Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064)

Abstract

Background Direct-acting antivirals can cure HCV. Persons with HCV/HIV and living with substance use are disadvantaged in benefitting from advances in HCV treatment. Methods In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments completed in January 2018. Care facilitation group participants received motivation and strengths-based case-management addressing retrieval of HCV load results, engagement in HCV/HIV care and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (e.g., receiving HCV results, initiating treatment, sustained viral response) of the HCV/HIV care continuum over 12 months post-randomization. Results Three hundred and eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% male and 72.6% Black/African American. Median HIV-1 viral load was 27,209 copies/ml with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention (2.44 steps) vs. control group (1.68 steps) [χ 2(1)=7.36, p=0.0067]. Men in the intervention (vs. control) group completed a statistically significantly higher number of steps. Eleven participants achieved sustained viral response with no difference by treatment group. Conclusions The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight the continued challenges to achieve individual patient sustained viral responses and population level HCV elimination.

Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C

“…In this randomized trial, those who received care facilitation moved along the HCV cascade further than those who did not. 21 However, those with HIV have additional steps often starting with engagement in HIV care, which may delay engagement in HCV care. As of April 2020, the United States Centers for Disease Control and Prevention recommends that all patients of adult age be screened for HCV.…”

Suicidality as a Predictor of Overdose among Patients with Substance Use Disorders

“…We analyzed data from eight multicenter CTN trials that included 2543 participants [ 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 ]. Only 2541 participants were included in the analysis (2 participants were excluded due to missing data).…”

“…For these overdose suspected cases, the medical monitor reviewed narratives from the study forms for an indication of involved substances which were then discussed by the panel to reach consensus on the adjudication of the outcome. For the 2 trials where both the hospitalization and death forms were used (CTN 0049 [ 33 , 41 ] and CTN 0064 [ 37 , 45 ]), the panel reviewed all causes for hospitalization (primary discharge diagnosis) and the primary cause of death as recorded in the database. Deaths due to overdose were listed as “Drug Use/Overdose” or “Substance Use”.…”

“…Given the correlation between depression and suicidality, the prevalence of baseline depression was also assessed by creating a binary indicator of depression using the instrument that had been part of each trial’s procedures. Depression measures included the 9-item Patient Health Questionnaire (PHQ-9 [ 26 ]: CTN0067 [ 38 , 46 ], CTN0068 [ 39 , 47 ]), the 18-item Brief Symptom Inventory (BSI-18 [ 48 ]: CTN0049 [ 33 , 41 ], CTN0064 [ 37 , 45 ]), the Addiction Severity Index Lite (ASI Lite [ 49 ];CTN0037 [ 32 , 40 ], CTN0051 [ 34 , 42 ]), the Medical and Psychiatric History (CTN0054 [ 36 , 44 ]), and the Hospital Anxiety and Depression Scale (HADS [ 50 ]: CTN0053 [ 35 , 43 ]). Because lifetime heroin use [ 51 ], recent alcohol and benzodiazepine use [ 52 ], and past psychiatric history [ 53 ], increase risk of overdose, these factors were also included as covariates in the model.…”

“…Each of these covariates was assessed by creating binary variables of each distinct instrument or question across the 8 trials. The assessment of lifetime use of heroin included the Addiction Severity Index Lite (ASI Lite [ 49 ]: 0037 [ 32 , 40 ], 0049 [ 33 , 41 ], 0051 [ 34 , 42 ], 0064 [ 37 , 45 ], 0067 [ 38 , 46 ]) and the Alcohol and Substance History (0054 [ 36 , 44 ], 0068 [ 39 , 47 ]). One trial, CTN 0054, did not assess lifetime use of heroin.…”