SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

PHASE4CompletedINTERVENTIONAL
Enrollment

984

Participants

Timeline

Start Date

January 2, 2023

Primary Completion Date

December 18, 2023

Study Completion Date

January 30, 2025

Conditions
HIV
Interventions
DRUG

Cabotegravir Injectable Suspension

CAB-LA will be one of the options for the Dynamic Choice Delivery intervention arm. CAB-LA will be a choice for at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Single-dose vial containing 600 mg/3 mL (200 mg/mL) of cabotegravir is a white to light pink, free-flowing, extended-release injectable suspension. CAB-LA administration will occur at health facilities.

OTHER

Dynamic Choice Delivery Model

The Dynamic Choice Delivery Model includes integrated PrEP (including CAB-LA) and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. The procedures for each trial include PrEP/PEP counseling and services, choice of service location, HIV testing options, option for longer PrEP refills, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, assessment of PrEP/PEP barriers and personalized actions, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services.

OTHER

Standard of Care

The standard of care differs according to country but does not routinely offer PEP or PrEP to clients seeking services, does not offer choice of service location, HIV testing option or access to medical provider mobile phone number.

Trial Locations (2)

Unknown

GPRT / SEARCH Office, Kisumu

IDRC Southwest Uganda, Mbarara

All Listed Sponsors
collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

collaborator

Makerere University

OTHER

collaborator

Kenya Medical Research Institute

OTHER

collaborator

University of California, Berkeley

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

ViiV Healthcare

INDUSTRY

collaborator

University of Pittsburgh

OTHER

lead

University of California, San Francisco

OTHER