The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.
The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Six monthly injections of extended-release naltrexone
Standard treatment for opioid use disorder provided at each HIV clinic
Tarzana Treatment Centers
Tarzana, California, United States
Jackson Memorial Hospital
Miami, Florida, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
University of Kentucky Bluegrass Care Clinic
Lexington, Kentucky, United States
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Complete Case
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Per-protocol
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Veterans Aging Cohort Study (VACS) Index
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.
Time frame: Baseline and 24 weeks
CD4 Count
Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Antiretroviral Therapy Prescribed
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.
Time frame: Baseline and 24 weeks
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
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.
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Johns Hopkins University, Bartlett Specialty Clinic
Baltimore, Maryland, United States
Time frame: 24 weeks
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
At least 1 HIV care visit in past 12 weeks
Time frame: 24 weeks
Number of Participants Who Had Unprotected Sex in Past 30 Days
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time frame: Baseline and 24 weeks
Number of Participants With Multiple Sex Partners in Past 30 Days
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Quality of Life
Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24. Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome
Time frame: Baseline and 24 weeks
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
Average 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 average 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).
Time frame: Between baseline and 24 weeks
Number of Participants Who Test Positive for Opioids at 24 Weeks
Number and percent of participants with UDS positive for opioids at 24 weeks.
Time frame: 24 weeks