Clinical trial NCT02067039: Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)
Official title: Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: HIV testing
Rapid HIV test
HIV self-testing
Men who have sex with men (MSM)
HIV diagnosis
Sexual behavior
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Emory University
name: Northwestern University
name: Public Health Solutions
First posted: 2014-02-20
Enrollment: 2665
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: The eSTAMP project will evaluate the use and impact of providing rapid HIV tests for use to men who have sex with men (MSM) recruited via the internet. Data obtained through this study will include who will use the tests, how they were used, the utility of the tests in identifying HIV infections and promoting engagement in HIV care. This will inform policies to guide the optimal use of rapid HIV tests.

This research project will be conducted in four sequential parts to evaluate the acceptability, use and effectiveness of rapid HIV test kits among MSM in cities with high HIV prevalence. Each part will be independent and they will provide information to implement the next part of the study. At the end of each part, the data will be evaluated. The findings will guide the implementation of subsequent parts of the study.

Part 1 will evaluate the materials, packaging and instructions for conducting self-testing activities. MSM will be recruited from prior research studies or over the internet to participate in focus groups and in-depth interviews by Emory University or Northwestern University. These activities will take place in Atlanta, GA and Chicago, IL. Completed.

Part 2 will evaluate the user proficiency of participants performing the rapid HIV test on themselves while under observation using the instructional and materials developed in the previous part of the study. MSM who had participated in prior research studies and consented to future contact for involvement in additional studies were recruited by Emory University. Participants will conduct activities at Emory University in Atlanta, GA. Completed.

Part 3 will evaluate the performance of the rapid HIV tests by the proposed study population in real world settings. Participants will be recruited via the internet and directed to a research study site for further study activities. Participants will be shipped study materials (one OraQuick In-home HIV test, one SureCheck HIV 1/2 Assay and one dried blood spot (DBS) collection kit). Participants will report their rapid HIV test results online and return the DBS card for laboratory HIV testing. Completed.

Part 4 will evaluate the use and effectiveness of providing free rapid HIV tests as a public health strategy for increasing testing among MSM. We will recruit 3200 participants who report being HIV negative or unaware of their HIV status for the main trial. These participants will be randomly assigned to either the intervention or comparison condition after completing a baseline survey. An additional 150 MSM who report being HIV-positive will be recruited to evaluate the distribution of rapid HIV tests to their network partners.

Comparison arm: After completing the baseline survey, comparison arm participants will receive a welcome greeting and HIV prevention information. The online information will cover the importance of testing, links to AIDSVu and other resources to locate HIV testing services and prevention information in their area. Comparison arm participants will receive follow-up surveys at 3, 6, 9 and 12 months. After completing the 12 month assessment, participants will be sent a performance kit consisting of 1 oral fluid HIV test kit (OraQuick) and 1 finger-stick blood HIV test kit (Sure Check) and a DBS specimen collection kit that will be returned for HIV testing at the CDC laboratory.

Intervention arm: After completing the baseline survey, a welcome kit with 4 rapid HIV tests (2 oral fluid test kits \[OraQuick\] and 2 finger-stick blood test kits \[Sure Check\] will be sent to participants in the intervention arm to use and/or give away. Intervention arm participants will receive follow-up surveys at 3, 6, 9 and 12 months and have the option to order additional test kits at 3, 6 and 9 months to replenish kits that have been used or distributed. After completing the 12 month assessment, participants will be sent a performance kit consisting of 1 oral fluid HIV test kit (OraQuick) and 1 finger-stick blood HIV test kit (Sure Check) and a DBS specimen collection kit that will be returned for HIV testing at the CDC laboratory.

The men who report being HIV-positive who will be assigned to a one-arm descriptive cohort. Participants in this group will take a baseline survey and will receive rapid HIV test kits (OraQuick) to distribute to persons in their social and sexual networks (secondary users). Men in the HIV-positive group will complete a short follow-up survey at 3 months. Secondary users who use the tests will have access to study materials and referral information.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for the Part 4 randomized controlled trial are:

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

Exclusion Criteria:

* The exclusion criteria for the Part 4 randomized controlled trial are:

  1. not male sex at birth
  2. do not currently identify their sex as male
  3. not able to provide informed consent
  4. under 18 years of age
  5. report being HIV-positive
  6. not a resident of United States or Puerto Rico.
  7. not able to read instructions and complete study survey instruments in English
  8. do not report anal sex with at least one man in the past 12 months
  9. 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
  10. ever diagnosed with a bleeding disorder
  11. part of an HIV vaccine trial
  12. taking antiretroviral medication for HIV.

Primary outcomes:
measure: Frequency of HIV Testing by Internet-recruited MSM.
timeFrame: 12 months
Secondary outcomes:
measure: Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.
timeFrame: 12 months
measure: Newly Identified HIV Infections
timeFrame: 12 months
measure: HIV Infections Among Social Network Associates
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Robin MacGowan, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Pollyanna Chavez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Patrick Sullivan, PhD, DVM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gwynn M, Chavez PR, Borkowf CB, Raiford JL, Gravens L, MacGowan RJ; eSTAMP Study Group. Pressure to Use HIV Self-Tests Among Men Who Have Sex With Men, United States, 2015-2016. AIDS Behav. 2022 Feb;26(2):623-630. doi: 10.1007/s10461-021-03422-6. Epub 2021 Aug 18.
citation: MacGowan RJ, Chavez PR, Borkowf CB, Owen SM, Purcell DW, Mermin JH, Sullivan PS; eSTAMP Study Group. Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):117-125. doi: 10.1001/jamainternmed.2019.5222.