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Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)

NCT02067039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2665

Last updated 2020-03-31

Study results available
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Summary

This study seeks to determine the public health impact of providing rapid HIV test kits to men who have sex with men (MSM) so they may test themselves at their convenience. The study will determine if men who receive the rapid HIV test kits report HIV testing at least three times per year. This study will be conducted in four consecutive parts. The first three parts are formative in nature to guide the development and implementation of Part 4 of the study. The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2 Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not approved for home use.

Conditions

  • HIV Infection

Interventions

DEVICE

OraQuick in home & Sure Check HIV tests

Provision of OraQuick in home \& Sure Check HIV tests

Sponsors & Collaborators

Principal Investigators

  • Robin MacGowan, MPH · Centers for Disease Control and Prevention

  • Pollyanna Chavez, PhD · Centers for Disease Control and Prevention

  • Patrick Sullivan, PhD, DVM · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2016-10-21
Completion
2016-10-21

Countries

  • United States

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 NCT02067039 on ClinicalTrials.gov