Adults 18 to 75, any sex, with Voluntary Medical Male Circumcision. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 VisitPrimary· Any AE before, and including, up to 22 days post VMMC to allow for logistical issues delaying attendance of the 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
Group
Value
95% CI
Text-based VMMC Follow-up
2.3
1.3 – 4.1
Routine VMMC Follow-up Care
1.01
0.4 – 2.3
Number of Non-study In-person VisitsPrimary· Less than or equal to 42 days post-operative
To determine follow-up visit reduction, the investigators will compare the number of in- person visits for intervention and control using a t-test.
Group
Value
95% CI
Text-based VMMC Follow-up
0.22
± 0.65
Routine VMMC Follow-up Care
1.34
± 0.85
Percent of Adverse Events (AE) Identified /on/ Day 14 VisitSecondary· AEs identified during Day 14 visits that occurred only in the window between post-operative days 13-22
Percentage of patients with an AE (moderate or severe) identified on the Day 14 in-person visit using AE definitions from: PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations
Group
Value
95% CI
Text-based VMMC Follow-up
0.20
0.03 – 1.2
Routine VMMC Follow-up Care
0.9
0.4 – 2.3
Number VMMC-related Severe Adverse Events Over 22 Post-operative DaysSecondary· Within 22 days post operative
The number of severe VMMC AEs over the first 22 post operative days. The definition of "severe" in this context is any wound requiring re-opening of the wound, such as adding new sutures, from here: PEPFAR's Best Practices for Voluntary Medical Male Circumcision Site Operations. These two severe AEs were bleeding, requiring additional compression and resuturing of the wound.
Group
Value
95% CI
Text-based VMMC Follow-up
2
Routine VMMC Follow-up Care
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 42 post-operative days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc
· Phase 2
· not yet recruiting
NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn
· NA
· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 27 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04327271.