Voluntary Medical Male Circumcision Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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