Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02067039|
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : March 31, 2020
Last Update Posted : March 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Device: OraQuick in home & Sure Check HIV tests||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2665 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities|
|Actual Study Start Date :||March 25, 2015|
|Actual Primary Completion Date :||October 21, 2016|
|Actual Study Completion Date :||October 21, 2016|
Experimental: HIV self-testing
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.
- Frequency of HIV Testing by Internet-recruited MSM. [ Time Frame: 12 months ]Frequency of HIV testing >=3 times reported by participants over a 12-month follow-up period.
- Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result. [ Time Frame: 12 months ]MSM who report accessing supplemental testing and care following a positive rapid HIV test results.
- Newly Identified HIV Infections [ Time Frame: 12 months ]Report of positive HIV test result (self-test or provider testing)
- HIV Infections Among Social Network Associates [ Time Frame: 12 months ]Number of social network associates (N=2150)who received a study self-test from ST participants (N=1325) and who reported a positive HIV self-test result. Sample size for this analyses is 2150.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067039
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|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|