Clinical trial NCT04677374: Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
Official title: Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: Voluntary medical male circumcision
Men with sexually transmitted infections
Uptake
Acceptability
Feasibility
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2020-12-21
Enrollment: 2242
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The intervention will be rolled-out in the implementation phase in a sequential and incremental manner called implementation blocks. Implementation blocks will be as follows: block 1: Intensified health education (I); block 2: Intensified health education and SMS/telephonic Tracing (IT) and finally, Block 3: Intensified health education, SMS/telephonic tracing and transport Reimbursement (RITe)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Male Clients Who Will Undergo Circumcision (Uptake of VMMC)
timeFrame: up to 30 days
measure: Median Number of Days Taken for Male Clients to Undergo Circumcision From the Day Offered Circumcision at the STI Clinic (Time-to-circumcision)
timeFrame: up to 30 days
Secondary outcomes:
measure: Percentage of Male Clients Who Reported the RITe Intervention As Acceptable
timeFrame: Baseline and Follow-Up, up to 30 days
measure: Number of Male Clients With Perception That the RITe Intervention is Acceptable
timeFrame: Baseline, End of Study Follow Up (approximately Week 82)
measure: Percentage of Healthcare Workers Who Rated the RITe Intervention as Feasible
timeFrame: End of Study Follow Up (approximately Week 82)
measure: Number of Healthcare Workers With Perception That the RITe Intervention is Feasible
timeFrame: End of Study Follow Up (approximately Week 82)
measure: Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at Baseline
timeFrame: Baseline
measure: Number of Healthcare Workers With Perception That the RITe Intervention is Acceptable at End of Study Follow Up
timeFrame: End of Study Follow Up (approximately Week 82)
measure: Percentage of Male Clients Who Reported the RITe Intervention As Appropriate
timeFrame: Baseline and Follow-Up, up to 30 days
measure: Number of Male Clients With Perception That the RITe Intervention is Appropriate
timeFrame: Baseline, End of Study Follow Up (approximately Week 82)
measure: Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at Baseline
timeFrame: Baseline
measure: Number of Healthcare Workers With Perception That the RITe Intervention is Appropriate at End of Study Follow Up
timeFrame: End of Study Follow Up (approximately Week 82)
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: UNC Project-Malawi (Bwaila District Hospital)
Study officials:
affiliation: UNC
name: Mitch Matoga, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.