NCT02067039

Brief Summary

This study seeks to determine the public health impact of providing rapid HIV test kits to men who have sex with men (MSM) so they may test themselves at their convenience. The study will determine if men who receive the rapid HIV test kits report HIV testing at least three times per year. This study will be conducted in four consecutive parts. The first three parts are formative in nature to guide the development and implementation of Part 4 of the study. The research study will use two different types of rapid HIV tests. The OraQuick® In-Home HIV Test for oral fluid (FDA approved for home use) and Sure Check® HIV 1/2 Assay, currently FDA-approved for professional use and distributed in the U.S. as Clearview® Complete HIV-1/2 Rapid Test. An Investigational Device Exemption will be obtained from the FDA to allow the contractor to supply the Sure Check® HIV 1/2 Assay to study participants since it is not approved for home use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,665

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

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

First Submitted

Initial submission to the registry

February 5, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 25, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 31, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

February 5, 2014

Results QC Date

January 30, 2020

Last Update Submit

March 18, 2020

Conditions

HIV Infection

Keywords

HIV testingRapid HIV testHIV self-testingMen who have sex with men (MSM)HIV diagnosisSexual behavior

Outcome Measures

Primary Outcomes (1)

  • Frequency of HIV Testing by Internet-recruited MSM.

    Frequency of HIV testing \>=3 times reported by participants over a 12-month follow-up period.

    12 months

Secondary Outcomes (3)

  • Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.

    12 months

  • Newly Identified HIV Infections

    12 months

  • HIV Infections Among Social Network Associates

    12 months

Study Arms (2)

HIV self-testing

EXPERIMENTAL

The intervention group of MSM (HIV negative or unaware of HIV status) will receive 4 rapid HIV test kits - 2 oral fluid tests (OraQuick), and 2 finger-stick blood tests (Sure Check). Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period, and men in the intervention arm will be allowed to order additional test kits to replenish the ones they use or give away. At month 12, all HIV-negative or those who are unaware of their HIV status participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a dried blood spot (DBS) specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.

Device: OraQuick in home & Sure Check HIV tests

Information only

NO INTERVENTION

All comparison group of MSM (HIV negative or unaware of HIV status) will take a baseline survey. Men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 12-month follow-up period. At month 12, all HIV-negative and unaware of their HIV status comparison arm participants will be sent 1 oral fluid test (OraQuick), 1 finger-stick blood test (Sure Check), and a DBS specimen collection kit to be mailed to Emory University after collecting a blood sample for laboratory testing.

Interventions

OraQuick in home & Sure Check HIV testsDEVICE

Provision of OraQuick in home \& Sure Check HIV tests

HIV self-testing

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male sex at birth
  • currently identify their sex as male
  • able to provide informed consent
  • at least 18 years of age
  • report being HIV-negative or unaware of HIV status
  • resident of United States and Puerto Rico.
  • able to read instructions and complete study survey instruments in English
  • reported anal sex with at least one man in the past 12 months
  • have a valid email address, a cell phone capable of sending and receiving text messages, and a physical shipping address to receive kits
  • never diagnosed with a bleeding disorder
  • not part of an HIV vaccine trial
  • not taking antiretroviral medication for HIV.

You may not qualify if:

  • not male sex at birth
  • do not currently identify their sex as male
  • not able to provide informed consent
  • under 18 years of age
  • report being HIV-positive
  • not a resident of United States or Puerto Rico.
  • not able to read instructions and complete study survey instruments in English
  • do not report anal sex with at least one man in the past 12 months
  • do not have a valid email address, a cell phone capable of sending and receiving text messages, or a physical shipping address to receive kits
  • ever diagnosed with a bleeding disorder
  • part of an HIV vaccine trial
  • taking antiretroviral medication for HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • Gwynn M, Chavez PR, Borkowf CB, Raiford JL, Gravens L, MacGowan RJ; eSTAMP Study Group. Pressure to Use HIV Self-Tests Among Men Who Have Sex With Men, United States, 2015-2016. AIDS Behav. 2022 Feb;26(2):623-630. doi: 10.1007/s10461-021-03422-6. Epub 2021 Aug 18.

    PMID: 34406551DERIVED

  • MacGowan RJ, Chavez PR, Borkowf CB, Owen SM, Purcell DW, Mermin JH, Sullivan PS; eSTAMP Study Group. Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):117-125. doi: 10.1001/jamainternmed.2019.5222.

    PMID: 31738378DERIVED

MeSH Terms

Conditions

HIV InfectionsHomosexualitySexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualityBehavior

Results Point of Contact

Title
Robin MacGowan
Organization
CDC
rmacgowan@cdc.gov
404-639-1920

Study Officials

  • Robin MacGowan, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Pollyanna Chavez, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Patrick Sullivan, PhD, DVM

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 20, 2014

Study Start

March 25, 2015

Primary Completion

October 21, 2016

Study Completion

October 21, 2016

Last Updated

March 31, 2020

Results First Posted

March 31, 2020

Record last verified: 2020-03

Locations

US(1)