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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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HIV Prevention Sexually Transmitted Diseases Pre-Exposure Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

The Intervention group will receive the HOME Study intervention.

Group Type EXPERIMENTAL

HOME Study intervention

Intervention Type BEHAVIORAL

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

Control

The Control group will receive standard of care.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes