HIVPhase 4NCT05549726
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
A Phase 4 study testing Cabotegravir Injectable Suspension and Dynamic Choice Delivery Model in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Cabotegravir Injectable Suspension and Dynamic Choice Delivery Model
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jan 2023to 30 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Cabotegravir Injectable Suspension, Dynamic Choice Delivery Model, Standard of Care
- Keywords
- Cabotegravir Injectable Suspension, PrEP, HIV Treatment and Prevention, Community Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Injectable SuspensionDrug
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 ModelOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cabotegravir Injectable Suspension; Other: Dynamic Choice Delivery Model |
| Standard of Care | Active comparator | The standard of care for PEP or PrEP differs according to each country's guidelines. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Secondary outcomes (3)
HIV Incident Infection
HIV incidence rate: number of HIV incident infections divided by number at risk (HIV incidence per 100 person-years)
Measured: 48 weeks
HIV Incident Infection
HIV incidence: number of HIV incident infection in intervention participants only. Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care discontinued the study at 48 weeks and were not analyzed for this outcome.
Measured: 48 weeks (during follow up weeks 48-96)
Biomedical Prevention During Periods of Self Assessed HIV Risk
Number of days participant was taking biomedical prevention divided by number of days participant had biomedical prevention use measured and self-assessed with HIV risk (intervention participants only). Participants in the intervention arm only were reconsented at 48 weeks for evaluation through 96 weeks. Participants in the standard of care discontinued the study at 48 weeks and were not analyzed for this outcome.
Measured: 48 weeks (during follow-up weeks 48-96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start2 Jan 2023
- Primary completion18 Dec 2023
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), ViiV Healthcare, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Diane Havlir, MD, Principal investigator, University of California, San FranciscoMoses Kamya, MBChB, PhD, Principal investigator, Makerere UniversityMaya Petersen, MD, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549726
- Sponsor's protocol ID
- SEARCH CAB LA Extension
- Other IDs
- U01AI150510
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2022
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39395424Balzer 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.
PubMed 41762058
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05549726
- Acronym / sponsor ID
- SEARCH CAB LA Extension
- Conditions
- HIV
- Keywords
- Cabotegravir Injectable Suspension, PrEP, HIV Treatment and Prevention, Community Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Makerere University, Kenya Medical Research Institute, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Mental Health (NIMH), National Heart, Lung, and Blood Institute (NHLBI), ViiV Healthcare, University of Pittsburgh
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dynamic choice prevention (including CAB LA) | Experimental | Drug: Cabotegravir Injectable Suspension, Other: Dynamic Choice Delivery ModelThe 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 | Other: Standard of CareThe standard of care for PEP or PrEP differs according to each country's guidelines. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir Injectable SuspensionCAB-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. | Drug | Dynamic choice prevention (including CAB LA) |
| Dynamic Choice Delivery ModelThe 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 | Dynamic choice prevention (including CAB LA) |
| Standard of CareThe 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. | Other | Standard of Care |
Primary outcome
Biomedical Prevention Covered Time
Time frame: 48 weeks
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
3 secondary outcomes
HIV Incident Infection
Time frame: 48 weeks
HIV Incident Infection
Time frame: 48 weeks (during follow up weeks 48-96)
Biomedical Prevention During Periods of Self Assessed HIV Risk
Time frame: 48 weeks (during follow-up weeks 48-96)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39395424Kamya 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.
- Derived from this study: PubMed 41762058Balzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Havlir, MD principal investigator
University of California, San Francisco
Moses Kamya, MBChB, PhD principal investigator
Makerere University
Maya Petersen, MD, PhD principal investigator
University of California, Berkeley
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabotegravir Injectable Suspension and Dynamic Choice Delivery Model in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomedical Prevention Covered Time (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.