HIV/AIDSNCT03565588
Manicaland VMMC Uptake Through Behavioural Incentives Trial
A study testing Education session with fixed incentive and Education session with lottery incentive in people with HIV/AIDS, run by Simon Gregson at 7 sites in Zimbabwe.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Education session with fixed incentive and Education session with lottery incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,028 participants
- Where
- 7 sitesZimbabwe
- Study dates
- 7 Jul 2018to 30 Jan 2021
- 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 15 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Men
- Age 15-29 years
Who cannot join
- Participants testing HIV-positive at baseline
- Self-reporting have already undergone circumcision
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Zimbabwe7 sites
Manicaland Centre for Public Health Research
Bonda, Manicaland Province
Manicaland Centre for Public Health Research
Hobhouse, Manicaland Province
Manicaland Centre for Public Health Research
Honde, Manicaland Province
Manicaland Centre for Public Health Research
Manicaland, Manicaland Province
Manicaland Centre for Public Health Research
Nyanga, Manicaland Province
Manicaland Centre for Public Health Research
Nyazura, Manicaland Province
Manicaland Centre for Public Health Research
Sakubva, Manicaland Province
About this study
Official title: Improving Risk Perception and Uptake of Voluntary Medical Male Circumcision (VMMC) With Education Sessions and Conditional Behavioural Incentives
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.
- Conditions
- HIV/AIDS
- Being tested
- Education session with fixed incentive, Education session with lottery incentive
- Keywords
- Voluntary medical male circumcision, HIV prevention, Risk perception
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education session with fixed incentiveBehavioural
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 incentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education session with fixed incentive | Experimental | Education sessions offered by a circumcised health worker and contribution towards transport costs to the health facility with payments conditional on being circumcised. Receives: Behavioral: Education session with fixed incentive |
| Education session with lottery incentive | Experimental | Education sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives. Receives: Behavioral: Education session with lottery incentive |
| Control arm | No intervention | No intervention will be administered to the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of voluntary medical male circumcision (VMMC)
Proportion of men taking up VMMC within 6 months measured through self-reports and matched to programme records
Measured: 6 months
Secondary outcomes (1)
Changes in perception of risk of HIV
Risk perception will be measured in a follow-up survey at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start7 Jul 2018
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Gregson
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Simon Gregson, Imperial College London
- Investigators
- Simon Gregson, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565588
- Sponsor's protocol ID
- P67251_VMMC
- Other IDs
- 1R01MH114562-01
- Status last verified
- Oct 2023
- First submitted
- 11 Jun 2018
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31973744
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Risk Perception and Uptake of Voluntary Medical Male Circumcision (VMMC) With Education Sessions and Conditional Behavioural Incentives
- ClinicalTrials.gov ID
- NCT03565588
- Acronym / sponsor ID
- P67251_VMMC
- Conditions
- HIV/AIDS
- Keywords
- Voluntary medical male circumcision, HIV prevention, Risk perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Simon GregsonUniversity, hospital or other
- Collaborators
- Biomedical Research and Training Institute, Zimbabwe, University of Copenhagen, London School of Economics and Political Science, National Institute of Mental Health (NIMH)
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education session with fixed incentive | Experimental | Behavioral: Education session with fixed incentiveEducation sessions offered by a circumcised health worker and contribution towards transport costs to the health facility with payments conditional on being circumcised. |
| Education session with lottery incentive | Experimental | Behavioral: Education session with lottery incentiveEducation sessions offered by a circumcised health worker and contribution towards transport costs but with conditional lottery financial incentives. |
| Control arm | No intervention | –No intervention will be administered to the control arm |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Men
- Age 15-29 years
Key exclusion criteria (2 listed)
- Participants testing HIV-positive at baseline
- Self-reporting have already undergone circumcision
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 |
|---|---|---|
| Education session with fixed incentiveAll 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. | Behavioural | Education session with fixed incentive |
| Education session with lottery incentiveAll 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. | Behavioural | Education session with lottery incentive |
Primary outcome
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
1 secondary outcome
Changes in perception of risk of HIV
Time frame: 6 months
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 23 Oct 2023.
- Derived from this study: PubMed 31973744Thomas 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.
- Individual participant dataSharing planned: Undecided
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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.
Simon Gregson, PhD principal investigator
Imperial College London
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education session with fixed incentive and Education session with lottery incentive in people with HIV/AIDS, run by Simon Gregson at 7 sites in Zimbabwe.
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 2 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Zimbabwe. 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?
Uptake of voluntary medical male circumcision (VMMC) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565588, which also lists 1 linked publication.
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 23 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.