Voluntary Medical Male CircumcisionCTT-VMMCNCT01857700
Economic Compensation to Increase Demand for Voluntary Medical Male Circumcision
A study testing Compensation for transport cost, Compensation for lost wages and Compensation for transport cost and lost wages in people with Voluntary Medical Male Circumcision and Circumcision Adult, run by University of North Carolina, Chapel Hill at 1 site in Kenya.
Trial summary
Research questions: What effect does provision of food vouchers have on uptake of voluntary medical male circumcision? What is the amount of food voucher that should be given? Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages due to VMMC and who undergo VMMC will be higher… Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Voluntary Medical Male Circumcision, Circumcision Adult
- What is being tested?
- Compensation for transport cost, Compensation for lost wages and Compensation for transport cost and lost wages
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,504 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2013to Mar 2014
- 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 25 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men
- aged 25-49
- living in enumerated locations and sublocations of Nyanza Province
- who intend to remain in their village for the next three months.
- Female partners of some of these eligible men are also eligible to be interviewed about their perceptions.
Who cannot join
- Men
- younger than 25,
- older than 49, or
- intending to move away from their village within three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compensation for Transport Costs and Lost Wages Associated With Voluntary Medical Male Circumcision (VMMC) Uptake: an Intervention to Increase VMMC Demand Among Older Men in Nyanza Province
Research questions: What effect does provision of food vouchers have on uptake of voluntary medical male circumcision? What is the amount of food voucher that should be given?
Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages due to VMMC and who undergo VMMC will be higher than the percentage of men who are compensated for lost wages or travel and undergo VMMC, and both of these percentages will be higher than the percentage of men who are not compensated for travel or lost wage costs but undergo VMMC.
Read the detailed description
Purpose: Implement a randomized trial to test whether offering compensation to older men conditional on their coming for medical male circumcision can increase uptake of circumcision services.
Participants: 1,500 uncircumcised men of ages 25-49 in Nyando District, 21 men who chose to be circumcised and 21 who did not get circumcised, 10 female partners of men who became circumcised and 10 female partners of men who did not will be interviewed
Procedures (methods): To increase uptake of male circumcision, investigators will offer conditional economic compensation for male circumcision. Randomly selected study participants will be given the opportunity, conditional on undergoing male circumcision, to obtain food vouchers that are intended to offset the cost of accessing the VMMC services and the potential lost work the day of the procedure and in the 2 days following the procedure. The food vouchers will be given after study participants choose to uptake VMMC services at any of the static or outreach sites operated by Impact Research and Development Organization (IRDO). Participants will be randomized to one of three intervention groups or to a control group. Participants in the intervention groups will have the opportunity to receive a food voucher valued at one of three amounts (in KES, Kenyan Shillings) if they choose to get circumcised. Participants in the control group will receive a soda but no food voucher if they choose to get circumcised. The amounts for the intervention groups were selected based on the approximate value of 3 days of work and average transportation costs within the district. The amounts were also chosen so that they are not so large as to be perceived as coercive. Investigators selected food vouchers instead of cash or mobile phone credit because the vouchers were deemed to be more acceptable given the sensitive nature of the intervention and men's concern with feeding their families; it was also considered more logistically feasible to offer vouchers at the health facilities rather than cash. Additional focus group discussions will be held to verify that this form and amount of compensation is acceptable and desirable in study communities and if necessary, the intervention can be changed based on these results.
The food vouchers will be valid at dukas (shops) located within the district. At the beginning of the study, these shops will be visited and informed about ways to receive cash for the vouchers at the central IRDO office in Nyando District. IRDO has previously explored the feasibility of implementing the voucher scheme and found that it can be implemented in the study areas.
Three months after enrollment of study participants, investigators will conduct qualitative research in which there will be in-depth interviews with a small sample of men who did and did not come for circumcision and with their partners. Three topics will be examined in the qualitative interview: men's decision-making, logistics of the intervention, and women's perceptions.
- Being tested
- Compensation for transport cost, Compensation for lost wages, Compensation for transport cost and lost wages, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensation for transport costOther
Compensation for lost wagesOther
Compensation for transport cost and lost wagesOther
Standard of CareOther
Consistent with standard of care, participants in this group will be offered a refreshment during their office visit.
| Study group | Role | What they receive |
|---|---|---|
| Conditional economic compensation | Experimental | A scratch off card will be used to randomly determine which of the compensations will be offered: compensation for transport cost, compensation for lost wages, or compensation for transport cost and lost wages Receives: Other: Compensation for transport cost; Other: Compensation for lost wages; Other: Compensation for transport cost and lost wages |
| Standard of Care | Placebo comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage who undergo voluntary medical male circumcision
Measured: 14 weeks
Secondary outcomes (3)
Qualitative Outcome Measure #1: men's decision-making around circumcision, including how the food voucher affected their decision and communications with their female partners surrounding circumcision.
men's concerns with circumcision (i.e., what man had heard about circumcision prior to enrollment; what man had thought about getting circumcised prior to enrollment; greatest concern with getting circumcised prior to enrollment; degree of financial barrier prior to enrollment), experience with how food voucher was explained (i.e., what man was told about voucher amount, what man was told about reason for voucher, what man was told about how it could be redeemed, whether anything was unclear, whether questions were answered satisfactorily), what was discussed with a female partner (i.e., whether circumcision had ever been discussed; her opinion of it; whether the study and food voucher were discussed and what was discussed; her opinion of the study and food voucher; her opinion of whether man should get circumcision; whether partner's opinions influenced man's decision about whether to go for circumcision)
Measured: 14 weeks
Qualitative Outcome Measure #2: impact of food voucher intervention on man
the effect of the food voucher on the man (i.e., whether it was volunteered as the biggest reason for deciding to get circumcised; whether it had changed his mind about getting circumcised; whether the value of the food voucher made it easier or more difficult to decide about getting circumcised)
Measured: 14 weeks
Qualitative Outcome Measure #3: impact of intervention logistics on man
use of food voucher (i.e., whether redeeming it with 30 days was a constraint; whether there were any problems with redeeming it) and transportation \& time away from work (i.e., distance between residence and nearest circumcision clinic; transportation to clinic and its total cost, number of days missed from work and lost wages because of missed work; whether the food voucher offset the costs of transportation and lost wages).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Voluntary Medical Male CircumcisionStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Impact Research & Development Organization, FHI 360
- Responsible party
- Sponsor
- Investigators
- Harsha Thirumurthy, PhD, Principal investigator, UNC-Chapel Hill, CPC and SPH-HPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857700
- Sponsor's protocol ID
- 12-1961
- Acronym
- CTT-VMMC
- Status last verified
- Apr 2014
- First submitted
- 7 May 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thirumurthy 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 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensation for Transport Costs and Lost Wages Associated With Voluntary Medical Male Circumcision (VMMC) Uptake: an Intervention to Increase VMMC Demand Among Older Men in Nyanza Province
- ClinicalTrials.gov ID
- NCT01857700
- Acronym / sponsor ID
- CTT-VMMC / 12-1961
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Impact Research & Development Organization, FHI 360
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 May 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.
Research questions: What effect does provision of food vouchers have on uptake of voluntary medical male circumcision? What is the amount of food voucher that should be given?
Hypothesis: The percentage of men who are compensated for costs of travel to and lost wages due to VMMC and who undergo VMMC will be higher than the percentage of men who are compensated for lost wages or travel and undergo VMMC, and both of these percentages will be higher than the percentage of men who are not compensated for travel or lost wage costs but undergo VMMC.
Detailed description
Purpose: Implement a randomized trial to test whether offering compensation to older men conditional on their coming for medical male circumcision can increase uptake of circumcision services.
Participants: 1,500 uncircumcised men of ages 25-49 in Nyando District, 21 men who chose to be circumcised and 21 who did not get circumcised, 10 female partners of men who became circumcised and 10 female partners of men who did not will be interviewed
Procedures (methods): To increase uptake of male circumcision, investigators will offer conditional economic compensation for male circumcision. Randomly selected study participants will be given the opportunity, conditional on undergoing male circumcision, to obtain food vouchers that are intended to offset the cost of accessing the VMMC services and the potential lost work the day of the procedure and in the 2 days following the procedure. The food vouchers will be given after study participants choose to uptake VMMC services at any of the static or outreach sites operated by Impact Research and Development Organization (IRDO). Participants will be randomized to one of three intervention groups or to a control group. Participants in the intervention groups will have the opportunity to receive a food voucher valued at one of three amounts (in KES, Kenyan Shillings) if they choose to get circumcised. Participants in the control group will receive a soda but no food voucher if they choose to get circumcised. The amounts for the intervention groups were selected based on the approximate value of 3 days of work and average transportation costs within the district. The amounts were also chosen so that they are not so large as to be perceived as coercive. Investigators selected food vouchers instead of cash or mobile phone credit because the vouchers were deemed to be more acceptable given the sensitive nature of the intervention and men's concern with feeding their families; it was also considered more logistically feasible to offer vouchers at the health facilities rather than cash. Additional focus group discussions will be held to verify that this form and amount of compensation is acceptable and desirable in study communities and if necessary, the intervention can be changed based on these results.
The food vouchers will be valid at dukas (shops) located within the district. At the beginning of the study, these shops will be visited and informed about ways to receive cash for the vouchers at the central IRDO office in Nyando District. IRDO has previously explored the feasibility of implementing the voucher scheme and found that it can be implemented in the study areas.
Three months after enrollment of study participants, investigators will conduct qualitative research in which there will be in-depth interviews with a small sample of men who did and did not come for circumcision and with their partners. Three topics will be examined in the qualitative interview: men's decision-making, logistics of the intervention, and women's perceptions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conditional economic compensation | Experimental | Other: Compensation for transport cost, Other: Compensation for lost wages, Other: Compensation for transport cost and lost wagesA scratch off card will be used to randomly determine which of the compensations will be offered: compensation for transport cost, compensation for lost wages, or compensation for transport cost and lost wages |
| Standard of Care | Placebo comparator | Other: Standard of Care |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men
- aged 25-49
- living in enumerated locations and sublocations of Nyanza Province
- who intend to remain in their village for the next three months.
- Female partners of some of these eligible men are also eligible to be interviewed about their perceptions.
Key exclusion criteria (4 listed)
- Men
- younger than 25,
- older than 49, or
- intending to move away from their village within three months.
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 |
|---|---|---|
| Compensation for transport cost | Other | Conditional economic compensation |
| Compensation for lost wages | Other | Conditional economic compensation |
| Compensation for transport cost and lost wages | Other | Conditional economic compensation |
| Standard of CareConsistent with standard of care, participants in this group will be offered a refreshment during their office visit. | Other | Standard of Care |
Primary outcome
percentage who undergo voluntary medical male circumcision
Time frame: 14 weeks
3 secondary outcomes
Qualitative Outcome Measure #1: men's decision-making around circumcision, including how the food voucher affected their decision and communications with their female partners surrounding circumcision.
Time frame: 14 weeks
Qualitative Outcome Measure #2: impact of food voucher intervention on man
Time frame: 14 weeks
Qualitative Outcome Measure #3: impact of intervention logistics on man
Time frame: 14 weeks
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 25 Apr 2014.
- Derived from this study: 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.
- This study is funded by the Bill \& Melinda Gates Foundation.Link provided by the sponsor.
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, PhD principal investigator
UNC-Chapel Hill, CPC and SPH-HPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensation for transport cost, Compensation for lost wages and Compensation for transport cost and lost wages in people with Voluntary Medical Male Circumcision and Circumcision Adult, run by University of North Carolina, Chapel Hill at 1 site in Kenya.
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 5 inclusion and 4 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 25 Apr 2014. 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 Kenya. 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. Some participants in this study may receive a placebo. 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?
percentage who undergo voluntary medical male circumcision (time frame: 14 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 NCT01857700, 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 25 Apr 2014.