Last reviewed · How we verify
NCT05799339
Optimizing CAB-LA as PrEP for Women Who Inject Drugs
trial in HIV Infections in 144 participants. Completed in 31 July 2025.
31 July 2025
Quick facts
| Lead sponsor | Alexis Roth |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 144 |
| Start date | 13 January 2022 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 1 location across United States |
Conditions studied
- HIV Infections — all drugs for HIV Infections →
- Opioid Use — all drugs for Opioid Use →
- Trauma, Psychological — all drugs for Trauma, Psychological →
Sponsor
Alexis Roth
Who can join
18 and older, female only, with HIV Infections or Opioid Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05799339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05799339 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alexis Roth
- Last refreshed: 29 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05799339.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing