Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Centers for Disease Control and Prevention
Sponsor:
Collaborators:
MANILA Consulting Group Inc.
Emory University
Northwestern University
Public Health Solutions
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02067039
First received: February 5, 2014
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
HIV Infection
Device: OraQuick in home & Sure Check HIV tests

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluation of Rapid HIV Self-testing Among MSM in High Prevalence Cities

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Frequency of HIV testing by internet-recruited MSM. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of HIV testing reported by participants over a 12-month follow-up period.


Secondary Outcome Measures:
  • Performance of rapid HIV tests used by internet-recruited MSM [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare results of rapid HIV tests used by MSM to Dried Blood Spot samples collected by participants and sent to laboratory for HIV testing.

  • Linkage to HIV testing and care services following a positive rapid test result. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Proportion of MSM who report accessing supplemental testing and care following a positive rapid HIV test results.

  • Changes in sexual behaviors following rapid HIV testing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in sexual risk behaviors (i.e., number of sex partners, unprotected anal intercourse, and sero-sorting) after using rapid HIV tests from date of rapid test through 12 month follow-up assessment.

  • Distribution of rapid HIV test to social and sexual partners. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Proportion of MSM who receive rapid HIV test kits and distribute the kits to social and sexual partners.


Estimated Enrollment: 3200
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OraQuick in home & Sure Check HIV tests
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
Provision of OraQuick in home & Sure Check HIV tests
No Intervention: Information only
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The inclusion criteria for the Part 4 randomized controlled trial are:

    1. male sex at birth
    2. currently identify their sex as male
    3. able to provide informed consent
    4. at least 18 years of age
    5. report being HIV-negative or unaware of HIV status
    6. resident of Atlanta, Baltimore, Chicago, Dallas, the District of Columbia, Houston, Los Angeles, Miami, New York City, Philadelphia, San Francisco, or San Juan
    7. able to read instructions and complete study survey instruments in English
    8. reported anal sex with at least one man in the past 12 months
    9. have a valid email address, a cell phone capable of sending and receiving text messages, and a physical shipping address to receive kits
    10. never diagnosed with a bleeding disorder
    11. not part of an HIV vaccine trial
    12. not taking antiretroviral medication for HIV.

Exclusion Criteria:

  • The exclusion criteria for the Part 4 randomized controlled trial are:

    1. not male sex at birth
    2. do not currently identify their sex as male
    3. not able to provide informed consent
    4. under 18 years of age
    5. report being HIV-positive
    6. not a resident of Atlanta, Baltimore, Chicago, Dallas, the District of Columbia, Houston, Los Angeles, Miami, New York City, Philadelphia, San Francisco, or San Juan
    7. not able to read instructions and complete study survey instruments in English
    8. do not report anal sex with at least one man in the past 12 months
    9. 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
    10. ever diagnosed with a bleeding disorder
    11. part of an HIV vaccine trial
    12. taking antiretroviral medication for HIV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067039

Contacts
Contact: Robin MacGowan, MPH 404-639-1920 rmacgowan@cdc.gov
Contact: Pollyanna Chavez, PhD 404-639-1742 pchavez@cdc.gov

Locations
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Patrick Sullivan, DVM, PhD    404-727-2038    pssulli@emory.edu   
Contact: AD McNaughten, PhD    404 727-8750    a.d.mcnaghten@emory.edu   
Principal Investigator: Patrick Sullivan, DVM, PhD         
Sponsors and Collaborators
MANILA Consulting Group Inc.
Emory University
Northwestern University
Public Health Solutions
Investigators
Principal Investigator: 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
Study Director: Stephen Tregear, PhD MANILA Consulting Group Inc.
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02067039     History of Changes
Other Study ID Numbers: CDC-eSTAMP-41989
Study First Received: February 5, 2014
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
HIV testing
Rapid HIV test
HIV self-testing
Men who have sex with men (MSM)
HIV diagnosis
Sexual behavior

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014