Human Immunodeficiency VirusNCT03583138

HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)

An observational study of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University at 1 site 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

STRIDE2 is a longitudinal, non-randomized study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman \& Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction
What is being tested?: buprenorphine
Type of treatment: Injection or infusion
How many people: 159 participants
Where: 1 siteUnited States
Study dates: 23 Jun 2014to 30 Jun 2017
Phase: Observational
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

Study population: 18 years of age or older, HIV+, meet DSM-IV criteria for opioid dependence, have health insurance accepted at Lab Corp, are able to read and understand English, and live in Washington, DC and plan to remain in DC.

Who may be able to join

HIV+, confirmed by rapid HIV test
Meet DSM-IV criteria for opioid dependence
18 years or older
Have health insurance that is accepted at Lab Corp.

Who cannot join

Are <18 years old;
Are HIV negative;
Are Unable to communicate in English;
Are not able to provide informed consent;
Do not meet DSM-IV criteria for opioid dependence;
Plan to leave the DC area

Trial locations and contacts

1 site in 1 country.

United States1 site

Howard University
Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC

Read the detailed description

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Conditions: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
Being tested: buprenorphine
Keywords: HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine
Medical subject headings: Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Substance-Related Disorders

What participants receive

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

buprenorphineDrug
Also called Suboxone
To provide buprenorphine for 12 months for those who are interested in receiving it.

Study groups in NCT03583138
Study group	Role	What they receive
Buprenorphine		Participants are eligible for the study if they are 18 years of age or older, HIV+, meet DSM-IV criteria for opioid dependence, have health insurance accepted at Lab Corp, are able to read and understand English, and live in Washington, DC and plan to remain in DC. The intervention is to provide buprenorphine for 12 months for those who are interested in receiving it. Receives: Drug: buprenorphine
No buprenorphine		No buprenorphine

What is being measured

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

VL <400
Blood test for HIV viral load
Measured: Month 0
CD4+ cell count
Blood test for HIV CD4+ cell count
Measured: Month 0
VL <400
Blood test for HIV viral load
Measured: 6 months
CD4+ cell count
Blood test for HIV CD4+ cell count
Measured: 6 months
VL <400
Blood test for HIV viral load
Measured: 12 months
CD4+ cell count
Blood test for HIV CD4+ cell count
Measured: 12 months

Secondary outcomes (12)

HIV risk behaviors
Survey for HIV risks
Measured: Month 0
HIV risk behaviors
Survey for HIV risks
Measured: 6 months
HIV risk behaviors
Survey for HIV risks
Measured: 12 months
Retention in HIV care
Survey data for retention
Measured: Month 0
Retention in HIV care
Survey data for retention
Measured: 6 months
Retention in HIV care
Survey data for retention
Measured: 12 months
Opioid use
Measure of relapse to opioid use
Measured: Month 0
Opioid use
Measure of relapse to opioid use
Measured: 6 months
Opioid use
Measure of relapse to opioid use
Measured: 12 months
Medically assisted therapy retention
Measure of length of time on Methadone or Buprenorphine
Measured: Month 0
Medically assisted therapy retention
Measure of length of time on Methadone or Buprenorphine
Measured: 6 months
Medically assisted therapy retention
Measure of length of time on Methadone or Buprenorphine
Measured: 12 months

Timeline

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

23 Jun 201430 Jun 2017

First posted11 Jul 2018
Study start23 Jun 2014
Primary completion15 Dec 2015
Study completion30 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03583138
Sponsor's protocol ID: 1011007631b
Other IDs: R01DA030768
Status last verified: May 2020
First submitted: 19 Mar 2018
Last updated: 27 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC
ClinicalTrials.gov ID: NCT03583138
Acronym / sponsor ID: 1011007631b
Conditions: Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
Keywords: HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine
Study type: Observational
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), George Mason University, Howard University
Study start: 23 Jun 2014 (actual)
Primary completion: 15 Dec 2015 (actual)
Study completion: 30 Jun 2017 (actual)
First posted: 11 Jul 2018 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Buprenorphine	–	Drug: buprenorphineParticipants are eligible for the study if they are 18 years of age or older, HIV+, meet DSM-IV criteria for opioid dependence, have health insurance accepted at Lab Corp, are able to read and understand English, and live in Washington, DC and plan to remain in DC. The intervention is to provide buprenorphine for 12 months for those who are interested in receiving it.
No buprenorphine	–	–No buprenorphine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 18 years of age or older, HIV+, meet DSM-IV criteria for opioid dependence, have health insurance accepted at Lab Corp, are able to read and understand English, and live in Washington, DC and plan to remain in DC.

Key inclusion criteria (4 listed)

HIV+, confirmed by rapid HIV test
Meet DSM-IV criteria for opioid dependence
18 years or older
Have health insurance that is accepted at Lab Corp.

Key exclusion criteria (6 listed)

Are <18 years old;
Are HIV negative;
Are Unable to communicate in English;
Are not able to provide informed consent;
Do not meet DSM-IV criteria for opioid dependence;

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
buprenorphineAlso: SuboxoneTo provide buprenorphine for 12 months for those who are interested in receiving it.	Drug	Buprenorphine

Primary outcome

VL <400
Time frame: Month 0
Blood test for HIV viral load
CD4+ cell count
Time frame: Month 0
Blood test for HIV CD4+ cell count
VL <400
Time frame: 6 months
Blood test for HIV viral load
CD4+ cell count
Time frame: 6 months
Blood test for HIV CD4+ cell count
VL <400
Time frame: 12 months
Blood test for HIV viral load
CD4+ cell count
Time frame: 12 months
Blood test for HIV CD4+ cell count

12 secondary outcomes

HIV risk behaviors
Time frame: Month 0
HIV risk behaviors
Time frame: 6 months
HIV risk behaviors
Time frame: 12 months
Retention in HIV care
Time frame: Month 0
Retention in HIV care
Time frame: 6 months
Retention in HIV care
Time frame: 12 months
Opioid use
Time frame: Month 0
Opioid use
Time frame: 6 months
Opioid use
Time frame: 12 months
Medically assisted therapy retention
Time frame: Month 0
Medically assisted therapy retention
Time frame: 6 months
Medically assisted therapy retention
Time frame: 12 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 27 May 2020.

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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.

Fredrick Altice, MD principal investigator

Yale University School of Medicine/AIDS Program

Faye Taxman, PhD principal investigator

George Mason University

William Lawson, MD principal investigator

Howard University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by Yale University at 1 site 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 6 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

VL <400 (time frame: Month 0). The study lists 6 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 NCT03583138.

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 27 May 2020.