Manicaland VMMC Uptake Through Behavioural Incentives Trial

Study Overview
=================
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.

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

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Behavioral: Education session with fixed incentive
* Behavioral: Education session with lottery incentive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Age 15-29 years Exclusion Criteria: Participants testing HIV-positive at baseline Self-reporting have already undergone circumcision

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education session with fixed incentive<br>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<br>* 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.<br>|
| Experimental: Education session with lottery incentive<br>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<br>* 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.<br>|
| No Intervention: Control arm<br>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) | 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 | Risk perception will be measured in a follow-up survey at 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voluntary medical male circumcision, HIV prevention, Risk perception