Human Immunodeficiency VirusCoRECTNCT02693145
Cooperative Re-Engagement Controlled Trial (CoRECT)
A study testing Anti-Retroviral Treatment and Access to Services (ARTAS) in people with Human Immunodeficiency Virus, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
CoRECT will help identify the important components of a data-sharing partnership between health departments and HIV care providers, and determine the extent to which a health department intervention can increase the number of HIV-infected persons out-of-care who: (a) link to an HIV clinic; (b) remain in HIV medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Anti-Retroviral Treatment and Access to Services (ARTAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,893 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2016to Aug 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
- Residents within the health department jurisdiction who have received HIV medical care at a CoRECT clinic and then disengage by either of the following definitions:
- Clinic definition: did not have a visit with a prescribing provider for 6 months.
- Health department definition: no CD4 or viral load test result reported to health department surveillance for more than 6 months.
- Residents within the health department jurisdiction with newly diagnosed HIV infection who have not linked to medical care within 90 days and have either:
- Received, but did not attend, an appointment at a CoRECT clinic; or
- Attended an enrollment visit but did not receive medical care at a CoRECT clinic.
Who cannot join
- Deceased
- Out of jurisdiction
- Changed providers
- Incarcerated
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts Department of Public Health
Boston, Massachusetts, 02108
Connecticut Department of Public Health
Hartford, Connecticut, 06106
Philadelphia Department of Health
Philadelphia, Pennsylvania, 19104
About this study
CoRECT will help identify the important components of a data-sharing partnership between health departments and HIV care providers, and determine the extent to which a health department intervention can increase the number of HIV-infected persons out-of-care who: (a) link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will also measure the cost-effectiveness of this intervention in regards to improved health in the individuals (re)-engaged in HIV care and reductions in further HIV transmission in the community.
Read the detailed description
Methods summary: Health departments will generate an out-of-care list using HIV laboratory surveillance data; collaborating clinics will concurrently generate out-of-care lists using appointment data. The combined out-of-care list will be reconciled by the health department and clinics, and discussed at monthly case conferences. All individuals determined to be out-of care will be randomized to receive either: (1) usual linkage and engagement in care services (standard of care [SOC]); or (2) an active health department field services intervention in addition to SOC. The active intervention activities will vary among jurisdictions; however all sites will include field services to locate, contact, and provide assistance, including a same-day appointment, to access HIV medical care.
Study design: Each site will enroll 600 out-of-care HIV-infected individuals (300 per arm) during a two-year enrollment period. An out-of-care individual will be defined as: (1) a person who has received HIV medical care at a CoRECT clinic and then disengages from care; or (2) a person with newly diagnosed HIV infection who has an appointment at a CoRECT clinic, but has not linked to medical care within 90 days.
Intervention: Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Services provided as part of the intervention will vary by jurisdiction, but may include assistance with expedited medical appointments, transportation, access to community resources such as traditional case management, strengths-based case management, or financial incentives (Appendix A).
Primary outcomes: The following outcomes will be compared between out-of-care HIV-infected individuals receiving the study intervention to those receiving usual services:
- Attend 1 clinic visit within 90 days;
- Remain engaged in care, defined as 2 clinic visits at least 3 months apart within 12 months;
- Achieve viral load suppression within 12 months;
- Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Anti-Retroviral Treatment and Access to Services (ARTAS)
- Keywords
- HIV/AIDS, re-engagement in care, data to care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Retroviral Treatment and Access to Services (ARTAS)Other
Anti-Retroviral Treatment and Access to Services (ARTAS) is an individual-level, multi-session, time-limited intervention with the goal of linking recently diagnosed persons with HIV to medical care soon after receiving their positive test result. ARTAS is based on the Strengths-based Case Management (SBCM) model, which is rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. SBCM is a model that encourages the client to identify and use personal strengths; create goals for himself/herself; and establish an effective, working relationship with the Linkage Coordinator (LC).
| Study group | Role | What they receive |
|---|---|---|
| standard of care (SOC) arm | No intervention | Individuals found to be out of HIV medical care will receive standard of care to re-engage. This will not include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. |
| Intervention arm | Experimental | Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Intervention may include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. Receives: Other: Anti-Retroviral Treatment and Access to Services (ARTAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attend one clinic visit
Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
Measured: within 90 days of randomization
Remain engaged in care
Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care
Measured: defined as 2 clinic visits at least 3 months apart within 12 months
Viral load suppression
Does the patient achieve viral load suppression within 12 months of randomization
Measured: within 12 months
Achieve durable viral load suppression
Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Measured: defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Connecticut State, Department of Mental Health and Addiction Services, Massachusetts Department of Health, Philadelphia Department of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693145
- Sponsor's protocol ID
- FOA PS14-001
- Acronym
- CoRECT
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
The White House Office of National AIDS Policy. National HIV/AIDS Strategy. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas. Accessed: 30 January 2015.
Bradley H, Hall HI, Wolitski RJ, Van Handel MM, Stone AE, LaFlam M, Skarbinski J, Higa DH, Prejean J, Frazier EL, Patel R, Huang P, An Q, Song R, Tang T, Valleroy LA. Vital Signs: HIV diagnosis, care, and treatment among persons living with HIV--United States, 2011. MMWR Morb Mortal Wkly Rep. 2014 Nov 28;63(47):1113-7.
PubMed 25426654Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180.
PubMed 25706928Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.
PubMed 15750396Gardner LI, Marks G, Craw JA, Wilson TE, Drainoni ML, Moore RD, Mugavero MJ, Rodriguez AE, Bradley-Springer LA, Holman S, Keruly JC, Sullivan M, Skolnik PR, Malitz F, Metsch LR, Raper JL, Giordano TP; Retention in Care Study Group. A low-effort, clinic-wide intervention improves attendance for HIV primary care. Clin Infect Dis. 2012 Oct;55(8):1124-34. doi: 10.1093/cid/cis623. Epub 2012 Jul 24.
PubMed 22828593Gardner LI, Giordano TP, Marks G, Wilson TE, Craw JA, Drainoni ML, Keruly JC, Rodriguez AE, Malitz F, Moore RD, Bradley-Springer LA, Holman S, Rose CE, Girde S, Sullivan M, Metsch LR, Saag M, Mugavero MJ; Retention in Care Study Group. Enhanced personal contact with HIV patients improves retention in primary care: a randomized trial in 6 US HIV clinics. Clin Infect Dis. 2014 Sep 1;59(5):725-34. doi: 10.1093/cid/ciu357. Epub 2014 May 15.
PubMed 24837481Dombrowski JC. Testing, Linkage and Retention in Care: Getting Control of the Cascade in Seattle. National Summit on HIV and Viral Hepatitis Diagnosis, Prevention, and Access to Care, Washington, DC, November 26-8, 2012.
Udeagu CC, Webster TR, Bocour A, Michel P, Shepard CW. Lost or just not following up: public health effort to re-engage HIV-infected persons lost to follow-up into HIV medical care. AIDS. 2013 Sep 10;27(14):2271-9. doi: 10.1097/QAD.0b013e328362fdde.
PubMed 23669157Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
PubMed 21767103Macharaviani E, Altice FL, Shrestha R, Truebig J, Carroll C, Nichols L, Ahmad B, Copenhaver M, Villanueva M. Disease Intervention Specialist Field Experience in Re-engaging Out-of-Care People with HIV in Project CoRECT: A Mixed Methods Study. AIDS Behav. 2025 Aug;29(8):2451-2460. doi: 10.1007/s10461-025-04707-w. Epub 2025 Apr 10.
PubMed 40205311Machavariani E, Miceli J, Altice FL, Fanfair RN, Speers S, Nichols L, Jenkins H, Villanueva M. Using Data-To-Care Strategies to Optimize the HIV Care Continuum in Connecticut: Results From a Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2024 May 1;96(1):40-50. doi: 10.1097/QAI.0000000000003391.
PubMed 38324241Elder H, Lang SG, Villanueva M, John B, Roosevelt K, Altice FL, Brady KA, Gibson B, Buchelli M, DeMaria A, Randall LM. Using the exploration, preparation, implementation, sustainment (EPIS) framework to assess the cooperative re-engagement controlled trial (CoRECT). Front Public Health. 2023 Dec 1;11:1223149. doi: 10.3389/fpubh.2023.1223149. eCollection 2023.
PubMed 38106893O'Shea J, Fanfair RN, Williams T, Khalil G, Brady KA, DeMaria A Jr, Villanueva M, Randall LM, Jenkins H, Altice FL, Camp N, Lucas C, Buchelli M, Samandari T, Weidle PJ. The Cooperative Re-Engagement Controlled Trial (CoRECT): Durable Viral Suppression Assessment. J Acquir Immune Defic Syndr. 2023 Jun 1;93(2):134-142. doi: 10.1097/QAI.0000000000003178.
PubMed 36812382
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperative Re-Engagement Controlled Trial (CoRECT)
- ClinicalTrials.gov ID
- NCT02693145
- Acronym / sponsor ID
- CoRECT / FOA PS14-001
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV/AIDS, re-engagement in care, data to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,893 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Connecticut State, Department of Mental Health and Addiction Services, Massachusetts Department of Health, Philadelphia Department of Public Health
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 26 Feb 2016 (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.
CoRECT will help identify the important components of a data-sharing partnership between health departments and HIV care providers, and determine the extent to which a health department intervention can increase the number of HIV-infected persons out-of-care who: (a) link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will also measure the cost-effectiveness of this intervention in regards to improved health in the individuals (re)-engaged in HIV care and reductions in further HIV transmission in the community.
Detailed description
Methods summary: Health departments will generate an out-of-care list using HIV laboratory surveillance data; collaborating clinics will concurrently generate out-of-care lists using appointment data. The combined out-of-care list will be reconciled by the health department and clinics, and discussed at monthly case conferences. All individuals determined to be out-of care will be randomized to receive either: (1) usual linkage and engagement in care services (standard of care [SOC]); or (2) an active health department field services intervention in addition to SOC. The active intervention activities will vary among jurisdictions; however all sites will include field services to locate, contact, and provide assistance, including a same-day appointment, to access HIV medical care.
Study design: Each site will enroll 600 out-of-care HIV-infected individuals (300 per arm) during a two-year enrollment period. An out-of-care individual will be defined as: (1) a person who has received HIV medical care at a CoRECT clinic and then disengages from care; or (2) a person with newly diagnosed HIV infection who has an appointment at a CoRECT clinic, but has not linked to medical care within 90 days.
Intervention: Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Services provided as part of the intervention will vary by jurisdiction, but may include assistance with expedited medical appointments, transportation, access to community resources such as traditional case management, strengths-based case management, or financial incentives (Appendix A).
Primary outcomes: The following outcomes will be compared between out-of-care HIV-infected individuals receiving the study intervention to those receiving usual services:
- Attend 1 clinic visit within 90 days;
- Remain engaged in care, defined as 2 clinic visits at least 3 months apart within 12 months;
- Achieve viral load suppression within 12 months;
- Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care (SOC) arm | No intervention | –Individuals found to be out of HIV medical care will receive standard of care to re-engage. This will not include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. |
| Intervention arm | Experimental | Other: Anti-Retroviral Treatment and Access to Services (ARTAS)Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Intervention may include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Residents within the health department jurisdiction who have received HIV medical care at a CoRECT clinic and then disengage by either of the following definitions:
- Residents within the health department jurisdiction with newly diagnosed HIV infection who have not linked to medical care within 90 days and have either:
Key exclusion criteria (4 listed)
- Deceased
- Out of jurisdiction
- Changed providers
- Incarcerated
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 |
|---|---|---|
| Anti-Retroviral Treatment and Access to Services (ARTAS)Anti-Retroviral Treatment and Access to Services (ARTAS) is an individual-level, multi-session, time-limited intervention with the goal of linking recently diagnosed persons with HIV to medical care soon after receiving their positive test result. ARTAS is based on the Strengths-based Case Management (SBCM) model, which is rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. SBCM is a model that encourages the client to identify and use personal strengths; create goals for himself/herself; and establish an effective, working relationship with the Linkage Coordinator (LC). | Other | Intervention arm |
Primary outcome
Attend one clinic visit
Time frame: within 90 days of randomization
Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
Remain engaged in care
Time frame: defined as 2 clinic visits at least 3 months apart within 12 months
Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care
Viral load suppression
Time frame: within 12 months
Does the patient achieve viral load suppression within 12 months of randomization
Achieve durable viral load suppression
Time frame: defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
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 21 Feb 2021.
- BackgroundThe White House Office of National AIDS Policy. National HIV/AIDS Strategy. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas. Accessed: 30 January 2015.
- Background: PubMed 25426654Bradley H, Hall HI, Wolitski RJ, Van Handel MM, Stone AE, LaFlam M, Skarbinski J, Higa DH, Prejean J, Frazier EL, Patel R, Huang P, An Q, Song R, Tang T, Valleroy LA. Vital Signs: HIV diagnosis, care, and treatment among persons living with HIV--United States, 2011. MMWR Morb Mortal Wkly Rep. 2014 Nov 28;63(47):1113-7.
- Background: PubMed 25706928Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180.
- Background: PubMed 15750396Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. doi: 10.1097/01.aids.0000161772.51900.eb.
- Background: PubMed 22828593Gardner LI, Marks G, Craw JA, Wilson TE, Drainoni ML, Moore RD, Mugavero MJ, Rodriguez AE, Bradley-Springer LA, Holman S, Keruly JC, Sullivan M, Skolnik PR, Malitz F, Metsch LR, Raper JL, Giordano TP; Retention in Care Study Group. A low-effort, clinic-wide intervention improves attendance for HIV primary care. Clin Infect Dis. 2012 Oct;55(8):1124-34. doi: 10.1093/cid/cis623. Epub 2012 Jul 24.
- Background: PubMed 24837481Gardner LI, Giordano TP, Marks G, Wilson TE, Craw JA, Drainoni ML, Keruly JC, Rodriguez AE, Malitz F, Moore RD, Bradley-Springer LA, Holman S, Rose CE, Girde S, Sullivan M, Metsch LR, Saag M, Mugavero MJ; Retention in Care Study Group. Enhanced personal contact with HIV patients improves retention in primary care: a randomized trial in 6 US HIV clinics. Clin Infect Dis. 2014 Sep 1;59(5):725-34. doi: 10.1093/cid/ciu357. Epub 2014 May 15.
- BackgroundDombrowski JC. Testing, Linkage and Retention in Care: Getting Control of the Cascade in Seattle. National Summit on HIV and Viral Hepatitis Diagnosis, Prevention, and Access to Care, Washington, DC, November 26-8, 2012.
- Background: PubMed 23669157Udeagu CC, Webster TR, Bocour A, Michel P, Shepard CW. Lost or just not following up: public health effort to re-engage HIV-infected persons lost to follow-up into HIV medical care. AIDS. 2013 Sep 10;27(14):2271-9. doi: 10.1097/QAD.0b013e328362fdde.
- Background: PubMed 21767103Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
- Derived from this study: PubMed 40205311Macharaviani E, Altice FL, Shrestha R, Truebig J, Carroll C, Nichols L, Ahmad B, Copenhaver M, Villanueva M. Disease Intervention Specialist Field Experience in Re-engaging Out-of-Care People with HIV in Project CoRECT: A Mixed Methods Study. AIDS Behav. 2025 Aug;29(8):2451-2460. doi: 10.1007/s10461-025-04707-w. Epub 2025 Apr 10.
- Derived from this study: PubMed 38324241Machavariani E, Miceli J, Altice FL, Fanfair RN, Speers S, Nichols L, Jenkins H, Villanueva M. Using Data-To-Care Strategies to Optimize the HIV Care Continuum in Connecticut: Results From a Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2024 May 1;96(1):40-50. doi: 10.1097/QAI.0000000000003391.
- Derived from this study: PubMed 38106893Elder H, Lang SG, Villanueva M, John B, Roosevelt K, Altice FL, Brady KA, Gibson B, Buchelli M, DeMaria A, Randall LM. Using the exploration, preparation, implementation, sustainment (EPIS) framework to assess the cooperative re-engagement controlled trial (CoRECT). Front Public Health. 2023 Dec 1;11:1223149. doi: 10.3389/fpubh.2023.1223149. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Retroviral Treatment and Access to Services (ARTAS) in people with Human Immunodeficiency Virus, run by Centers for Disease Control and Prevention 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 4 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 21 Feb 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?
Attend one clinic visit (time frame: within 90 days of randomization). The study lists 4 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 NCT02693145, which also lists 13 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 21 Feb 2021.