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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.

This study is currently recruiting participants.
Verified May 2017 by Susan Buchbinder, Public Health Foundation Enterprises, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03138135
First Posted: May 3, 2017
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
San Francisco Department of Public Health
University of California, San Francisco
Information provided by (Responsible Party):
Susan Buchbinder, Public Health Foundation Enterprises, Inc.
  Purpose

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.


Condition Intervention
HIV Prevention Sexually Transmitted Diseases Pre-Exposure Prophylaxis Behavioral: HOME Study intervention Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Susan Buchbinder, Public Health Foundation Enterprises, Inc.:

Primary Outcome Measures:
  • Efficacy of the HOME package to support linkage to PrEP or HIV care [ Time Frame: 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. [ Time Frame: 9 months ]
    The proportion of participants reporting HIV and STI testing rates between visits.


Secondary Outcome Measures:
  • Feasibility of the individual components of the study intervention. [ Time Frame: 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. [ Time Frame: 9 months ]
    Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.


Other Outcome Measures:
  • Who uses home HIV self-testing and home STI self-collection. [ Time Frame: 9 months ]
    Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.

  • Who uses a buddy. [ Time Frame: 9 months ]
    Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.

  • Use of HIV prevention services. [ Time Frame: 9 months ]
    Proportion of HIV uninfected participants who attend group or individual counseling services.


Estimated Enrollment: 200
Actual Study Start Date: January 9, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138135


Contacts
Contact: Kenneth Coleman, MA 415-437-7443 kenneth.coleman@sfdph.org
Contact: Rafael Gonzalez 415-437-7455 rafael.gonzalez@sfdph.org

Locations
United States, California
Bridge HIV, San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94102
Principal Investigator: Susan Buchbinder, MD         
Principal Investigator: Hyman Scott, MD, MPH         
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
San Francisco Department of Public Health
University of California, San Francisco
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
  More Information

Additional Information:
Responsible Party: Susan Buchbinder, Director, Bridge HIV, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03138135     History of Changes
Other Study ID Numbers: 16-20492
R01AI104309 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2017
First Posted: May 3, 2017
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Buchbinder, Public Health Foundation Enterprises, Inc.:
PrEP
HIV prevention
Risk reduction
STI prevention
Home HIV testing
HIV testing
STI testing

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female