Optimizing CAB-LA as PrEP for Women Who Inject Drugs

NCT ID: NCT05799339

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2025-07-31

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.

Conditions

HIV Infections; Opioid Use; Trauma, Psychological

Keywords

PrEP; Preexposure Prophylaxis; WWID; Women who inject drugs; CAB-LA; Long-acting injectable cabotegravir

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Alexis Roth

OTHER

Sponsor Role: lead

Responsible Party

Alexis Roth

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexis M Roth, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Prevention Point Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

https://clinicaltrials.gov/ct2/show/NCT05192434?term=Alexis+Roth&cond=HIV&draw=1&rank=2

Link to TIARAS ClinicalTrials.gov protocol and results description

Other Identifiers

2105008584_ViiV

Identifier Type: -

Identifier Source: org_study_id