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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE January 23, 2019
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03654690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
Official Title  ICMJE eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Diagnostic Test: HIV self-test
    Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
  • Behavioral: Counseling
    Post-Test HIV Risk ReductionCounseling
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: HIV self-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.
    Interventions:
    • Diagnostic Test: HIV self-test
    • Behavioral: Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03654690
Other Study ID Numbers  ICMJE GR5270540
1R01MH114891-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tyler B Wray, PhD Brown University
PRS Account Brown University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP