Clinical trial NCT03138135: HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
Official title: HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Sexually Transmitted Diseases
Pre-Exposure Prophylaxis
Keywords: PrEP
HIV prevention
Risk reduction
STI prevention
Home HIV testing
HIV testing
STI testing
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: San Francisco Department of Public Health
name: University of California, San Francisco
First posted: 2017-05-03
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").

We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.

Detailed description: Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).

Eligibility criteria: Inclusion Criteria:

* Self-identify as Black or Latino.
* Report anal sex with at least one male sex partner in the prior 12 months.
* HIV negative by self-report.
* Currently own a cell phone.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Inadequate contact information for follow-up.
* In a mutually monogamous sexual relationship for the past 12 months.
* Currently taking PrEP.
* Does not have reliable access to the Internet.
* Does not live, work, or play in the San Francisco Bay Area.
* Planning to move out of the Bay Area during the 9 month study period.
* Previously participated in the HOME Pilot study.
* Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Primary outcomes:
measure: Efficacy of the HOME package to support linkage to PrEP or HIV care
timeFrame: 9 months
measure: Efficacy of the HOME package to increase HIV and STI testing frequency.
timeFrame: 9 months
Secondary outcomes:
measure: Feasibility of the individual components of the study intervention.
timeFrame: 9 months
measure: Acceptability of the HOME package to support linkage to HIV care or PrEP.
timeFrame: 9 months
Other outcomes:
measure: Who uses home HIV self-testing and home STI self-collection.
timeFrame: 9 months
measure: Who uses a buddy.
timeFrame: 9 months
measure: Use of HIV prevention services.
timeFrame: 9 months
Locations:
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
Study officials:
affiliation: Public Health Foundation Enterprises; San Francisco Department of Public Health
name: Hyman Scott, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Public Health Foundation Enterprises; San Francisco Department of Public Health
name: Susan Buchbinder, MD
role: PRINCIPAL_INVESTIGATOR
References: