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

P

Public Health Foundation Enterprises, Inc.

Status

Completed

Conditions

Sexually Transmitted Diseases
Pre-Exposure Prophylaxis
HIV Prevention

Treatments

Behavioral: Control
Behavioral: HOME Study intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03138135
R01AI104309 (U.S. NIH Grant/Contract)
16-20492

Details and patient eligibility

About

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.

Full 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).

Enrollment

104 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Intervention
Experimental group
Description:
The Intervention group will receive the HOME Study intervention.
Treatment:
Behavioral: HOME Study intervention
Control
Active Comparator group
Description:
The Control group will receive standard of care.
Treatment:
Behavioral: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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