NCT02012816

Brief Summary

The Centre for Infectious Disease Research in Zambia (CIDRZ) and researchers from the University of North Carolina at Chapel Hill (UNC) have partnered to pilot an peer-referral incentive program to increase voluntary medical male circumcision (VMMC) uptake in Zambia. The program allows each man coming for circumcision to refer up to 5 uncircumcised men in their social network for VMMC services and receive a monetary reward for each successful referral. The peer-referral program offers several advantages over traditional demand-creation approaches that rely on employing mobilizers or community health workers (CHWs). The amount of the monetary incentive will be analogous to the amount of incentive that CHWs might receive for comparable effort, making the program suitable for large-scale expansion. The effect of the peer-referral program on uptake of VMMC services will be evaluated using a rigorous methodology proposed by UNC researchers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
725

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

December 5, 2013

Last Update Submit

June 3, 2016

Conditions

Keywords

Uncircumcised menVoluntary Medical Male circumcisionPeer-referral incentive

Outcome Measures

Primary Outcomes (1)

  • Primary outcome will be the number of men coming for circumcision in each clinic during the intervention period divided by the adult male population in the catchment area of each clinic.

    Primary outcome will be the number of men coming for circumcision in each clinic during the intervention period divided by the adult male population in the catchment area of each clinic. The calculated proportion in the intervention clinics will be compared to the calculated proportion in the control clinics using standard t-test.

    1 year

Study Arms (1)

Uncircumcised men

OTHER

The program allows each man coming for circumcision to refer up to 5 uncircumcised men in their social network for VMMC services and receive a monetary reward for each successful referral.

Other: Peer-referral incentive program to increase VMMC uptake

Interventions

The proposed intervention will allow men coming for male circumcision in randomly selected intervention clinics to refer up to 5 uncircumcised men in their social network and receive a monetary reward for each referred man who undergoes male circumcision. Men who come for circumcision will each be given 5 referral vouchers that they can then provide to uncircumcised men in their social network who may be interested in undergoing VMMC. If these uncircumcised men come to the CIDRZ VMMC clinics and undergo the circumcision procedure, they can present the referral voucher to clinic staff who will then retain the voucher until the man who made the referral comes to collect his incentive payment.

Uncircumcised men

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Harsha Thirumurthy, MD

    UNC at Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Harsha Thirumurthy

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 16, 2013

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

June 6, 2016

Record last verified: 2016-06

Locations