Trial · NCT01936857
Buprenorphine to Improve HIV Care Engagement and Outcomes
NCT01936857, Phase 4, Completed, Oregon Health and Science University; results first posted 2020-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Buprenorphine to Improve HIV Care Engagement and Outcomes. Trials, record NCT01936857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01936857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buprenorphine to Improve HIV Care Engagement and Outcomes
- NCT number
- NCT01936857
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 281 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- HIV, Substance Related Disorders
- Interventions
- Buprenorphine/naloxone, Methadone Maintenance Therapy
- First posted
- 2013-09-06
- Last updated
- 2022-05-17
- Results first posted
- 2020-06-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With HIV Viral Suppression | 12 months | HIV-1 RNA \< 200 copies/mL |
| Primary | Participants With Heroin Use (Urine Drug Screen) | 12 months | |
| Primary | Participants With Heroin Use (Self-report) | 12 months | |
| Secondary | Number of Participants in Receipt of Antiretroviral Therapy (ART) | 12 months | Initiation of and retention on treatment with antiretroviral medications. |
| Secondary | Number of Participants in Retention in HIV Care | 12 months | HIV clinic visit in past 3 months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With HIV Viral Suppression | 12 months | Follow up viral suppression was not available for 50 buprenorphine group participants, and 33 of methadone group participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With Heroin Use (Urine Drug Screen) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Participants With Heroin Use (Self-report) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants in Receipt of Antiretroviral Therapy (ART) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants in Retention in HIV Care | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With HIV Viral Suppression | Buprenorphine/Naloxone | Viral suppression at baseline | 97 | Participants | |
| Number of Participants With HIV Viral Suppression | Methadone Maintenance Therapy | Viral suppression at baseline | 92 | Participants | |
| Number of Participants With HIV Viral Suppression | Buprenorphine/Naloxone | Viral suppression at 12 months | 74 | Participants | |
| Number of Participants With HIV Viral Suppression | Methadone Maintenance Therapy | Viral suppression at 12 months | 99 | Participants | |
| Participants With Heroin Use (Urine Drug Screen) | Buprenorphine/Naloxone | 66 | Participants | ||
| Participants With Heroin Use (Urine Drug Screen) | Methadone Maintenance Therapy | 72 | Participants | ||
| Participants With Heroin Use (Self-report) | Buprenorphine/Naloxone | 64 | Participants | ||
| Participants With Heroin Use (Self-report) | Methadone Maintenance Therapy | 67 | Participants | ||
| Number of Participants in Receipt of Antiretroviral Therapy (ART) | Buprenorphine/Naloxone | 108 | Participants | ||
| Number of Participants in Receipt of Antiretroviral Therapy (ART) | Methadone Maintenance Therapy | 116 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine/Naloxone | 141 | |
| Overall Study | STARTED | Methadone Maintenance Therapy | 140 | |
| Overall Study | COMPLETED | Buprenorphine/Naloxone | 107 | |
| Overall Study | COMPLETED | Methadone Maintenance Therapy | 115 | |
| Overall Study | NOT COMPLETED | Buprenorphine/Naloxone | 34 | |
| Overall Study | NOT COMPLETED | Methadone Maintenance Therapy | 25 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Unintentional injury | Injury, poisoning and procedural complications | Buprenorphine/Naloxone | 12 | 141 | 12 |
| other | Unintentional injury | Injury, poisoning and procedural complications | Methadone Maintenance Therapy | 2 | 140 | 2 |
| other | Abnormal lab result | General disorders | Buprenorphine/Naloxone | 1 | 141 | 1 |
| other | Abnormal lab result | General disorders | Methadone Maintenance Therapy | 0 | 140 | 0 |
| other | Neuropathy | Nervous system disorders | Buprenorphine/Naloxone | 1 | 141 | 1 |
| other | Neuropathy | Nervous system disorders | Methadone Maintenance Therapy | 1 | 140 | 1 |
| other | Suspected infection | Infections and infestations | Buprenorphine/Naloxone | 5 | 141 | 5 |
| other | Suspected infection | Infections and infestations | Methadone Maintenance Therapy | 0 | 140 | 0 |
| other | Vascular | Vascular disorders | Buprenorphine/Naloxone | 1 | 141 | 1 |
| other | Vascular | Vascular disorders | Methadone Maintenance Therapy | 0 | 140 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine/Naloxone | 7 | 141 |
| Total, all-cause mortality | Methadone Maintenance Therapy | 3 | 140 |
| Total, other adverse events | Buprenorphine/Naloxone | 23 | 141 |
| Total, other adverse events | Methadone Maintenance Therapy | 3 | 140 |
| Total, serious adverse events | Buprenorphine/Naloxone | 10 | 141 |
| Total, serious adverse events | Methadone Maintenance Therapy | 4 | 140 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA037441 | Buprenorphine to Improve HIV Care Engagement and Outcomes: A Randomized Trial | KORTHUIS, PHILIP TODD | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2018 |
Source NIH RePORTER
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: Participants With Heroin Use (Self-report) | Trial comparisons |
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: Number of Participants in Receipt of Antiretroviral Therapy (ART) | Trial comparisons |
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: Participants With Heroin Use (Urine Drug Screen) | Trial comparisons |
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: Number of Participants in Retention in HIV Care | Trial comparisons |
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: deaths from any cause | Trial comparisons |
| Buprenorphine/Naloxone vs Methadone Maintenance Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01936857
GET https://conductscience.org/api/trials/v1/NCT01936857/events?page=2