NCT01895556

Brief Summary

The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

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

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

June 28, 2013

Last Update Submit

July 3, 2013

Conditions

Keywords

MalawiRisk CompensationMale CircumcisionDemand

Outcome Measures

Primary Outcomes (1)

  • Condom use

    frequency of reported condom use across all sexual acts (never, sometimes, always)

    One year after baseline survey

Secondary Outcomes (3)

  • Male circumcision

    One year after baseline survey

  • Condom purchases

    one year after baseline survey

  • number of sexual partners

    one year after baseline survey

Study Arms (2)

Information

EXPERIMENTAL

Information about male circumcision and HIV risk

Other: Information

Control

PLACEBO COMPARATOR

Control

Other: Control

Interventions

Information
ControlOTHER
Control

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The study will involve men between the ages of 25 and 40

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rebecca Thornton, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Susan Godlonton, PhD

    University of Michigan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 10, 2013

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Last Updated

July 10, 2013

Record last verified: 2013-07