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

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ClinicalTrials.gov Identifier: NCT03442192
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Adherence, Patient Other: PrEP Care Anywhere Services Not Applicable

Detailed Description:

According to the Centers for Disease Control and Prevention (CDC), the estimated lifetime risk for HIV is 1 in 2 for Black men who have sex with men (MSM) and 1 in 4 for Latino MSM. In 2012, the U.S. Food and Drug Administration approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. However, PrEP uptake and adherence among MSM of color in particular remains low. Part of the challenge of increasing PrEP uptake and adherence among MSM of color is related to a historical lack of ethnic and sexual minority engagement in health care systems, perceptions of racism and negativity, and inequities in treatment.

In order to engage, recruit, link, and retain MSM at substantial risk of HIV infection, this study proposes a randomized controlled pilot trial among 100 HIV-negative MSM of color (50 per arm) in Baltimore City to determine differences in engagement, retention and adherence to Truvada along with PrEP services. 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, as a more client-centered approach, will improve adherence and retention.

The specific aims of the Randomized Controlled Trial (RCT) pilot are:

  • To explore differences in linkage, engagement (uptake) and retention in PrEP services between traditional clinic-based PrEP services compared to the PrEP Care Anywhere (i.e., virtual) approach

Secondary Objectives

  • To describe engagement with the smartphone application, PrEP me, in the PrEP Care Anywhere arm
  • To evaluate the feasibility and scalability of the intervention package by measuring the number of peer intervention contacts (e.g., text message, email, phone, in person, mobile app chats) per participant over 12 months
  • To evaluate biological markers of adherence among a subset of HIV-negative participants and all participants who seroconvert
  • To evaluate agreement in self-reported daily adherence (app-based reporting) to standard quarterly clinic-based self-report and to correlate self-reported adherence with biomarkers of adherence including peripheral blood mononuclear cells (PBMC) and plasma levels of tenofovir disoproxil fumarate (TDF) in a subset of participants
  • To compare longitudinal changes in sexual risk behavior, health care utilization, intimate partner violence, stigma, substance use and mental health between the two study arms over 12 months by administering questionnaires at baseline, month 1 and quarterly visits
  • To assess feasibility and acceptability of virtual self-testing for HIV and sexually transmitted infections
  • To compare the experience of and satisfaction with linkage to and engagement in ongoing HIV prevention services among participants by conducting and analyzing exit interviews

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men (PCA)
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: PrEP Standard of Care
The standard of care (SOC) arm will receive traditional face-to-face clinical PrEP services. The practice offers CDC-guided PrEP activities including peer PrEP case management for linkage and retention services and has numerous providers with extensive training in HIV prevention and treatment services. Patients randomized to the SOC arm will receive all services offered by the clinic without study intervention. Medical information will be obtained by the research team through patient interview and/or medical record abstraction
Active Comparator: PrEP Care Anywhere Services
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, patients randomized to the PrEP Care Anywhere Virtual TeleHealth Visit arm 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

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




Primary Outcome Measures :
  1. PrEP Uptake [ Time Frame: 1 month ]
    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


Secondary Outcome Measures :
  1. PrEP Adherence [ Time Frame: 12 months ]
    Adherence at Month 12, defined as persistent TFV levels of 35.5 ng/mL between the arms will be evaluated by Cox Proportional Hazard models


Other Outcome Measures:
  1. PrEP Retention [ Time Frame: Month 3, 6 and 9 months ]
    Retention will be tested at 3, 6 and 9 months using chi-square test to compare retention between the two arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   men who have sex with men (MSM)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

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): NCT03442192


Contacts
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Contact: Kelly Lowensen, MSN 4105023101 klowens1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kelly L Lowensen, RN, MSN    443-326-5759    klowens1@jhu.edu   
Principal Investigator: Jason E Farley, PhD, MPH, NP         
Sponsors and Collaborators
Johns Hopkins University
Gilead Sciences
Investigators
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Principal Investigator: Jason E Farley, PhD Johns Hopkins University School of Nursing

Additional Information:
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03442192     History of Changes
Other Study ID Numbers: IRB00132612
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
PrEP
virtual
adherence
retention