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临床试验/NCT01857700
NCT01857700已完成不适用

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 1,504 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,504
试验地点
1
主要终点
percentage who undergo voluntary medical male circumcision

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

percentage who undergo voluntary medical male circumcision

时间窗: 14 weeks

次要结局

  • 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.(14 weeks)
  • Qualitative Outcome Measure #2: impact of food voucher intervention on man(14 weeks)
  • Qualitative Outcome Measure #3: impact of intervention logistics on man(14 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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