Manicaland VMMC Uptake Through Behavioural Incentives Trial

October 19, 2023 updated by: Simon Gregson

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1028

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Manicaland, Zimbabwe
        • Manicaland Centre for Public Health Research
    • Manicaland
      • 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
      • Nyanga, Manicaland, Zimbabwe
        • Manicaland Centre for Public Health Research
      • Nyazura, Manicaland, Zimbabwe
        • Manicaland Centre for Public Health Research
      • Sakubva, Manicaland, Zimbabwe
        • Manicaland Centre for Public Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men
  • Age 15-29 years

Exclusion Criteria:

  • Participants testing HIV-positive at baseline
  • Self-reporting have already undergone circumcision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education session with fixed incentive
Education sessions offered by a circumcised health worker and contribution towards transport costs to the health facility with payments conditional on being circumcised.
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.
Experimental: Education session with lottery incentive
Education sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives.
Behavioral: 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.
No Intervention: Control arm
No intervention will be administered to the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of voluntary medical male circumcision (VMMC)
Time Frame: 6 months
Proportion of men taking up VMMC within 6 months measured through self-reports and matched to programme records
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in perception of risk of HIV
Time Frame: 6 months
Risk perception will be measured in a follow-up survey at 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Gregson

Collaborators

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

Investigators

  • Principal Investigator: Simon Gregson, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2018

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P67251_VMMC
  • 1R01MH114562-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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