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

March 18, 2020 updated by: Centers for Disease Control and Prevention

Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2665

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Newly Identified HIV Infections
Time Frame: 12 months
Report of positive HIV test result (self-test or provider testing)
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

Northwestern University
Emory University
Public Health Solutions

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2015

Primary Completion (Actual)

October 21, 2016

Study Completion (Actual)

October 21, 2016

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-eSTAMP-41989

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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