NCT02369627

Brief Summary

The purpose of this study is to evaluate a new approach to increase HIV testing among young adult Black, Hispanic, and white men-who-have-sex-with-men (MSM). In this randomized, controlled trial, participants will be assigned to one of three HIV testing groups: (1) rapid HIV self-testing group (OraQuick® In-home HIV Test), (2) conventional "home-based" HIV testing group (Home Access Express), and (3) community/medical-based HIV testing group. Upon completion of testing, participants will receive a questionnaire to evaluate their HIV testing experience, and also inquire about recommendations for future testing. Study participants will also have the option to refer other study eligible males to the study via email.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P50-P75 for phase_3 hiv

Timeline
Completed

Started Feb 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

February 17, 2015

Last Update Submit

April 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Facilitating HIV Testing Among Young Adult MSM Through Social Networking Questionnaire

    Three Months

Study Arms (3)

Rapid HIV Self-Test

EXPERIMENTAL

Participants will perform a rapid HIV self-test using the OraQuick® In-home HIV Test.

Device: Rapid HIV Self-Test (OraQuick® In-home HIV Test)

Conventional Home-Based HIV Test

ACTIVE COMPARATOR

Participants will perform a conventional home-based HIV test using the Home Access Express HIV-1 Test System.

Device: Conventional Home-Based HIV Test (Home Access Express)

Community/Medical-Based HIV Test

ACTIVE COMPARATOR

Participants will receive a link to a CDC website (https://gettested.cdc.gov) that allows them to search for HIV testing locations of their choice.

Other: Community/Medical-Based HIV Test

Interventions

The participant will utilize materials and directions contained within the OraQuick In-Home HIV Test kit to properly perform a rapid HIV self-test. The participant will first swab his upper and lower gums using an Oral Swab Test Stick. The participant will then place this device in a test tube, and the results will be displayed in the Test Window within 20 minutes. Test results expire after 40 minutes.

Rapid HIV Self-Test

The participant will utilize materials and directions contained within the Home Access Express HIV-1 Test System to properly perform a conventional home-based HIV test. The participant is required to gather a blood sample by lancing his finger. Blood samples are collected by placing drops of blood on a packaged specimen card. The participant will then mail his blood sample to the Home Access laboratory using a self-addressed, pre-paid shipping envelope. The Home Access laboratory will process the blood sample, and the participant is required to call the facility to learn his HIV test result.

Conventional Home-Based HIV Test

The participant will receive a link to a CDC website (https://gettested.cdc.gov) to search for HIV testing locations in his surroudning community. This resource website will provide the participant with places that offer HIV testing for free or at a low cost. The participant also has the option of going to places that can use his insurance or charge for testing. The pariticant is responsible to pay for any testing costs.

Community/Medical-Based HIV Test

Eligibility Criteria

Age18 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wentz AE, Merchant RC, Clark MA, Liu T, Rosenberger JG, Bauermeister JA, Mayer KH. Blood Donation, Sexual Practices, and Self-Perceived Risk for HIV in the United States Among Young Adult Men Who Have Sex With Men. Public Health Rep. 2019 Jan/Feb;134(1):36-46. doi: 10.1177/0033354918815182. Epub 2018 Dec 7.

  • Merchant RC, Clark MA, Liu T, Romanoff J, Rosenberger JG, Bauermeister J, Mayer KH. Comparison of Home-Based Oral Fluid Rapid HIV Self-Testing Versus Mail-in Blood Sample Collection or Medical/Community HIV Testing By Young Adult Black, Hispanic, and White MSM: Results from a Randomized Trial. AIDS Behav. 2018 Jan;22(1):337-346. doi: 10.1007/s10461-017-1802-x.

MeSH Terms

Interventions

Residence Characteristics

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Roland C Merchant, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine and Epidemiology at Alpert Medical School of Brown University and Rhode Island Hospital

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

February 1, 2015

Primary Completion

February 28, 2016

Study Completion

April 27, 2017

Last Updated

May 2, 2017

Record last verified: 2017-04