Trial · NCT03275350

Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

NCT03275350, Phase 2, Phase 3, Completed, Oregon Health and Science University; results first posted 2022-04-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up. Trials, record NCT03275350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03275350

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
NCT number: NCT03275350
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 114 participants, actual
Lead sponsor: Oregon Health and Science University
Conditions: Opioid-use Disorder, Hiv
Interventions: Naltrexone Injectable Suspension, Treatment as usual
First posted: 2017-09-07
Last updated: 2022-04-27
Results first posted: 2022-04-27

Source ClinicalTrials.gov

Registered outcomes13

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, Missing Imputed as Unsuppressed	12 weeks and 24 weeks	HIV-1 RNA \<200 copies/ml
Primary	Number of Participants With HIV Viral Suppression, Complete Case	12 weeks and 24 weeks	HIV-1 RNA \<200 copies/ml
Primary	Number of Participants With HIV Viral Suppression, Per-protocol	12 weeks and 24 weeks	HIV-1 RNA \<200 copies/ml
Secondary	Veterans Aging Cohort Study (VACS) Index	Baseline and 24 weeks	Absolute value of participant VACS Index at baseline and 24 weeks Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.
Secondary	CD4 Count	Baseline and 24 weeks	Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.
Secondary	Engagement in HIV Care: Antiretroviral Therapy Prescribed	Baseline and 24 weeks	Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.
Secondary	Engagement in HIV Care: 100% Antiretroviral Therapy Adherence	24 weeks	Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.
Secondary	Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks	24 weeks	At least 1 HIV care visit in past 12 weeks
Secondary	Number of Participants Who Had Unprotected Sex in Past 30 Days	Baseline and 24 weeks	Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Secondary	Number of Participants With Multiple Sex Partners in Past 30 Days	Baseline and 24 weeks	Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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, Missing Imputed as Unsuppressed	12 weeks and 24 weeks	Non-inferiority analyses of HIV viral suppression by treatment arm Intent to Treat Group Missing imputed as unsuppressed	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With HIV Viral Suppression, Complete Case	12 weeks and 24 weeks	Non-inferiority analyses of HIV viral suppression by treatment arm Complete case: Includes 81 participants with non-missing viral load data at 12 and 24 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With HIV Viral Suppression, Per-protocol	12 weeks and 24 weeks	Non-inferiority analyses of HIV viral suppression by treatment arm Missing as unsuppressed Per-protocol population includes 69 participants who received at least one dose of their assigned study medication.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Veterans Aging Cohort Study (VACS) Index	Baseline and 24 weeks		score on a scale	MEAN
SECONDARY	CD4 Count	Baseline and 24 weeks		cells/mm3	MEAN
SECONDARY	Engagement in HIV Care: Antiretroviral Therapy Prescribed	Baseline and 24 weeks	Number analyzed at 24 weeks lower than baseline due to study retention and availability of data.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Engagement in HIV Care: 100% Antiretroviral Therapy Adherence	24 weeks	This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks	24 weeks	This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Had Unprotected Sex in Past 30 Days	Baseline and 24 weeks	Those reporting no sex are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Multiple Sex Partners in Past 30 Days	Baseline and 24 weeks	Two or more sex partners during past month, those reporting no sex partners are excluded	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed	Extended-release Naltrexone (XR-NTX)	12 Weeks	23	Participants
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed	Treatment as Usual (TAU)	12 Weeks	21	Participants
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed	Extended-release Naltrexone (XR-NTX)	24 Weeks	29	Participants
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed	Treatment as Usual (TAU)	24 Weeks	29	Participants
Number of Participants With HIV Viral Suppression, Complete Case	Extended-release Naltrexone (XR-NTX)	12 Weeks	23	Participants
Number of Participants With HIV Viral Suppression, Complete Case	Treatment as Usual (TAU)	12 Weeks	19	Participants
Number of Participants With HIV Viral Suppression, Complete Case	Extended-release Naltrexone (XR-NTX)	24 Weeks	26	Participants
Number of Participants With HIV Viral Suppression, Complete Case	Treatment as Usual (TAU)	24 Weeks	26	Participants
Number of Participants With HIV Viral Suppression, Per-protocol	Extended-release Naltrexone (XR-NTX)	12 weeks	11	Participants
Number of Participants With HIV Viral Suppression, Per-protocol	Treatment as Usual (TAU)	12 weeks	16	Participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Extended-release Naltrexone (XR-NTX)	55
Overall Study	STARTED	Treatment as Usual (TAU)	59
Overall Study	COMPLETED	Extended-release Naltrexone (XR-NTX)	47
Overall Study	COMPLETED	Treatment as Usual (TAU)	51
Overall Study	NOT COMPLETED	Extended-release Naltrexone (XR-NTX)	8
Overall Study	NOT COMPLETED	Treatment as Usual (TAU)	8

Source ClinicalTrials.gov

Adverse events24

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	Infections	Infections and infestations	Extended-release Naltrexone (XR-NTX)	2	55	2
other	Infections	Infections and infestations	Treatment as Usual (TAU)	5	59	5
other	Injury	Injury, poisoning and procedural complications	Extended-release Naltrexone (XR-NTX)	1	55	1
other	Injury	Injury, poisoning and procedural complications	Treatment as Usual (TAU)	2	59	2
other	Gastrointestinal disorders	Gastrointestinal disorders	Extended-release Naltrexone (XR-NTX)	3	55	3
other	Gastrointestinal disorders	Gastrointestinal disorders	Treatment as Usual (TAU)	0	59	0
other	Respiratory disorders	Respiratory, thoracic and mediastinal disorders	Extended-release Naltrexone (XR-NTX)	2	55	2
other	Respiratory disorders	Respiratory, thoracic and mediastinal disorders	Treatment as Usual (TAU)	1	59	1
other	Psychiatric disorders	Psychiatric disorders	Extended-release Naltrexone (XR-NTX)	2	55	2
other	Psychiatric disorders	Psychiatric disorders	Treatment as Usual (TAU)	1	59	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Extended-release Naltrexone (XR-NTX)	2	55
Total, all-cause mortality	Treatment as Usual (TAU)	1	59
Total, other adverse events	Extended-release Naltrexone (XR-NTX)	11	55
Total, other adverse events	Treatment as Usual (TAU)	7	59
Total, serious adverse events	Extended-release Naltrexone (XR-NTX)	5	55
Total, serious adverse events	Treatment as Usual (TAU)	7	59

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34758887	DERIVED	PubMed
37712113	DERIVED	PubMed
40342086	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Extended-release Naltrexone (XR-NTX) vs Treatment as Usual (TAU): Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks	Trial comparisons
Extended-release Naltrexone (XR-NTX) vs Treatment as Usual (TAU): Engagement in HIV Care: 100% Antiretroviral Therapy Adherence	Trial comparisons
Extended-release Naltrexone (XR-NTX) vs Treatment as Usual (TAU): deaths from any cause	Trial comparisons
Extended-release Naltrexone (XR-NTX) vs Treatment as Usual (TAU): 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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