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HIVNCT01614106

Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

A study testing Retention Clinic in people with HIV and AIDS, run by Columbia University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV, AIDS, Substance Abuse
What is being tested?
Retention Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesUnited States
Study dates
Jan 2013to 12 Mar 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

  • Participating individuals must:
  • be at least 18 years old
  • be HIV-seropositive (confirmed via medical record/laboratory results or via rapid HIV test in conjunction with confirmatory test or viral load)
  • meet one of the following: a) have an (*)AIDS-defining illness OR b) have a CD4 count <350 cells/uL AND a viral load >1000 copies/mL in the medical record in the past 3 months OR c) have a CD4 count <350 cells/uL AND a viral load >200 copies/mL as obtained via baseline blood draw OR d) have a clinical profile indicative of a persistently detectable HIV viral load (>200 copies/mL) attributed to non-adherence to HIV medications as per PI evaluation of the individual and/or individual's medical record
  • report (OR have evidence in the medical record of) any cocaine (including crack) use in the past 3 months OR (**)have a positive toxicology result for cocaine via the study toxicology screen
  • agree to have their blood drawn for CD4 and viral load testing
Show all 14Show fewer
  • report living in or near either Miami, Florida (FL), or Atlanta, Georgia (GA), and be able to return for follow-up visits
  • provide locator information
  • be able to communicate in English
  • provide written informed consent
  • sign a HIPAA Authorization form/medical record release to facilitate medical record abstraction
  • be willing to go to the study clinic
  • ()Site PI discretion will be used to assess whether or not the AIDS-defining illness is a good indicator of eligibility. For example, if a patient does not meet the CD4 and viral load criteria and does have an AIDS-defining illness, the Site PI will assess the AIDS-defining illness to determine whether or not the patient is a suitable candidate for the study.
  • ()Per PI discretion, the urine toxicology screen may be administered as part of the screening process if the participant's self-report and/or medical record data renders him/her ineligible on the drug use criterion.

Who cannot join

  • Individuals will be excluded from study participation if they:
  • do not meet any one or more of the above-described inclusion criteria
  • are receiving patient navigator services for HIV care and/or substance abuse treatment
  • have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
  • are terminated via site PI decision

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Grady Health System-Ponce De Leon Center

    Atlanta, Georgia, 30308

  • Jackson Health System-Special Immunology Clinic

    Miami, Florida, 33136

Other trials in United States

About this study

This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial. A total of 360 HIV-infected individuals who report cocaine (including crack) use will be randomized across study sites. The primary hypothesis is that more participants randomized to the "Retention Clinic" will have undetectable viral load than will participants randomized to the treatment as usual group.

Read the detailed description

This study will evaluate the efficacy of an integrated "Retention Clinic" in achieving virologic suppression among HIV-infected cocaine (including crack) users by using a two-group randomized, prospective trial.

Participants will be randomized to one of two groups: 1) "Retention Clinic" group and 2) Treatment as Usual. The intervention content of these groups is briefly described below:

Retention Clinic (RC) Group: This group will receive comprehensive and integrated services from a Retention Clinic. Services include HIV primary care, substance abuse treatment and mental health services, as needed. Participants in this group will also receive hands-on assistance with navigating through the clinic and accessing these services from a patient navigator.

Treatment as Usual (TAU) Group: This group will receive no protocol directed intervention. They will get the standard retention services from their local clinic.

All participants will provide informed consent and will complete a baseline audio computer-assisted self-interview or ACASI focusing on drug use, mental health, demographics and socio-economic factors, HIV care, and drug treatment history as well as blood draws for viral load and CD4 count. Follow-up assessments consisting of both ACASI and blood draws in all groups will be collected at 6 and 12 months post-randomization. Medical records will be reviewed to document use of HIV care, drug treatment and mental health services during the study period.

Being tested
Retention Clinic
Keywords
HIV/AIDS, Drug Users, Crack-Cocaine Use, HIV Primary Care
Medical subject headings
Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Drug Misuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retention ClinicBehavioural

    The central components of the Retention Clinic will include: Primary HIV Care; Patient Navigator services (including Informational support, Educational information, Motivational/Emotional support, Skill Building activities); Mental Health Services; and On-Site Substance Abuse Treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).

Study groups in NCT01614106
Study groupRoleWhat they receive
InterventionExperimentalThe Retention Clinic will incorporate HIV primary care and mental health services with on-site substance abuse treatment and patient navigation. The central components will include: Primary HIV Care; Mental Health Services; Skill-building; and On-Site substance abuse treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
Receives: Behavioral: Retention Clinic
Treatment as Usual (TAU)No interventionThe treatment as usual (TAU) group condition will represent standard of care at both of the participating clinics. Standard of care at both clinics includes primary HIV care, the provision of mental health services, and the assignment of a clinic case manager. These case managers meet with patients when they first come to clinic and then meet with them as needed and typically offer substance-using patients a referral to substance abuse treatment in the community as needed. Case managers usually do not follow up to determine the uptake of these referrals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virologic suppression

    To evaluate the effectiveness of the integrated "Retention Clinic" in achieving virologic suppression (defined as having an HIV-1 viral load <200 copies/mL at 6 and 12 months) among HIV-infected cocaine (including crack) users

    Measured: 12 months

Secondary outcomes (4)

  1. Attendance to HIV Care Visits

    To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at HIV care visits.

    Measured: 12 months

  2. Adherence to HIV Treatment Regimens

    To evaluate the effectiveness of the integrated care Retention Clinic in increasing adherence to HIV treatment regimens.

    Measured: 12 months

  3. Attendance to Substance Abuse Treatment

    To evaluate the effectiveness of the integrated care Retention Clinic in increasing attendance at substance abuse treatment.

    Measured: 12 months

  4. Decreasing Substance Use

    To evaluate the effectiveness of the integrated care Retention Clinic in decreasing substance use.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2017
  4. Study completion12 Mar 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614106
Sponsor's protocol ID
AAAK0606
Other IDs
R01DA032098
Status last verified
May 2022
First submitted
14 Mar 2012
Last updated
12 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Metsch LR, Feaster DJ, Gooden LK, Pan Y, Parish CL, Waldrop D, Rodriguez A, Colasanti JA, Armstrong WS, Root C, Del Rio C, Castellon PC, Miller M, Pereyra MR. Project RETAIN: Providing Integrated Care for People With HIV Who Use Cocaine. Open Forum Infect Dis. 2025 Mar 3;12(4):ofaf104. doi: 10.1093/ofid/ofaf104. eCollection 2025 Apr.

    PubMed 40276720

Questions about this trial

What is this clinical trial studying?

A study testing Retention Clinic in people with HIV and AIDS, run by Columbia University at 2 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 14 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Virologic suppression (time frame: 12 months). 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 NCT01614106, 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 12 May 2022.

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