earlier. If 2wT patients do not respond to texts or return for any visit by day 14, they will be traced by SMS, phone or home visit. All study participants will be asked to come to the clinic for study-specific, Day 14 follow-up to review healing and verify adverse event reporting. At Day 21, we will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.

Text-based VMMC follow-up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Only men will be enrolled in the study on male circumcision. Health care workers/key informants may be male or female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For VMMC clients:
• are at least 18 years of age or over
• Possession of own phone at enrollment
• Willing to respond to daily text
• Provides contact details (phone, address)
• Undergoes surgical MC
• Willing to follow NDoH VMMC protocols
• No interoperative AE
• Informed consent
• Receives confirmed 2wT enrollment text.

You may not qualify if:

• For VMMC clients:
• Not meeting above requirements
• Men without cell phones
• Men who chose PrePex device-based VMMC
• Inter-operative AE during VMMC
• No informed consent

Sponsors & Collaborators

• University of Washington: lead
• Aurum Institute: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (9)

Mogwase

Mogwase, Bojanala, South Africa

Location

Bafokeng

Phokeng, Bojanala, South Africa

Location

Tsakane Clinic

Brakpan, Gauteng, South Africa

Location

Katlehong North Clinic

Katlehong, Gauteng, South Africa

Location

Winnie Mandela Male Health Clinic

Tembisa, Gauteng, 1632, South Africa

Location

Nchabeleng Community Health Centre

Apel, Limpopo, 0739, South Africa

Location

Philadelphia Hospital

Dennilton, Limpopo, 1030, South Africa

Location

Dilokong Hospital

Driekop, Limpopo, 1129, South Africa

Location

Matlala Hospital

Marble Hall, Limpopo, 0450, South Africa

Location

Related Publications (6)

• Feldacker C, Murenje V, Barnhart S, Xaba S, Makunike-Chikwinya B, Holeman I, Tshimanga M. Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe's voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial. Trials. 2019 Jul 23;20(1):451. doi: 10.1186/s13063-019-3470-9.

  PMID: 31337414 BACKGROUND

• Feldacker C, Murenje V, Holeman I, Xaba S, Makunike-Chikwinya B, Korir M, Gundidza PT, Holec M, Barnhart S, Tshimanga M. Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program. J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):16-23. doi: 10.1097/QAI.0000000000002198.

  PMID: 31809358 BACKGROUND

• Feldacker C, Holeman I, Murenje V, Xaba S, Korir M, Wambua B, Makunike-Chikwinya B, Holec M, Barnhart S, Tshimanga M. Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe. PLoS One. 2020 Jun 16;15(6):e0233234. doi: 10.1371/journal.pone.0233234. eCollection 2020.

  PMID: 32544161 BACKGROUND

• Babigumira JB, Barnhart S, Mendelsohn JM, Murenje V, Tshimanga M, Mauhy C, Holeman I, Xaba S, Holec MM, Makunike-Chikwinya B, Feldacker C. Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program. PLoS One. 2020 Sep 30;15(9):e0239915. doi: 10.1371/journal.pone.0239915. eCollection 2020.

  PMID: 32997710 BACKGROUND

• Setswe G, Day S, Ndebele F, Pienaar J, Ncube V, Feldacker C. Finding the balance between rigour and relevance: implementing adaptations to the implementation of a pragmatic randomised controlled trial of a two-way texting intervention for voluntary medical male circumcision in South Africa. BMJ Open. 2025 Apr 28;15(4):e091934. doi: 10.1136/bmjopen-2024-091934.

  PMID: 40295128 DERIVED

• Feldacker C, Pienaar J, Wasunna B, Ndebele F, Khumalo C, Day S, Tweya H, Oni F, Sardini M, Adhikary B, Waweru E, Wafula MB, Dixon A, Jafa K, Su Y, Sherr K, Setswe G. 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. J Med Internet Res. 2023 May 9;25:e42111. doi: 10.2196/42111.

  PMID: 37159245 DERIVED

Related Links

• Definitions of moderate and severe adverse events from "PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations"

Limitations and Caveats

Mild AEs are not reported to the Ministry of Health nor in the study. Notifiable AEs could be underreported in either group: men could seek care for AEs at another clinic, treat themselves and not report it, or otherwise heal without intervention. Men in the 2wT arm received enhanced AE identification education with illustrative photos to explain the words of the daily response, a bias that could have increased AE identification as compared to routine. Longer term outcomes are unknown.

Results Point of Contact

• Title: Caryl Feldacker
• Organization: University of Washington

cfeld@uw.edu

+1-314-600-6743

Study Officials

• Caryl Feldacker, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Geoffrey Setswe, DrPH, MPH

  Aurum Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health, Global Health

Model Details: 2wT clients will receive automated daily texts from days 1-13. If a 2wT VMMC client responds that he suspects an AE, a VMMC nurse will exchange modifiable, scripted texts with clients to determine symptoms, frequency, and severity

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 31, 2020
• Study Start: June 7, 2021
• Primary Completion: February 3, 2022
• Study Completion: March 24, 2022
• Last Updated: January 27, 2023
• Results First Posted: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (9)