Clinical trial NCT01857700: Economic Compensation to Increase Demand for Voluntary Medical Male Circumcision
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voluntary Medical Male Circumcision
Circumcision Adult
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Impact Research & Development Organization
name: FHI 360
First posted: 2013-05-20
Enrollment: 1504
Sex: ALL
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Men

* younger than 25,
* older than 49, or
* intending to move away from their village within three months.

Primary outcomes:
measure: percentage who undergo voluntary medical male circumcision
timeFrame: 14 weeks
Secondary outcomes:
measure: 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.
timeFrame: 14 weeks
measure: Qualitative Outcome Measure #2: impact of food voucher intervention on man
timeFrame: 14 weeks
measure: Qualitative Outcome Measure #3: impact of intervention logistics on man
timeFrame: 14 weeks
Other outcomes:
measure: Qualitative Outcome Measure #4: couple's decision-making around circumcision (including how the food voucher affected their decision and communications with male partners surrounding circumcision) as reported by female partner
timeFrame: 14 weeks
measure: Qualitative Outcome Measure #5: impact of food voucher intervention on couple, as reported by female partner
timeFrame: 14 weeks
measure: Qualitative Outcome Measure #6: impact of intervention logistics on couple, as reported by female partner
timeFrame: 14 weeks
Locations:
city: Kisumu
country: Kenya
facility: Impact Research & Development Organization
state: Nyanza
Study officials:
affiliation: UNC-Chapel Hill, CPC and SPH-HPM
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.