Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03275350|
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder Hiv||Drug: Naltrexone Injectable Suspension Other: Treatment as usual||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up|
|Actual Study Start Date :||February 5, 2018|
|Actual Primary Completion Date :||November 8, 2019|
|Actual Study Completion Date :||November 8, 2019|
Active Comparator: XR-NTX
Drug: Naltrexone Injectable Suspension
Six monthly injections of extended-release naltrexone
Active Comparator: TAU
Treatment as usual
Other: Treatment as usual
Standard treatment for opioid use disorder provided at each HIV clinic
- HIV Viral Suppression [ Time Frame: 24 weeks ]HIV-1 RNA <200 copies/ml
- Veterans Aging Cohort Study (VACS) Index [ Time Frame: 24 weeks ]Change in VACS Index compared with screening
- Cluster of Differentiation 4 (CD4) [ Time Frame: 24 weeks ]Change in CD4 count compared with screening
- Engagement in HIV Care: Antiretroviral Therapy Prescribed [ Time Frame: 24 weeks ]Change in the proportion of study participants prescribed ART within 24 weeks following randomization, compared to baseline. 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.
- Engagement in HIV Care: Antiretroviral Therapy Adherence [ Time Frame: 24 weeks ]Proportion 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.
- Engagement in HIV Care: Retention in HIV Care [ Time Frame: 24 weeks ]Number of HIV primary care visits at 24 weeks (count, chart abstraction). Outcome scores will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.
- Engagement in HIV Care: HIV Risk Behaviors [ Time Frame: Week 24 ]Past 30 day injection drug use, unprotected sex, multiple sexual partners as measured by the Risk Assessment Battery at week 24 (binary; self-report). Chi-squared test comparing proportion to treatment assignment.
- Engagement in HIV Care: Quality of Life [ Time Frame: 24 weeks ]Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at week 24. Change from baseline in mean EQ-5D score assessed by treatment group using paired t-test, or analysis of change via ordinary least squares.
- Antiretroviral Therapy Adherence Mediation Variables: Days of Opioid Use [ Time Frame: Between baseline and 24 weeks ]Number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data). Analyzed using rank-based methods such as Wilcoxon rank-sum tests.
- Antiretroviral Therapy Adherence Mediation Variables: Opioid Abstinence [ Time Frame: Weeks 20-24 ]Past 30 day opioid abstinence (by Addiction Severity Index (ASI)-life self-report, Timeline Follow-Back and UDS confirmation) in the final 30 days of the 24 week trial (binary; self-report + UDS). Analyzed via rank-based methods such as Wilcoxon rank-sum tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275350
|United States, California|
|Tarzana Treatment Centers|
|Tarzana, California, United States, 91356|
|United States, Florida|
|Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Ruth M. Rothstein CORE Center|
|Chicago, Illinois, United States, 60612|
|United States, Kentucky|
|University of Kentucky Bluegrass Care Clinic|
|Lexington, Kentucky, United States, 40536|
|United States, Maryland|
|Johns Hopkins University, Bartlett Specialty Clinic|
|Baltimore, Maryland, United States, 21287|