Optimizing CAB-LA as PrEP for Women Who Inject Drugs

NCT05799339 | Completed DMC

• 1 other identifier: 2105008584_ViiV
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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. 1.How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool?
2. 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. 3.Do PrEP outcomes (e.g., adherence) and engagement in care over time differ between WWID prescribed CAB-LA versus daily oral PrEP?

Conditions

HIV Infections; Opioid Use; Trauma, Psychological

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  PrEP uptake will be operationalized as the number of participants who are prescribed (1) CAB-LA AND receive their first injection OR (2) daily oral tenofovir-based PrEP AND receive their first week of medication, as verified in the patient's electronic medical record (EMR).

  6-months

Secondary Outcomes (5)

• CAB-LA adherence

  6-months

• PrEP persistence

  6-months

• Late injection

  6-months

• CAB-LA restart (reinitation)

  6-months

• PrEP product switching

  6-months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender females eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who inject drugs

You may qualify if:

• 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)

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Alexis Roth: lead
• ViiV Healthcare: collaborator
• University of Miami: collaborator
• University of Michigan: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Prevention Point Philadelphia

Philadelphia, Pennsylvania, 19143, United States

Location

Related Links

• Link to TIARAS ClinicalTrials.gov protocol and results description

MeSH Terms

Conditions

HIV Infections; Psychological Trauma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alexis M Roth, PhD, MPH

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: January 13, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)