HIV PositiveNCT01941121
CCTG 593: Testing and Linkage to Care
A study testing Linkage to PrEP or Care in people with HIV Positive and HIV Seronegative, run by University of California, San Diego at 3 sites in United States.
Trial summary
This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Positive, HIV Seronegative
- What is being tested?
- Linkage to PrEP or Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2013to 9 Feb 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Has had an HIV test result form the CCTG Consortium testing site as either positive or negative
- Ability to provide informed consent
- English or Spanish Speaking
Who cannot join
- Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
- Acute medical illness that requires transfer to a non CCTG hospital
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Long Beach Department of Health and Human Services
Long Beach, California, 90815
University of Southern California
Los Angeles, California, 90033
University of California, San Diego
San Diego, California, 92103
About this study
Official title: CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group
This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care.
If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.
Read the detailed description
Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to
- link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
- link confirmed HIV antibody negative persons with continued high risk behaviors to PrEP centers
Duration: Each subject who agrees to linkage will receive ALERT follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to PrEP, whichever comes first. The duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass for linkage to care or 90 days for linkage to PrEP.
Sample Size: Up to 600 subjects will be tested and offered linkage across all CCTG sites: LA County-USC Medical Center, Harbor-UCLA/City of Long Beach Department of Health and Human Services, UCSD/San Diego Health and Human Services Agency.
Study Population: Eligible subjects will include any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LA County + USC, Long Beach Department of Health and Human Services, and San Diego Health and Human Services Agency).
- Conditions
- HIV Positive, HIV Seronegative
- Being tested
- Linkage to PrEP or Care
- Keywords
- HIV Screening, Linkage to PrEP, Linkage to Care, CCTG, 593
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linkage to PrEP or CareBehavioural
Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.
| Study group | Role | What they receive |
|---|---|---|
| Linkage to PrEP or Care | Experimental | Subjects screened for HIV at any CCTG consortium site will be offered Linkage to PrEP or Care, depending on HIV status. After results are received, HIV testers will obtain verbal consent from the subject to connect with the ALERT Specialist, or otherwise offer the subject the ALERT Specialist contact information. When contacted, the ALERT Specialist will coordinate with the subject the scheduling of the PrEP or Care visit, and remain in contact to ensure linkage. Receives: Behavioral: Linkage to PrEP or Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects linked to Care or PrEP
The primary outcome will measure the proportion of subjects linked a) to HIV care within 60 days of testing HIV-positive or b) to PrEP within 90 days of testing HIV-negative
Measured: Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test
Secondary outcomes (1)
Acceptance of the linkage program
Secondary outcomes will measure the acceptance of the linkage program, which is defined as those individuals who, after testing either positive or HIV antibody negative, will agree to be contacted by the ALERT specialist.
Measured: 60 days from date of HIV screening test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start26 Jul 2013
- Primary completion22 Jan 2018
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
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, Jill Blumenthal, University of California, San Diego
- Investigators
- Kathleen Jacobson, MD, Study chair, University of Southern CaliforniaMichael Menchine, MD, MPH, Study chair, University of Southern CaliforniaJill Blumenthal, MD, Principal investigator, UC San Diego AntiViral Research Center (AVRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941121
- Sponsor's protocol ID
- CCTG 593
- Status last verified
- May 2021
- First submitted
- 9 Sep 2013
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCTG 593: Testing and Linkage to Care, A Multicenter Demonstration Project of the California Collaborative Treatment Group
- ClinicalTrials.gov ID
- NCT01941121
- Acronym / sponsor ID
- CCTG 593
- Conditions
- HIV Positive, HIV Seronegative
- Keywords
- HIV Screening, Linkage to PrEP, Linkage to Care, CCTG, 593
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- 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
- 26 Jul 2013 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 13 Sep 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.
This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care.
If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.
Detailed description
Design: CCTG 593 is a project to evaluate the uptake and effectiveness of an ALERT specialist serving to
- link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and
- link confirmed HIV antibody negative persons with continued high risk behaviors to PrEP centers
Duration: Each subject who agrees to linkage will receive ALERT follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to PrEP, whichever comes first. The duration of the 593 project will be for 3.5 years or until all subjects have been enrolled and successfully linked, or 60 days pass for linkage to care or 90 days for linkage to PrEP.
Sample Size: Up to 600 subjects will be tested and offered linkage across all CCTG sites: LA County-USC Medical Center, Harbor-UCLA/City of Long Beach Department of Health and Human Services, UCSD/San Diego Health and Human Services Agency.
Study Population: Eligible subjects will include any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LA County + USC, Long Beach Department of Health and Human Services, and San Diego Health and Human Services Agency).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linkage to PrEP or Care | Experimental | Behavioral: Linkage to PrEP or CareSubjects screened for HIV at any CCTG consortium site will be offered Linkage to PrEP or Care, depending on HIV status. After results are received, HIV testers will obtain verbal consent from the subject to connect with the ALERT Specialist, or otherwise offer the subject the ALERT Specialist contact information. When contacted, the ALERT Specialist will coordinate with the subject the scheduling of the PrEP or Care visit, and remain in contact to ensure linkage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Has had an HIV test result form the CCTG Consortium testing site as either positive or negative
- Ability to provide informed consent
- English or Spanish Speaking
Key exclusion criteria (2 listed)
- Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
- Acute medical illness that requires transfer to a non CCTG hospital
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 |
|---|---|---|
| Linkage to PrEP or CareEnsuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist. | Behavioural | Linkage to PrEP or Care |
Primary outcome
Proportion of subjects linked to Care or PrEP
Time frame: Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test
The primary outcome will measure the proportion of subjects linked a) to HIV care within 60 days of testing HIV-positive or b) to PrEP within 90 days of testing HIV-negative
1 secondary outcome
Acceptance of the linkage program
Time frame: 60 days from date of HIV screening test
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 12 May 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.
Kathleen Jacobson, MD study chair
University of Southern California
Michael Menchine, MD, MPH study chair
University of Southern California
Jill Blumenthal, MD principal investigator
UC San Diego AntiViral Research Center (AVRC)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage to PrEP or Care in people with HIV Positive and HIV Seronegative, 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 4 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: finished, as of the sponsor's last update on 12 May 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?
Proportion of subjects linked to Care or PrEP (time frame: Up to 60 days for positives and up to 90 days for negatives from date of HIV screening test). 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 12 May 2021.