NCT01857700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,504

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

9 months

First QC Date

May 7, 2013

Last Update Submit

April 23, 2014

Conditions

Voluntary Medical Male CircumcisionCircumcision Adult

Outcome Measures

Primary Outcomes (1)

  • percentage who undergo voluntary medical male circumcision

    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.

    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

Other Outcomes (3)

  • 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

    14 weeks

  • Qualitative Outcome Measure #5: impact of food voucher intervention on couple, as reported by female partner

    14 weeks

  • Qualitative Outcome Measure #6: impact of intervention logistics on couple, as reported by female partner

    14 weeks

Study Arms (2)

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

Other: Compensation for transport costOther: Compensation for lost wagesOther: Compensation for transport cost and lost wages

Standard of Care

PLACEBO COMPARATOR
Other: Standard of Care

Interventions

Compensation for transport costOTHER
Conditional economic compensation
Compensation for lost wagesOTHER
Conditional economic compensation
Compensation for transport cost and lost wagesOTHER
Conditional economic compensation
Standard of CareOTHER

Consistent with standard of care, participants in this group will be offered a refreshment during their office visit.

Standard of Care

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Impact Research & Development Organization

Kisumu, Nyanza, Kenya

Location

Related Publications (1)

  • 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.

    PMID: 25042290DERIVED

Related Links

MeSH Terms

Interventions

Compensation and RedressStandard of Care

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsJurisprudenceSocial Control, FormalQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Harsha Thirumurthy, PhD

    UNC-Chapel Hill, CPC and SPH-HPM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 20, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

KE(1)