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Introduction Pre‐exposure prophylaxis (PrEP) is an important HIV prevention option. Two randomized trials have provided efficacy evidence for long‐acting injectable cabotegravir (CAB‐LA) as PrEP. In considering CAB‐LA as an additional PrEP modality for people at substantial risk of HIV, it is important to understand community response to injectable PrEP. We conducted a systematic review of values, preferences and perceptions of acceptability for injectable PrEP to inform global guidance. Methods We searched nine databases and conference websites for peer‐reviewed and grey literature (January 2010−September 2021). There were no restrictions on location. A two‐stage review process assessed references against eligibility criteria. Data from included studies were organized by constructs from the Theoretical Framework of Acceptability. Results We included 62 unique references. Most studies were observational, cross‐sectional and qualitative. Over half of the studies were conducted in North America. Men who have sex with men were the most researched group. Most studies (57/62) examined injectable PrEP, including hypothetical injectables (55/57) or placebo products (2/57). Six studies examined CAB‐LA specifically. There was overall interest in and often a preference for injectable PrEP, though there was variation within and across groups and regions. Many stakeholders indicated that injectable PrEP could help address adherence challenges associated with daily or on‐demand dosing for oral PrEP and may be a better lifestyle fit for individuals seeking privacy, discretion and infrequent dosing. End‐users reported concerns, including fear of needles, injection site pain and body location, logistical challenges and waning or incomplete protection. Discussion Despite an overall preference for injectable PrEP, heterogeneity across groups and regions highlights the importance of enabling end‐users to choose a PrEP modality that supports effective use. Like other products, preference for injectable PrEP may change over time and end‐users may switch between prevention options. There will be a greater understanding of enacted preference as more end‐users are offered anti‐retroviral (ARV)‐containing injectables. Future research should focus on equitable implementation, including real‐time decision‐making and how trained healthcare providers can support choice. Conclusions Given overall acceptability, injectable PrEP should be included as part of a menu of prevention options, allowing end‐users to select the modality that suits their preferences, needs and lifestyle.

Introduction Approval of the first long‐acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The “Accelerating Implementation of Multilevel Strategies to Advance Long‐Acting Injectable for Underserved Populations (ALAI UP Project)” aims to accelerate the systematic and equitable delivery of LAI ART. Methods We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short‐answer responses by clinics across the United States responding to ALAI UP's solicitation to participate in the project between November 2022 and January 2023. Results Thirty‐eight clinics responded to ALAI UP's solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient‐facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics’ LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38). Conclusions Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.

Aripiprazole as a long-acting injectable (LAI) is initiated in oral aripiprazole-stabilised patients and needs, after first injection, 14 days supplementation of oral aripiprazole (one-injection start, OIS). Recently, an alternative two-injection start (TIS) was advanced, involving two 400 mg injections with a single 20 mg oral supplementation of aripiprazole. We tested the two regimens in patients with schizophrenia (SCZ, n = 152, 90 men and 62 women) with (SUD+; n = 93) or without (SUD–; n = 59) substance use disorders (SUDs), comparing OIS (n = 66) with TIS (n = 86) and SUD+ vs. SUD–. For 26 patients, we measured weekly for one month, aripiprazole + dehydroaripiprazole (active moiety) levels. Patients were followed for three months after LAI with psychopathology and quality-of-life scales (BPRS, CGI-S, ACES, BIS-11, and WHOQOL). All groups improved in psychopathology with no differences between OSI and TIS and between SCZ–SUD+ and SCZ–SUD–. The TIS group was associated with serum blood levels of the active moiety within the therapeutic window, while the OIS group showed peaks above the window, possibly exposing patients to toxicity. Treatments were well-tolerated. Here we showed no disadvantages for TIS vs. OIS and possibly increased safety. Shifting the initiation of aripiprazole LAIs to the TIS modality may be safe and pharmacokinetically advantageous.

Introduction Injectable cabotegravir (CAB‐LA) is highly effective for HIV prevention, but real‐world implementation studies in Africa are ongoing. We assessed feasibility and acceptability among participants who used CAB‐LA in the SEARCH Dynamic Choice HIV Prevention extension study in rural Uganda and Kenya. Methods From January 2023 to December 2024, we followed females and males who were aged ≥ 15 years, with self‐assessed risk for HIV acquisition, in the intervention arm of the SEARCH Dynamic Choice HIV Prevention extension study, and received at least one CAB‐LA injection during the first 48 weeks. To assess the feasibility and acceptability of CAB‐LA, we designed quantitative surveys based on the Theoretical Framework for Acceptability. Surveys were administered at CAB‐LA initiation, after 24 and 48 weeks of use, and discontinuation of CAB‐LA. Results Of 487 intervention arm participants, 274 (56%) started CAB‐LA (183 females; 91 males; 79 youth aged 15–24 years). Of whom, 264 completed the survey at initiation, 206 after 24 weeks on CAB‐LA, 201 after 48 weeks on CAB‐LA and 69 at discontinuation of CAB‐LA. Most participants (65%; 171/264) reported choosing CAB‐LA because it was easier to take than pills, and nearly all (99%; 261/264) had limited knowledge of CAB‐LA prior to the study. Concerns for side effects were the largest anticipated and experienced barrier to CAB‐LA. Overall and with subgroups, satisfaction with CAB‐LA was high at 24 weeks (97%; 200/206) and 48 weeks (96%; 193/201). Nearly all participants reported that taking CAB‐LA was easy at 24 weeks (95%; 195/206) and 48 weeks (99%; 198/201). At CAB‐LA discontinuation, 83% (57/69) were likely to extremely likely to recommend CAB‐LA to a friend: 80% (20/25) of males, 84% (37/44) of females, 100% (19/19) of youth and 76% (38/50) of older adults. Conclusions In rural Uganda and Kenya, over half of participants in the SEARCH trial who were offered choice of oral PrEP/PEP or CAB‐LA chose and started CAB‐LA during the first 48 weeks. For both males and females and younger and older adults, CAB‐LA was both feasible and acceptable to deliver with satisfaction remaining high throughout the study, and nearly all reporting ease of use. Clinical Trial Number 05549726

Background Anorexia nervosa (AN), comorbid with autism spectrum disorder (ASD), poses significant treatment challenges due to cognitive rigidity, poor insight, and frequent nonadherence to pharmacological interventions. Although second‐generation antipsychotics (SGAs) have been used off‐label in AN, evidence for long‐acting injectable (LAI) formulations remains scarce, particularly in adult patients with neurodevelopmental disorders. Case Presentation We report the case of a 27‐year‐old woman with severe AN and comorbid ASD who exhibited repeated hospitalizations due to critical underweight and persistent refusal of oral medications. Cognitive assessment revealed mild intellectual disability (IQ 56). The patient demonstrated obsessive‐compulsive traits and extreme rigidity toward food intake, and was resistant to multiple oral antipsychotics. While risperidone was tolerated, poor adherence limited its efficacy. After obtaining informed consent, LAI paliperidone palmitate was initiated (initial dose 25 mg, increased to 50 mg monthly). Following a short period of psychoeducation and lifestyle intervention, the patient maintained psychiatric and nutritional stability over a 3‐year outpatient follow‐up without rehospitalization. Her body mass index stabilized at approximately 24 kg/m2. No severe adverse effects were reported. Conclusion This case highlights the potential role of LAI paliperidone palmitate in managing treatment‐refractory AN with comorbid ASD and intellectual disability, particularly in patients with poor adherence and prominent obsessive traits. Although antipsychotics are not standard for AN, LAI formulations may offer pragmatic, sustainable benefits in selected cases. Further studies are warranted to assess long‐term safety and efficacy in this population.

Introduction Cabotegravir + rilpivirine long‐acting (CAB+RPV LA) injectable was approved in the United States in 2021 for HIV‐1 treatment in virologically suppressed (viral load [VL] <50 copies/mI individuals. In clinical trials, CAB+RPV LA was non‐inferior to oral antiretroviral therapy (ART) regimens in virologically suppressed individuals. We compared real‐world effectiveness between CAB+RPV LA and oral ART regimens and assessed predictors of confirmed virologic failure (CVF) on CAB+RPV LA. Methods From the OPERA® cohort, ART‐experienced, virologically suppressed adults with HIV switching to CAB+RPV LA or a new oral ART regimen between 21 January 2021 and 31 December 2022 were followed through 30 June 2023. CVF was defined as 2 VL ≥200 copies/ml or 1 VL ≥200 copies/ml + discontinuation. Logistic regression was used to assess CVF risk by regimen and CVF predictors among CAB+RPV LA users. Results During the study period, 1362 virologically suppressed adults switched to CAB+RPV LA, and 2783 switched to a new oral ART regimen (92% second‐generation integrase inhibitor [INSTI]‐based). Compared to oral ART users, CAB+RPV LA users were younger, on their prior regimen less time and more likely to switch from an INSTI; median CD4 counts at initiation were similar. At study end, 81% of CAB+RPV LA users and 80% of oral ART users were on their respective regimens. CVF risk with CAB+RPV LA did not statistically differ compared to oral ART (adjusted odds ratio: 0.64; 95% confidence interval [CI]: 0.34, 1.14). Among CAB+RPV LA users, only baseline CD4 predicted CVF; every 100 CD4 cells/µl increase was associated with 20% lower CVF risk (OR [95% CI]: 0.80 [0.64, 0.97]). Conclusions In the United States, routine clinical care, CVF risk did not differ between a switch to CAB+RPV LA or new oral ART, with most individuals remaining on their regimens at study end. Lower CD4 count at initiation was the only predictor of CVF on CAB+RPV LA.

Aims To investigate the negative attitudes of Japanese psychiatrists toward atypical long‐acting injectable (LAI) antipsychotics, which are the current mainstream LAIs in Japan. Methods We surveyed 69 Japanese psychiatrists using a 5‐point Likert scale to assess their attitudes toward atypical LAI antipsychotics. Our assessment referenced concerns identified in a study conducted in Japan a decade ago, which found significant differences when compared with a survey of German psychiatrists. We also identified the factors influencing these negative attitudes. Additionally, the results were compared with those of previous Japanese and German studies. Results More than 50% of Japanese psychiatrists expressed negative attitudes toward atypical LAI antipsychotics in various areas. These concerns included apprehensions about cost, reluctance to recommend them initially, pain from injections, complexity of switching to LAI, usage in first‐episode cases, and sufficient medication adherence with oral drugs. In all three studies, cost and adequate adherence to oral medication were concerns that exceeded the average of the three negative comments. Age and experience in psychiatry influenced the psychiatrists' attitudes toward using these drugs in first‐episode cases. Conclusions These findings shed light on the reasons for the underutilization of atypical LAI antipsychotics and suggest opportunities to enhance their appropriate use in clinical settings. We investigated the barriers to the use of long‐acting injectable atypical antipsychotics from a comparative psychiatrist survey in Japan.

Aims There is increasing evidence showing the importance of long‐acting injectable antipsychotics in the management of schizophrenia, especially in terms of improving patient medication compliance. A panel of experienced clinicians in Hong Kong mapped out a set of consensus statements with an aim to facilitate the understanding and use of long‐acting injectable antipsychotics among local physicians. Methods Eight discussion areas regarding long‐acting injectable antipsychotics were selected by the chairman of the consensus group. A series of meetings were held for the panelists to discuss the published literature and their clinical experience, followed by the drafting of consensus statements. At the final meeting, each consensus statement was voted on anonymously by all members based on its practicability of recommendation in Hong Kong. Results A total of 12 consensus statements on the rational use of long‐acting injectable antipsychotics were established and accepted by the consensus group. Conclusion The consensus statements aim to provide practical guidance for Hong Kong physicians on the use of long‐acting injectable antipsychotics in schizophrenia patients. These statements may also serve as a reference for doctors in other parts of the Asia–Pacific region.

The aim of this study was to clarify whether early symptomatic improvement in response to a long-acting injectable antipsychotic (LAI) contributes to subsequent social functional remission in patients with schizophrenia using the previous clinical trial data (EudraCT registration number: 2011-004889-15). Associations between other factors and social functional remission were also explored. We analyzed 428 patients with schizophrenia in which the personal and social performance scale (PSP) and the involvement evaluation questionnaire (IEQ) at the time of the base line were recorded. Social functional remission was defined as participants who scored PSP >70 at the end of 65 weeks. Logistic regression analyses were done to examine associations between social functional remission and clinical and demographic characteristics including early symptomatic response evaluated by Positive and Negative Syndrome Scale (PANSS) at week one. One hundred out of 428 patients showed social functional remission at the end of the observation period. Shorter duration of illness, higher baseline score of supervision evaluated by IEQ and higher baseline PSP were significantly associated with the social functional remission. Improvement of positive subscale of PANSS at one week was significantly associated with later social functional remission when baseline PSP scores were excluded from predictive variables. Shorter duration of illness, residual type of schizophrenia, higher baseline score of supervision and higher baseline social functioning were predictors of subsequent social functional remission. Although its effect seems to be limited, early symptomatic improvement could be also was a predictor of social functional remission.

Introduction Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long‐acting (LA) regimen recommended for maintaining HIV‐1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation–effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months. Methods Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm‐S) or enhanced arm (Arm‐E). Arm‐S included video injection training and provider/patient toolkits. Additionally, Arm‐E included skilled wrap‐around team meetings, face‐to‐face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi‐structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1–5 Likert scale ranging from 1 = “completely disagree” to 5 = “completely agree”). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed. Results Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation‐ and intervention‐based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (n = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections. Conclusions CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible. ClinicalTrials.gov number NCT04399551