HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
- Conditions
- HIV PreventionPre-Exposure ProphylaxisSexually Transmitted Diseases
- Interventions
- Behavioral: ControlBehavioral: HOME Study intervention
- Registration Number
- NCT03138135
- Lead Sponsor
- Public Health Foundation Enterprises, Inc.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 104
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control The Control group will receive standard of care. Intervention HOME Study intervention The Intervention group will receive the HOME Study intervention.
- Primary Outcome Measures
Name Time Method Efficacy of the HOME package to support linkage to PrEP or HIV care 9 months Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.
Efficacy of the HOME package to increase HIV and STI testing frequency. 9 months The proportion of participants reporting HIV and STI testing rates between visits.
- Secondary Outcome Measures
Name Time Method Feasibility of the individual components of the study intervention. 9 months Combined analysis of overall use of study intervention: Usage of home HIV self-testing, with and without buddies, as well as STI-self collection; Proportion of participants who log-in to the HOME Study site at least once, distribution of numbers of log-ins, and use of HOME Study pages, as measured by numbers of clicks and views for each page.
Acceptability of the HOME package to support linkage to HIV care or PrEP. 9 months Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.
Trial Locations
- Locations (1)
Bridge HIV, San Francisco Department of Public Health
🇺🇸San Francisco, California, United States