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Completed

NCT Number: NCT03565588

Manicaland VMMC Uptake Through Behavioural Incentives Trial

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Manicaland Centre for Public Health Research, Bonda, Manicaland Province, Zimbabwe

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men
  • Age 15-29 years

Exclusion criteria

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

Treatment and study plan

Education session with fixed incentive

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Simon Gregson

Other

Collaborators

  • Biomedical Research and Training Institute, Zimbabwe
  • London School of Economics and Political Science
  • National Institute of Mental Health (NIMH)
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2018
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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