Uptake of Medical Male Circumcision Among Men With Sexually Transmitted Infections (VMMC-RITe)

• ClinicalTrials.gov Identifier: NCT04677374
• Recruitment Status: Recruiting
• First Posted: December 21, 2020
• Last Update Posted: December 15, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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 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 their 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections; Sexually Transmitted Infections	Other: Standard of care; Behavioral: Intensified Health Education; Behavioral: SMS/telephonic Tracing; Behavioral: Transportation Reimbursement	Not Applicable

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 us to compare the effectiveness of different combinations of the strategies in the intervention without necessarily randomizing participants. The sample size for each block is 80 uncircumcised men with STIs. The investigators anticipate that each block may last about 4-12 weeks with one week of no intervention between interventions as a wash out period.

The study population will be men attending the Bwaila STI clinic in Lilongwe Malawi. The study will enroll 320 men to increase uptake of circumcision from 28% to 60% (national target) among uncircumcised men.

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 (Clinical Trial)
• Estimated Enrollment: 320 participants
• 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
• Official Title: Uptake of Voluntary Medical Male Circumcision Among Men Attending a Sexually Transmitted Infections Clinic in Lilongwe, Malawi
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Standard of care; Participants in this arm will be offered Standard of Care (SOC) referral process for voluntary medical male circumcision (VMMC) services	Other: Standard of care; Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
Experimental: Block 1 (intensified health education); Participants in this arm will be offered intensified health education	Behavioral: 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
Experimental: Block 2 (intensified health education and SMS/telephonic tracing); Participants in this arm will be offered intensified health education and SMS/telephonic tracing	Behavioral: SMS/telephonic Tracing; SMS tracing to remind participants of VMMC appointments
Experimental: 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	Behavioral: Transportation Reimbursement; Transportation reimbursement to offset the cost of transportation for VMMC appointments

Outcome Measures

Primary Outcome Measures :

1. Proportion of Participants Who Will Undergo Circumcision (Uptake of VMMC) [ Time Frame: Weeks 0 to 96 ]
   Each participant will be followed for 30 days to determine whether or not they receive circumcision. Proportion of participants who will undergo circumcision will be calculated as the number of participants who will undergo circumcision divided by the number of participants offered circumcision, with the corresponding 95% confidence interval. 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. The proportion of participants for each intervention block who will undergo circumcision (uptake) will be compared to the standard of care block using the two-sample test of proportions test at α=0.05 significance level.
2. Number of Days Taken for Participants to Undergo Circumcision from the Day Offered Circumcision at the STI Clinic (Time-to-circumcision) [ Time Frame: Weeks 0 to 96 ]
   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, within the 30 days of follow-up, for each participant to undergo VMMC from the day the participant will be offered VMMC within each intervention block. Mean/median duration for each intervention block will be analyzed using Kaplan Meier methods and compared to the standard of care duration using the Logrank test.

Secondary Outcome Measures :

1. Composite Median Score for Acceptability of the RITe Intervention among Participants [ Time Frame: Weeks 0 to 96 ]
   Acceptability will be measured quantitatively using the Acceptability of Intervention Measure (AIM) Likert scale surveys. The AIM Likert scale measures acceptability based on four constructs that assess whether an intervention is appealing, likable, welcome and approvable. Surveys for acceptability will be conducted at baseline and during implementation of each intervention block. An overall composite median score (and interquartile range) for acceptability for each intervention block will be calculated and compared to baseline using the Wilcoxon rank sum test. The AIM score range is 6 - 80 from a scale with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more acceptability items. The percentage who strongly agree, agree, neutral, disagree or strongly disagree to each construct will be plotted on bar charts. The investigators will use electronic tablets to administer the surveys.
2. Composite Median Score for Feasibility of the RITe Intervention among Healthcare Workers [ Time Frame: Weeks 12 to 96 ]
   Feasibility will be measured quantitatively using the Feasibility of Intervention Measure (FIM) Likert scale surveys. The FIM measures feasibility based on four constructs that assess whether an intervention is implementable, possible, doable, and easy to use. Feasibility will be assessed among healthcare workers only as implementers of the intervention. Surveys for feasibility will be conducted for each intervention block during the implementation phase only. An overall composite median score (and interquartile range) for feasibility for each intervention block will be calculated and compared to baseline using the Wilcoxon rank sum test. The FIM score range is 5 - 60 with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more feasibility items. The percentage who strongly agree, agree, neutral, disagree or strongly disagree to each construct will be plotted on bar charts.
3. Perception that the RITe Intervention is Acceptable among Study Participants [ Time Frame: Up to 96 weeks ]
   Qualitative assessments for acceptability will be conducted using in-depth interviews and focus group discussions. In-depth interviews will be conducted with healthcare workers and focus group discussions will be conducted with uncircumcised men. Both interviews and focus groups discussions will be conducted at baseline and end-line to complement quantitative findings. Interview and focus group discussions will be analyzed using thematic analysis and a summary of common themes will be presented. Assessed at Baseline and end-line.
4. Perception that the RITe Intervention has been Successfully Implemented at Bwaila STI Clinic [ Time Frame: Week 96 ]
   Qualitative assessments for feasibility will be conducted using in-depth interviews with healthcare workers only. The interviews will be conducted at end-line to complement quantitative findings. The Interviews will be analyzed using thematic analysis and a summary of common themes will be presented.
5. Composite Median Score for Appropriateness of the RITe Intervention among Participants [ Time Frame: Week 0 to 96 weeks ]
   Appropriateness will be measured quantitatively using the Intervention Appropriateness Measure (IAM) Likert scale surveys. The IAM Likert scale measures appropriateness based on four constructs that assess whether an intervention is fitting, suitable, applicable and a good match. Surveys for appropriateness will be conducted at baseline and during implementation of each intervention block. An overall composite median score (and interquartile range) for appropriateness for each intervention block will be calculated and compared to baseline using the Wilcoxon rank sum test. The IAM score range is 5 - 85 from a scale with 1=completely disagree, 2=disagree, 3=Neutral, 4=agree and 5=completely agree. Higher scores indicate agreement with more appropriateness items. The percentage who strongly agree, agree, neutral, disagree or strongly disagree to each construct will be plotted on bar charts. The investigators will use electronic tablets to administer the surveys.
6. Perception that the RITe Intervention is Appropriate among Study Participants [ Time Frame: Up tp 96 weeks ]
   Qualitative assessments for appropriateness will be conducted using in-depth interviews and focus group discussions. In-depth interviews will be conducted with healthcare workers and focus group discussions will be conducted with uncircumcised men. Both interviews and focus groups discussions will be conducted at baseline and end-line to complement quantitative findings. Interview and focus group discussions will be analyzed using thematic analysis and a summary of common themes will be presented. Assessed at Baseline and end-line.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Mitch M Matoga, MD, MSc; +265999511726; mmatoga@email.unc.edu

Contact: Mina C Hosseinipour, MD, MPH; +265888202153; mina_hosseinipour@med.unc.edu

Locations

Malawi

UNC Project-Malawi (Bwaila District Hospital); Recruiting

Lilongwe, Malawi

Contact: Mitch Matoga, MD, MSc mmatoga@unclilongwe.org

Contact: Mina Hosseinipour, MD mina_hosseinipour@med.unc.edu

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institutes of Health (NIH)

Fogarty International Center of the National Institute of Health

Investigators

• Principal Investigator: Mitch Matoga, MD, MSc; UNC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04677374
• Other Study ID Numbers: 19-2559; D43TW010060 ( U.S. NIH Grant/Contract )
• First Posted: December 21, 2020
• Last Update Posted: December 15, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

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

Additional relevant MeSH terms:

Infections; Communicable Diseases; Sexually Transmitted Diseases; Disease Attributes; Pathologic Processes