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

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

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