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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Adherence, Patient

Intervention / Treatment
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* Other: PrEP Care Anywhere Services


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Changed from randomization to provide PrEP Care Anywhere approach to everyone enrolled to determine differences in engagement, retention and adherence.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PrEP Care Anywhere Services<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, virtual, adherence, retention