HIV/AIDSPhase 2Sensor-SBDOHNCT06480578
An Integrated Intervention Using a Pill Ingestible Sensor System
A Phase 2 study testing ISS-SBDOH arm in people with HIV/AIDS and Medication Adherence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Medication Adherence, Social Determinants of Health (SDOH)
- What is being tested?
- ISS-SBDOH arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected individuals in HIV care
- Greater than 17 years of age
- Demonstrated ability to take co-encapsulated ARVs at the time of screening
- Able to provide informed consent
- Receiving ART with sub-optimal adherence estimated by patient (self-reports < 90% adherence over last 28 days) or treating clinician [e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty
- Currently receiving antiretroviral treatment that includes one of the following:
Show all 19Show fewer
- TDF/FTC (Truvada)
- TAF/FTC (Descovy)
- EFV/FTC/TDF (Atripla)
- ABC/3TC (Epzicom)
- DTG/ABC/3TC (Triumeq)
- RPV/TAF/FTC (Odefsey)
- EVG/c/FTC/TAF (Genvoya)
- BIC/FTC/TAF (Biktarvy)
- For participants of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU/mL at screening. This will be repeated again at study entry.
- NOTE: Participants are considered to be NOT of reproductive potential if:
- participants have had amenorrhea for at least 12 consecutive months prior to study entry (i.e., who have had no menses within 12 months prior to study entry), and have a documented FSH >40 IU/mL; OR
- an FSH level is not available, but participants have had 24 consecutive months of amenorrhea (in the absence of medications known to induce amenorrhea); OR
- participants report having undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation/hysteroscopic tubal occlusion).
Who cannot join
- Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
- Pregnancy (Evaluated during the screening visit through a pregnancy test.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lundquist
Los Angeles, California, 90502
Mario Guerrero, mguerrero@lundquist.org
Eric Daar, MD
About this study
Official title: An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH
This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.
Read the detailed description
Undetectable equals Untransmittable (U=U) reduces HIV stigma, empowers people living with HIV (PLWH), and has become a pillar in the goal of ending the HIV epidemic. Viral suppression eliminating risk of sexual HIV transmission emphasizes the importance of adherence to antiretroviral therapy (ART). Strategies to enhance adherence have typically not intervened in real-time and have focused on pill-taking reminders without interventions that address adverse social and behavioral determinants of health (SBDOH) associated with poor adherence and engagement in care. The complex multifactorial pathways of SBDOH, such as food insecurity, unstable housing, and substance use disorders, have led to inequities in achieving optimal adherence and sustained viral suppression. Los Angeles (LA) County, a hot spot for HIV infection and transmission, has been reported to have viral suppression rates of ~60%, well below the 95% target of Ending HIV Epidemic by 2030. Our team has an extensive track record of research on measurement of and interventions to enhance adherence to ART. The investigators have used novel technology-based adherence measures of ART developed in the past two decades, including the cutting-edge ingestible sensor (IS) technology to obtain non-inferred, real-time adherence monitoring by Proteus® Digital Health Feedback (PDHF) system. Despite its validation reported in our recent publications, the PDHF system has been limited by the lack of incorporation of SBDOH. For many years, a major focus in HIV clinics has been to have multidisciplinary teams of nurses, social workers, and case managers to address SBDOH; however, timing of interventions are often weeks to months after such problems have been identified. This study will develop and test an integrated intervention that combines IS technology and adverse SBDOH alerts to maximize adherence and viral suppression. Using real-time IS monitoring, our integrated intervention will be able to immediately trigger the existing multidisciplinary team at clinic to address SBDOH issues as soon as predefined patterns of poor adherence are observed. A cohort of 110 adult patients who have or are at high risk for sub-optimal adherence will be recruited from a LA County safety net HIV clinic, located in a geographic HIV hotspot, dealing many adverse SBDOH issues. Participants will be randomized into the intervention or usual care. The integrated intervention will run for 20 weeks, followed by a 10-week period to assess sustainability. The primary end points include acceptability of the integrated intervention, frequency and timeliness of SBDOH interventions, level of challenges of SBDOH in HIV treatment, and adherence to ART. The secondary end points include viral load, high-risk sexual activity defined by self-report, and detection of sexually transmitted infections. The overarching goals are to evaluate (i) acceptability of the integrated intervention, frequency and timeliness of SBDOH intervention, and level of challenges of SBDOH in HIV treatment; (ii) the efficacy of the integrated intervention for monitoring, facilitating, and improving adherence to ART; and (iii) the efficacy of the integrated intervention for improving virologic outcome and reducing high-risk sexual activity.
- Being tested
- ISS-SBDOH arm
- Keywords
- HIV/AIDS, Medication Adherence, SDOH
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISS-SBDOH armBehavioural
Once the ID-Cap ISS system has identified a participant who has missed his/her prescribed ARVs for five (5) consecutive days, a member of the multidisciplinary team will be informed automatically by the system and reach out to the participant immediately. The team will work with the primary provider and the participant to evaluate and understand the patient's SBDOH profile and status and develop a coordinated plan that fits the patient's specific need to address the patient's particular challenges in SBDOH. This plan (all SBDOH interventions) is considered standard of care and would be initiated in the same manner regardless of participation. Participation in this study will not alter the planned interventions determined by the HIV Care team.
| Study group | Role | What they receive |
|---|---|---|
| ISS-SBDOH arm | Experimental | Ingestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm Receives: Behavioral: ISS-SBDOH arm |
| Usual Care (UC) arm | No intervention | Usual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability to the integrated intervention
Acceptability to the integrated intervention will be evaluated by quantitative measures interviews. The items in the quantitative measure will be rated on five-item Likert scales ranging from very strongly disagree to very strongly agree. Domains to be assessed will include overall satisfaction (would recommend to friend, would use outside of study setting, satisfied with system), utility, and specific items such as helpfulness and convenience. In addition, the investigators will ask participants to rate items specific to the ID-Cap system (comfort of wristband, comfort receiving text messages).
Measured: week 4, 8, 12, and 16
Frequency and timeliness of SBDOH intervention, level of challenges of SBDOH in HIV treatment
The investigators will collect SBDOH measures, such as economic stability (e.g., food security), health (e.g., gap in health coverage), neighborhood and built environment (e.g. transportation needs), social and community context (e.g., violence, and criminal justice involvement), and substance and alcohol use, sexual behavior, and other health related behaviors. Challenges of SBDOH will be measured as (i) the count of SBDOH issues one is facing, and (ii) the degree of each issue (e.g., low/medium/high with housing challenge) with summary scores. Frequency and timeliness of SBDOH intervention are measured as number of sessions, and time to first, and subsequent sessions, if applicable, from baseline, and others. This information will also be collected when intervention if triggered by the monitoring system.
Measured: week 4, 8, 12, 16, 20, and 28
Adherence to ART--percent of prescribed medication taken
Adherence to ART measured by ID(identification)-Cap system for up to 20 weeks, defined as percent of prescribed medication taken
Measured: week 4, 8, 12, 16, and 20
Self-Reported Medication Adherence--percent of prescribed dose taken
The investigators will use a widely used measure of percent of prescribed dose taken during the preceding seven days. This measure is easy to use and has been significantly associated with virological and immunological outcomes.
Measured: week 4, 8, 12, 16, 20, and 28
Patterns of dosing
Patterns of dosing such as Patterns of consecutive missed doses in the past two weeks,
Measured: week 4, 8, 12, 16, 20, and 28
Secondary outcomes (3)
Concentration of Plasma HIV viral load
Concentration of Plasma HIV viral load
Measured: baseline, week 4, 8, 12, 16, 20, and 28
number of sexual partners
number of sexual partners
Measured: baseline, week 8, 16, and 28
Number of condomless sex
Number of condomless sex
Measured: baseline, week 8, 16, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start19 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, EtectRX, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Honghu Liu, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480578
- Sponsor's protocol ID
- R01MD019188
- Other IDs
- R01MD019188
- Acronym
- Sensor-SBDOH
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that this data will be presented annually based on data collected after the third year, once sufficient baseline data is collected. Most of the papers and data-based projects/presentations are expected to occur in year 4, when all baseline data is collected, and the 30-week outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention. Additionally, there will be submissions to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages, and contact information for the MPIs will be provided in all manuscripts and publications as another means of accessing data.
Publications
Liu H, Shen J, Wang Y, Carnes TC, Hamilton AB, Witt MD, Daar ES. Study protocol to evaluate an integrated intervention using a pill ingestible sensor system to trigger actions on multifaceted social and behavioral determinants of health among PLWH: an open-label, usual care-controlled, randomized trial. BMC Public Health. 2025 Oct 31;25(1):3719. doi: 10.1186/s12889-025-24909-0.
PubMed 41174603
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Intervention Using a Pill Ingestible Sensor System to Trigger Actions on Multifaceted Social and Behavioral Determinants of Health Among PLWH
- ClinicalTrials.gov ID
- NCT06480578
- Acronym / sponsor ID
- Sensor-SBDOH / R01MD019188
- Keywords
- HIV/AIDS, Medication Adherence, SDOH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, EtectRX, Inc., National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study integrates technology-based adherence measures with alerts for social and behavioral determinants of health (SBDOH) to improve HIV treatment outcomes. It involves 110 adult patients from a Los Angeles County HIV clinic, focusing on those at risk for poor adherence. Participants will be randomized into intervention or usual care groups, with endpoints including intervention acceptability, SBDOH interventions, adherence to ART, viral load, and high-risk sexual activity. The study aims to assess the effectiveness of the integrated intervention in improving adherence, virologic outcomes, and reducing high-risk behavior among PLWH.
Detailed description
Undetectable equals Untransmittable (U=U) reduces HIV stigma, empowers people living with HIV (PLWH), and has become a pillar in the goal of ending the HIV epidemic. Viral suppression eliminating risk of sexual HIV transmission emphasizes the importance of adherence to antiretroviral therapy (ART). Strategies to enhance adherence have typically not intervened in real-time and have focused on pill-taking reminders without interventions that address adverse social and behavioral determinants of health (SBDOH) associated with poor adherence and engagement in care. The complex multifactorial pathways of SBDOH, such as food insecurity, unstable housing, and substance use disorders, have led to inequities in achieving optimal adherence and sustained viral suppression. Los Angeles (LA) County, a hot spot for HIV infection and transmission, has been reported to have viral suppression rates of ~60%, well below the 95% target of Ending HIV Epidemic by 2030. Our team has an extensive track record of research on measurement of and interventions to enhance adherence to ART. The investigators have used novel technology-based adherence measures of ART developed in the past two decades, including the cutting-edge ingestible sensor (IS) technology to obtain non-inferred, real-time adherence monitoring by Proteus® Digital Health Feedback (PDHF) system. Despite its validation reported in our recent publications, the PDHF system has been limited by the lack of incorporation of SBDOH. For many years, a major focus in HIV clinics has been to have multidisciplinary teams of nurses, social workers, and case managers to address SBDOH; however, timing of interventions are often weeks to months after such problems have been identified. This study will develop and test an integrated intervention that combines IS technology and adverse SBDOH alerts to maximize adherence and viral suppression. Using real-time IS monitoring, our integrated intervention will be able to immediately trigger the existing multidisciplinary team at clinic to address SBDOH issues as soon as predefined patterns of poor adherence are observed. A cohort of 110 adult patients who have or are at high risk for sub-optimal adherence will be recruited from a LA County safety net HIV clinic, located in a geographic HIV hotspot, dealing many adverse SBDOH issues. Participants will be randomized into the intervention or usual care. The integrated intervention will run for 20 weeks, followed by a 10-week period to assess sustainability. The primary end points include acceptability of the integrated intervention, frequency and timeliness of SBDOH interventions, level of challenges of SBDOH in HIV treatment, and adherence to ART. The secondary end points include viral load, high-risk sexual activity defined by self-report, and detection of sexually transmitted infections. The overarching goals are to evaluate (i) acceptability of the integrated intervention, frequency and timeliness of SBDOH intervention, and level of challenges of SBDOH in HIV treatment; (ii) the efficacy of the integrated intervention for monitoring, facilitating, and improving adherence to ART; and (iii) the efficacy of the integrated intervention for improving virologic outcome and reducing high-risk sexual activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISS-SBDOH arm | Experimental | Behavioral: ISS-SBDOH armIngestion Sensor System (ISS) - Social and Behavioral Determinants of Health (SBDOH) arm |
| Usual Care (UC) arm | No intervention | –Usual Care (UC) arm UC is chosen as the control condition because it meets ethical and moral requirements to attempt treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- HIV-infected individuals in HIV care
- Greater than 17 years of age
- Demonstrated ability to take co-encapsulated ARVs at the time of screening
- Able to provide informed consent
- Receiving ART with sub-optimal adherence estimated by patient (self-reports < 90% adherence over last 28 days) or treating clinician [e.g., based on gaps in treatment (e.g. missed appointments) or viral load elevations within 6 months], or at high risk for sub-optimal adherence, or with known challenges with SBDOH (e.g. unstable housing, substance use disorder, and poverty
Key exclusion criteria (2 listed)
- Inability to follow the study procedures manifested during the intake, as evidenced by mental confusion, disorganization, intoxication, withdrawal, risky or threatening behavior
- Pregnancy (Evaluated during the screening visit through a pregnancy test.)
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 |
|---|---|---|
| ISS-SBDOH armOnce the ID-Cap ISS system has identified a participant who has missed his/her prescribed ARVs for five (5) consecutive days, a member of the multidisciplinary team will be informed automatically by the system and reach out to the participant immediately. The team will work with the primary provider and the participant to evaluate and understand the patient's SBDOH profile and status and develop a coordinated plan that fits the patient's specific need to address the patient's particular challenges in SBDOH. This plan (all SBDOH interventions) is considered standard of care and would be initiated in the same manner regardless of participation. Participation in this study will not alter the planned interventions determined by the HIV Care team. | Behavioural | ISS-SBDOH arm |
Primary outcome
Acceptability to the integrated intervention
Time frame: week 4, 8, 12, and 16
Acceptability to the integrated intervention will be evaluated by quantitative measures interviews. The items in the quantitative measure will be rated on five-item Likert scales ranging from very strongly disagree to very strongly agree. Domains to be assessed will include overall satisfaction (would recommend to friend, would use outside of study setting, satisfied with system), utility, and specific items such as helpfulness and convenience. In addition, the investigators will ask participants to rate items specific to the ID-Cap system (comfort of wristband, comfort receiving text messages).
Frequency and timeliness of SBDOH intervention, level of challenges of SBDOH in HIV treatment
Time frame: week 4, 8, 12, 16, 20, and 28
The investigators will collect SBDOH measures, such as economic stability (e.g., food security), health (e.g., gap in health coverage), neighborhood and built environment (e.g. transportation needs), social and community context (e.g., violence, and criminal justice involvement), and substance and alcohol use, sexual behavior, and other health related behaviors. Challenges of SBDOH will be measured as (i) the count of SBDOH issues one is facing, and (ii) the degree of each issue (e.g., low/medium/high with housing challenge) with summary scores. Frequency and timeliness of SBDOH intervention are measured as number of sessions, and time to first, and subsequent sessions, if applicable, from baseline, and others. This information will also be collected when intervention if triggered by the monitoring system.
Adherence to ART--percent of prescribed medication taken
Time frame: week 4, 8, 12, 16, and 20
Adherence to ART measured by ID(identification)-Cap system for up to 20 weeks, defined as percent of prescribed medication taken
Self-Reported Medication Adherence--percent of prescribed dose taken
Time frame: week 4, 8, 12, 16, 20, and 28
The investigators will use a widely used measure of percent of prescribed dose taken during the preceding seven days. This measure is easy to use and has been significantly associated with virological and immunological outcomes.
Patterns of dosing
Time frame: week 4, 8, 12, 16, 20, and 28
Patterns of dosing such as Patterns of consecutive missed doses in the past two weeks,
3 secondary outcomes
Concentration of Plasma HIV viral load
Time frame: baseline, week 4, 8, 12, 16, 20, and 28
number of sexual partners
Time frame: baseline, week 8, 16, and 28
Number of condomless sex
Time frame: baseline, week 8, 16, and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 41174603Liu H, Shen J, Wang Y, Carnes TC, Hamilton AB, Witt MD, Daar ES. Study protocol to evaluate an integrated intervention using a pill ingestible sensor system to trigger actions on multifaceted social and behavioral determinants of health among PLWH: an open-label, usual care-controlled, randomized trial. BMC Public Health. 2025 Oct 31;25(1):3719. doi: 10.1186/s12889-025-24909-0.
- Individual participant dataSharing planned: Yes. It is anticipated that this data will be presented annually based on data collected after the third year, once sufficient baseline data is collected. Most of the papers and data-based projects/presentations are expected to occur in year 4, when all baseline data is collected, and the 30-week outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention. Additionally, there will be submissions to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages, and contact information for the MPIs will be provided in all manuscripts and publications as another means of accessing data.
Related trials for HIV/AIDS
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
RecruitingPhase 1
Dasatinib for HIV-1 Reservoir Reduction
HIV Infections
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Human Immunodeficiency Virus (HIV) Infection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISS-SBDOH arm in people with HIV/AIDS and Medication Adherence, run by University of California, Los Angeles at 1 site in United States.
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 19 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Shen, PhD (3105917541, shenjie@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability to the integrated intervention (time frame: week 4, 8, 12, and 16). The study lists 5 primary outcomes in all. 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 NCT06480578, which also lists 1 linked publication.
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 13 Feb 2026.