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

Completed · Not applicable

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT02067039

Run by

Centers for Disease Control and Prevention

People needed

2665

Starts

2015-03-25

Expected to finish

2016-10-21

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• The inclusion criteria for the Part 4 randomized controlled trial are:
• male sex at birth
• currently identify their sex as male
• able to provide informed consent
• at least 18 years of age
• report being HIV-negative or unaware of HIV status
• resident of United States and Puerto Rico.
• able to read instructions and complete study survey instruments in English
• reported anal sex with at least one man in the past 12 months
• have a valid email address, a cell phone capable of sending and receiving text messages, and a physical shipping address to receive kits
• never diagnosed with a bleeding disorder
• not part of an HIV vaccine trial
• not taking antiretroviral medication for HIV.

You may not qualify if…

• The exclusion criteria for the Part 4 randomized controlled trial are:
• not male sex at birth
• do not currently identify their sex as male
• not able to provide informed consent
• under 18 years of age
• report being HIV-positive
• not a resident of United States or Puerto Rico.
• not able to read instructions and complete study survey instruments in English
• do not report anal sex with at least one man in the past 12 months
• do not have a valid email address, a cell phone capable of sending and receiving text messages, or a physical shipping address to receive kits
• ever diagnosed with a bleeding disorder
• part of an HIV vaccine trial
• taking antiretroviral medication for HIV.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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