Implementation of Rapid HIV Self-Testing Among MSM Project (iSTAMP)

Emory University

Status

Completed

Conditions

HIV/AIDS

Treatments

Other: Self-test Kit

Behavioral: Know@Home

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT04219878

1U01PS005181 (U.S. NIH Grant/Contract)

IRB00099710

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,195 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)