Back to resultsHOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
Primary Purpose
HIV Prevention, Sexually Transmitted Diseases, Pre-Exposure Prophylaxis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOME Study intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for HIV Prevention focused on measuring PrEP, HIV prevention, Risk reduction, STI prevention, Home HIV testing, HIV testing, STI testing
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.
Sites / Locations
- Bridge HIV, San Francisco Department of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
The Intervention group will receive the HOME Study intervention.
The Control group will receive standard of care.
Outcomes
Primary Outcome Measures
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.
Efficacy of the HOME package to increase HIV and STI testing frequency.
The proportion of participants reporting HIV and STI testing rates between visits.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03138135
First Posted
April 14, 2017
Last Updated
April 6, 2021
Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03138135
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Foundation Enterprises, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, Sexually Transmitted Diseases, Pre-Exposure Prophylaxis
Keywords
PrEP, HIV prevention, Risk reduction, STI prevention, Home HIV testing, HIV testing, STI testing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The Intervention group will receive the HOME Study intervention.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The Control group will receive standard of care.
Intervention Type
Behavioral
Intervention Name(s)
HOME Study intervention
Intervention Description
Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.
Primary Outcome Measure Information:
Title
Efficacy of the HOME package to support linkage to PrEP or HIV care
Description
Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.
Time Frame
9 months
Title
Efficacy of the HOME package to increase HIV and STI testing frequency.
Description
The proportion of participants reporting HIV and STI testing rates between visits.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Feasibility of the individual components of the study intervention.
Description
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.
Time Frame
9 months
Title
Acceptability of the HOME package to support linkage to HIV care or PrEP.
Description
Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Who uses home HIV self-testing and home STI self-collection.
Description
Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.
Time Frame
9 months
Title
Who uses a buddy.
Description
Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.
Time Frame
9 months
Title
Use of HIV prevention services.
Description
Proportion of HIV uninfected participants who attend group or individual counseling services.
Time Frame
9 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyman Scott, MD, MPH
Organizational Affiliation
Public Health Foundation Enterprises; San Francisco Department of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Buchbinder, MD
Organizational Affiliation
Public Health Foundation Enterprises; San Francisco Department of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridge HIV, San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://helpfighthiv.org
Description
Bridge HIV Health Equity Studies homepage
Learn more about this trial
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
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