- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799339
Optimizing CAB-LA as PrEP for Women Who Inject Drugs
Exploring Engagement and Opportunities to Optimize CAB-LA as Pre-exposure Prophylaxis (PrEP) for Women Who Inject Drugs
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:
- How do WWID perceive long-acting injectable cabotegravir (CAB-LA) as a HIV prevention tool?
- 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)?
- 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).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexis M Roth, PhD, MPH
- Phone Number: 317-213-3960
- Email: amr395@drexel.edu
Study Contact Backup
- Name: Erin C McDowell, MA
- Phone Number: 248-345-8237
- Email: ecm88@drexel.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19143
- Recruiting
- Prevention Point Philadelphia
-
Contact:
- Amy Jessop, MD
- Phone Number: 610-220-7473
- Email: amy@ppponline.org
-
Contact:
- Rachel Holbert, MPH
- Phone Number: 215.510.3599
- Email: rholbert@ppponline.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEP Uptake
Time Frame: 6-months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAB-LA adherence
Time Frame: 6-months
|
To assess PrEP adherence in women initiating long-acting injectable cabotegravir (CAB-LA), we will extract the dates of CAB-LA injections from participants' electronic medical records and will determine whether each follow-up CAB-LA injection occurred within recommended dosing windows according to Apretude prescribing information (+/- 7 days).
In primary analysis, any injection occurring within the recommended dosing window will be considered adherent.
Injections outside this dosing window will be considered non-adherent.
|
6-months
|
PrEP persistence
Time Frame: 6-months
|
To describe PrEP persistence, we will calculate the proportion of days covered by a PrEP prescription over the 12-month study period, among those who initiate PrEP (see PrEP uptake).
Dates and number of pills dispensed and/or date of each CAB-LA injection will be extracted from the EMR.
Persistence will be operationalized as: (sum of days with an "active" PrEP prescription) ÷ (365 days) × 100.
|
6-months
|
Late injection
Time Frame: 6-months
|
Any CAB-LA injection occurring outside of the dosing window (+/- 7 days of each scheduled injection) will be considered late.
Dates of each injection will be extracted from the patient's electronic medical record.
|
6-months
|
CAB-LA restart (reinitation)
Time Frame: 6-months
|
A restart (reinitation) will be defined as any CAB-LA injection occurring more than 4 weeks from when it was scheduled/due but within the 12-month study timeframe.
Dates for each CAB-LAI injection will be extracted from the patient's electronic medical record.
|
6-months
|
PrEP product switching
Time Frame: 6-months
|
We will describe patterns of switching between PrEP modalities over time among those who initiate CAB-LA (see PrEP uptake).
For example, we will assess the number/proportion of women switching from daily oral PrEP to CAB-LA (or vice versa), the timing of when switching occurred (e.g., after one month of PrEP uptake), and the average number of switches per participant.
|
6-months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexis M Roth, PhD, MPH, Drexel University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2105008584_ViiV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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