SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05549726
• Other study ID #: SEARCH CAB LA Extension
• Secondary ID: U01AI150510
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 984
• Est. completion date: January 2025
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
Kenya	GPRT / SEARCH Office	Kisumu
Uganda	IDRC Southwest Uganda	Mbarara

Sponsors (11)

Lead Sponsor

Collaborator

University of California, San Francisco

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

Countries where clinical trial is conducted

Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomedical prevention covered time	Number of months participant taking biomedical prevention divided by number of months participant biomedical prevention use measured.; Biomedical prevention includes PrEP tenofovir disoproxil fumarate/lamivudine (TDF/3TC) or cabotegravir long-acting injectable (CAB-LA) and PEP	48 weeks
Secondary	HIV incident infection	HIV incidence rate: number of HIV incident infections divided by person time follow-up	48 weeks
Secondary	HIV incident infection	HIV incidence rate: number of HIV incident infections divided by person time follow-up	96 weeks
Secondary	Biomedical prevention during periods of self assessed HIV risk	Number of months participant taking biomedical prevention and at self-assessed risk of HIV infection divided by number of months measured and at risk self-assessed risk of HIV infection	96 weeks