NCT05549726CompletedPhase 4
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa: SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 984 (actual)
- First submitted
- 16 Sept 2022
- Start date
- 2 Jan 2023
- Primary completion date
- 18 Dec 2023
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT05549726
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 984
- From 2 Jan 2023 to the primary completion date, 18 Dec 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin ii. Antimycobacterials: Rifampin, rifapentine
Other illness
- Participant has Hepatitis B or chronic Hepatitis C Diagnosis
- Participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis
- 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).
Lab values
- Participant has ALT \>=5x ULN
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GPRT / SEARCH Office Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
| IDRC Southwest Uganda Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
Related publications
- Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet data-adaptive learning.Clin Trials · 2026 · PMID 41762058
This page is information, not medical advice. Discuss any trial with your doctor.