SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Summary

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.

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.

Sponsors & Collaborators

• Infectious Diseases Research Collaboration, Uganda

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• ViiV Healthcare

  collaborator INDUSTRY

• University of Pittsburgh

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Diane Havlir, MD · University of California, San Francisco

• Moses Kamya, MBChB, PhD · Makerere University

• Maya Petersen, MD, PhD · University of California, Berkeley

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-02

Primary Completion

2023-12-18

Completion

2025-01-30

FDA Drug

Yes

Countries

• Kenya
• Uganda

Study Locations