Patient AdherenceNCT01957748
CCTG 594: Engagement and Retention in Care for HIV+
A study testing SoC + ALERT Intervention in people with Patient Adherence and HIV Positive, run by University of California, San Diego at 3 sites in United States.
Trial summary
CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Adherence, HIV Positive
- What is being tested?
- SoC + ALERT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2013to 24 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western blot is not available, HIV infection may be documented by two HIV RNA values ≥2000 copies/mL, drawn at least 24 hours apart. The RNA assays must have been run at a CLIA-approved laboratory or equivalent.
- 18 years of age or older.
- Able to give written informed consent.
- New patient to the clinic (defined as someone who has never engaged in HIV care) or a patient returning to care (defined as a patient previously seen at least once by a prescribing HIV provider who has not seen a prescribing HIV provider in the last 180 days and is not on a stable ARV regimen).
- English or Spanish Speaking.
- Registered to receive HIV primary care services at one of the identified CCTG-affiliated clinic, i.e. the Owen Clinic at UC San Diego Health System, Harbor-UCLA Medical Center clinic or Rand Schrader clinic at USC.
Who cannot join
- Unstable neurologic, psychiatric, or physical condition which, in the opinion of the investigator, would limit participation with study procedures for the duration of the study.
- A level of drug or alcohol use that, in the opinion of the investigator, would preclude safe participation in the study.
- Resident of nursing home or skilled facility.
- Pregnant or breastfeeding.
- Patient's first primary care visit (for new patients) or return to care visit (for patients returning to care) occurred > 60 days ago.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Southern California
Los Angeles, California, 90033
University of California, San Diego
San Diego, California, 92103
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group
CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.
Read the detailed description
Design: CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.
Duration: Each subject will receive follow-up of at least 48 weeks.
Sample Size: A total of 300 subjects will be randomized, 150 per arm.
Study Population: Eligible subjects will include 1) newly diagnosed HIV-infected individuals entering primary HIV care at one of the CCTG clinics, or 2) previously diagnosed HIV-infected individuals who are "out of care" defined as having no visit with a prescribing HIV provider in the last 180 days and not on a stable ARV regimen.
Stratification: Subjects will be stratified based on study site and if they are newly diagnosed or returning to care.
- Conditions
- Patient Adherence, HIV Positive
- Being tested
- SoC + ALERT Intervention
- Keywords
- Retention, Care, Engagement
- Medical subject headings
- Patient Compliance, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoC + ALERT InterventionBehavioural
Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | No intervention | Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services. |
| SoC + ALERT Intervention | Active comparator | Subjects randomized into the ALERT Enhanced Retention Intervention Arm will receive SoC at the HIV clinic where subjects are seen. In addition to SoC, the Intervention arm will receive aggressive engagement efforts by the ALERT specialist to ensure visit continuity and retention into care. The ALERT specialist will also administer an education intervention consisting of 5 retention modules designed to improve HIV knowledge and self-efficacy, and will also monitor health care visits and intervene via methods to track, find, and re-engage patients during the study. Receives: Behavioral: SoC + ALERT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to lost to follow up
The CCTG 594 primary outcome is "time to lost to follow up." Lost to follow up is defined as "no visit with a prescribing HIV provider in the last 180 days. All randomized subjects will be followed for a minimum of 48 weeks. Subjects that do not meet the primary endpoint by the time the study ends will be censored.
Measured: Baseline to Week 48
Secondary outcomes (1)
Time to initiation of ART
The CCTG 594 secondary outcome is "time to initiation of ART." All randomized subjects will be followed for a minimum of 48 weeks. Subjects that do not initiate ART will be censored at their last visit date.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start8 Oct 2013
- Primary completion15 Dec 2017
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, City of Long Beach Department of Health and Human Services, California HIV/AIDS Research Program
- Responsible party
- Principal investigator, Maile Young Karris, University of California, San Diego
- Investigators
- Maile Karris, MD, Principal investigator, CCTG, UCSD AVRC, UCSD Owen ClinicKatya Calvo, MD, Study chair, CCTG, Harbor-UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957748
- Sponsor's protocol ID
- CCTG 594
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2013
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCTG 594: Engagement and Retention in Care for HIV+, A Multicenter Trial of the California Collaborative Treatment Group
- ClinicalTrials.gov ID
- NCT01957748
- Acronym / sponsor ID
- CCTG 594
- Conditions
- Patient Adherence, HIV Positive
- Keywords
- Retention, Care, Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, City of Long Beach Department of Health and Human Services, California HIV/AIDS Research Program
- Study start
- 8 Oct 2013 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.
Detailed description
Design: CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.
Duration: Each subject will receive follow-up of at least 48 weeks.
Sample Size: A total of 300 subjects will be randomized, 150 per arm.
Study Population: Eligible subjects will include 1) newly diagnosed HIV-infected individuals entering primary HIV care at one of the CCTG clinics, or 2) previously diagnosed HIV-infected individuals who are "out of care" defined as having no visit with a prescribing HIV provider in the last 180 days and not on a stable ARV regimen.
Stratification: Subjects will be stratified based on study site and if they are newly diagnosed or returning to care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | No intervention | –Subjects randomized to the Standard of Care Arm will receive their HIV clinic's current standard of care retention services. |
| SoC + ALERT Intervention | Active comparator | Behavioral: SoC + ALERT InterventionSubjects randomized into the ALERT Enhanced Retention Intervention Arm will receive SoC at the HIV clinic where subjects are seen. In addition to SoC, the Intervention arm will receive aggressive engagement efforts by the ALERT specialist to ensure visit continuity and retention into care. The ALERT specialist will also administer an education intervention consisting of 5 retention modules designed to improve HIV knowledge and self-efficacy, and will also monitor health care visits and intervene via methods to track, find, and re-engage patients during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western blot is not available, HIV infection may be documented by two HIV RNA values ≥2000 copies/mL, drawn at least 24 hours apart. The RNA assays must have been run at a CLIA-approved laboratory or equivalent.
- 18 years of age or older.
- Able to give written informed consent.
- New patient to the clinic (defined as someone who has never engaged in HIV care) or a patient returning to care (defined as a patient previously seen at least once by a prescribing HIV provider who has not seen a prescribing HIV provider in the last 180 days and is not on a stable ARV regimen).
- English or Spanish Speaking.
Key exclusion criteria (5 listed)
- Unstable neurologic, psychiatric, or physical condition which, in the opinion of the investigator, would limit participation with study procedures for the duration of the study.
- A level of drug or alcohol use that, in the opinion of the investigator, would preclude safe participation in the study.
- Resident of nursing home or skilled facility.
- Pregnant or breastfeeding.
- Patient's first primary care visit (for new patients) or return to care visit (for patients returning to care) occurred > 60 days ago.
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 |
|---|---|---|
| SoC + ALERT InterventionEnhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care. | Behavioural | SoC + ALERT Intervention |
Primary outcome
Time to lost to follow up
Time frame: Baseline to Week 48
The CCTG 594 primary outcome is "time to lost to follow up." Lost to follow up is defined as "no visit with a prescribing HIV provider in the last 180 days. All randomized subjects will be followed for a minimum of 48 weeks. Subjects that do not meet the primary endpoint by the time the study ends will be censored.
1 secondary outcome
Time to initiation of ART
Time frame: Baseline to Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
Maile Karris, MD principal investigator
CCTG, UCSD AVRC, UCSD Owen Clinic
Katya Calvo, MD study chair
CCTG, Harbor-UCLA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoC + ALERT Intervention in people with Patient Adherence and HIV Positive, run by University of California, San Diego at 3 sites 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 6 inclusion and 5 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to lost to follow up (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2021.