HIV InfectionNCT02012816
The Use of Peer Referral Incentives to Increase Demand for Voluntary Medical Male Circumcision in Zambia
A study testing Peer-referral incentive program to increase VMMC uptake in people with HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Peer-referral incentive program to increase VMMC uptake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 725 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria for receiving vouchers: Uncircumcised men 18-49 years old seeking VMMC services and undergoing male circumcision at one of the clinics selected for the study during the 5 months of the active intervention.
- Inclusion criteria for a successful referral: The referred person needs to be a previously uncircumcised man 18-49 and seeking VMMC services at that clinic during the 3 months of eligibility for voucher redemption.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Peer Referral Incentives to Increase Demand for Voluntary Medical Male Circumcision in Zambia: an Impact Evaluation
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.
Read the detailed description
The investigators propose a cluster randomized design in which the CIDRZ-supported VMMC clinics in the Southern Province in Zambia will be randomly selected to have a peer referral incentive program or not. In approximately 10 randomly selected intervention clinics, all men who reside in the catchment area of the clinic and come for male circumcision services will be eligible to receive 5 referral vouchers that will entitle them to receive monetary compensation for each voucher that is subsequently presented by a man who comes to the clinic and undergoes male circumcision. In 10 remaining clinics (control group), VMMC services will proceed as per the current standard of care, without peer referral incentives. All clinics including those allocated to the control group will have the standard mobilization and promotion activities that are used by CIDRZ.
In intervention clinics:
- All eligible men seeking VMMC in intervention clinics will be asked if they want to participate in the study. This can happen on the day of the circumcision or within 7 days after the circumcision.
- If yes, a file is open for them as "referring person". They receive 5 vouchers. They also receive MC brochures to distribute to friends.
- As his friends or relatives come in as referrals, they are written in his file He can then claim reimbursement any time between the time a referred friend comes for VMMC and the expiration of the voucher. The referring person needs to bring the voucher in order to receive reimbursement.
- Friends who come as referrals are given the possibility to become referring persons too, if within the intervention period. In that case, a new file is open for them as "referring persons".
- Conditions
- HIV Infection
- Being tested
- Peer-referral incentive program to increase VMMC uptake
- Keywords
- Uncircumcised men, Voluntary Medical Male circumcision, Peer-referral incentive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-referral incentive program to increase VMMC uptakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Peer-referral incentive program to increase VMMC uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Centre for Infectious Disease Research in Zambia
- Responsible party
- Principal investigator, Harsha Thirumurthy, PhD, University of North Carolina, Chapel Hill
- Investigators
- Harsha Thirumurthy, MD, Principal investigator, UNC at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012816
- Sponsor's protocol ID
- CIDRZ 1310
- Status last verified
- Jun 2016
- First submitted
- 5 Dec 2013
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Peer Referral Incentives to Increase Demand for Voluntary Medical Male Circumcision in Zambia: an Impact Evaluation
- ClinicalTrials.gov ID
- NCT02012816
- Acronym / sponsor ID
- CIDRZ 1310
- Conditions
- HIV Infection
- Keywords
- Uncircumcised men, Voluntary Medical Male circumcision, Peer-referral incentive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Centre for Infectious Disease Research in Zambia
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose a cluster randomized design in which the CIDRZ-supported VMMC clinics in the Southern Province in Zambia will be randomly selected to have a peer referral incentive program or not. In approximately 10 randomly selected intervention clinics, all men who reside in the catchment area of the clinic and come for male circumcision services will be eligible to receive 5 referral vouchers that will entitle them to receive monetary compensation for each voucher that is subsequently presented by a man who comes to the clinic and undergoes male circumcision. In 10 remaining clinics (control group), VMMC services will proceed as per the current standard of care, without peer referral incentives. All clinics including those allocated to the control group will have the standard mobilization and promotion activities that are used by CIDRZ.
In intervention clinics:
- All eligible men seeking VMMC in intervention clinics will be asked if they want to participate in the study. This can happen on the day of the circumcision or within 7 days after the circumcision.
- If yes, a file is open for them as "referring person". They receive 5 vouchers. They also receive MC brochures to distribute to friends.
- As his friends or relatives come in as referrals, they are written in his file He can then claim reimbursement any time between the time a referred friend comes for VMMC and the expiration of the voucher. The referring person needs to bring the voucher in order to receive reimbursement.
- Friends who come as referrals are given the possibility to become referring persons too, if within the intervention period. In that case, a new file is open for them as "referring persons".
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uncircumcised men | Other | Other: Peer-referral incentive program to increase VMMC uptakeThe 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Inclusion criteria for receiving vouchers: Uncircumcised men 18-49 years old seeking VMMC services and undergoing male circumcision at one of the clinics selected for the study during the 5 months of the active intervention.
- Inclusion criteria for a successful referral: The referred person needs to be a previously uncircumcised man 18-49 and seeking VMMC services at that clinic during the 3 months of eligibility for voucher redemption.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-referral incentive program to increase VMMC uptakeThe 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. | Other | Uncircumcised men |
Primary outcome
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.
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harsha Thirumurthy, MD principal investigator
UNC at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-referral incentive program to increase VMMC uptake in people with HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.