Circumcision, MalePhase 3NCT02511548
Increasing Medical Male Circumcision Uptake
A Phase 3 study testing Financial incentive in people with Circumcision, Male and Circumcision Status: Circumcised, Uncircumcised, run by Progressus.
Trial summary
The main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa). 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
- Circumcision, Male, Circumcision Status: Circumcised, Uncircumcised
- What is being tested?
- Financial incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2016
- Phase
- Phase 3
- 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
- Uncircumcised men
- Willing to participate
- Living in Orange Farm
- Able to speak and read English, Sotho or Zulu
Who cannot join
- Unable to give informed consent
- Planning to leave the study area within the next year
Trial locations and contacts
No sites are listed yet.
Bertran Auvert, MD, PhD contact
About this study
Official title: Increasing Medical Male Circumcision Uptake in Orange Farm (South Africa): An Operational Study of Demand Creation
The main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa).
Read the detailed description
The World Health Organization and the United Nations Programme on HIV/AIDS recommend voluntary adult medical male circumcision as an intervention against HIV in Africa since 2007 and has estimated that achieving 80% male circumcision coverage would have a major public health impact. Despite evidence of its effectiveness, feasibility, cost-effectiveness and acceptability, its roll-out in Eastern and Southern Africa, the region where HIV prevalence is highest in the world, remains slow. Developing and testing innovative strategies to accelerate voluntary adult medical male circumcision roll-out is thus necessary. As a target community of this prevention method, Orange Farm (Gauteng Province) is a prime setting to conduct operational research. The team presenting this project conducted the first voluntary adult medical male circumcision randomized trial (ANRS-1265), successfully led the ANRS-12126 voluntary adult medical male circumcision roll-out, and has just completed the ANRS-12285 study on voluntary adult medical male circumcision and HIV incidence. Due to the roll-out, male circumcision prevalence increased from 12% in 2008 to 53% in 2011 in the township, but to date this prevalence has remained stagnant.
The main objective of this study is to reach 80% circumcised men in randomized clusters of Orange Farm (Gauteng Province), a township where voluntary adult medical male circumcision roll-out is ongoing since 2007.
Existing communication strategies will be revised and supplemented by personalised individual discussions to increase motivation for voluntary adult medical male circumcision and translate it into actual uptake.
The project consists of: 1) A preparatory phase to establish collaborations and prepare the communication activities, 2) a survey phase during which a) a mass communication campaign will be launched and b) 300 uncircumcised men selected from randomized clusters of Orange Farm will be recruited and undergo a baseline assessment including voluntary adult medical male circumcision general counselling, and 3) a follow-up phase during which repeated motivational interviews will be conducted to address their individual reasons for not being circumcised. Financial incentive will also be tested in a randomized trial.
Willing men will be referred to the free local voluntary adult medical male circumcision clinic and asked to attend an interview on the reasons that motivated them to become circumcised. At the end of the study, male circumcision prevalence among participants will be calculated. Factors associated with voluntary adult medical male circumcision uptake will be studied.
The survey phase will include a total of 600 uncircumcised and circumcised adult men. Among them, an expected 200 uncircumcised men will be included in the follow-up phase.
Participants will receive a financial compensation for their participation.
The study will last about 4 months.
- Being tested
- Financial incentive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentiveOther
Financial incentive will be proposed to participant of the intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Financial incentive Receives: Other: Financial incentive |
| Control | No intervention | No financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Male circumcision uptake
The proportion of participants who will accept to become circumcised during the course of the study in each arm.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progressus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bertran Auvert, Progressus
- Investigators
- Bertran Auvert, MD, PhD, Principal investigator, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511548
- Sponsor's protocol ID
- MCUptake
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Bouscaillou J, Peytavin G, Mahiane SG, Sitta R, Puren A, Lewis D. Association of the ANRS-12126 male circumcision project with HIV levels among men in a South African township: evaluation of effectiveness using cross-sectional surveys. PLoS Med. 2013;10(9):e1001509. doi: 10.1371/journal.pmed.1001509. Epub 2013 Sep 3.
PubMed 24019763Thirumurthy H, Masters SH, Rao S, Bronson MA, Lanham M, Omanga E, Evens E, Agot K. Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):703-11. doi: 10.1001/jama.2014.9087.
PubMed 25042290
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Medical Male Circumcision Uptake in Orange Farm (South Africa): An Operational Study of Demand Creation
- ClinicalTrials.gov ID
- NCT02511548
- Acronym / sponsor ID
- MCUptake
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- ProgressusUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 30 Jul 2015 (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 main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa).
Detailed description
The World Health Organization and the United Nations Programme on HIV/AIDS recommend voluntary adult medical male circumcision as an intervention against HIV in Africa since 2007 and has estimated that achieving 80% male circumcision coverage would have a major public health impact. Despite evidence of its effectiveness, feasibility, cost-effectiveness and acceptability, its roll-out in Eastern and Southern Africa, the region where HIV prevalence is highest in the world, remains slow. Developing and testing innovative strategies to accelerate voluntary adult medical male circumcision roll-out is thus necessary. As a target community of this prevention method, Orange Farm (Gauteng Province) is a prime setting to conduct operational research. The team presenting this project conducted the first voluntary adult medical male circumcision randomized trial (ANRS-1265), successfully led the ANRS-12126 voluntary adult medical male circumcision roll-out, and has just completed the ANRS-12285 study on voluntary adult medical male circumcision and HIV incidence. Due to the roll-out, male circumcision prevalence increased from 12% in 2008 to 53% in 2011 in the township, but to date this prevalence has remained stagnant.
The main objective of this study is to reach 80% circumcised men in randomized clusters of Orange Farm (Gauteng Province), a township where voluntary adult medical male circumcision roll-out is ongoing since 2007.
Existing communication strategies will be revised and supplemented by personalised individual discussions to increase motivation for voluntary adult medical male circumcision and translate it into actual uptake.
The project consists of: 1) A preparatory phase to establish collaborations and prepare the communication activities, 2) a survey phase during which a) a mass communication campaign will be launched and b) 300 uncircumcised men selected from randomized clusters of Orange Farm will be recruited and undergo a baseline assessment including voluntary adult medical male circumcision general counselling, and 3) a follow-up phase during which repeated motivational interviews will be conducted to address their individual reasons for not being circumcised. Financial incentive will also be tested in a randomized trial.
Willing men will be referred to the free local voluntary adult medical male circumcision clinic and asked to attend an interview on the reasons that motivated them to become circumcised. At the end of the study, male circumcision prevalence among participants will be calculated. Factors associated with voluntary adult medical male circumcision uptake will be studied.
The survey phase will include a total of 600 uncircumcised and circumcised adult men. Among them, an expected 200 uncircumcised men will be included in the follow-up phase.
Participants will receive a financial compensation for their participation.
The study will last about 4 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Financial incentiveFinancial incentive |
| Control | No intervention | –No financial incentive |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Uncircumcised men
- Willing to participate
- Living in Orange Farm
- Able to speak and read English, Sotho or Zulu
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Planning to leave the study area within the next year
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 |
|---|---|---|
| Financial incentiveFinancial incentive will be proposed to participant of the intervention arm | Other | Intervention |
Primary outcome
Male circumcision uptake
Time frame: 3 weeks
The proportion of participants who will accept to become circumcised during the course of the study in each arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 24019763Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Bouscaillou J, Peytavin G, Mahiane SG, Sitta R, Puren A, Lewis D. Association of the ANRS-12126 male circumcision project with HIV levels among men in a South African township: evaluation of effectiveness using cross-sectional surveys. PLoS Med. 2013;10(9):e1001509. doi: 10.1371/journal.pmed.1001509. Epub 2013 Sep 3.
- Background: PubMed 25042290Thirumurthy H, Masters SH, Rao S, Bronson MA, Lanham M, Omanga E, Evens E, Agot K. Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):703-11. doi: 10.1001/jama.2014.9087.
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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.
Bertran Auvert, MD, PhD contact
Bertran Auvert, MD, PhD principal investigator
University of Versailles
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Financial incentive in people with Circumcision, Male and Circumcision Status: Circumcised, Uncircumcised, run by Progressus.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertran Auvert, MD, PhD (bertran.auvert@uvsq.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Male circumcision uptake (time frame: 3 weeks). 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 NCT02511548, which also lists 2 linked publications.
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 30 Jul 2015.