NCT03138135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 14, 2017

Last Update Submit

April 6, 2021

Conditions

HIV PreventionSexually Transmitted DiseasesPre-Exposure Prophylaxis

Keywords

PrEPHIV preventionRisk reductionSTI preventionHome HIV testingHIV testingSTI testing

Outcome Measures

Primary Outcomes (2)

  • 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.

    9 months

  • Efficacy of the HOME package to increase HIV and STI testing frequency.

    The proportion of participants reporting HIV and STI testing rates between visits.

    9 months

Secondary Outcomes (2)

  • Feasibility of the individual components of the study intervention.

    9 months

  • Acceptability of the HOME package to support linkage to HIV care or PrEP.

    9 months

Other Outcomes (3)

  • Who uses home HIV self-testing and home STI self-collection.

    9 months

  • Who uses a buddy.

    9 months

  • Use of HIV prevention services.

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

The Intervention group will receive the HOME Study intervention.

Behavioral: HOME Study intervention

Control

ACTIVE COMPARATOR

The Control group will receive standard of care.

Behavioral: Control

Interventions

HOME Study interventionBEHAVIORAL

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

Intervention
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Related Links

MeSH Terms

Conditions

Sexually Transmitted DiseasesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Bridge HIV

Study Record Dates

First Submitted

April 14, 2017

First Posted

May 3, 2017

Study Start

January 9, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)