The major goal of this study is to evaluate a multi-component, multilevel HIV prevention
intervention that targets theoretically-informed and empirically-identified barriers to
and facilitators of both HIV testing and PEP/PrEP uptake by combining existing
evidence-based and novel evidence-informed components and integrating them into a
community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program.
The existing evidence-based, individual-level component is TRUST (R01 DA-038108), a
single-session peer-based HIV self-testing intervention for Black MSM. The existing,
evidence-based community-level component is a social/print media campaign (CHHANGE [R21
MH-102182-01] & PEPTALK [R21 AI-122996]) to reduce community-level HIV stigma and drive
demand for HIV testing, PEP and PrEP. The novel, evidence-informed, individual-level
component is "Do It Yourself (DIY)", a 3-session enhancement of the CBO SOC peer
navigation program that promotes empowerment, autonomy, stigma coping/resistance and
social support via a novel "sexual self-care in-a-box" and peer-to-peer training to
increase HIV testing and PEP/PrEP uptake.
The Specific Aims are:
Component test DIY, adapt social/print media campaign & manualize full intervention.
We will conduct modified intervention mapping, component testing and post-test
interviews with 20 PrEP-eligible Black MSM (for DIY) and focus groups with 20
PrEP-eligible Black MSM (for media campaign adaptation). A 15-person community
consulting group of Black MSM, community leaders, media professionals, and service
providers, will provide feedback on both components and the full manualized
intervention.
Estimate main and interactive effects of components on recent HIV testing and
PEP/PrEP uptake.
H1: Exposure to TRUST, DIY, and the media campaign will each be associated with (1)
higher past 3-month HIV testing; and (2) shorter time to PrEP uptake over time.
H2: A multiplicative interaction among TRUST, DIY and length of exposure to the
media campaign will emerge, such that exposure to combination of multiple
interventions will be associated with the more positive outcomes compared to the
impact of each intervention component individually.
Primary outcomes: (1) HIV testing in past 3 months; (2) time to PrEP uptake:
assessed via self-report, medical record, urine test (UrSure, qualitative,
visually-read point of care test [validated machine analysis] measuring adherence to
tenofovir, metabolite of tenofovir disopropil fumarate (TDF) and tenofovir
alafenamide (TAF) via lateral flow immunoassay). Secondary outcomes:
consistent HIV testing (2+ tests 3 months apart in 9 months), PEP uptake
(self-report, medical record), PrEP/PEP adherence (self-report/ medical record/urine
test). To test hypotheses, we will use a 2x2 factorial design to randomize and
follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in NYC to one
of four combinations: 1) SOC, DIY & TRUST; 2) SOC & TRUST (no DIY); 3) SOC & DIY (no
TRUST); 4) SOC ALONE (no TRUST and no DIY). Hypotheses will be tested via regression
(GEE) and Cox proportional hazard models; impact of the social/media campaign,
delivered to both geographic (print media) and Black MSM communities (social media)
and launched midway through recruitment, will be assessed through assessment of
timing and length of exposure as covariates in the regression models and through
interrupted time series methods.
Describe the feasibility, acceptability, and usability of intervention components
and package via the Re-AIM implementation framework with an emphasis on component
implementation by a CBO program.