Evaluation of direct-to-inject point-of-care HIV testing to facilitate rapid initiation of long-acting Cabotegravir for pre-exposure prophylaxis
| ISRCTN | ISRCTN74312863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74312863 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | Nil Known |
- Submission date
- 17/10/2025
- Registration date
- 23/10/2025
- Last edited
- 23/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study will describe and evaluate the implementation of conducting all HIV testing at a patient's first injection appointment to facilitate rapid initiation of long-acting Cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP). Rapid initiation of PrEP helps protect patients from HIV during high-risk periods. Programs offering CAB-LA need to address delays and patient loss during the initiation process. Conducting all necessary HIV testing at the first injection appointment, rather than beforehand, could shorten the time from referral to first injection and reduce patient drop-off during this critical period.
Who can participate?
Adult participants from our PrEP Clinic at Grady Memorial Hospital, USA.
What does the study involve?
All patients referred for CAB-LA during the study period will be included in this prospective analysis. The PrEP clinic does not target specific groups for CAB-LA initiation. The team anticipate receiving 250 referrals and starting 200 patients on CAB-LA during this timeframe. A prospective chart review will be conducted for all patients referred to the GHS PrEP program from April 1, 2025, through March 31, 2026, from referral to up to 12 months after CAB-LA initiation (Aims 1 and 2). Interviews will be run for 30 patients after their first injection, and for 10 staff delivering first injections (Aim 3). There are no medical interventions, and all clinical protocols evaluated are standard of care for the clinic.
Patients recruited to participate in the qualitative portion of this study will complete 1 hour 1-hour-long interview. Total enrollment will be 40 participants, including 30 patients and 10 staff participants. The study does not bank any specimens. Chart review data will be banked. Any requests to use this data will require IRB approval. A waiver of informed consent will be requested for the chart review portion of the protocol. Participants recruited for interviews will be asked to consent verbally immediately before the interview. A HIPAA waiver will be requested as all audio recordings will be de-identified before analysis, and will not be linked to any clinical data obtained through chart review.
What are the possible benefits and risks of participating?
Possible benefits:
Participants will not receive direct benefits from taking part in this study. However, their involvement will help improve how HIV prevention programs deliver injectable PrEP in the future by identifying ways to make the process faster, more efficient, and more patient-centered. Staff input will also support improvements in training and workflow for PrEP delivery.
Possible risks:
The study poses no to minimal risk to participants as all medical procedures are the current standard of care in our clinic, and there is no medical intervention. Individuals participating in patient and staff interviews may experience minor emotional discomfort when discussing personal experiences during interviews. There are no physical or medical risks involved, and participation is entirely voluntary.
Where is the study run from?
Emory University School of Medicine, USA.
When is the study starting and how long is it expected to run for?
March 2025 to September 2026
Who is funding the study?
ViiV Healthcare (UK)
Who is the main contact?
Dr Dylan Baker, dylan.mathieu-henri.baker@emory.edu
Contact information
Public, Scientific, Principal investigator
Emory University School of Medicine
1599 Clifton Rd N E
Atlanta, Georgia
30322
United States of America
| dylan.mathieu-henri.baker@emory.edu |
Study information
| Study design | Mixed-methods prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Other |
| Scientific title | Evaluation of direct-to-inject point-of-care HIV testing to facilitate rapid initiation of long-acting Cabotegravir for PrEP |
| Study objectives | Describe and evaluate the implementation of a direct-to-inject HIV testing approach to facilitate rapid initiation of long-acting Cabotegravir for PrEP. By evaluating outcomes of this testing strategy, this research may inform other clinical sites of the impact of implementing this testing strategy for rapid initiation of CAB-LA, as well as future injectable PrEP options. |
| Ethics approval(s) |
Approved 05/03/2025, Emory University Institutional Review Board (IRB) (1599 Clifton Rd N E, Atlanta, GA 30322, United States of America; +1 404-712-0720; IRB@emory.edu), ref: STUDY00009264 |
| Health condition(s) or problem(s) studied | Describe and evaluate the implementation of a direct-to-inject HIV testing approach to facilitate rapid initiation of long-acting Cabotegravir for PrEP |
| Intervention | 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 HIV PrEP within the Grady Health System (GHS) PrEP Program. The population will include all patients referred to the GHS PrEP Program between October 1, 2025, and September 30, 2026, who are eligible for CAB-LA initiation, as well as clinical staff administering first injections. The intervention is the implementation of a “direct-to-inject” strategy in which same-day initiation of CAB-LA is offered using integrated HIV testing (rapid POC 4th-generation Ag/Ab, serum Ag/Ab, and HIV RNA testing) without requiring a prior testing visit or oral lead-in. There is no formal comparison group, as we will study the implementation of our current standard clinical practice, and there are no changes to clinical protocols associated with this study. The outcomes will include quantitative measures of implementation timeliness (e.g., time from referral to initiation), retention and persistence on CAB-LA, safety and appropriateness (including HIV testing results and seroconversions), and sociodemographic predictors of progression along the CAB-LA care continuum. We will use the RE-AIM implementation science framework to provide a structure for our evaluation. Our primary outcome aims to evaluate reach and effectiveness. We will describe the protocol’s reach in starting high-risk individuals on CAB-LA. The effectiveness of this method will be evaluated by describing concordance of pre-initiation and serum testing results, the time taken from medication approval to first injection, and the proportion of patients approved for CAB-LA who were started on the medication. Qualitative outcomes will include patient and staff perceptions of acceptability, feasibility, satisfaction, and implementation barriers and facilitators related to the direct-to-inject strategy. The study period will include a prospective chart review for up to 12 months following initiation (Aims 1–2) and semi-structured interviews with approximately 30 patients and 10 staff (Aim 3). |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 05/03/2025 |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 300 |
| Key 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 |
| Key exclusion criteria | Minors, prisoners, cognitive impairment or impaired decision making capacity |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Atlanta, Georgia
30303
United States of America
Atlanta, Georgia
30308
United States of America
Sponsor information
Industry
79 New Oxford Street
London
WC1A 1DG
England
United Kingdom
| Phone | +44 20 8047 5000 |
|---|---|
| viiv.partnering@viivhealthcare.com | |
| Website | https://www.viivhealthcare.com/ |
"ROR" |
https://ror.org/01cc9yk21 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- ViiV Healthcare Limited
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/10/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are not publicly available to protect participant privacy. |
Editorial Notes
22/10/2025: Study's existence confirmed by the Emory University Institutional Review Board (IRB), USA.
