Extension of SEARCH SAPPHIRE Dynamic Choice Prevention Study

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall purpose of this SEARCH SAPPHIRE CAB-LA extension study is to 1) Determine if adding the option of Cabotegravir Injectable Suspension (CAB-LA) as a prevention choice using a patient-centered HIV prevention delivery model increases prevention coverage compared to the standard-of-care in three ongoing randomized trials of Dynamic Choice Prevention in rural Uganda and Kenya; and, 2) Conduct a hybrid implementation study (Primary Objective Clinical and Secondary Objective Implementation) focusing on initial implementation of a patient-centered model for CAB-LA using the RE-AIM evaluation framework among persons randomized to the intervention arms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Infectious Diseases Research Collaboration, Uganda; Kenya Medical Research Institute; Makerere University; National Heart, Lung, and Blood Institute (NHLBI); National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Mental Health (NIMH); National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of California, Berkeley; University of Pittsburgh; ViiV Healthcare
• Treatments: Cabotegravir

Criteria

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).