Manicaland VMMC Uptake Through Behavioural Incentives Trial

NCT ID: NCT03565588

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1028 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-07

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Education session with fixed incentive

Intervention Type BEHAVIORAL

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

Education sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives.

Group Type EXPERIMENTAL

Education session with lottery incentive

Intervention Type BEHAVIORAL

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.

Control arm

No intervention will be administered to the control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men
* Age 15-29 years

Exclusion Criteria

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

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biomedical Research and Training Institute, Zimbabwe

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

London School of Economics and Political Science

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Simon Gregson

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Simon Gregson

Professor of Demography and Behavioural Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simon Gregson, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Manicaland Centre for Public Health Research

Bonda, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Hobhouse, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Honde, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Manicaland, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Nyanga, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Nyazura, Manicaland Province, Zimbabwe

Site Status

Manicaland Centre for Public Health Research

Sakubva, Manicaland Province, Zimbabwe

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Zimbabwe

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31973744 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01MH114562-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P67251_VMMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Male Circumcision and HIV Rates in Kenya
NCT00059371 COMPLETED PHASE3
Zambia One Love Aim 3 Trial
NCT02744586 COMPLETED NA
Confidential Care and Adolescent HIV Testing
NCT06279949 NOT_YET_RECRUITING NA