Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections

NCT04677374 | Completed Results

• 2 other identifiers: 19-2559D43TW010060
• Study Type: interventional
• Target: 2,242
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Keywords

Voluntary medical male circumcision; Men with sexually transmitted infections; Uptake; Acceptability; Feasibility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (4)

Standard of care

PLACEBO COMPARATOR

Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services

Other: Standard of care

Block 1 (intensified health education)

EXPERIMENTAL

Participants in this arm will be offered intensified health education

Behavioral: Intensified Health Education

Block 2 (intensified health education and SMS/telephonic tracing)

EXPERIMENTAL

Participants in this arm will be offered intensified health education and SMS/telephonic tracing

Behavioral: SMS/telephonic Tracing

Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement)

EXPERIMENTAL

Participants in this arm will be offered intensified health education, SMS/telephonic tracing and transport reimbursement

Behavioral: Transportation Reimbursement

Interventions

Standard of care OTHER

Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.

Standard of care

Intensified Health Education BEHAVIORAL

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 1 (intensified health education)

SMS/telephonic Tracing BEHAVIORAL

SMS tracing to remind participants of VMMC appointments

Block 2 (intensified health education and SMS/telephonic tracing)

Transportation Reimbursement BEHAVIORAL

Transportation reimbursement to offset the cost of transportation for VMMC appointments

Block 3 (intensified health education, SMS/telephonic tracing and transport reimbursement)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

UNC Project-Malawi (Bwaila District Hospital)

Lilongwe, Malawi

Location

Related Publications (3)

• 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.

  PMID: 38633812 DERIVED

• 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.

  PMID: 37788927 DERIVED

• 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.

  PMID: 35042709 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Mitch Matoga, MD, MS
• Organization: University of North Carolina at Chapel Hill

mmatoga@email.unc.edu

00265 1 755056

Study Officials

• Mitch Matoga, MD, MSc

  UNC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: February 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)