Parya Saberi

Background: Scalable, low-cost strategies for monitoring antiretroviral therapy adherence are increasingly important, particularly in decentralized and telehealth-based care settings. This study assessed both the feasibility and performance of at-home, point-of-care (POC) urine tenofovir (TFV) testing for adherence monitoring, using tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS) as a pharmacological standard of adherence. Setting: This study was conducted within the LetSync cohort of people with HIV in primary romantic relationships, primarily Black men who have sex with men, across the U.S. Methods: Participants self-collected POC urine TFV testing and DBS samples over five timepoints across eight months. Adequate adherence was defined as TFV-DP ≥4 doses/week in DBS. Generalized estimating equation models evaluated associations between urine TFV results and DBS-based adherence, as well as the probability of sample return over time. Results: Among 86 participants and 341 paired samples, detectable urine TFV was strongly associated with adequate adherence in DBS (aRR = 2.86; 95% CI: 1.37–5.99). The urine POC test demonstrated high sensitivity (97%) and positive predictive value (85%), with lower specificity (31%). Across timepoints, urine samples showed higher return rates compared to DBS (aRR = 1.04; 95% CI: 1.01–1.08). Participants with detectable viral load had lower return rates for DBS compared to urine. Conclusions: At-home POC urine TFV testing is a sensitive and feasible approach for monitoring adherence. Its simplicity and consistently high return rates support its potential as a practical adherence monitoring tool, particularly in settings where VL testing is infrequent or logistically limited.

Introduction: This scoping review aimed to characterize the prevalence and determinants of HIV acquisition among transgender women in Southwest Asia and North Africa (SWANA), to describe HIV preventive activities and measures, and to examine barriers to HIV and gender‐affirming care, including experiences of stigma, discrimination and mental health challenges among transgender women in the region. Methods: We searched PubMed, PsycINFO and CINAHL for any articles published through 12 June 2026, that included transgender women, used primary or secondary data and were published in Arabic or English. Studies meeting these criteria were screened in Covidence. Discrepancies were resolved following data extraction. Results: A total of 276 articles were identified (152 duplicates removed). After screening titles and abstracts, 49 full texts were assessed for eligibility. The articles included ( N = 23) were primarily cross‐sectional studies ( N = 20) conducted in Iran, Lebanon, Turkey, Morocco and Tunisia. Three were non‐randomized experimental studies; one intervention was designed specifically for transgender women, focusing on gender affirmation and social support. Cross‐sectional studies examined HIV prevention, sexual activities and mental health. Condomless receptive anal intercourse and low HIV testing rates were most common among those engaged in sex work, which was attributed to coercion, perceived low risk for HIV acquisition or fear of disclosing one's HIV status. Stigma, physical and sexual violence, anxiety, depression and suicidality were highly prevalent among transgender women in SWANA and served as barriers to accessing healthcare services, including HIV and gender‐affirming care. Discussion: This review highlights critical areas for trans‐specific interventions addressing transgender women's needs in SWANA, where HIV incidence remains on the rise. Conclusions: Future longitudinal research is needed to evaluate the effectiveness of interventions in reducing HIV rates, improving mental health outcomes and mitigating structural barriers hindering healthcare access among transgender women in SWANA.

Background: Clinic-based administration of long-acting injectable antiretroviral therapy (LAI-ART) is resource-intensive and may exacerbate disparities in access to care. Home-based administration by trained layperson injectors, or treatment buddies (TBYs), could expand access to LAI-ART; however, maintaining high-quality clinical care requires selecting suitable TBYs for its implementation. This paper describes the development of the TBY Selection Tool to support people with HIV (PWH) in identifying appropriate TBYs. Methods: The tool development process consisted of 5 phases. In Phase 1, semi-structured interviews were conducted with 19 clinicians, 16 PWH, and 15 candidate TBYs. Transcripts were thematically coded to identify domains influencing TBY suitability. In Phase 2, draft items were developed and refined into a structured survey. In Phase 3, 7 PWH completed the tool during a 2-month pilot. In Phase 4, a Community Advisory Panel (CAP) (n = 10) reviewed items for clarity, relevance, and comprehensiveness. In Phase 5, feedback was incorporated to finalize the tool. Results: Clinicians emphasized the reliability of TBYs, the confidentiality of home-based injections, and the importance of adhering to injection schedules. PWH prioritized trust in the TBYs, TBY availability, and comfort with bodily intimacy. TBYs highlighted emotional steadiness, willingness to learn, and responsibility for continuity of care. These domains were operationalized into a survey assessing relationship history, reliability, confidentiality, availability, proximity, and comfort with injections. Pilot testing showed 100% completion without difficulties. CAP feedback led to refined wording, expanded response options, and clearer phrasing, which were used to finalize a 12-item survey. Conclusions: The TBY Selection Tool provides a structured framework to support PWH in identifying appropriate TBYs for home-based LAI-ART. By integrating clinical, individual, and community perspectives, the tool addresses factors important for the safe, acceptable, and feasible implementation of home-based LAI-ART. Psychometric assessment, scoring, and further validation in larger, more diverse populations is needed.

The National Clinician Consultation Center (NCCC) has operated for the past 30 years as a federally supported educational resource for US clinicians, addressing a wide range of questions regarding HIV and viral hepatitis care. Changes in practice spurred on by scientific breakthroughs and new research have led to new questions and challenges for HIV practitioners. These include optimal clinical and laboratory monitoring for people receiving postexposure prophylaxis, preexposure prophylaxis, or long-acting injectable antiretroviral therapy; evolving approaches to maternal and infant antiretroviral therapy for prevention of perinatal HIV transmission; and management of comorbidities such as hepatitis C and substance use disorders. Prevalent questions received by NCCC consultants over the last 5 years are described, high-lighting key areas of HIV medicine that clinicians and clinical educators commonly face in practice, as well as opportunities for future research to address areas of ongoing clinical uncertainty.

Background: The use of long-acting injectable (LAI) lenacapavir (LEN) plus cabotegravir (CAB) +/− rilpivirine (RPV) may increase viral suppression in people with HIV (PWH) with a history of oral antiretroviral therapy (ART) adherence challenges or drug-resistant virus. Data on the LEN+ CAB+/−RPV effectiveness and tolerability are limited. Methods: We report observations on real-world LEN+ CAB+/−RPV use from the National Clinician Consultation Center (NCCC), a federally funded teleconsultation resource for US-based clinicians. Providers contacting NCCC from 1 December 2022 to 30 August 2024 for cases related to ART modification to LEN+ CAB+/−RPV were surveyed. Data from NCCC's secure database and survey responses were summarized using descriptive statistics. Results: Among 76 potential cases, 50 (66%) surveys were completed. Of these, 14 (28%) modified ART to LEN+ CAB+/−RPV, including 9 (64%) who changed to LEN+ CAB/RPV and 1 (7%) to LEN+ CAB, and 4 (29%) with no regimen details. ART modification was not made in 35 cases, and in one, the provider was unsure of changes. Nonexclusive reasons for LAI-ART modifications included viremia on oral ART (n = 6, 43%), inability/refusal to take oral ART (3, 21%), non-nucleoside reverse transcriptase inhibitor mutation(s) (3, 21%), integrase strand transferase inhibitor mutation(s) (2, 14%), or persistent viremia on CAB/RPV alone (2, 14%). LEN+ CAB+/−RPV was effective and well-tolerated: among 10 cases with follow-up information, viral load decreased by a mean of 3.88log10 copies/mL within a median of 56 days (range = 29–166 days), and 5 experienced injection-site reactions rated as “not at all” to “slightly” problematic. Conclusions: These data support further investigations into LEN+ CAB+/−RPV use among PWH with oral ART challenges and/or drug resistance.

Introduction There is high interest in long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), with many conveniences for uptake and persistence. However, both patients and clinicians have expressed important barriers to effective implementation, including concerns about frequent clinic visits and strain on clinic resources. Administration of LAI-ART by a trained layperson injector (such as family, friend or partner of the patient) can help mitigate some of these patient-identified and clinician-identified barriers. Alternative LAI-ART delivery methods have the potential to increase the PWH and layperson injector’s confidence, empowerment, convenience, privacy and self-management skills and ultimately facilitate LAI-ART uptake and persistence. Methods and analysis INVITE-Home (innovative administration of long-acting injectables for HIV treatment enhancement at home) will support the expansion of LAI-ART in non-clinical settings by developing, implementing and evaluating a comprehensive, theory-informed training to support the administration of LAI-ART by a trained layperson injector. First, INVITE-Home will design and develop an innovative, theory-based layperson injector training to improve acceptability and uptake of LAI-ART in home-based settings, grounded in qualitative evaluation of training barriers and needs of PWH, layperson injectors and clinicians to develop the training. In Aim 2, INVITE-Home will enhance understanding of home-based LAI-ART using the training, by examining implementation and effectiveness of home-based LAI-ART injections. Ethics and dissemination This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board and the scientific staff of HIV Research Branch, Division of HIV Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, at the Centers for Disease Control and Prevention. Study staff will disseminate findings locally (eg, to partnering clinics, via the UCSF Center for AIDS Prevention Studies’ Community Engagement Core), statewide (eg, the California Department of Public Health’s Office of AIDS) and nationally at conferences related to HIV. Trial registration number NCT06488846.