Facilitating HIV Testing Among Young Adult MSM Through Social Networking

April 28, 2017 updated by: Roland C. Merchant, MD. MPH, ScD, Rhode Island Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Young adult (18-24-year-old) Black, Hispanic, and white men-who-have-sex-with-men (MSM) have among the highest incidences of new HIV infections in the US yet have low HIV testing rates. Access, cost, time, and concerns about confidentiality are some of the barriers that limit these men from being tested at traditional medical/community-based testing sites. A new US Food and Drug Administration-approved rapid HIV self-test (OraQuick® In-home HIV Test) might encourage and facilitate HIV testing because of its widespread access, convenience, ease of usage, oral fluid collection system, privacy, and rapid provision of test results. Despite these advantages, the investigators do not know if the new rapid HIV self-test will be preferred over medical/community-based or conventional "home-based" HIV testing, and if it will serve as a means of improving HIV testing use among young adult MSM.

The objectives of this study are to: (1) determine if testing uptake is higher in a rapid HIV self-testing group than in a conventional "home-based" HIV testing group and a community/medical-based testing referral group; (2) determine if time to initiation of HIV testing is shorter in the rapid HIV self-testing group, as compared to the other two participant groups; (3) determine if participants are more willing to contact and refer other young adult MSM to this study to use a rapid HIV self-test vs. a conventional "home-based" HIV test, or vs. a community/medical-based HIV test; (4) determine if those referred for rapid HIV self-testing are more likely to enroll in the study, have a higher uptake of testing, and have a shorter time to initiate HIV testing than those referred for conventional "home-based" HIV test, or a community/medical-based HIV test.

This study is comprised of three stages, the first of which is closed. In Stage I of this study, the investigators surveyed a large sample of MSM social-networking website users and assessed their acceptance, facilitators/barriers to use, utilization, preferences, and opinions regarding the new rapid HIV self-test, as compared to conventional "home-based" HIV testing or medical or community-based HIV testing. Of the participants enrolled in Stage I, 150 Black, 150 Hispanic, and 150 white MSM will be invited to participant in Stage II of this study. 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. Participants assigned to the rapid and conventional HIV testing groups will receive an internet-based coupon to order a free HIV testing kit from a specified pharmacy's website that will be delivered to the address of their choosing. The rapid HIV self-test kit and the conventional "home-based" HIV test kit contain all materials and instructions needed to conduct an HIV test. Participants assigned to the community/medical-based HIV testing group will receive a link to a CDC website (https://gettested.cdc.gov) that allows them to search for HIV testing locations of their choice. Participants in all three groups will receive an email explaining that the investigators are measuring uptake and time to testing among study participants. They will also be informed that the investigators will contact them after they have been tested to ask for their opinions regarding their testing experience. At the end of Stage II, participants will have the opportunity to refer other young adult MSM to the study via email. Referral participants will encompass Stage III of the study. Stage III participants will be assigned to the same testing group as the individual who referred them. Confidentiality will be maintained throughout all three stages of this study.

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Stage II inclusion criteria is contingent upon the enrollment and completion of Stage I of this study.
  • Stage III inclusion criteria include: (1) 18-24 year-old male; (2) US resident; (3) previously had anal intercourse (insertive or receptive) with at least one male partner; (4) known to be HIV negative.

Exclusion Criteria:

  • Female

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapid HIV Self-Test
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)
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.
Active Comparator: Conventional Home-Based HIV Test
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)
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.
Active Comparator: Community/Medical-Based HIV Test
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Facilitating HIV Testing Among Young Adult MSM Through Social Networking Questionnaire
Time Frame: Three Months
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Roland C Merchant, MD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 477192-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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