Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Manicaland VMMC Uptake Through Behavioural Incentives Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03565588
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : October 6, 2021
Sponsor:
Collaborators:
Biomedical Research and Training Institute, Zimbabwe
University of Copenhagen
London School of Economics and Political Science
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Simon Gregson, Imperial College London

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Education session with fixed incentive Behavioral: Education session with lottery incentive Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Risk Perception and Uptake of Voluntary Medical Male Circumcision (VMMC) With Education Sessions and Conditional Behavioural Incentives
Actual Study Start Date : July 7, 2018
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in perception of risk of HIV [ Time Frame: 6 months ]
    Risk perception will be measured in a follow-up survey at 6 months


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Age 15-29 years

Exclusion Criteria:

  • Participants testing HIV-positive at baseline
  • Self-reporting have already undergone circumcision
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565588


Locations
Layout table for location information
Zimbabwe
Manicaland Centre for Public Health Research
Bonda, Manicaland, Zimbabwe
Manicaland Centre for Public Health Research
Eastern Highlands, 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
Selbourne, Manicaland, Zimbabwe
Sponsors and Collaborators
Simon Gregson
Biomedical Research and Training Institute, Zimbabwe
University of Copenhagen
London School of Economics and Political Science
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Simon Gregson, PhD Imperial College London
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Simon Gregson, Professor of Demography and Behavioural Science, Imperial College London
ClinicalTrials.gov Identifier: NCT03565588    
Other Study ID Numbers: P67251_VMMC
1R01MH114562-01 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Gregson, Imperial College London:
Voluntary medical male circumcision
HIV prevention
Risk perception
Additional relevant MeSH terms:
Layout table for MeSH terms
Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases