Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03119337
• Date of registration: 31/03/2017
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: Text-based Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program 2WT
• Scientific title: Reducing Provider Workload While Preserving Patient Safety: A 2-Way Texting Intervention in Zimbabwe's Voluntary Medical Male Circumcision Program
• Date of first enrolment: June 18, 2018
• Target sample size: 780
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03119337
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zimbabwe

Contacts

• Name: Caryl Feldacker, PhD, MPH
• Affiliation: University of Washington

Key inclusion & exclusion criteria

Inclusion: For health care workers (Aim 3):

1. are employees posted at the site;

2. are at least 18 years of age or over;

3. provide health care services to patients as part of the VMMC programs; and

4. are able to provide written informed consent.

For VMMC clients (Aims 1): Eligibility criteria for VMMC clients are:

1. 18 years or older;

2. possession of own phone at enrollment;

3. provides contact details (phone, physical location);

4. receives surgical VMMC;

5. willing to follow MoHCC VMMC protocols;

6. willing to come in Day 14;

7. Able and willing to respond to a questionnaire administered by phone 42 days after
circumcision.

Exclusion for Healthcare workers:

1. not willing to participate

2. not willing to be recorded

Exclusion for VMMC clients:

1. men without cell phones;

2. those who chose PrePex as PrePex requires a device-removal visit 7 days after
placement and has distinctly different follow-up protocols;

3. men who have an inter-operative AE during routine VMMC will be withdrawn from the
study as these men will have known, additional follow-up risks and mandatory in-person
visits.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Voluntary Medical Male Circumcision

Intervention(s)

Other: Text-based follow-up

Primary Outcome(s)

Mean number of in-person visits [Time Frame: Before 42 day visit for each participant with analysis completed in year 1.]

2WT acceptability [Time Frame: The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.]

2WT feasibility [Time Frame: The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.]

2wT costs [Time Frame: The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1]

Cumulative adverse event (AE) rate (moderate or severe) [Time Frame: = Day 14 for each participant with analysis completed in year 1.]

Secondary Outcome(s)

AE rates on Day 14 [Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1.]

time between 2wT AE text reporting and follow-up [Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1.]

severity of AEs. [Time Frame: Day 14 data collection for each participant with analysis to be completed in year 1.]

Secondary ID(s)

STUDY00001839

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Training and Education Center for Health

University of Zimbabwe

ZICHIRe

Medic Mobile