HIV InfectionsNCT05799339
Optimizing CAB-LA as PrEP for Women Who Inject Drugs
An observational study of HIV Infections and Opioid Use, run by Alexis Roth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Opioid Use, Trauma, Psychological
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who inject drugs
Who may be able to join
- 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)
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19143
About this study
Official title: 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).
Read the 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
- Medical subject headings
- HIV Infections, Psychological Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-months
Secondary outcomes (5)
CAB-LA adherence
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.
Measured: 6-months
PrEP persistence
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.
Measured: 6-months
Late injection
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.
Measured: 6-months
CAB-LA restart (reinitation)
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.
Measured: 6-months
PrEP product switching
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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start13 Jan 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexis Roth
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, University of Miami, University of Michigan, Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor-investigator, Alexis Roth, Drexel University
- Investigators
- Alexis M Roth, PhD, MPH, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799339
- Sponsor's protocol ID
- 2105008584_ViiV
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Engagement and Opportunities to Optimize CAB-LA as Pre-exposure Prophylaxis (PrEP) for Women Who Inject Drugs
- ClinicalTrials.gov ID
- NCT05799339
- Acronym / sponsor ID
- 2105008584_ViiV
- Conditions
- HIV Infections, Opioid Use, Trauma, Psychological
- Keywords
- PrEP, Preexposure Prophylaxis, WWID, Women who inject drugs, CAB-LA, Long-acting injectable cabotegravir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Alexis RothUniversity, hospital or other
- Collaborators
- ViiV Healthcare, University of Miami, University of Michigan, Beth Israel Deaconess Medical Center
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who inject drugs
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
CAB-LA adherence
Time frame: 6-months
PrEP persistence
Time frame: 6-months
Late injection
Time frame: 6-months
CAB-LA restart (reinitation)
Time frame: 6-months
PrEP product switching
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Link to TIARAS ClinicalTrials.gov protocol and results descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis M Roth, PhD, MPH principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Opioid Use, run by Alexis Roth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Uptake (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.