Project Summary/Abstract
Overview and Background. This is a proposal for a hybrid 2 implementation-effectiveness randomized
controlled trial (RCT) of FINISHING HIV, an implementation strategy bundle of a social network support
component and a one-stop-shop PrEP component to improve PrEP initiation of Latino men who have sex with
men (LMSM). PrEP can reduce HIV transmission by up to 99%,1 however, PrEP services are not being
sufficiently accessed by Latinos in Miami, the epicenter of the HIV epidemic in the US.2 Further, LMSM who do
not self-identify as gay have lower PrEP awareness than LMSM who self-identify as gay.3 To prepare for this
study, we have developed an innovative approach that tailors LMSM engagement based on sexual self-identity
using community-based social events and pharmacies. Preliminary work. The trial is a direct next step from
our “Ending the HIV Epidemic” (EHE) planning supplements, where we conducted the needed preliminary
study to launch this hybrid trial, and with ISCI3 support, the team jointly assessed feasibility, refined strategies
and built a logic model informed by local context needs and preferences. Over the past two years, the PI has
built partnerships with Latinos Salud (a local HIV agency for LMSM) and CVS Health. Design. We will use an
innovative network-based approach informed by the PI’s K99/R00 funded research and Social Contagion
Theory,4 which states that health behavior preferences, including PrEP initiation, are affected by opinions and
attitudes prevailing in one’s social environment, and spread through friendship networks.5 Penetration at
pharmacies and social events will lead to random assignment of the participants to either FINISHING HIV
(social network support component + one-stop-shop PrEP component; N=24 seeds and 288 LMSM friends) or
to standard health promotion (N=312). Participants will be assessed at baseline, and receive follow ups and
dried blood spots collection at 6 and 12 months to quantify tenofovir diphosphate concentrations. For
implementation (Aim 1), we will use RE-AIM framework6 to evaluate Reach (the extent to which high risk
persons initiate participation in the program), and Implementation (the extent to which implementation
strategies are delivered as designed) of FINISHING HIV. We will also use Consolidated Framework for
Implementation Science Research7 to examine contextual factors associated with Reach and Implementation
(e.g., facilitators and challenges or barriers to reach and implementation; participants reaction to these
strategies). We will compare effectiveness (Aim 2) of the strategies in PrEP initiation (primary outcome), as
well as PrEP knowledge, retention, and adherence (secondary outcomes). We will identify theory-based
moderators (e.g., recruitment at social events vs. pharmacies) and social network mediators of intervention
effects. We will also assess how friendship network structural evolutions contribute to increasing PrEP
initiation. Implications. Our use of a social network support, one-stop-shop PrEP, and community and national
pharmacy chain partners is a promising model that can be replicated in other EHE priority areas nationwide.
