Clinical trial NCT04832477: Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US
Official title: PrEP Connected Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Seropositivity
Substance Use
STI
Stigma, Social
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men.

Detailed description: HIV incidence among Black men who have sex with men (BMSM) in the southeastern United States is one of the highest in the world. Our research team has conducted studies with BMSM in Atlanta that have demonstrated 35% HIV prevalence and over 5% annual HIV incidence. Although PrEP is highly effective for preventing HIV transmission, it is not reaching BMSM. The failures in our ability to engage BMSM in PrEP use are highly problematic given the alarming rates of HIV transmission among this group. Of particular concern is the impact of substance use as a barrier in PrEP linkage, uptake, adherence, and persistence. Substance use is common among BMSM in our study, with 43% (n=204/474) reporting recent substance use. Further complicating PrEP use is the potential impact of COVID-19 on health care access, health care infrastructure, and sex behavior. The need to better understand PrEP use in the context of our new health care landscape is critical to making advances in PrEP use. At this point, assessing how substance use impacts PrEP use is challenging because PrEP implementation is so low among this group. The current study aims to provide substance using BMSM with evidence-based PrEP engagement counseling to address barriers to accessing PrEP (not for intervention testing, but for facilitating PrEP use) and to assess the multiple forms and paths of stigma and substance use as they relate to PrEP linkage, uptake, adherence, and persistence. The investigators propose using the HIV Stigma Framework as a conceptual model for investigating the intersecting pathways of stigma drivers and stigma mechanisms as they relate to PrEP use among substance using BMSM. Aim 1: Enroll a prospective cohort of N=500 BMSM who test HIV negative and test substance use positive on toxicology testing, and provide evidence-based PrEP engagement counseling to facilitate access to PrEP care. Aim 2: Conduct psychosocial and health care access assessments every 2-months for 18-months, and conduct HIV/STI testing and dried blood spot testing for TFV-DP every 3-months for 18-months. Aim 3: Using data collected from Aims 1 and 2, model stigma pathways of advancing and reverting along the PrEP cascade (i.e., linkage, uptake, adherence, persistence), with these pathways mediated by health care access and moderated by substance use. Achieving the aims will provide critical insight for translating and adapting interventions to enhance potency and durability for individuals at exceedingly elevated risk for HIV.

Eligibility criteria: Inclusion Criteria:

* Men (based on male sex assignment at birth)
* Age 18 or older
* Identify as Black, African-American, Afro-Brazilian, Afro-Carribean, or African diaspora,
* Report condomless anal sex with man in past six months
* Test HIV negative
* Report recent (\<3 months) substance use
* Positive drug toxicology for substance use

Exclusion Criteria:

-

Primary outcomes:
measure: PrEP Use
timeFrame: 12 months
Secondary outcomes:
measure: PrEP stigma
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: SHARE Project
state: Georgia
Study officials:
affiliation: University of Connecticut
name: Lisa A Eaton, PhD
role: PRINCIPAL_INVESTIGATOR
References: