Manicaland VMMC Uptake Through Behavioural Incentives Trial

HIV/AIDS Clinical Trial

Official title:

Improving Risk Perception and Uptake of Voluntary Medical Male Circumcision (VMMC) With Education Sessions and Conditional Behavioural Incentives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565588
• Other study ID #: P67251_VMMC
• Secondary ID: 1R01MH114562-01
• Status: Completed
• Phase: N/A
• Start date: July 7, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1028
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 29 Years

Eligibility

Inclusion Criteria:

• Men

• Age 15-29 years

Exclusion Criteria:

• Participants testing HIV-positive at baseline

• Self-reporting have already undergone circumcision

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Education session with fixed incentive
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.
• Education session with lottery incentive
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.

Locations

Country	Name	City	State
Zimbabwe	Manicaland Centre for Public Health Research	Bonda	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Hobhouse	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Honde	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Nyanga	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Nyazura	Manicaland
Zimbabwe	Manicaland Centre for Public Health Research	Sakubva	Manicaland

Sponsors (5)

Lead Sponsor	Collaborator
Simon Gregson	Biomedical Research and Training Institute, Zimbabwe, London School of Economics and Political Science, National Institute of Mental Health (NIMH), University of Copenhagen

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Changes in perception of risk of HIV	Risk perception will be measured in a follow-up survey at 6 months	6 months