Clinical trial NCT04219878: Implementation of Rapid HIV Self-Testing Among MSM Project
Official title: Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Sexually transmitted infections
Behavioral intervention
Public health
HIV preexposure prophylaxis (PrEP)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-01-07
Enrollment: 2195
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

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)

Primary outcomes:
measure: Number of participants initiating HIV treatment
timeFrame: Up to Month 4
measure: Number of participants initiating PrEP treatment
timeFrame: Up to Month 4
measure: Number of participants testing for STIs
timeFrame: Up to Month 4
measure: Number of participants engaging in HIV prevention services
timeFrame: Up to Month 4
measure: Number of participants engaging in HIV social services
timeFrame: Up to Month 4
measure: Cost of different online venues for study enrollment
timeFrame: Baseline
measure: Cost of different online venues for HIV test results returned
timeFrame: Month 1
measure: Cost of different online venues for identifying new HIV diagnoses
timeFrame: Month 1
Secondary outcomes:
measure: Cost of linkage to HIV counseling
timeFrame: Month 4
measure: Cost of linkage to HIV treatment
timeFrame: Month 4
measure: Cost of linkage to PrEP counseling
timeFrame: Month 4
measure: Cost of linkage to PrEP uptake
timeFrame: Month 4
measure: Cost of Sexually Transmitted Infection (STI) testing
timeFrame: Month 4
measure: Cost of linkage to STI treatment
timeFrame: Month 4
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Patrick Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References: