NCT03565588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

July 7, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

June 11, 2018

Last Update Submit

October 19, 2023

Conditions

Keywords

Voluntary medical male circumcisionHIV preventionRisk perception

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in perception of risk of HIV

    6 months

Study Arms (3)

Education session with fixed incentive

EXPERIMENTAL

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

Education session with lottery incentive

EXPERIMENTAL

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

Control arm

NO INTERVENTION

No intervention will be administered to the control arm

Interventions

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 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 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.

Education session with lottery incentive

Eligibility Criteria

Age15 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Men
  • Age 15-29 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Manicaland Centre for Public Health Research

Bonda, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Hobhouse, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Honde, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Manicaland, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Nyanga, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Nyazura, Manicaland Province, Zimbabwe

Location

Manicaland Centre for Public Health Research

Sakubva, Manicaland Province, Zimbabwe

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Simon Gregson, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Demography and Behavioural Science

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 21, 2018

Study Start

July 7, 2018

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations