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Pre-exposure prophylaxis (PrEP) uptake among women in the United States has been low. To increase uptake, we developed a peer outreach and navigation PrEP intervention. Semi-structured qualitative interviews with 32 cisgender women and 3 transgender women were conducted to assess the intervention. We used a thematic approach to identify barriers to, and facilitators of the intervention. Facilitators included interest in PrEP, offer of health and social services, the intervention's women-focused approach, and peer outreach and navigation. Barriers were perceived HIV risk, concerns about medication side effects or interactions, housing insecurity and travel, co-occurring health-related conditions, and caregiving responsibilities. We recommend that future interventions consider packaging PrEP in local community settings, such as syringe exchange programs; include services such as food and housing assistance; use peers to recruit and educate women; integrate a culturally appropriate women's focus; and consider providing same-day PrEP.

Pre-exposure prophylaxis (PrEP) uptake remains woefully low among U.S. women at high risk for HIV acquisition. We evaluated a pilot intervention which involved Peers providing brief PrEP education and counseling at mobile syringe exchange sites and at sex worker and syringe exchange drop-in centers followed by navigation to PrEP care. Peers recruited English-proficient, self-identified women (i.e., cisgender and transgender women and persons with other transfeminine identities) over a 3-month period and delivered the intervention to 52 HIV-negative/status unknown participants. Thirty-eight participants (73.1%) reported PrEP interest, 27 (51.9%) accepted the offer of a PrEP appointment, 13 (25.0%) scheduled a PrEP appointment, 3 (5.8%) attended an initial PrEP appointment, and none were prescribed PrEP. We found a gap between PrEP interest and connecting women to PrEP care. Further study is needed to understand this gap, including exploring innovative approaches to delivering PrEP care to women at highest risk for HIV.

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study—a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes. [ABSTRACT FROM AUTHOR]

Background: Treating hepatitis C virus (HCV) in people who inject drugs (PWID) has been associated with increased health-related quality of life (HRQOL). Polysubstance use (PSU) is common among PWID, but no studies have investigated PSU influence on PWID's HRQOL HCV treatment. Methods: Participants included 150 PWID receiving HCV treatment at opioid agonist treatment clinics in Bronx, NY. The EQ-5D-3 L measurement tool assessed five health dimensions producing an index of HRQOL measured at baseline, 4-, 8-, and 12-weeks during treatment and 12- and 24-weeks post-treatment. PSU was determined at baseline. Generalized estimating equations assessed the influence of baseline PSU on changes in mean EQ-5D-3 L index over time. Results: Of the 150 participants, 46 (30.7%) reported PSU and mean HRQOL overall was 0.655, indicating moderate HRQOL. Mean HRQOL was lower at all time-points for the PSU group compared to the non-PSU group. Though PSU group showed improvements in mean HRQOL from baseline (0.614) to 4-, 12- and follow-up week 24 (0.765, 0.768, and 0.731, respectively), the mean change of HRQOL scores was not significantly associated with PSU (p-value =.956). Conclusions: For individuals with PWID, our study showed no difference in HRQOL between those who did and did not engage in PSU following HCV treatment. [ABSTRACT FROM AUTHOR]

This study is a secondary analysis of a randomized clinical trial (October 2013–April 2017) involving 150 People Who Inject Drugs (PWIDs) with hepatitis C virus (HCV) seen in opioid agonist treatment programs in the Bronx, New York, and investigates the impact of distrust in the healthcare system on adherence to Direct-Acting Antivirals (DAAs) HCV treatment therapy among PWIDs. The distrust was scaled on a 9-item instrument and the adherence to DAA medications was measured using electronic blister packs. This study demonstrated a significant inverse relationship between levels of distrust and medication adherence: 71.8 ± 2.2% (se) vs. 77.9 ± 1.8%, p = 0.024 between participants with higher and lower distrust levels. Despite the absence of significant association of distrust with sociodemographic or substance use characteristics, these findings suggest that building trust within the healthcare system is paramount for improving adherence to DAAs among PWIDs. The results call for a healthcare approach that emphasizes trust-building through patient-centered care, sensitivity training, peer support, and health system reform to effectively address the treatment needs of this marginalized population. [ABSTRACT FROM AUTHOR]

Background Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. Methods We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. Results The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P =.004) and those with drug use at baseline (F(3478) = 5.11; P <.01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. Conclusions This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms. [ABSTRACT FROM AUTHOR]

Keywords: adherence; DAA; drug use; HCV; PWID EN adherence DAA drug use HCV PWID 172 175 4 01/19/23 20230201 NES 230201 Abbreviations DAA direct-acting antiviral DTF daily time frame GT groups therapy HCV hepatitis C infection mDOT modified directly observed therapy OTP opioid treatment program PWID people who inject drugs SIT standard individual therapy SVR sustained virologic response INTRODUCTION Direct-acting antiviral (DAA) therapies are more effective for treating hepatitis C virus (HCV) with higher rates of sustained virologic response (SVR) and fewer side effects than older interferon-based treatments.[1] DAAs are effective even among people who inject drugs (PWID),[2] a population disproportionately infected by HCV.[3] Nonetheless, adequate adherence is crucial for PWID living with HCV to achieve SVR and reduce transmission, a public health goal which has been prioritized for global efforts to eliminate HCV by 2030.[4] How ongoing drug use interferes with HCV treatment adherence support remains unknown.[[5]] The PREVAIL study[2] was conducted in opioid treatment program (OTP) settings to test the effectiveness of three models of HCV care for PWID. Hepatitis C virus direct-acting antiviral treatment adherence patterns and sustained viral response among people who inject drugs treated in opioid agonist therapy programs. [Extracted from the article]

Among people who inject drugs (PWID), 60% have HCV and 50–90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71–78%) and 76% (95%CI=70–83%), respectively (p=.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes. [ABSTRACT FROM AUTHOR]

Background Although efforts to treat hepatitis C virus (HCV) in people who inject drugs (PWID) yield high rates of sustained virologic response (SVR), the relationship between successful HCV treatment and health-related quality of life (HRQOL) among PWID is poorly understood. We examined HRQOL changes throughout HCV treatment and post-treatment for PWID achieving SVR. Methods Participants included 141 PWID who achieved SVR following HCV treatment onsite at 3 opioid agonist treatment (OAT) clinics in the Bronx, New York. EQ-5D-3L assesses 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), producing an index of HRQOL ranging from 0 to 1. EQ-5D-3L was measured at baseline; 4, 8, and 12 weeks during treatment; and 12 and 24 weeks post-treatment. Linear mixed effects regression models assessed changes in the mean EQ-5D-3L index over time. Results Mean EQ-5D-3L index baseline was 0.66 (standard error [SE] = 0.02). While over half the population reported no baseline problems with self-care (85.1%), usual activities (56.0%), and mobility (52.5%), at least two-thirds reported problems with pain/discomfort (78.0%) and anxiety/depression (66.0%). Twenty-four weeks post-treatment, proportions reporting pain/discomfort and anxiety/depression decreased by 25.7% and 24.0%, respectively. Mean EQ-5D-3L index significantly improved during treatment (P  < .0001), and improvement was sustained following treatment completion, with mean EQ-5D-3L index of 0.77 (SE = 0.02) 12 weeks post-SVR. Conclusions HCV treatment led to sustained improvement in HRQOL for PWID on OAT who achieved SVR. Future research is necessary to determine whether improvements in HRQOL can be sustained beyond 12 weeks post-SVR. [ABSTRACT FROM AUTHOR]