SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

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.

Inclusion Criteria: Inclusion criteria for the Extension include: 1. Enrollment in a SEARCH Sapphire Dynamic prevention study (NCT04810650) 2. HIV negative at start of extension 3. Residing in study region Additional inclusion criteria to access CAB-LA as a prevention option 1. Not pregnant or breastfeeding at time of initial CAB-LA injection 2. Participant weighs at least 35kg Exclusion Criteria: Exclusion criteria to access CAB-LA as a prevention option: 1. Participant has Hepatitis B or chronic Hepatitis C Diagnosis 2. Participant has ALT \>=5x ULN 3. Participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis 4. Previous hypersensitivity reaction to cabotegravir 5. 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 6. 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).