984
Participants
Start Date
January 2, 2023
Primary Completion Date
December 18, 2023
Study Completion Date
January 30, 2025
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.
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.
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.
GPRT / SEARCH Office, Kisumu
IDRC Southwest Uganda, Mbarara
Collaborators (2)
Infectious Diseases Research Collaboration, Uganda
OTHER
Makerere University
OTHER
Kenya Medical Research Institute
OTHER
University of California, Berkeley
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
ViiV Healthcare
INDUSTRY
University of Pittsburgh
OTHER
University of California, San Francisco
OTHER