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An editorial is presented which expresses the views on shifting the narrative of preexposure prophylaxis (PrEP) adherence counseling for cisgender women. Topics include the challenges of achieving high adherence rates for HIV prevention among cisgender women, the effectiveness of daily oral F/TDF PrEP in real-world conditions, and the need for tailored adherence support measures and the development of new PrEP products to address gender-specific barriers to PrEP uptake.

Background Pre-exposure prophylaxis (PrEP) is an effective human immunodeficiency virus (HIV) prevention intervention, but its access and use are suboptimal, especially for women. Healthcare providers provision of PrEP is a key component of the Ending the HIV Epidemic initiative. Although training gaps are an identified barrier, evidence is lacking regarding how to tailor trainings for successful implementation. Title X family planning clinics deliver safety net care for women and are potential PrEP delivery sites. To inform provider training, we assessed PrEP knowledge, attitudes, and self-efficacy in the steps of PrEP care among Title X providers in the Southern United States. Methods We used data from providers in clinics that did not currently provide PrEP from a web-based survey administered to Title X clinic staff in 18 Southern states from February to June 2018. We developed generalized linear mixed models to evaluate associations between provider-, clinic-, and county-level variables with provider knowledge, attitudes, and self-efficacy in PrEP care, guided by the Consolidated Framework for Implementation Research. Results Among 351 providers from 193 clinics, 194 (55%) were nonprescribing and 157 (45%) were prescribing providers. Provider ability to prescribe medications was significantly associated PrEP knowledge, attitudes, and self-efficacy. Self-efficacy was lowest in the PrEP initiation step of PrEP care and was positively associated with PrEP attitudes, PrEP knowledge, and contraception self-efficacy. Conclusions Our findings suggest that PrEP training gaps for family planning providers may be bridged by addressing unfavorable PrEP attitudes, integrating PrEP and contraception training, tailoring training by prescribing ability, and focusing on the initiation steps of PrEP care. [ABSTRACT FROM AUTHOR]

Long-acting injectable (LAI) pre-exposure prophylaxis (PrEP) has the potential to facilitate adherence and transform HIV prevention. However, little LAI PrEP research has occurred among women, who face unique barriers. We conducted 30 in-depth interviews with HIV-negative women from 2017–2018 across six sites (New York; Chicago; San Francisco; Atlanta; Washington, DC; Chapel Hill) of the Women's Interagency HIV Study. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Few women expressed interest in PrEP and when prompted to choose a regimen, 55% would prefer LAI, 10% daily pills, and 33% said they would not take PrEP regardless of formulation. Perceived barriers included: (1) the fear of new—and perceived untested—injectable products and (2) potential side effects (e.g., injection-site pain, nausea). Facilitators included: (1) believing shots were more effective than pills; (2) ease and convenience; and (3) confidentiality. Future studies should incorporate women's LAI PrEP-related experiences to facilitate uptake. [ABSTRACT FROM AUTHOR]

Medications for antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) are currently daily pill regimens, which pose barriers to long-term adherence. Long-acting injectable (LAI) modalities have been developed for ART and PrEP, but minimal LAI-focused research has occurred among women. Thus, little is known about how women's history of injection for medical or nonmedical purposes may influence their interest in LAI. We conducted 89 in-depth interviews at 6 sites (New York, NY; Chicago, IL; San Francisco, CA; Atlanta, GA; Chapel Hill, NC; Washington, DC) of the Women's Interagency HIV study. Interviews occurred with women living with HIV (n = 59) and HIV-negative women (n = 30) from November 2017 to October 2018. Interviews were recorded, transcribed, and analyzed using thematic content analysis. Women's prior experiences with injections occurred primarily through substance use, physical comorbidities, birth control, or flu vaccines. Four primary categories of women emerged; those who (1) received episodic injections and had few LAI-related concerns; (2) required frequent injections and would refuse additional injections; (3) had a history of injection drug use, of whom some feared LAI might trigger a recurrence, while others had few LAI-related concerns; and (4) were currently injecting drugs and had few LAI-related concerns. Most women with a history of injectable medication would prefer LAI, but those with other frequent injections and history of injection drug use might not. Future research needs to address injection-related concerns, and develop patient-centered approaches to help providers best identify which women could benefit from LAI use. [ABSTRACT FROM AUTHOR]

Background: Multipurpose prevention technologies (MPTs) are being developed to simultaneously protect women from unintended pregnancy and sexually transmitted infections (STIs) or human immunodeficiency virus. This study aims to determine MPT characteristics desired by young women in the United States (U.S.). Materials and Methods: This is a cross-sectional national survey administered online by MTurk. Eligibility criteria included female sex, age 18–29 years, U.S. residence, and sexual activity with a male partner in the past 3 months. MPT characteristics were rated for importance. Odds ratios were generated to explore associations between demographics, sexual behaviors, and prior contraceptive use and likelihood of using various MPT formulations. Results: Of 835 women, the largest proportion reported being likely to use MPTs in the form of injectables (45.6%), followed by vaginal gels (33.7%), vaginal rings (26.3%) and diaphragms (17.3%). Women with prior experience using a specific method of contraception appeared more likely to try an MPT of the same form. Women concerned about STIs and unwanted pregnancy, or with a history of such undesirable outcomes, expressed higher likelihood of use for a broad range of products. Women indicated that safety and efficacy at preventing pregnancy were the most important product characteristics when choosing an MPT. Conclusions: MPTs in the form of injectables are most highly desired, but many women would use vaginal methods, highlighting the importance of developing different delivery methods. Women desire safety and emphasize contraceptive efficacy over infection prevention. MPT preferences must be considered during product development to promote future acceptance among young women in the U.S. [ABSTRACT FROM AUTHOR]

Rationale: Assays to quantify antiretrovirals in hair samples are increasingly used to monitor adherence and exposure in both HIV prevention and treatment studies. Atazanavir (ATV) is a protease inhibitor used in combination antiretroviral therapy (ART). We developed and validated a liquid chromatography/tandem mass spectrometry (LC/MS/MS)‐based method to quantify ATV in human hair, per the NIH Division of AIDS Clinical Pharmacology Quality Assurance (CPQA) program and the FDA bioanalytical method validation guidelines. Methods: ATV was extracted from hair using optimized methods and the extracts were injected onto a BDS C‐18 column (5 μm, 4.6 × 100 mm), followed by isocratic elution via a mobile phase composed of 55% acetonitrile, 45% water, 0.15% acetic acid, and 4 mM ammonium acetate, at a flow rate of 0.8 mL/min prior to analysis by MS/MS. Levels were quantified using positive electrospray ionization by multiple reaction monitoring (MRM) for the transitions MH+ m/z 705.3 to m/z 168.0 and MH+ m/z 710.2 to m/z 168.0 for ATV and ATV‐d5 (internal standard), respectively. Results: Our assay demonstrated a linear standard curve (r = 0.99) over the concentration range of 0.0500 ng ATV/mg hair to 20.0 ng/mg hair. The inter‐ and intraday accuracy of ATV quality control (QC) samples was −1.33 to 4.00% and precision (% coefficient of variation (%CV)) was 1.75 to 6.31%. The %CV for ATV levels in hair samples from highly adherent patients (incurred samples) was less than 10%. No significant endogenous peaks or crosstalk were observed in the specificity test with other HIV drugs. The overall extraction efficiency of ATV from incurred hair samples was greater than 95%. Conclusions: This highly sensitive, highly specific and validated assay can be considered for therapeutic drug monitoring for HIV‐infected patients on ATV‐based ART. [ABSTRACT FROM AUTHOR]

Background: Understanding the immune profile of CD4 T cells, the primary targets for HIV, in the female genital tract (FGT) is critical for evaluating and developing effective biomedical HIV prevention strategies in women. However, longitudinal investigation of HIV susceptibility markers expressed by FGT CD4 T cells has been hindered by low cellular yield and risk of sampling-associated trauma. We investigated three minimally invasive FGT sampling methods to characterize and compare CD4 T cell yield and phenotype with the goal of establishing feasible sampling strategies for immune profiling of mucosal CD4 T cells. Methods and results: FGT samples were collected bimonthly from 12 healthy HIV negative women of reproductive age in the following order: 1) Cervicovaginal lavage (CVL), 2) two sequential endocervical flocked swabs (FS), and 3) two sequential endocervical cytobrushes (CB1, CB2). Cells were isolated and phentoyped via flow cytometry. CD4 T cell recovery was highest from each individual CB compared to either CVL or FS (p < 0.0001). The majority of CD4 T cells within the FGT, regardless of sampling method, expressed CCR5 relative to peripheral blood (p < 0.01). Within the CB, CCR5+ CD4 T cells expressed significantly higher levels of α4β7, CD69, and low levels of CD27 relative to CCR5- CD4 T cells (all p < 0.001). We also identified CD4 Treg lineage cells expressing CCR5 among CB samples. Conclusions: Using three different mucosal sampling methods collected longitudinally we demonstrate that CD4 T cells within the FGT express CCR5 and α4β7 and are highly activated, attributes which could act in concert to facilitate HIV acquisition. FS and CB sampling methods can allow for investigation of strategies to reduce HIV target cells in the FGT and could inform the design and interpretation microbicide and vaccine studies in women. [ABSTRACT FROM AUTHOR]

Background: Among women in the United States, non-Latina black women in the South have disproportionately high rates of new HIV infections but low use of pre-exposure prophylaxis (PrEP). Effective strategies to identify factors associated with PrEP eligibility could facilitate improved screening, offering, and uptake of PrEP among US women at risk of HIV. Setting and methods: We applied 2014 CDC criteria for PrEP use to at-risk HIV-negative women enrolled in the Southern US sites (Atlanta, Chapel Hill, Birmingham/Jackson, Miami) of the Women's Interagency HIV Study from 2014 to 2015 to estimate PrEP eligibility and assess PrEP knowledge and acceptability. Factors associated with PrEP eligibility were assessed using multivariable models. Results: Among 225 women, 72 (32%) were PrEP-eligible; the most common PrEP indicator was condomless sex. The majority of PrEP-eligible women (88%) reported willingness to consider PrEP. Only 24 (11%) PrEP-eligible women had previously heard of PrEP, and only 1 reported previous use. Education level less than high school [adjusted odds ratio (aOR) 2.56; 95% confidence interval (CI): 1.22 to 5.37], history of sexual violence (aOR 4.52; 95% CI: 1.52 to 17.76), and medium to high self-perception of HIV risk (aOR 6.76; 95% CI: 3.26 to 14.05) were significantly associated with PrEP eligibility in adjusted models. Conclusions: Extremely low PrEP awareness and use despite a high proportion of eligibility and acceptability signify a critical need to enhance PrEP education and delivery for women in this region. Supplementing CDC eligibility criteria with questions about history of sexual violence and HIV risk self-assessment may enhance PrEP screening and uptake among US women. [ABSTRACT FROM AUTHOR]

Objective: Family planning (FP) clinics are an ideal setting to disseminate information about pre-exposure prophylaxis (PrEP), but little is known about women's preferences for learning about PrEP in this setting.Study Design: We surveyed 500 women seeking care at 4 FP clinics in Atlanta. Before their provider visit, participants completed an HIV-risk screener. After, we asked participants about the HIV prevention counseling they received and how clinics could share information about PrEP. We performed descriptive analyses on demographics, HIV risk, and PrEP awareness/interest, and conducted thematic analysis on open-ended responses.Results: Only 18% knew about PrEP before the study; 28% of 376 sexually-active women had≥1 risk indicator consistent with PrEP eligibility. Three hundred forty seven women (69%) shared suggestions about how clinics should share PrEP information. We categorized suggestions into 4 themes - Advertising, Conversations, Awareness and Access. Participants (n=150) suggested clinics should advertise PrEP via brochures, posters, texts, or emails; 134 wanted providers to talk to patients about PrEP. Several (n=71) suggested sharing PrEP information broadly in the community and with other clinics/providers; others (n=11) wanted improved access to PrEP services.Conclusions: Our results demonstrate overwhelming patient interest in learning more about PrEP through educational materials and directly from FP providers. Women were vocal about increasing PrEP awareness in the community, particularly among populations especially at risk for HIV (e.g., teens). These suggestions can be translated into actionable steps FP clinics can take to increase PrEP awareness and expand their reach to benefit women at risk for HIV.Implications: High HIV rates among women in the South make it imperative to increase awareness of PrEP among women. Atlanta women seeking care in FP clinics valued learning about PrEP and recommended feasible strategies for disseminating information about PrEP in community settings, the clinic or during patient-provider discussion. [ABSTRACT FROM AUTHOR]