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NCT05549726 | Active, not recruiting | HIV


SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
Sponsor:

University of California, San Francisco

Brief 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.

Condition or disease

HIV

Intervention/treatment

Cabotegravir Injectable Suspension

Dynamic Choice Delivery Model

Standard of Care

Phase

Phase 4

Detailed Description:

The SEARCH CAB-LA (Cabotegravir Injectable Suspension) dynamic choice HIV prevention study is a randomized extension study of a person-centered Dynamic Choice HIV Prevention model for delivering existing evidence-based biomedical prevention interventions vs. standard of care (SOC). The study is conducted in 3 settings in rural Western Uganda and Kenya: antenatal (ANC) clinics, the outpatient department (primary care clinics), and in community settings. Participants previously randomized to Dynamic Choice HIV Prevention or SOC are re-consented and remain in their initial randomized arm. During the extension, the Dynamic Choice HIV Prevention intervention offers participants choices of biomedical prevention product (oral Pre-Exposure Prophylaxis (PrEP), oral post-exposure prophylaxis (PEP), or Cabotegravir Injectable Suspension (CAB-LA)) on an ongoing basis with the option to switch products over time based on participant preference and perceived risk. The primary endpoint is proportion of time that is covered by a biomedical prevention product over 48 weeks; secondary endpoints are: i) incident HIV infection over 48 weeks; and, ii) proportion of time during which a participant reports risk of HIV infection that is covered by a biomedical prevention product over 48 weeks. Participants in the intervention arm only are reconsented at 48 weeks for implementation evaluation up to 96 weeks.}}

Study Type : Interventional
Estimated Enrollment : 984 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa: SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
Actual Study Start Date : January 2, 2023
Estimated Primary Completion Date : December 18, 2023
Estimated Study Completion Date : January 2025
Arm Intervention/treatment

Experimental: Dynamic choice prevention (including CAB LA)

The Dynamic Choice Delivery Model includes integrated PrEP and PEP services at outpatient clinics, antenatal clinics, and via VHT workers in community households. CAB-LA will be integrated into the dynamic choice delivery model as an additional biomedical prevention option in a patient-centered delivery model based on the precede framework.

Drug: Cabotegravir Injectable Suspension

Active Comparator: Standard of Care

The standard of care for PEP or PrEP differs according to each country's guidelines.

Other: Dynamic Choice Delivery Model

Ages Eligible for Study: 15 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Inclusion criteria for the Extension include
    • Enrollment in a SEARCH Sapphire Dynamic prevention study (NCT04810650)
    • HIV negative at start of extension
    • Residing in study region
    • Additional inclusion criteria to access CAB-LA as a prevention option
    • Not pregnant or breastfeeding at time of initial CAB-LA injection
    • Participant weighs at least 35kg
    Exclusion Criteria
    • Exclusion criteria to access CAB-LA as a prevention option
      • Participant has Hepatitis B or chronic Hepatitis C Diagnosis
      • Participant has ALT >=5x ULN
      • Participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis
      • Previous hypersensitivity reaction to cabotegravir
      • 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
        • 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).

SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Location Details


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SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Kenya,

GPRT / SEARCH Office

Kisumu, Kenya,

Not yet recruiting

Uganda,

IDRC Southwest Uganda

Mbarara, Uganda,

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