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eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men (eTest)

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ClinicalTrials.gov Identifier: NCT03654690
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brown University

Brief Summary:
The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.

Condition or disease Intervention/treatment Phase
HIV Infections Diagnostic Test: HIV self-test Behavioral: Counseling Not Applicable

Detailed Description:

HIV disproportionately affects men who have sex with men (MSM) in the United States, and new infections continue to increase particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV testing can produce reductions in incidence when implemented on a broad scale by facilitating earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the number of MSM who are aware of their status by overcoming key barriers to clinic-based testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. Existing, FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who seek it, but few users do, and this "passive" approach may miss critical opportunities to engage with MSM for further prevention services.

To address these challenges, the investigators developed a mobile health platform ("eTEST") that uses internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, allowing the investigators to provide timely, "active" follow-up counseling and referral over the phone after they do so. In a pilot study, the investigators show that providing HBST by mail at regular intervals boosted rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing reminders. Moreover, those who received follow-up phone counseling after HBST were more likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants are not informed of their condition assignment, but may infer it via the procedures they are provided. Both investigators and staff assessing outcomes are blinded to participants' group assignments.
Primary Purpose: Prevention
Official Title: eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Control
Participants will receive SMS text message reminders to get tested for HIV in a clinic.
Active Comparator: Standard Self-Testing
Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.
Diagnostic Test: HIV self-test
Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)

Experimental: Enhanced Self-Testing
Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test.
Diagnostic Test: HIV self-test
Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)

Behavioral: Counseling
Post-Test HIV Risk ReductionCounseling




Primary Outcome Measures :
  1. HIV testing [ Time Frame: In 3-month intervals over a 12 month study period ]
    Whether participants were tested for HIV, either at a clinic or via self-test


Secondary Outcome Measures :
  1. Receipt of a prescription for pre-exposure prophylaxis (PrEP) [ Time Frame: Over a 12 month period ]
    Whether participants received a prescription for PrEP, assessed via self-report and medical record verification

  2. Receipt of consultation about pre-exposure prophylaxis (PrEP) [ Time Frame: Over a 12 month period ]
    Whether participants sought consultation with a medical provider about beginning a PrEP regimen, as assessed via self-report and medical records review

  3. Receipt of testing for other sexually-transmitted infections [ Time Frame: In 6-month intervals over a 12 months study period ]
    Whether participants were tested for other STIs, as assessed via self-report and medical record review

  4. Receipt of counseling to reduce HIV-risk behavior [ Time Frame: In 3-month intervals over a 12 month period ]
    Whether participants received counseling about ways to reduce their risk for HIV, as assessed via self-report


Other Outcome Measures:
  1. Number of condomless anal sex events with partners of unknown HIV and PrEP status [ Time Frame: Past 30 days ]
    Assessed via a Timeline Followback (TLFB) of sexual behavior



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • report any of the following in the past six months: anal sex without condoms outside of a monogamous partnership with a recently tested, HIV-negative male, having been diagnosed with an STI, or being in an ongoing sexual partnership with an HIV-positive male
  • not tested for HIV in the last 12 months
  • have a stable residence in one of the site metros where they can securely receive packages
  • use an iOS/Android smartphone with a data plan or home wifi
  • fluent in either English or Spanish

Exclusion Criteria:

  • currently on PrEP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654690


Contacts
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Contact: Erik M Simpanen, B.S. 401-863-6681 erik_simpanen@brown.edu
Contact: Tyler B Wray, PhD 401-863-6659 tyler_wray@brown.edu

Locations
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United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02906
Contact: Erik Simpanen    401-863-6659    erik_simpanen@brown.edu   
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tyler B Wray, PhD Brown University

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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03654690     History of Changes
Other Study ID Numbers: GR5270540
1R01MH114891-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases