Trial Outcomes & Findings for SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension (NCT NCT05549726)

Last Updated: 2025-02-20

Results Overview

Number of days participant taking biomedical prevention divided by number of days participant biomedical prevention use measured. Biomedical prevention includes PrEP tenofovir disoproxil fumarate/lamivudine (TDF/3TC) or cabotegravir long-acting injectable (CAB-LA) and PEP

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

984 participants

Primary outcome timeframe

48 weeks

Results posted on

2025-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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: 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 for PEP or PrEP differs according to each country's guidelines. 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.
Overall Study STARTED	487	497
Overall Study COMPLETED	485	492
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynamic Choice Prevention (Including CAB LA) n=487 Participants 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. 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: 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 n=497 Participants The standard of care for PEP or PrEP differs according to each country's guidelines. 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.	Total n=984 Participants Total of all reporting groups
Age, Customized Age · 15-24	139 Participants n=5 Participants	159 Participants n=7 Participants	298 Participants n=5 Participants
Age, Customized Age · >=25	348 Participants n=5 Participants	338 Participants n=7 Participants	686 Participants n=5 Participants
Sex: Female, Male Female	358 Participants n=5 Participants	358 Participants n=7 Participants	716 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	139 Participants n=7 Participants	268 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	487 Participants n=5 Participants	497 Participants n=7 Participants	984 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Uganda	242 participants n=5 Participants	239 participants n=7 Participants	481 participants n=5 Participants
Region of Enrollment Kenya	245 participants n=5 Participants	258 participants n=7 Participants	503 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Study Participants at Week 48 with data on biomedical HIV prevention coverage during follow-up of the extension

Outcome measures

Outcome measures
Measure	Dynamic Choice Prevention (Including CAB LA) n=485 Participants 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. 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: 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 n=492 Participants The standard of care for PEP or PrEP differs according to each country's guidelines. 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.
Biomedical Prevention Covered Time	69.7 % of days Interval 64.9 to 74.5	13.3 % of days Interval 10.2 to 16.3

SECONDARY outcome

Timeframe: 48 weeks

HIV incidence rate: number of HIV incident infections divided by number at risk (HIV incidence per 100 person-years)

Outcome measures

Outcome measures
Measure	Dynamic Choice Prevention (Including CAB LA) n=485 Participants 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. 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: 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 n=486 Participants The standard of care for PEP or PrEP differs according to each country's guidelines. 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.
HIV Incident Infection	0 infections per 100 person-years	1.8 infections per 100 person-years

SECONDARY outcome

Timeframe: 96 weeks

HIV incidence rate: number of HIV incident infections divided by person time follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 weeks

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

Outcome measures

Outcome data not reported

Adverse Events

Dynamic Choice Prevention (Including CAB LA)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Dynamic Choice Prevention (Including CAB LA) n=487 participants at risk 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. 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: 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 n=497 participants at risk The standard of care for PEP or PrEP differs according to each country's guidelines. 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.
Eye disorders Ocular injury	0.21% 1/487 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.00% 0/497 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.
Injury, poisoning and procedural complications Hospitalization due to physical altercation	0.21% 1/487 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.00% 0/497 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.
Pregnancy, puerperium and perinatal conditions Premature birth and deaths of twins	0.21% 1/487 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.00% 0/497 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.
Pregnancy, puerperium and perinatal conditions Miscarriage following blunt abdominal trauma	0.21% 1/487 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.00% 0/497 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.
Injury, poisoning and procedural complications Death due to motorcycle accident	0.00% 0/487 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.20% 1/497 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.
General disorders Death due to unknown causes	0.00% 0/487 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.	0.20% 1/497 • Number of events 1 • Adverse Events were collected over 48 weeks. Adverse Events were captured and classified using the NIAID Adverse Event Grading of Severity scale in the intervention arm. All deaths, life threatening events, hospitalizations, significant disability due to AE, and congenital anomaly/birth defects were classified as SAE regardless of relationship. Grade 3 and 4 and non-serious adverse drug reaction leading to withdrawal were captured for participants on CAB-LA.

Other adverse events

Adverse event data not reported

Additional Information

Tamara Clark

UCSF

Phone: 415-517-3444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place