Clinical trial NCT03565588: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Voluntary medical male circumcision
HIV prevention
Risk perception
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Biomedical Research and Training Institute, Zimbabwe
name: University of Copenhagen
name: London School of Economics and Political Science
name: National Institute of Mental Health (NIMH)
First posted: 2018-06-21
Enrollment: 1028
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Men
* Age 15-29 years

Exclusion Criteria:

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

Primary outcomes:
measure: Uptake of voluntary medical male circumcision (VMMC)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in perception of risk of HIV
timeFrame: 6 months
Other outcomes:
Locations:
city: Bonda
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Hobhouse
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Honde
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Nyanga
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Nyazura
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Sakubva
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
state: Manicaland
city: Manicaland
country: Zimbabwe
facility: Manicaland Centre for Public Health Research
Study officials:
affiliation: Imperial College London
name: Simon Gregson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.