Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections (VMMC-RITe)

Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi

The intervention includes provision of transport reimbursement for men who will undergo voluntary medical male circumcision (VMMC), intensified health education by a VMMC mobilizer and a male and female VMMC champion and use of a cell phone short messaging service (SMS) and/or telephonic tracing to remind clients of their VMMC appointment (the RITe intervention). The investigators will assess the uptake of VMMC, and acceptability, appropriateness and feasibility of the RITe intervention among uncircumcised men attending a Sexually Transmitted Infection (STI) clinic and health care workers.

This intervention was initially designed to include escorting men interested in circumcision from the STI clinic to a VMMC clinic co-located in the same facility. However, the VMMC clinic space was repurposed to a COVID-19 isolation unit therefore clinic escorts were excluded. In Lieu of clinic escorts, participants will be linked to the nearest health facility of choice where VMMC services are provided by the VMMC mobilizer.

The purpose of the study is to evaluate the impact of using transport reimbursement, intensified health education and SMS/telephonic tracing in increasing the uptake of voluntary medical male circumcision at this clinic.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Infections
• Intervention / Treatment: Other: Standard of care; Behavioral: Intensified Health Education; Behavioral: SMS/telephonic Tracing; Behavioral: Transportation Reimbursement

Detailed Description

This study will be a pragmatic, pre- and post-interventional quasi-experimental study combined with a prospective observational study design. The study will have pre-implementation and implementation phases and use a concurrent exploratory mixed method approach.

The study will evaluate the effect of multi-faceted intervention on the uptake of VMMC. The intervention includes use of transport reimbursement for men who will undergo VMMC, Intensified health education by VMMC champions and women and use of SMS/telephonic Tracing to remind clients of their VMMC appointment (the RITe intervention).

The intervention will be conducted in a sequential and incremental manner called implementation blocks. After collecting data from the standard of care period, the first implementation block will be for intensified health education. The next block will combine intensified health education with SMS/telephonic tracing. The last block will combine intensified health education with SMS/telephonic tracing and transport reimbursements. This approach will allow the investigator to compare the effectiveness of different combinations of the strategies in the intervention without necessarily randomizing participants. The sample size for each block is expected to be at least 80 uncircumcised men with STIs. The investigators anticipate that each block may last about 4-12 weeks (to allow the interventions to mature) with one week of no intervention between interventions as a wash out period. However, sample size may be higher if more uncircumcised men present within the minimum 4-week intervention period.

The study population will be men attending the Bwaila STI clinic in Lilongwe Malawi. The study will enroll a minimum of 320 men to depict an uptake rate of circumcision of about 28% (national average including traditional circumcision) among uncircumcised men. However, for each intervention to settle, the investigator will implement each intervention for at least 4 weeks.

Data on uptake of VMMC will be collected through a standardize data collection form in conjunction with routine data from the STI clinic electronic medical registry. Data on acceptability, appropriateness and feasibility will be collected through surveys, interviews and focus group discussions. The investigators will conduct about 280 surveys for acceptability, appropriateness and feasibility with men selected randomly through the implementation period (70 men per intervention block). About 20 in-depth interviews with healthcare workers equally divided by intervention block will be conducted to assess acceptability, appropriateness and feasibility. Finally, the investigators will conduct four focus group discussions with men through the study period to assess acceptability, appropriateness and feasibility of the RITe strategy.

• Study Type: Interventional
• Enrollment (Actual): 2242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • UNC Project-Malawi (Bwaila District Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male
• 18 years or older
• Seeking STI care at the Bwaila STI clinic
• Not circumcised
• Healthcare workers at Bwaila STI and VMMC clinic

Exclusion Criteria:

• < 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard of care; Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Other: Standard of care; Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
Experimental: Block 1 (intensified health education); Participants in this arm will be offered intensified health education	Behavioral: Intensified Health Education; More detailed health talk conducted during each group health talk session by the VMMC mobilizer and champions describing VMMC, its benefits and how to access the service and testimonies from men who have successfully undergone VMMC
Experimental: Block 2 (intensified health education and SMS/telephonic tracing); Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Behavioral: SMS/telephonic Tracing; SMS tracing to remind participants of VMMC appointments
Experimental: Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement); Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement	Behavioral: Transportation Reimbursement; Transportation reimbursement to offset the cost of transportation for VMMC appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)	Each participant will be followed for 30 days to determine whether or not they receive circumcision. Number of participants who will undergo circumcision will be reported. The investigators will collect data on the number of participants offered VMMC and the number of participants who will undergo VMMC for each intervention block.	up to 30 days
Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)	The duration in days from when participants are offered VMMC to when the participants will undergo VMMC. The investigators will collect data on the number of days taken from the day circumcision is offered for each participant to undergo VMMC through the 30-day Follow-Up period.	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Male Clients Who Reported the RITe Intervention As Acceptable	Acceptability measured quantitatively using the Acceptability of Intervention Measure (AIM) Likert scale surveys. The AIM Likert scale measures acceptability based on four constructs that assess whether an intervention is appealing, likable, welcome and approvable. The AIM score ranges from 6 - 80 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more acceptability items. The percentage is reported for those who strongly agree or agree assessed at Baseline and Follow-Up.	Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Acceptable	Qualitative assessments for acceptability conducted using focus group discussions with uncircumcised men. Focus group discussions were conducted at Baseline and End of Study Follow Up to complement quantitative findings. Focus group discussions analyzed using thematic analysis and a summary of common themes presented.	Baseline, End of Study Follow Up (approximately Week 82)
Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible	Feasibility measured quantitatively using the Feasibility of Intervention Measure (FIM) Likert scale surveys. The FIM measures feasibility based on four constructs that assess whether an intervention is implementable, possible, resources, and difficult to use. Feasibility assessed among Healthcare Workers only as implementers of the intervention. Surveys for feasibility will be conducted for each intervention block during the implementation phase only. The FIM score range is 5 - 60 with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more feasibility items. The percentage is reported for those who strongly agree or agree assessed at End of Study Follow Up.	End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Feasible	Qualitative assessments for intervention feasibility conducted using in-depth interviews with Healthcare Workers only at End of Study Follow Up to complement quantitative findings. The interviews were analyzed using thematic analysis and a summary of common themes presented.	End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline	Qualitative assessments for acceptability conducted using in-depth interviews with Healthcare Workers at Baseline for the Standard of Care arm to complement quantitative findings. In-depth interviews were analyzed using thematic analysis and a summary of common themes presented.	Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up	Qualitative assessments for acceptability conducted using in-depth interviews with Healthcare Workers at End of Study Follow Up for the Block 3 arm to complement quantitative findings. In-depth interviews were analyzed using thematic analysis and a summary of common themes presented.	End of Study Follow Up (approximately Week 82)
Percentage of Male Clients Who Reported the RITe Intervention As Appropriate	Appropriateness measured quantitatively using the Intervention Appropriateness Measure (IAM) Likert scale surveys. The IAM Likert scale measures appropriateness based on four constructs that assess whether an intervention is embarrassing, culturally & religiously suitable, and a good idea. Surveys for appropriateness were conducted at baseline and during implementation of each intervention block. The IAM score range is 5 - 85 from a scale with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more appropriateness items. The percentage is reported for those who strongly agree or agree assessed at Baseline and Follow-Up.	Baseline and Follow-Up, up to 30 days
Number of Male Clients With Perception That the RITe Intervention is Appropriate	Qualitative assessments for appropriateness conducted using focus group discussions with uncircumcised men. Focus group discussions conducted at Baseline and End of Study Follow Up to complement quantitative findings. Focus group discussions were analyzed using thematic analysis and a summary of common themes presented.	Baseline, End of Study Follow Up (approximately Week 82)
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline	Qualitative assessments for appropriateness conducted using in-depth interviews with Healthcare Workers only. The interviews were conducted at Baseline to complement quantitative findings. The Interviews were analyzed using thematic analysis and a summary of common themes presented.	Baseline
Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up	Qualitative assessments for appropriateness conducted using in-depth interviews with Healthcare Workers only. The interviews were conducted at End of Study Follow Up to complement quantitative findings. The Interviews were analyzed using thematic analysis and a summary of common themes presented.	End of Study Follow Up (approximately Week 82)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Mitch Matoga, MD, MSc, UNC

Publications and helpful links

General Publications

• Matoga MM, Hosseinipour MC, Jewett S, Chasela C. Uptake of voluntary medical male circumcision among men with sexually transmitted infections in Lilongwe, Malawi: a protocol for a pre-interventional and post-interventional study. BMJ Open. 2022 Jan 18;12(1):e057507. doi: 10.1136/bmjopen-2021-057507.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Uptake; Voluntary medical male circumcision; Men with sexually transmitted infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 19-2559; D43TW010060 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No