Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections
Condition: HIV Infections; Sexually Transmitted Infections
MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases
Study type: Interventional

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.
    

Intervention name(s): Standard of care; Intensified Health Education; SMS/telephonic Tracing; Transportation Reimbursement
Intervention type(s): Other; Behavioral; Behavioral; Behavioral
Intervention description(s): Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.; 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 tracing to remind participants of VMMC appointments; Transportation reimbursement to offset the cost of transportation for VMMC appointments
Allocation: Non-Randomized
Intervention model: Sequential Assignment
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)
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Voluntary medical male circumcision; Men with sexually transmitted infections; Uptake; Acceptability; Feasibility