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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| University of Southern California | OTHER |
| City of Long Beach Department of Health and Human Services | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SoC + ALERT Intervention | Behavioral | Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analyses | Descriptive secondary analyses comparing the two randomized groups will include:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maile Karris, MD | CCTG, UCSD AVRC, UCSD Owen Clinic | Principal Investigator |
| Katya Calvo, MD | CCTG, Harbor-UCLA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Southern California | Los Angeles | California | 90033 | United States | ||
| University of California, San Diego |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2016 | Nov 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| California HIV/AIDS Research Program |
| OTHER |
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| Baseline to two years |
| Return to Care after Primary Endpoint | Proportions of subjects that meet the primary endpoint but subsequently return to care will be compared between the randomized groups. The times between last visit and return visit will also be compared between the randomized groups. | Baseline to 2 years |
| San Diego |
| California |
| 92103 |
| United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |