Phase 4
N=984
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
HIV
Bottom Line
View on ClinicalTrials.gov: NCT05549726 ↗Enrolled (actual)
984
Serious AEs
0.6%
Results posted
Jan 2025
Primary outcome: Primary: Biomedical Prevention Covered Time — 69.7; 13.3 % of days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cabotegravir Injectable Suspension (Drug); Dynamic Choice Delivery Model (Other); Standard of Care (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biomedical Prevention Covered Time |
69.7; 13.3 | — |
| SECONDARY HIV Incident Infection |
— | — |
| SECONDARY HIV Incident Infection |
— | — |
| SECONDARY Biomedical Prevention During Periods of Self Assessed HIV Risk |
— | — |
Summary
The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study is to determine if adding the option of CAB-LA as a prevention choice using a person-centered dynamic choice HIV (human immunodeficiency virus) prevention model, with option to switch products over time, compared to the standard of care: 1) increases prevention coverage; 2) reduces HIV incident infection; and 3) increases prevention coverage during periods of self-assessed risk of HIV infection, in three settings in rural Uganda and Kenya.
In addition, this study will describe implementation of a person-centered model for dynamic choice HIV prevention including CAB-LA, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) evaluation framework among persons randomized to the intervention arm.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria for the Extension include:
- Enrollment in a SEARCH Sapphire Dynamic prevention study (NCT04810650)
- HIV negative at start of extension
- Residing in study region
Additional inclusion criteria to access CAB-LA as a prevention option
- Not pregnant or breastfeeding at time of initial CAB-LA injection
- Participant weighs at least 35kg
Exclusion Criteria
Exclusion criteria to access CAB-LA as a prevention option:
- Participant has Hepatitis B or chronic Hepatitis C Diagnosis
- Participant has ALT >=5x ULN
- Participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis
- Previous hypersensitivity reaction to cabotegravir
- Receiving the following co-administered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase:
i. Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin ii. Antimycobacterials: Rifampin, rifapentine
- Participants with a current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding, except for the use of anticoagulation for deep vein thrombosis (DVT) prophylaxis (e.g., postoperative DVT prophylaxis) or the use of low dose acetylsalicylic acid (≤325 mg).
Data sourced from ClinicalTrials.gov (NCT05549726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.