Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities|
- Frequency of HIV testing by internet-recruited MSM. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Frequency of HIV testing reported by participants over a 12-month follow-up period.
- Performance of rapid HIV tests used by internet-recruited MSM [ Time Frame: 12 months ] [ Designated as safety issue: No ]Compare results of rapid HIV tests used by MSM to Dried Blood Spot samples collected by participants and sent to laboratory for HIV testing.
- Linkage to HIV testing and care services following a positive rapid test result. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Proportion of MSM who report accessing supplemental testing and care following a positive rapid HIV test results.
- Changes in sexual behaviors following rapid HIV testing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Changes in sexual risk behaviors (i.e., number of sex partners, unprotected anal intercourse, and sero-sorting) after using rapid HIV tests from date of rapid test through 12 month follow-up assessment.
- Distribution of rapid HIV test to social and sexual partners. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Proportion of MSM who receive rapid HIV test kits and distribute the kits to social and sexual partners.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: OraQuick in home & Sure Check HIV tests
The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
Device: OraQuick in home & Sure Check HIV tests
Provision of OraQuick in home & Sure Check HIV tests
No Intervention: Information only
All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02067039
|Contact: Robin MacGowan, MPHfirstname.lastname@example.org|
|Contact: Pollyanna Chavez, PhDemail@example.com|
|United States, Georgia|
|Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Patrick Sullivan, DVM, PhD 404-727-2038 firstname.lastname@example.org|
|Contact: AD McNaughten, PhD 404 727-8750 email@example.com|
|Principal Investigator: Patrick Sullivan, DVM, PhD|
|Principal Investigator:||Robin MacGowan, MPH||Centers for Disease Control and Prevention|
|Principal Investigator:||Pollyanna Chavez, PhD||Centers for Disease Control and Prevention|
|Principal Investigator:||Patrick Sullivan, PhD, DVM||Emory University|
|Study Director:||Stephen Tregear, PhD||MANILA Consulting Group Inc.|