Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
NCT ID: NCT04677374
Last Updated: 2023-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2242 participants
INTERVENTIONAL
2021-02-01
2022-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard of care
Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services
Standard of care
Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
Block 1 (intensified health education)
Participants in this arm will be offered intensified health education
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
Block 2 (intensified health education and SMS/telephonic tracing)
Participants in this arm will be offered intensified health education and SMS/telephonic tracing
SMS/telephonic Tracing
SMS tracing to remind participants of VMMC appointments
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
Transportation Reimbursement
Transportation reimbursement to offset the cost of transportation for VMMC appointments
Interventions
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Standard of care
Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
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
SMS/telephonic Tracing
SMS tracing to remind participants of VMMC appointments
Transportation Reimbursement
Transportation reimbursement to offset the cost of transportation for VMMC appointments
Eligibility Criteria
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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
99 Years
MALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Fogarty International Center of the National Institute of Health
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Mitch Matoga, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
UNC
Locations
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UNC Project-Malawi (Bwaila District Hospital)
Lilongwe, , Malawi
Countries
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References
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Matoga MM, Kudowa E, Chikuni J, Tsidya M, Tseka J, Ndalama B, Bonongwe N, Mathiya E, Jere E, Yatina D, Kamtambe B, Kapito M, Hosseinipour MC, Chasela CS, Jewett S. Acceptability, feasibility and appropriateness of intensified health education, SMS/phone tracing and transport reimbursement for uptake of voluntary medical male circumcision in a sexually transmitted infections clinic in Malawi: a mixed methods study. medRxiv [Preprint]. 2024 Apr 4:2024.03.27.24304985. doi: 10.1101/2024.03.27.24304985.
Matoga MM, Kudowa E, Ndalama B, Bonongwe N, Mathiya E, Jere E, Kamtambe B, Chagomerana M, Chasela C, Jewett S, Hosseinipour MC. Effectiveness of an intervention to increase uptake of voluntary medical male circumcision among men with sexually transmitted infections in Malawi: a preinterventional and postinterventional study. BMJ Open. 2023 Oct 3;13(10):e072855. doi: 10.1136/bmjopen-2023-072855.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-2559
Identifier Type: -
Identifier Source: org_study_id
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