Clinical trial NCT05799339: Optimizing CAB-LA As PrEP for Women Who Inject Drugs
Official title: Exploring Engagement and Opportunities to Optimize CAB-LA As Pre-exposure Prophylaxis (PrEP) for Women Who Inject Drugs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Opioid Use
Trauma, Psychological
Keywords: PrEP
Preexposure Prophylaxis
WWID
Women who inject drugs
CAB-LA
Long-acting injectable cabotegravir
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: University of Miami
name: University of Michigan
name: Beth Israel Deaconess Medical Center
First posted: 2023-04-05
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who inject drugs

Brief summary: The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject drugs (WWID), a population with high unmet need that has been understudied in all phases of PrEP research. The main questions this study aims to answer are:

1. How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool?
2. If and how their decisions to initiate CAB-LA as PrEP are informed by their experiences with other long-acting medications, experience with daily oral medications, and their personal circumstance (e.g., like housing or addition severity)?
3. Do PrEP outcomes (e.g., adherence) and engagement in care over time differ between WWID prescribed CAB-LA versus daily oral PrEP?

The sample for this study will be derived from and ongoing prospective trial of "TIARAS," a multi-component behavioral intervention designed to reduce HIV acquisition risk among women who inject drugs (see NCT05192434).

Detailed description: This open-label community demonstration project draws from parent study TIARAS (NCT05192434), a multi-component behavioral intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). Participants are prescribed PrEP prior to enrollment based on consultation with their medical provider. They then simultaneously enroll in TIARAS and this observational study. Over six months, we will use data extracted from participant's electronic medical records to (1) describe CAB-LA and daily oral PrEP uptake among WWID and (2) assess for differences in adherence and persistence among WWID prescribed CAB-LA versus daily oral PrEP. All quantitative analyses will control for random group assignment in the TIARAS trial (NCT05192434). To understand uptake (primary outcome), we will purposively sample 20 WWID who were prescribed CAB and 20 prescribed daily oral PrEP. Participants will complete a semi-structured interview designed to explore their decision to initiate PrEP and the product-related attributes that influenced their decision, accounting for previous PrEP experience or use of long-acting injectable medications (e.g., birth control or MOUD), and examining how structural factors, like homelessness or medical mistrust influence decision-making. To understand persistence and adherence, at endline (six-months) we will purposively recruit 10 women who initiated CAB-LA who remained actively engaged in care and 10 who did not. We will also purposively recruit 10 women who initiated daily oral PrEP who remained actively engaged in care and 10 who did not. All participants will complete a semi-structured interview that explores facilitators and barriers to adherence and persistence (secondary outcomes). We will focus on strategies to increase engagement in care. Because previous research highlights the important influence of seasons of risk on PrEP outcomes (i.e., women are less interested in PrEP during periods of low perceived HIV risk such as during drug abstinence), we will examine how individual and structural factors influence PrEP persistence. Finally, should we find that \>10% of the sample switches or discontinues a PrEP formulation over time, we will recruit a subset (n=15) to understand their decision-making process about switching.

Eligibility criteria: Inclusion Criteria:

* HIV-negative cisgender female
* age ≥ 18 years
* speaks/reads English
* reporting past 6 months day non-prescription injection drug use
* enrolled in the TIARAS trial (NCT05192434)

Exclusion Criteria:

• Unable to provide informed consent

Primary outcomes:
measure: PrEP Uptake
timeFrame: 6-months
Secondary outcomes:
measure: CAB-LA adherence
timeFrame: 6-months
measure: PrEP persistence
timeFrame: 6-months
measure: Late injection
timeFrame: 6-months
measure: CAB-LA restart (reinitation)
timeFrame: 6-months
measure: PrEP product switching
timeFrame: 6-months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Prevention Point Philadelphia
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Alexis M Roth, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: