Manicaland VMMC Uptake Through Behavioural Incentives Trial
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Education session with fixed incentive
Education session with lottery incentive
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring Voluntary medical male circumcision, HIV prevention, Risk perception
Eligibility Criteria
Inclusion Criteria:
- Men
- Age 15-29 years
Exclusion Criteria:
- Participants testing HIV-positive at baseline
- Self-reporting have already undergone circumcision
Sites / Locations
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
- Manicaland Centre for Public Health Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Education session with fixed incentive
Education session with lottery incentive
Control arm
Arm Description
Education sessions offered by a circumcised health worker and contribution towards transport costs to the health facility with payments conditional on being circumcised.
Education sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives.
No intervention will be administered to the control arm
Outcomes
Primary Outcome Measures
Uptake of voluntary medical male circumcision (VMMC)
Proportion of men taking up VMMC within 6 months measured through self-reports and matched to programme records
Secondary Outcome Measures
Changes in perception of risk of HIV
Risk perception will be measured in a follow-up survey at 6 months
Full Information
NCT ID
NCT03565588
First Posted
June 11, 2018
Last Updated
October 19, 2023
Sponsor
Simon Gregson
Collaborators
Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03565588
Brief Title
Manicaland VMMC Uptake Through Behavioural Incentives Trial
Official Title
Improving Risk Perception and Uptake of Voluntary Medical Male Circumcision (VMMC) With Education Sessions and Conditional Behavioural Incentives
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2018 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon Gregson
Collaborators
Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary Objective The purpose of this study is to evaluate the impact of an interactive VMMC education session offered by a circumcised health worker and contribution to transport costs for accessing VMMC along with either (1) conditional economic compensation for wages or (2) lottery-based economic incentives on the uptake of VMMC.
Hypothesis VMMC education session offered by a role model - a young male health worker who has been previously benefited from VMMC services in this community - addressing risks of HIV infection, benefits of VMMC, and the fear of pain associated with VMMC, with/without a conditional fixed or lottery-based financial incentives off-setting present-biased preferences, will improve risk perception and increase uptake of VMMC in HIV-negative young men.
Study outcomes The primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of men taking up VMMC within 6 months measured through self-reports and matched to program records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Voluntary medical male circumcision, HIV prevention, Risk perception
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1028 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education session with fixed incentive
Arm Type
Experimental
Arm Description
Education sessions offered by a circumcised health worker and contribution towards transport costs to the health facility with payments conditional on being circumcised.
Arm Title
Education session with lottery incentive
Arm Type
Experimental
Arm Description
Education sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention will be administered to the control arm
Intervention Type
Behavioral
Intervention Name(s)
Education session with fixed incentive
Intervention Description
All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants assigned to receive fixed incentives will receive payment through mobile payments. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.
Intervention Type
Behavioral
Intervention Name(s)
Education session with lottery incentive
Intervention Description
All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants will participate in a lottery with prizes equivalent in expected value to the fixed incentives. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.
Primary Outcome Measure Information:
Title
Uptake of voluntary medical male circumcision (VMMC)
Description
Proportion of men taking up VMMC within 6 months measured through self-reports and matched to programme records
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in perception of risk of HIV
Description
Risk perception will be measured in a follow-up survey at 6 months
Time Frame
6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men
Age 15-29 years
Exclusion Criteria:
Participants testing HIV-positive at baseline
Self-reporting have already undergone circumcision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Gregson, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manicaland Centre for Public Health Research
City
Bonda
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Hobhouse
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Honde
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Nyanga
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Nyazura
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Sakubva
State/Province
Manicaland
Country
Zimbabwe
Facility Name
Manicaland Centre for Public Health Research
City
Manicaland
Country
Zimbabwe
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31973744
Citation
Thomas R, Skovdal M, Galizzi MM, Schaefer R, Moorhouse L, Nyamukapa C, Maswera R, Mandizvidza P, Hallett TB, Gregson S. Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial. Trials. 2020 Jan 23;21(1):108. doi: 10.1186/s13063-020-4048-2.
Results Reference
derived
Learn more about this trial
Manicaland VMMC Uptake Through Behavioural Incentives Trial
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