MedTrace Logo

An Open Label, Blinded Assessor, Trial Comparing Odor Levels Due to Different Hygiene Methods With PrePexTM

NCT02153658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2014-06-03

No results posted yet for this study

Summary

The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing trainings and formal guidelines. As part of the Government's efforts to improve the PrePex implementation, it made efforts to improve the psychology acceptability of the PrePex by men and thus to increase the uptake with VMMC in sub-Saharan Africa.

Some men who gone through the PrePex procedure complained of foreskin odor while wearing the PrePex 3-7 days after it is placed. This complaint was identified as potential risk for the PrePex uptake. Researchers from Rwanda assumed there is a possible relation between the level of foreskin odor to the patient foreskin hygiene technique. It was speculated that a patient that follows an appropriate foreskin hygiene technique while wearing the device will have a significantly lower foreskin odor on day 7 than a patient who does not follow such technique. The Government of Rwanda decided to investigate those assumptions in a scientific way and conduct a study to test different hygiene cleaning methods in order to increase the acceptability of PrePex and mitigate the odor concern.

Conditions

  • Odor Levels of Study Arms

Interventions

PROCEDURE

Subjects cleaned the foreskin with soapy water using a syringe once a day.

PROCEDURE

Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.

Sponsors & Collaborators

  • Ministry of Health, Rwanda

    lead OTHER_GOV

Principal Investigators

  • Vincent Mutabazi, M.D. · RBC-Medical Research Centre (MRC)

  • Jean Paul Bitega, M.D. · Military Insurance Medical

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Rwanda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153658 on ClinicalTrials.gov