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Evaluation of direct-to-inject point-of-care HIV testing to facilitate rapid initiation of long-acting Cabotegravir for pre-exposure prophylaxis

Evaluation of direct-to-inject point-of-care HIV testing to facilitate rapid initiation of long-acting Cabotegravir for PrEP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN74312863
Enrollment
300
Registered
2025-10-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Describe and evaluate the implementation of a direct-to-inject HIV testing approach to facilitate rapid initiation of long-acting Cabotegravir for PrEP Other

Interventions

In this mixed-methods observational study, we will evaluate the implementation of a direct-to-inject HIV testing strategy for the rapid initiation of long-acting injectable cabotegravir (CAB-LA) for H

Sponsors

ViiV Healthcare (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients aged 18 and older referred to our clinical CAB-LA program from April 1st 2025, to March 31st 2026, will be eligible for manual chart abstraction of data. 2. All people who initiate CAB-LA with the GHS PrEP program between October 2025 and September 30th 2026, will be eligible to participate in the patient interview. 3. Any healthcare staff who participates in the care of patients on CAB-LA will be eligible to participate in the interview if they: 3.1. Are a licensed CMA, LPN, or APP at GHS 3.2. Have administered at least 5 CAB-LA injections prior to interview 3.3. Have completed at least 5 POC HIV tests prior to interview 3.4. Have completed prior training on CAB-LA administration 3.5. Have completed prior training on POC HIV testing

Exclusion criteria

Exclusion criteria: Minors, prisoners, cognitive impairment or impaired decision making capacity

Design outcomes

Primary

MeasureTime frame
The time between CAB-LA PrEP referral and first CAB-LA injection using the direct-to-inject HIV testing strategy for CAB-LA initiation, measured using EMR abstraction of referral and injection dates to calculate the interval between events for all patients referred from October 1st, 2025, and September 30th, 2026

Secondary

MeasureTime frame
1. The GHS PrEP CAB-LA Continuum of Care using a direct-to-injection approach measured using EMR abstraction of referral, education, medication authorization, and injection dates to assess completion of each step in the continuum between October 1st, 2025, and September 30th, 2026 2. The appropriateness of using a direct-to-inject HIV testing strategy for CAB-LA initiation, measured using congruence between point-of-care (POC) HIV test results and corresponding serum HIV laboratory results abstracted from the electronic medical record (EMR) at the time of first CAB-LA injection between October 01, 2025 and September 30, 2026 3. Staff and patient perspectives regarding the adoption of same-day POC HIV testing for CAB- LA initiation measured using semi-structured interviews analyzed through thematic analysis within 30 days of CAB-LA initiation for patients and within 12 months of study start for staff

Countries

United States of America

Contacts

Public ContactDylan Baker
dylan.mathieu-henri.baker@emory.edu-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026