MedTrace Logo

Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males

NCT03218839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2017-07-17

No results posted yet for this study

Summary

This study will assess the safety of the PrePex device as applied to HIV positive men by assessing the rate of clinical adverse events. The study will include adult, HIV + men who are eligible to receive the PrePex procedure per the Zimbabwe Ministry of Health and Child Care (MOHCC) eligibility criteria.

Conditions

  • HIV Seropositivity

Interventions

DEVICE

PrePex male circumcision device

PrePex non-surgical male circumcision device applied to eligible, consenting HIV-infected men in Zimbabwe to determine the rate of adverse events as compared to non HIV-infected men.

Sponsors & Collaborators

Principal Investigators

  • Scott Barnhart, MD, MPH · University of Washington

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

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 NCT03218839 on ClinicalTrials.gov