HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing

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.

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases; HIV Prevention; Pre-Exposure Prophylaxis
• Intervention / Treatment: Behavioral: HOME Study intervention; Behavioral: Control

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).

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • Bridge HIV, San Francisco Department of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; The Intervention group will receive the HOME Study intervention.	Behavioral: HOME Study intervention; Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.
ACTIVE_COMPARATOR: Control; The Control group will receive standard of care.	Behavioral: Control; Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the HOME package to support linkage to PrEP or HIV care	Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.	9 months
Efficacy of the HOME package to increase HIV and STI testing frequency.	The proportion of participants reporting HIV and STI testing rates between visits.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the individual components of the study intervention.	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.	9 months
Acceptability of the HOME package to support linkage to HIV care or PrEP.	Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.	9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Who uses home HIV self-testing and home STI self-collection.	Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.	9 months
Who uses a buddy.	Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.	9 months
Use of HIV prevention services.	Proportion of HIV uninfected participants who attend group or individual counseling services.	9 months

Collaborators and Investigators

• Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of California, San Francisco; San Francisco Department of Public Health
• Investigators: Principal Investigator: Hyman Scott, MD, MPH, Public Health Foundation Enterprises; San Francisco Department of Public Health; Principal Investigator: Susan Buchbinder, MD, Public Health Foundation Enterprises; San Francisco Department of Public Health

Publications and helpful links

Helpful Links

• Bridge HIV Health Equity Studies homepage

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2017
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: PrEP; HIV prevention; HIV testing; Risk reduction; STI prevention; Home HIV testing; STI testing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: 16-20492; R01AI104309 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No