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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI150510 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Makerere University | OTHER |
| Kenya Medical Research Institute | OTHER |
| University of California, Berkeley |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic choice prevention (including CAB LA) | Experimental | 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. |
|
| Standard of Care | Active Comparator | The standard of care for PEP or PrEP differs according to each country's guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir Injectable Suspension | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomedical Prevention Covered Time | 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 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Incident Infection | HIV incidence rate: number of HIV incident infections divided by number at risk (HIV incidence per 100 person-years) | 48 weeks |
| HIV Incident Infection | HIV incidence rate: number of HIV incident infections divided by person time follow-up |
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Inclusion Criteria:
Inclusion criteria for the Extension include:
Additional inclusion criteria to access CAB-LA as a prevention option
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).
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| Name | Affiliation | Role |
|---|---|---|
| Diane Havlir, MD | University of California, San Francisco | Principal Investigator |
| Moses Kamya, MBChB, PhD | Makerere University | Principal Investigator |
| Maya Petersen, MD, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GPRT / SEARCH Office | Kisumu | Kenya | ||||
| IDRC Southwest Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41762058 | Derived | Balzer LB, van der Laan MJ, Petersen ML. Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet data-adaptive learning. Clin Trials. 2026 Jun;23(3):289-296. doi: 10.1177/17407745261417227. Epub 2026 Feb 28. | |
| 39395424 | Derived | Kamya MR, Balzer LB, Ayieko J, Kabami J, Kakande E, Chamie G, Sutter N, Sunday H, Litunya J, Schwab J, Schrom J, Bacon M, Koss CA, Rinehart AR, Petersen M, Havlir DV; SEARCH Consortium. Dynamic choice HIV prevention with cabotegravir long-acting injectable in rural Uganda and Kenya: a randomised trial extension. Lancet HIV. 2024 Nov;11(11):e736-e745. doi: 10.1016/S2352-3018(24)00235-2. Epub 2024 Oct 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biomedical Prevention Covered Time | 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 | Study Participants at Week 48 with data on biomedical HIV prevention coverage during follow-up of the extension | Posted | Mean | 95% Confidence Interval | % of days | 48 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular injury | Eye disorders | DAIDS | Systematic Assessment |
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Participants maintained their original randomization group; so balance at extension start wasn't guaranteed. Sensitivity analyses adjusted for baseline differences, but unmeasured differences may remain. Self-reported pill ingestion (PrEP/PEP) may have recall bias; CABLA injections were logged. HIV incidence differences validate intervention impact.We relied on self-reported risk without specific classifications and evaluated a combination intervention,complicating effect attribution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Clark | UCSF | 415-517-3444 | tamara.clark@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2023 | Dec 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2023 | Dec 16, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2022 | Dec 16, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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 |
Participants initially randomized to the Dynamic Choice Prevention delivery model will be given the option to use CAB-LA as part of the dynamic choice prevention delivery package. Participants initially randomized to standard of care will continue to receive standard of care.
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| Dynamic Choice Delivery Model | Other | 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 | Other | 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. |
|
| 96 weeks |
| 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 |
| Mbarara |
| Uganda |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | HIV Incident Infection | HIV incidence rate: number of HIV incident infections divided by number at risk (HIV incidence per 100 person-years) | Posted | Number | infections per 100 person-years | 48 weeks |
|
|
|
| Secondary | HIV Incident Infection | HIV incidence rate: number of HIV incident infections divided by person time follow-up | Not Posted | 96 weeks | Participants |
| 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 | Not Posted | 96 weeks | Participants |
| 0 |
| 487 |
| 4 |
| 487 |
| 0 |
| 487 |
| EG001 | 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. | 2 | 497 | 2 | 497 | 0 | 497 |
| Hospitalization due to physical altercation | Injury, poisoning and procedural complications | DAIDS | Systematic Assessment |
|
| Premature birth and deaths of twins | Pregnancy, puerperium and perinatal conditions | DAIDS | Systematic Assessment |
|
| Miscarriage following blunt abdominal trauma | Pregnancy, puerperium and perinatal conditions | DAIDS | Systematic Assessment |
|
| Death due to motorcycle accident | Injury, poisoning and procedural complications | DAIDS | Systematic Assessment |
|
| Death due to unknown causes | General disorders | DAIDS | Systematic Assessment |
|
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