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 : November 20, 2019
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|
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
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
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, 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:
- 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
- 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
- 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
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
|Contact: Kelly Lowensen, MSNemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kelly L Lowensen, RN, MSN 443-326-5759 firstname.lastname@example.org|
|Principal Investigator: Jason E Farley, PhD, MPH, NP|
|Principal Investigator:||Jason E Farley, PhD||Johns Hopkins University School of Nursing|