Black/African American (B/AA) gay, bisexual, and other men who have sex with men (MSM)
are at high risk for HIV acquisition in the United States (US). Although B/AA MSM account
for less than 1% of the US population, they comprise 26% of new HIV infections. An
estimated 41% of B/AA MSM acquire HIV during their lifetimes. HIV pre-exposure
prophylaxis (PrEP) can dramatically reduce HIV incidence for B/AA MSM.
B/AA MSM have poorer outcomes at every stage of the PrEP care continuum. B/AA MSM are
less likely to initiate PrEP, and be retained in care than non-Hispanic White MSM. PrEP
care outcomes among B/AA MSM are influenced by complex social and structural factors,
such as difficulty accessing culturally congruent healthcare services, insufficient
health insurance, high out-of-pocket costs, and stigma associated with PrEP, sexual
orientation, and HIV. The US Ending the HIV Epidemic (EtHE) initiative and the National
HIV/AIDS Strategy call for expanding PrEP to B/AA MSM at community health centers (CHCs),
but few interventions exist to overcome barriers and improve PrEP care outcomes in this
setting. Moreover, access to PrEP navigation services in real-world settings is uneven.
While some clinics offer PrEP navigation services, there is no standard or scientific
consensus about how to enhance PrEP adherence and retention in care for B/AA MSM. There
is also a lack of data on the degree of intensity and time for navigation services to
achieve optimal PrEP outcomes for this population.
The investigator's NIH-funded pilot randomized controlled trial (RCT) (R34MH109371; MPI:
Nunn, Chan, Mena) developed and evaluated the Retain and Adhere MSM on PrEP Intervention
(RAMP-IT-UP), a strengths-based patient navigation program to enhance PrEP care outcomes
among B/AA MSM at a CHC in Jackson, Mississippi. RAMP-IT-UP included one 60-minute
personalized patient navigation session, bidirectional communication, scheduled short
(10-minute) phone check-ins with navigators, tailored strengths-based strategies to
overcome barriers, optional tailored daily medication reminders via text message, and
transportation assistance as needed. RAMP-IT-UP also included monthly calls to patients'
pharmacies to assess prescription pick-ups, allowing the navigator to connect with
patients in a timely manner to understand why a PrEP prescription was not filled.
RAMP-IT-UP provides real-time support to overcome social, structural and clinical
barriers to PrEP initiation, retention, and adherence and was highly acceptable among
B/AA MSM. Compared to control participants, RAMP-It-Up participants were much more likely
to initiate PrEP (93% vs. 63%, p=0.01) and to adhere to PrEP based on pharmacy fill data
(70% vs. 23%, p<0.01) and 3-month drug levels (83% vs. 50%, p=0.20). Additionally,
RAMP-It-Up participants were more likely to be retained in PrEP care at 3-month (70% vs.
43%, p=0.05) and 6-month (37% vs. 27%, p=0.42) PrEP visits.
The objectives of the proposed study are to conduct a fully multi-site RCT to determine
the effectiveness and cost-effectiveness of RAMP-It-Up for improving PrEP care outcomes
among B/AA MSM in real-world CHC settings. The long-term goal of this work is to decrease
HIV incidence among B/AA MSM, which aligns with EtHE and National HIV/AIDS Strategy
goals. The investigators propose the following specific aims:
Specific Aim #1: Conduct a fully powered RCT to estimate the effectiveness of RAMP-It-Up
among B/AA MSM attending CHCs. The investigators will enroll n=300 B/AA MSM who intend to
initiate daily oral PrEP at CHCs in three US urban centers (N=100 each site): Jackson,
Mississippi; Washington, District of Columbia; and Providence, Rhode Island. Block
randomization will be used to randomize participants at each site to either RAMP-IT-UP or
an attention-matched information/referral control condition (enhanced treatment-as usual
[ETAU]). Quantitative research assessments will be conducted at baseline and 3-, 6-, 9-,
and 12-months post-baseline. The primary outcome will be PrEP adherence, given that
adherence is the definitive marker associated with protection from HIV infection. The
investigators will measure adherence with pharmacy refill data and validate pharmacy
refill data with PrEP drug levels. Secondary analyses will evaluate PrEP initiation and
retention in care at clinical visits. The investigators hypothesize that, compared to
ETAU, RAMP-It-Up will significantly improve PrEP initiation, adherence, and retention in
care outcomes.
Specific Aim #2: Estimate the cost-effectiveness of RAMP-It-Up among B/AA MSM attending
CHCs compared to ETAU. The investigators will employ intervention costing methods to
evaluate costs of delivering RAMP-It-Up based on a comprehensive suite of tailored
navigation services compared to ETAU. The investigators will then use a Markov
state-transition model to estimate the cost-effectiveness of RAMP-It-Up compared to ETAU,
in terms of cost-per-person initiating PrEP, adhering to PrEP, and being retained in PrEP
care. The investigators will also determine the cost-effectiveness of differing levels of
intensity of navigation services to prevent HIV based on data collected in Specific Aim
#1. The ultimate goal is to develop a cost-effective intervention that enhances PrEP care
outcomes and reduces HIV incidence among B/AA MSM that will be relevant for CHCs. This
study is led by a highly successful research team with a long-standing history of
collaboration on PrEP implementation studies in real-world settings. This proposal aligns
with EtHE and National HIV/AIDS Strategy goals of scaling PrEP in real-world settings in
geographic hotspots, with a focus on B/AA MSM.