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Completed

NCT Number: NCT03138135

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

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.

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Key information

Conditions

HIV Prevention Behavior Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-exposure Prophylaxis Risk Reduction Behavior Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HOME Study intervention

Behavioral

Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.

Control

Behavioral

Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. Use of HIV prevention services.

    Time frame: 9 months

    Proportion of HIV uninfected participants who attend group or individual counseling services.

Sponsors and collaborators

Lead sponsor

Public Health Foundation Enterprises, Inc.

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • San Francisco Department of Public Health
  • University of California, San Francisco

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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