Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,242
- Locations
- 1
- Primary Endpoint
- Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Standard of care
Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services
Intervention: Standard of care (Other)
Block 1 (intensified health education)
Participants in this arm will be offered intensified health education
Intervention: Intensified Health Education (Behavioral)
Block 2 (intensified health education and SMS/telephonic tracing)
Participants in this arm will be offered intensified health education and SMS/telephonic tracing
Intervention: SMS/telephonic Tracing (Behavioral)
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
Intervention: Transportation Reimbursement (Behavioral)
Outcomes
Primary Outcomes
Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)
Time Frame: up to 30 days
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.
Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)
Time Frame: up to 30 days
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.
Secondary Outcomes
- Percentage of Male Clients Who Reported the RITe Intervention As Acceptable(Baseline and Follow-Up, up to 30 days)
- Number of Male Clients With Perception That the RITe Intervention is Acceptable(Baseline, End of Study Follow Up (approximately Week 82))
- Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible(End of Study Follow Up (approximately Week 82))
- Number of Healthcare Workers With Perception That the RITe Intervention is Feasible(End of Study Follow Up (approximately Week 82))
- Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline(Baseline)
- Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up(End of Study Follow Up (approximately Week 82))
- Percentage of Male Clients Who Reported the RITe Intervention As Appropriate(Baseline and Follow-Up, up to 30 days)
- Number of Male Clients With Perception That the RITe Intervention is Appropriate(Baseline, End of Study Follow Up (approximately Week 82))
- Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline(Baseline)
- Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up(End of Study Follow Up (approximately Week 82))