A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men

NCT03442192 | Terminated

• 1 other identifier: IRB00132612
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City. In 2012, the U.S. Food and Drug Administration (FDA) approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, which is more patient-centered, will improve adherence and retention in PrEP care.

Conditions

Adherence, Patient

Keywords

PrEP; virtual; adherence; retention

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  Primary outcome 1 will examine PrEP uptake at Month 1, among those not already taking PrEP at baseline, defined as Tenofovir (TFV) levels of 35.5 ng/mL or greater, using students T-test

  1 month

Secondary Outcomes (1)

• PrEP Adherence

  12 months

Other Outcomes (1)

• PrEP Retention

  Month 3, 6 and 9 months

Study Arms (1)

PrEP Care Anywhere Services

OTHER

The PrEP Care Anywhere intervention adapts peer PrEP case management for virtual delivery and provides clinical services through a tele-health program, delivered by the same clinic providers. After an initial face-to-face intake clinical evaluation within the clinic, will then receive the remaining PrEP clinical evaluations via telemedicine using the HIPPA compliant polycom platform. Case management interventions will be conducted virtually via the PrEPme application, telephone consultation, text, or email.

Other: PrEP Care Anywhere Services

Interventions

PrEP Care Anywhere Services OTHER

PrEP Virtual Clinic Visits. PrEP clinical care will follow guidelines as established by the CDC for PrEP clinical evaluation and follow-up. Appointments will be set up in the same process as any practice visit and require the same clinical documentation and billing requirements, but will have a separate clinic designation for the visit type. At any time during the study, a patient can request a face-to-face visit with the provider. The provider may also request a face-to-face visit based on patient presentation and/or laboratory results. The typical visit options will include: * On demand peer interim visits- participants can text, chat (via PrEPme app) or call to access an on demand virtual support visit with a peer Case Manager (CM). * HIV and Sexually Transmitted Infection (STI) at Home Self-Testing

PrEP Care Anywhere Services

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: men who have sex with men (MSM)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older who are HIV-negative and meeting CDC risk criteria
• Persons self-identifying as Black/African American, Latino or other men of color up to 20% Caucasian
• Men who report unprotected sex with another male partner in preceding twelve months
• Expressed interest in seeking HIV PrEP clinical services
• Willing to participate in study-related procedures, including baseline and study visits every three months
• Willing and able (i.e., access to internet connectivity) to participate in virtual PrEP model through EPIC, polycom platform
• Insured with plan that is accepted by Johns Hopkins (study team will conduct monthly tracking of insurance plans accepted by the Bartlett Specialty Care Clinic)
• Willing to receive PrEP care at Johns Hopkins

You may not qualify if:

• Under 18 years of age
• Unable to read, write or speak English
• For medical reasons, are unable to receive TDF/FTC for PrEP (including HIV- positive persons)
• Participating in another PrEP clinical trial or HIV vaccination study
• Not insured with a plan that is accepted at Johns Hopkins
• Not willing or able (i.e. access to internet connectivity) to participate in virtual PrEP model
• Not willing to receive PrEP care at Johns Hopkins

Sponsors & Collaborators

• Johns Hopkins University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (14)

• Kirby T, Thornber-Dunwell M. Uptake of PrEP for HIV slow among MSM. Lancet. 2014 Feb 1;383(9915):399-400. doi: 10.1016/s0140-6736(14)60137-9. No abstract available.

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• Arnold EA, Rebchook GM, Kegeles SM. 'Triply cursed': racism, homophobia and HIV-related stigma are barriers to regular HIV testing, treatment adherence and disclosure among young Black gay men. Cult Health Sex. 2014 Jun;16(6):710-22. doi: 10.1080/13691058.2014.905706. Epub 2014 May 2.

  PMID: 24784224 BACKGROUND

• Cahill S, Taylor SW, Elsesser SA, Mena L, Hickson D, Mayer KH. Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts. AIDS Care. 2017 Nov;29(11):1351-1358. doi: 10.1080/09540121.2017.1300633. Epub 2017 Mar 12.

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• Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.

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• Zheng JH, Rower C, McAllister K, Castillo-Mancilla J, Klein B, Meditz A, Guida LA, Kiser JJ, Bushman LR, Anderson PL. Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots. J Pharm Biomed Anal. 2016 Apr 15;122:16-20. doi: 10.1016/j.jpba.2016.01.038. Epub 2016 Jan 21.

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MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jason E Farley, PhD

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Changed from randomization to provide PrEP Care Anywhere approach to everyone enrolled to determine differences in engagement, retention and adherence.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: July 30, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)