Trial Outcomes & Findings for Two-way Texting for VMMC Follow-up in Republic of South Africa (NCT NCT04327271)

NCT ID: NCT04327271

Last Updated: 2023-01-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1093 participants
• Primary outcome timeframe: Any AE before, and including, up to 22 days post VMMC to allow for logistical issues delaying attendance of the Day 14 visit
• Results posted on: 2023-01-27

Participant Flow

Participant milestones

Measure	Text-based VMMC Follow-up 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care Routine VMMC follow up care with in person visits according to national guidelines.
Overall Study STARTED	553	540
Overall Study COMPLETED	547	537
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Measure	Text-based VMMC Follow-up 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care Routine VMMC follow up care with in person visits according to national guidelines.
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study randomization error (data capture)	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Text-based VMMC Follow-up n=553 Participants 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care n=540 Participants Routine VMMC follow up care with in person visits according to national guidelines.	Total n=1093 Participants Total of all reporting groups
Age, Continuous	31.7 years n=5 Participants	31.4 years n=7 Participants	31.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	553 Participants n=5 Participants	540 Participants n=7 Participants	1093 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	553 Participants n=5 Participants	540 Participants n=7 Participants	1093 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment South Africa	553 participants n=5 Participants	540 participants n=7 Participants	1093 participants n=5 Participants

PRIMARY outcome

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

Population: The denominator is restricted to men who had at least one in-person visit before day 22 which includes the window of attendance for the D14 visit. This window also includes all AEs identified in the study.

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

Outcome measures

Measure	Text-based VMMC Follow-up n=477 Participants 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care n=494 Participants Routine VMMC follow up care with in person visits according to national guidelines.
Cumulative Percentage of Patients With an Adverse Event (AE) (Moderate or Severe) on or Before Day 14 Visit	2.3 percentage of participants Interval 1.3 to 4.1	1.01 percentage of participants Interval 0.4 to 2.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Text-based VMMC Follow-up n=547 Participants 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care n=537 Participants Routine VMMC follow up care with in person visits according to national guidelines.
Number of Non-study In-person Visits	0.22 Number of in-person visits Standard Deviation 0.65	1.34 Number of in-person visits Standard Deviation 0.85

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Text-based VMMC Follow-up n=547 Participants 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care n=537 Participants Routine VMMC follow up care with in person visits according to national guidelines.
Percent of Adverse Events (AE) Identified /on/ Day 14 Visit	0.20 percentage of participants Interval 0.03 to 1.2	0.9 percentage of participants Interval 0.4 to 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Text-based VMMC Follow-up n=547 Participants 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. Text-based VMMC follow-up: 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.	Routine VMMC Follow-up Care n=537 Participants Routine VMMC follow up care with in person visits according to national guidelines.
Number VMMC-related Severe Adverse Events Over 22 Post-operative Days	2 WHO-defined severe VMMC adverse events	0 WHO-defined severe VMMC adverse events

Adverse Events

Texting

Serious events: 0 serious events

Other events: 11 other events

Deaths: 1 deaths

Routine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Texting n=547 participants at risk Men who received 2-way texting (intervention)	Routine n=537 participants at risk Routine follow-up (control)
Surgical and medical procedures Bleeding	0.73% 4/547 • Number of events 4 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.	0.00% 0/537 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.
Surgical and medical procedures Infection	0.73% 4/547 • Number of events 4 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.	0.37% 2/537 • Number of events 2 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.
Surgical and medical procedures Swelling	0.00% 0/547 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.	0.19% 1/537 • Number of events 1 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.
Surgical and medical procedures Wound disruption	0.55% 3/547 • Number of events 3 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.	0.37% 2/537 • Number of events 2 • 42 post-operative days Severe and moderate adverse events defined according to, US President's Emergency Plan for AIDS Relief's (PEPFAR's) guidelines on AEs in adult voluntary medical male circumcision. AEs documented in accordance with PEPFAR guidance on routine VMMC forms. Death (suicide) not related to the study: MG1011-2351 enrolled on 10 November, 2021 and randomized to texting. No suspected AEs reported by participant. 1 December 2021 report from his work colleague of suicide on the 30th of November 2021.

Additional Information

Caryl Feldacker

University of Washington

Phone: +1-314-600-6743

Email: cfeld@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place