Implementation of Rapid HIV Self-Testing Among MSM Project

This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.

To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.

All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.

Eligibility Criteria:
Inclusion Criteria for MSM Participants:

* Black/African-American race or Hispanic/Latino ethnicity
* Male sex at birth
* Currently identify as male
* Reported anal sex with at least one man in the past 12 months
* Aged 18 or over
* Has an Android or Apple mobile phone with currently active service
* Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
* Willing to download a study participation management mobile app
* Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants.
* Successful completion of baseline survey

Exclusion Criteria for MSM Participants:

* Currently participating in another HIV prevention research study or program
* Has a bleeding disorder preventing use of dried blood spot testing
* Has previously participated in an HIV vaccine study.
* Currently taking PrEP for HIV prevention
* Self-reports living with HIV
* Has plans to move out of a study state during the study period (4 months)

Inclusion Criteria for TGW:

* Male sex at birth
* Currently identify as transgender woman or female
* Aged 18 or over
* Has an Android or Apple mobile smartphone with currently active service
* Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
* Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants
* Successful completion of baseline survey

Exclusion Criteria for TGW:

* Currently participating in another HIV prevention clinical trial or intervention
* Has a bleeding disorder preventing use of dried blood spot testing
* Has previously participated in an HIV vaccine study
* Currently taking PrEP for HIV prevention
* Self-reports living with HIV
* Has plans to move out of a study state during the study period (4 months)