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

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.

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.