Aims The advent of direct-acting antivirals for hepatitis C virus (HCV) and limited effectiveness of prevention have generated interest in “Treatment as Prevention” (TasP), in which those most likely to transmit HCV (i.e. people who inject drugs [PWID]) are treated to reduced secondary transmission. However, there are scant data regarding the feasibility of treating PWID at high risk for secondary transmission or the optimal approach to treatment delivery. Methods We conducted a 2:1 randomized trial of modified directly-observed (mDOT) versus unobserved HCV treatment with ledipasvir-sofosbuvir daily for 8 weeks among PWID with 36 weeks of follow-up in San Francisco from 2015–2017. We evaluated recruitment-enrollment, treatment completion, end-of-treatment and 12-week response, and reinfection rate. Results Of 83 individuals eligible for screening, 72 (87.6%) attended the screening visit, 33 were eligible, and 31 enrolled; mean age was 42 years, 81% were male, 74% white. All but one participant (in the mDOT arm) completed treatment and 89.4% of mDOT and 96.6% of unobserved arm visits were attended. HCV was undetectable for 96.8% (30/31) at end of treatment and 89.7% (26/29) 12 weeks later (1 relapse, 1 reinfection), with no differences by arm. Two additional reinfections were subsequently identified, for a reinfection rate of 16.3 (95% CI 5.3–50.5) per 100 person-years of observation. Conclusions It was feasible to recruit active PWID for HCV treatment and achieve high retention, viral response, and satisfaction with either mDOT or unobserved protocols, supporting treatment of PWID at risk of transmitting HCV to others. The reinfection rate suggests we successfully reached a high-risk population and that successful HCV TasP initiatives may aim to be sufficient in scope to significantly lower prevalence in the community. Trial registration clinicaltrials.gov NCT02609893 .
It is important for both individual- and population-level health that HIV-infected individuals progress through the Care Continuum. However, HIV-infected youth frequently disengage from care during transition from pediatric/adolescent to adult care; only 50% remain in adult care after 1 year. Understanding how providers define and approach a successful healthcare transition can improve the delivery of HIV-related services during critical years of HIV treatment. We conducted 58 staff interviews across 14 Adolescent Trials Network clinics (n = 30) and 20 adult clinics (n = 28). We used the constant comparative method to examine how providers defined and approached youths' successful transition. Providers identified four components critical to successful transition: (1) clinical outcomes (e.g., medication adherence and viral suppression); (2) youth knowing how to complete treatment-related activities (e.g., refilling prescriptions and making appointments); (3) youth taking responsibility for treatment-related activities and their overall health (e.g., "when they stop reaching out to the adolescent [clinic] to solve all their problems."); and (4) youth feeling a connection and trust toward the adult clinic (e.g., "they feel safe here"), with some providers even prioritizing connectedness over clinical outcomes (e.g., "Even if they're not taking meds but are connected [to care], …that's a success."). The identification of key components of successful transition can guide focused interventions and resources to improve youth maintenance in the HIV Care Continuum as they transition to adult care. Identifying what facilitates successful transitions, and the gaps that interventions can target, will help to ensure HIV-infected youth remain healthy across their lifespan.
Background: Adherence to antiretroviral therapy (ART) is imperative for viral suppression and reducing HIV transmission, but many people living with HIV report difficultly sustaining long-term adherence. Long-acting injectable (LAI) ART has the potential to transform HIV treatment and prevention. However, little LAI ART–related behavioral research has occurred among women, particularly outside of clinical trials. Setting: Six Women's Interagency HIV Study sites: New York, Chicago, Washington DC, Atlanta, Chapel Hill, and San Francisco. Methods: We conducted 59 in-depth interviews with women living with HIV across 6 Women's Interagency HIV Study sites (10 per site; 9 at Washington DC). We interviewed women who were not included in LAI ART clinical trials but who receive care at university settings that will administer LAI ART once it is approved. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Results: Most women enthusiastically endorsed monthly LAI ART and would prefer it over pills. The following 3 reasons emerged for this preference: (1) convenience and confidentiality, (2) avoiding daily reminders about living with HIV, and (3) believing that shots are more effective than pills. Challenges remain, however, specifically around (1) medical mistrust, (2) concerns about safety and effectiveness, (3) pill burden for HIV and other conditions, and (4) barriers to additional medical visits. Conclusions: Most women preferred LAI ART over daily pills given its benefits, including convenience, privacy, and perceived effectiveness. Future research should incorporate more women into LAI ART trials to better understand and align development with user concerns and preferences to enhance uptake.
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