N/A
N=1,093
Two-way Texting for VMMC Follow-up in Republic of South Africa
Voluntary Medical Male Circumcision
Bottom Line
View on ClinicalTrials.gov: NCT04327271 ↗Enrolled (actual)
1,093
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit — 2.3; 1.01 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Text-based VMMC follow-up (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit |
2.3; 1.01 | — |
| PRIMARY Number of Non-study In-person Visits |
0.22; 1.34 | 0.001 sig |
| SECONDARY Percent of Adverse Events (AE) Identified /on/ Day 14 Visit |
0.20; 0.9 | — |
| SECONDARY Number VMMC-related Severe Adverse Events Over 22 Post-operative Days |
2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT04327271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.