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INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) for HIV-1 infection is over 99% effective in protecting against HIV acquisition when used consistently and appropriately. However, PrEP uptake and persistent use remains suboptimal, with a substantial gap in utilization among key populations who could most benefit from PrEP. In Latin America specifically, there is poor understanding of barriers to PrEP uptake and persistence among transgender (trans) women. METHODS: In April-May 2018, we conducted qualitative interviews lasting 25-45 min as part of an end-of-project evaluation of TransPrEP, a pilot RCT that examined the impact of a social network-based peer support intervention on PrEP adherence among trans women in Lima, Peru. Participants in the qualitative evaluation, all adult trans women, included individuals who either (1) screened eligible to participate in the TransPrEP pilot, but opted not to enroll (n = 8), (2) enrolled, but later withdrew (n = 6), (3) were still actively enrolled at the time of interview and/or successfully completed the study (n = 16), or (4) were study staff (n = 4). Interviews were audio recorded and transcribed verbatim. Codebook development followed an immersion/crystallization approach, and coding was completed using Dedoose. RESULTS: Evaluation participants had a mean age of 28.2 years (range 19-47). When describing experiences taking PrEP, participant narratives highlighted side effects that spanned three domains: physical side effects, such as prolonged symptoms of gastrointestinal distress or somnolence; economic challenges, including lost income due to inability to work; and social concerns, including interpersonal conflicts due to HIV-related stigma. Participants described PrEP use within a broader context of social and economic marginalization, with a focus on daily survival, and how PrEP side effects negatively contributed to these stressors. Persistence was, in some cases, supported through the interventions educational workshops. CONCLUSION: This research highlights the ways that physical, economic, and social side effects of PrEP can impact acceptability and persistence among trans women in Peru, amplifying and layering onto existing stressors including economic precarity. Understanding the unique experiences of trans women taking PrEP is crucial to informing tailored interventions to improve uptake and persistence.

INTRODUCTION: HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial. METHODS: Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis. RESULTS: Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules). CONCLUSIONS: Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

BackgroundSub-optimal HbA1c control is a driver of disparities in diabetes outcomes among Hispanic patients. Differences in medication adherence may underlie racial/ethnic differences in HbA1c level.ObjectiveTo examine the relationship between medication adherence and disparities in HbA1c level among Hispanic patients, relative to other racial/ethnic groups, obtaining care in the University of California Health System (UC Health).DesignThis study used clinical, administrative, and prescription dispensing data (January-December 2021) derived from the electronic health records of 5 Academic Medical Centers in UC Health, and linear regression models (LRMs) to conduct a cross-sectional analysis of the association between medication adherence, race/ethnicity, and HbA1c level. Adjusted LRMs were run with and without the measure of medication adherence to assess this relationship.ParticipantsPatients with a UC Health primary care physician (PCP), with ≥ 1 PCP visit within the last 3 years, ages 18-75, reporting Asian, Hispanic, or White race/ethnicity, and who had ≥ 2 encounters with an ICD diagnosis of diabetes or had a prescription for a diabetes medication within the last 2 years, as of 12/31/21 (N = 27, 542; Asian = 6253, Hispanic = 7216, White = 14,073).Main measuresOur measure of medication adherence was the proportion of days covered (PDC) for diabetes medications in 2021. Our outcome was the most recent HbA1c value.Key resultsIn the LRM excluding the PDC, Hispanic ethnicity was positively associated with HbA1c level (β = 0.31, p =

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

BackgroundCisgender women account for 1 in 5 new HIV infections in the United States, yet remain under-engaged in HIV prevention. Women experiencing violence face risk for HIV due to biological and behavioral mechanisms, and barriers to prevention, such as challenges to Pre-Exposure Prophylaxis for HIV Prevention (PrEP) adherence. In this analysis, we aim to characterize intimate partner violence (IPV) among cisgender heterosexual women enrolled in a PrEP demonstration project and assess the associations with PrEP adherence.MethodsAdherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label study of PrEP adherence in HIV-negative cisgender women in Southern California (N = 130) offered daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). From 6/2016 to 10/2018, women completed a survey reporting HIV risk behavior and experiences of any IPV (past 90-days) and IPV sub-types (past-year, lifetime) and biological testing for HIV/STIs at baseline, and concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots at weeks 4, 12, 24, 36, and 48. Outcomes were TFV-DP concentrations consistent with ≥ 4 or ≥ 6 doses/week at one or multiple visits. Multivariable logistic regression models were conducted to examine associations.ResultsPast-90-day IPV was reported by 34.4% of participants, and past-year and lifetime subtypes reported by 11.5-41.5%, and 21.5-52.3%, respectively. Women who engaged in sex work and Black women were significantly more likely to report IPV than others. Lifetime physical IPV was negatively associated with adherence at ≥ 4 doses/week at ≥ 3 of 5 visits, while other relationships with any IPV and IPV sub-types were variable.ConclusionIPV is an indication for PrEP and important indicator of HIV risk; our findings suggest that physical IPV may also negatively impact long-term PrEP adherence.Clinical trials registrationNCT02584140 (ClinicalTrials.gov), registered 15/10/2015.

Hydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested 2 mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center, non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week preintervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; P < 0.001) and sustained (39.7% to 51.4%, P < 0.001). Mean HbF increased (10.95% to 12.78%; P = 0.03). Self-reported pain frequency reduced (3.54 to 3.35 events/year; P = 0.041). InCharge Health was used ≥1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with ≥1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, P = 0.0045) and weeks 25-36 (1.25 events/patient, P = 0.0015). PDC increased with app use (P < 0.001), with the greatest effect in those with private insurance (P = 0.0078), older subjects (P = 0.033), and those with lower pain interference (P = 0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, 4 unreported), only 11.2% used HU Toolbox ≥1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence can potentially improve adherence and provide clinical benefits. A definitive randomized study is warranted. This trial was registered at www.clinicaltrials.gov as #NCT04080167.

BACKGROUND: New oral oncology medications bring novel challenges when patients are initiating treatment. Rates of primary medication nonadherence (PMN), the rate at which a medication is prescribed but not obtained, of up to 30% have been reported for oral oncology medications. More research is needed to identify causes and develop strategies for health system specialty pharmacies (HSSPs) to improve cancer treatment initiation rates. OBJECTIVE: To evaluate the rate and reasons for PMN to specialty oral oncology medications in an HSSP setting. METHODS: We performed a multisite retrospective cohort study across 7 HSSP sites. Patients were included if they had an orally self-administered oncology medication referral generated by the health system of the affiliated specialty pharmacy between May 1, 2020, and July 31, 2020. Data collected at each site using pharmacy software and the electronic health record were deidentified and aggregated for analysis. After identifying unfilled referrals within a 60-day fill window, a retrospective chart review was performed to identify final referral outcomes and reasons for unfilled referrals. Referral outcomes were categorized as unknown fill outcomes (because of being referred to another fulfillment method or if received for benefits investigation only), filled by the HSSP, or not filled. The primary outcome was PMN for each PMN-eligible referral and secondary outcomes included reason for PMN and time to fill. The final PMN rate was calculated by dividing the number of unfilled referrals by total referrals with a known fill outcome. RESULTS: Of 3,891 referrals, 947 were PMN eligible, representing patients with a median age of 65 years (interquartile range = 55-73), near equal distribution between male and female (53% vs 47%), and most commonly with Medicare pharmacy coverage (48%). The most referred medication was capecitabine (14%), and the most common diagnosis was prostate cancer (14%). Among PMN-eligible referrals, 346 (37%) had an unknown fill outcome. Of the 601 referrals with known fill outcome, 69 referrals were true instances of PMN, yielding the final PMN rate of 11%. Most referrals were filled by the HSSP (56%). Patient decision was the most common reason for not filling (25%; 17/69 PMN cases). The median time to fill after initial referral was 5 days (interquartile range = 2-10). CONCLUSIONS: HSSPs have a high percentage of patient initiation of new oral oncology medication treatments in a timely manner. More research is needed to understand patient reasons for deciding not to start therapy and to improve patient-centered cancer treatment planning decisions. DISCLOSURES: Dr Crumb was a planning committee member with Horizon CME for the Nashville APPOS 2022 Conference. Dr Patel received funding and support for attending meetings and/or travel from the University of Illinois Chicago College of Pharmacy.

BackgroundSouth African women experience high levels of alcohol use and HIV infection during the perinatal period. Oral pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV risk. We examined associations between alcohol use and PrEP use during pregnancy and postpartum.MethodsThe PrEP in Pregnant and Postpartum women study is a prospective observational cohort of 1200 HIV-negative pregnant women enrolled at first antenatal care visit and followed through 12 months' postpartum in Cape Town, South Africa. The analytic sample comprised pregnant women who initiated PrEP at baseline and were not censored from study follow-up before 3-month follow-up. We examined associations between any or hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥3) in the year before pregnancy and PrEP continuation and adherence during pregnancy (self-report of missing

BACKGROUND: Timely, accurate adherence data may support oral pre-exposure prophylaxis (PrEP) success and inform prophylaxis choice. We evaluated a Food and Drug Administration (FDA)-approved digital health feedback system (DHFS) with ingestible-sensor-enabled (IS) tenofovir-disoproxil-fumarate plus emtricitabine (Truvada®) in persons starting oral PrEP. METHODS: Human immunodeficiency virus (HIV)-negative adults were prescribed IS-Truvada® with DHFS for 12 weeks to observe medication taking behavior. Baseline demographics, urine toxicology, and self-report questionnaires were obtained. Positive detection accuracy and adverse events were computed as percentages, with Kaplan Meier Estimate for persistence-of-use. In participants persisting ≥28 days, adherence patterns (taking and timing) were analyzed, and mixed-effects logistic regression modeled characteristics associated with treatment adherence. RESULTS: Seventy-one participants were enrolled, mean age 37.6 years (range 18-69), 90.1% male, 77.5% White, 33.8% Hispanic, 95.8% housed, and 74.6% employed. Sixty-three participants (88.7%) persisted ≥28 days, generating 4987 observation days, average 79.2 (29-105). Total confirmed doses were 86.2% (95% confidence interval [CI] 82.5, 89.4), decreasing over time, odds ratio (OR) 0.899 (95% CI .876, .923) per week, P < .001; 79.4% (95% CI 66.7%, 87.3%) of participants had ≥80% adherence. Pattern analysis showed days without confirmed doses clustered (P = .003); regular dose timing was higher among participants with ≥80% confirmed doses (0.828, 95% CI .796 to .859) than among those with

Transgender women experience a disproportionate prevalence of HIV and barriers to linkage to care, retention in care, medication adherence, and viral suppression. As part of a national cooperative agreement funded by the Health Resources and Services Administrations HIV/AIDS Bureau, we searched the literature from January 1, 2010, through June 1, 2020, for English-language articles on interventions designed to improve at least 1 HIV care continuum outcome or address 1 barrier to achieving HIV care continuum outcomes among transgender women diagnosed with HIV in the United States. To be included, articles needed to identify transgender women as a priority population for the intervention. We found 22 interventions, of which 15 reported quantitative or qualitative outcomes and 7 reported study protocols. Recent interventions have incorporated a range of strategies that show promise for addressing pervasive structural and individual barriers rooted in societal and cultural stigma and discrimination against transgender people. Cross-cutting themes found among the interventions included meaningful community participation in the design and implementation of the interventions; culturally affirming programs that serve as a gateway to HIV care and combine gender-affirming care and social services with HIV care; interventions to improve behavioral health outcomes; peer-led counseling, education, and navigation; and technology-based interventions to increase access to care management and online social support. Ongoing studies will further elucidate the efficacy and effectiveness of these interventions, with the goal of reducing disparities in the HIV care continuum and bringing us closer to ending the HIV epidemic among transgender women in the United States.

IntroductionIncreasing administrative workload is linked with lower quality of patient care and physician burnout. Conversely, models involving pharmacists can positively impact patient care and physician well-being. Research has consistently demonstrated that pharmacist-physician collaboration can improve outcomes for chronic diagnoses. Pharmacist-managed refill services may improve provider workload measures and clinical outcomes.MethodsThis was an evaluation of a pharmacist-managed refill service at a Federally Qualified Health Center (FQHC). Under collaborative practice agreement, pharmacists addressed refill requests and recommended interventions. Data analysis evaluated effectiveness of the model, including clinical interventions, and involved descriptive statistics and qualitative approaches.ResultsAverage patient age was 55.5 years old and 53.1% were female. Turnaround time was within 48 h for 87.8% of refill encounters. During an average of 3.2 h per week, pharmacists addressed 9.2% (n = 1683 individual requests in 1255 indirect patient encounters) of the total clinic refill requests during the 1-year study period. In 453 of these encounters (36.1%), pharmacists recommended a total of 642 interventions. 64.8% of these were need for appointment (n = 211) or labs (n = 205). Drug therapy problems and medication list discrepancies were identified in 12.6% (n = 81) and 11.9% (n = 76) of encounters, respectively.Discussion and conclusionsThe results of this study are consistent with previous literature demonstrating the value of interprofessional collaboration. Pharmacists addressed refills in an efficient, clinically effective manner in an FQHC setting. This may positively impact primary care provider workload, patients' medication persistence, and clinical care.

BackgroundTransgender and nonbinary individuals at risk for HIV may benefit from adherence support for pre-exposure prophylaxis.MethodsBetween June 2017 and September 2020, 255 transgender and nonbinary individuals received daily oral tenofovir disoproxil fumarate/emtricitabine for 48 weeks randomized 1:1 to receive individualized Texting for Adherence Building (iTAB) or iTAB plus motivational interviewing (iTAB + MI) through phone for nonadherence. The primary end point was dried blood spot tenofovir diphosphate concentrations at weeks 12 and 48 (or last on-drug study visit) ≥1246 fmol/punch consistent with ≥7 doses/week (ie, near-perfect adherence). Secondary outcomes included dried blood spot tenofovir diphosphate concentrations ≥719 fmol/punch consistent with ≥4 doses/week (ie, adequate adherence) and self-reported adherence by daily text messages.ResultsAdherence for the outcome ≥1246 fmol/punch and ≥719 fmol/punch, respectively, was 49.1% and 57.9% for transgender men, 37.7% and 47.2% for nonbinary individuals, and 31.0% and 44.1% for transgender women. No difference was seen in iTAB + MI compared with iTAB alone by drug levels except where it approached significance in transgender women for the outcome of ≥719 fmol/punch in the iTAB + MI group compared with iTAB only (52% versus 35.7%, P = 0.065). There was a significant difference in self-reported daily dose adherence in the iTAB + MI group compared with iTAB alone (57.9% of days versus 46.4%, P = 0.009). In transgender women, the mean percentage of daily doses taken was 58.5% with iTAB + MI and 37.3% with iTAB alone ( P < 0.001).ConclusionsIn addition to automated approaches to adherence promotion, phone-based MI triggered by repeatedly missing doses may improve pre-exposure prophylaxis adherence among transgender women.

BackgroundDaily dosing of tenofovir disoproxil fumarate, with or without emtricitabine, has high efficacy in preventing human immunodeficiency virus (HIV) infection when individuals are adherent. The target protective plasma concentration of tenofovir (TFV), however, is not fully understood. The aim of this study is to estimate the protective TFV plasma concentration.MethodsParticipant data from TFV-based daily oral and topical active arms of phase 3 trials (iPrEx, VOICE, and Partners PrEP) were pooled (n = 2950). Individual specific risk scores (low and high risk) of acquiring HIV, based on an earlier placebo analysis, were created. Longitudinal TFV pharmacokinetics (PK), HIV outcome, individual risk scores and the effect of sex at birth data were integrated and analyzed using non-linear mixed effects models.ResultsAround 50% of the individuals were estimated to be adherent, which differed from self-reported adherence (∼90%) and large variation between longitudinal adherence patterns were identified. Following oral administration, the estimated protective TFV trough concentration was substantially higher in high-risk females (45.8 ng/mL) compared with high-risk males (16.1 ng/mL) and to low-risk individuals (∼7.5 ng/mL). Dosing simulations indicated that high-risk women require full adherence to maintain protective levels.ConclusionsUsing the largest PK-HIV outcome database to date, we developed a population adherence-PK-risk-outcome model. Our results indicate that high-risk females need higher levels of plasma TFV to achieve HIV protection compared with males. HIV protection exceeds 90% in all populations if daily adherence is achieved.

ObjectivesTo explore the associations between intersectional poverty, HIV, sex, and racial stigma, adherence to antiretroviral therapy (ART), and viral suppression among women with HIV (WHIV).DesignWe examined intersectional stigmas, self-report ART adherence, and viral suppression using cross-sectional data.MethodsParticipants were WHIV ( N  = 459) in the Women's Adherence and Visit Engagement, a Women's Interagency HIV Study substudy. We used Multidimensional Latent Class Item Response Theory and Bayesian models to analyze intersectional stigmas and viral load adjusting for sociodemographic and clinical covariates.ResultsWe identified five intersectional stigma-based latent classes. The likelihood of viral suppression was approximately 90% lower among WHIV who experienced higher levels of poverty, sex, and racial stigma or higher levels of all intersectional stigmas compared with WHIV who reported lower experiences of intersectional stigmas. ART adherence accounted for but did not fully mediate some of the associations between latent intersectional stigma classes and viral load.ConclusionThe negative impact of intersectional stigmas on viral suppression is likely mediated, but not fully explained, by reduced ART adherence. We discuss the research and clinical implications of our findings.

Little is known about gender effects of alcohol and drug use (AOD) among people living with HIV (PLWH) in resource-limited settings. Using multilevel models, we tested whether gender moderated the effect of Khanya, a cognitive-behavioral therapy-based intervention addressing antiretroviral (ART) adherence and AOD reduction. We enrolled 61 participants from HIV care and examined outcomes at 3- and 6-months compared to enhanced treatment as usual (ETAU). Gender significantly moderated the effect of Khanya on ART adherence (measured using electronically-monitored and biomarker-confirmed adherence), such that women in Khanya had significantly lower ART adherence compared to men in Khanya; no gender differences were found for AOD outcomes. Exploratory trajectory analyses showed men in Khanya and both genders in ETAU had significant reductions in at least one AOD outcome; women in Khanya did not. More research is needed to understand whether a gender lens can support behavioral interventions for PLWH with AOD.Trial registry ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.

Couple relationships can be leveraged to improve adherence to antiretroviral therapy (ART), but few studies have identified relationship factors to target in interventions in sub-Saharan Africa. We conducted a cross-sectional study with 211 couples in southern Malawi with at least one partner on ART to test for associations between ART adherence and relationship dynamics (intimacy, trust, relationship satisfaction, unity, commitment, and partner support). We measured ART adherence through subjective measures (patient and partner reports) and an objective measure (ART drug levels in hair) and hypothesized that more positive relationship dynamics (e.g., higher intimacy) would be associated with better adherence. Multi-level logistic and linear regression models were used to evaluate study hypotheses, controlling for the clustering of individuals within couples. High levels of adherence were found by all three measures. Unity, satisfaction, and partner support were associated with higher patient and partner reports of adherence, and additional relationship dynamics (intimacy, trust) were associated with higher partner reported adherence. No associations were found between relationship dynamics and drug levels in hair, although drug levels were high overall. Future studies should perform longitudinal assessments of relationship dynamics and objective metrics of adherence, and examine these associations in populations with lower adherence levels such as young women or individuals starting ART.

BackgroundWe examined change in antiretroviral treatment (ART) adherence after breastfeeding (BF) cessation using hair tenofovir (TFV) concentrations as an objective metric of medication consumption.MethodsA subset of postpartum women in Zimbabwe randomized in IMPAACT PROMISE to take ART while BF and post-BF cessation had hair TFV measured longitudinally. Using linear mixed-effect models, we estimated differences in hair TFV levels after BF cessation, accounting for trends in levels over time regardless of BF status and change in slope after breastfeeding cessation. We also estimated the relative risk of viremia (>50 copies/mL) per doubling of hair TFV concentration.ResultsAmong 55 women (median age 26, interquartile range 24-29 years), hair TFV levels (n = 305) were available for a median of 9 visits per woman between 3 and 29 months postpartum. Hair TFV levels ranged from undetected to 0.25 ng/mg (median 0.04 ng/mg). Controlling for trends since delivery [decline of 2.2% per month, 95% confidence interval (CI): -5.3 to 1.0], TFV levels averaged 24.4% higher (95% CI: -5.1 to 63.1) post-BF cessation than during BF, with no change in slope (0.0% per month, 95% CI: -3.8 to 3.9). Postpartum, 42% of women were ever viremic. Higher TFV levels were strongly protective; relative risk of viremia per doubling of TFV was 0.52 (95% CI: 0.43 to 0.63; P < 0.0001).ConclusionsLeveraging an objective metric of ART use, we observed modestly declining adherence across the postpartum period, but no additional decline associated with breastfeeding cessation. High viremia frequency and varying postpartum TFV levels observed highlight the importance of enhanced adherence support with viral load monitoring among postpartum women.

BACKGROUND: Adolescent girls and young women in southern and eastern Africa have adherence challenges with daily oral HIV pre-exposure prophylaxis (PrEP). High adherence is most important during periods of HIV risk (prevention-effective adherence). We aimed to describe HIV risk behaviour and to understand patterns in PrEP adherence during periods of risk among adolescent girls and young women from sub-Saharan Africa. METHODS: We did a secondary analysis of the HPTN 082 trial, an open-label, interventional, randomised controlled trial of sexually active adolescent girls and young women (aged 16-25 years) testing negative for HIV in Johannesburg and Cape Town, South Africa, and in Harare, Zimbabwe. The primary outcomes were high cumulative PrEP adherence, dichotomised as intracellular tenofovir diphosphate concentrations of at least 700 fmol/punch in dried blood spots at weeks 13, 26, and 52, and high recent PrEP adherence, dichotomised as plasma tenofovir concentrations of at least 40 ng/mL at weeks 13, 26, and 52, among participants who accepted PrEP. We collected data on sexual behaviour every 3 months. We categorised visits into a binary variable of any HIV risk based on condomless sex, more than one sexual partner, primary partners HIV status and antiretroviral use, transactional sex, drug or alcohol use around sexual activity, and laboratory-diagnosed STIs. We used generalised estimating equations to evaluate associations between HIV risk (reflecting behaviour during the previous 3 months) and high cumulative and recent adherence to PrEP and any PrEP use (quantifiable drug concentrations). The trial is registered with ClinicalTrials.gov, NCT02732730. FINDINGS: Between Oct 12, 2016, and Oct 25, 2018, 451 women were recruited, and 427 participants (median age 21·0 years [IQR 19·0-22·0]) were eligible for inclusion in this analysis. The proportion of participants reporting at least one HIV risk factor decreased significantly over follow-up, from 364 (85%) participants at enrolment, 226 (60%) at week 13, and 243 (65%) at week 26, to 224 (61%) at week 52 (p

PURPOSE: Oral anti-cancer medications are increasingly common and endocrine therapies represent the most common oral anti-cancer medications in breast cancer. Adjuvant endocrine therapies reduce the likelihood of recurrence and mortality in the approximately 80% of women diagnosed with hormone-receptor-positive breast cancer, thus rendering adherence essential. Real-time medication adherence monitors, such as the Wisepill electronic pillbox, transmit adherence data remotely, allowing for early intervention for non-adherence. However, their feasibility and acceptability have yet to be examined among breast cancer survivors taking endocrine therapies. METHODS: This study presents quantitative patient-report and technical support data and qualitative patient acceptability data on Wisepill, a common real-time adherence monitor, among 88 breast cancer survivors prescribed adjuvant endocrine therapy. RESULTS: This mixed-methods study of a common real-time adherence monitor, among the first in breast cancer survivors taking adjuvant endocrine therapy, demonstrates its technical feasibility and patient acceptability. CONCLUSION: The use of wireless medication monitors that transmit real-time adherence data is uniquely promising for maximizing the benefits of adjuvant endocrine therapy by allowing for continuous tracking, ongoing communication with oncologic or research teams, and early intervention. This study demonstrates the feasibility and patient acceptability of one such real-time adherence monitor.

BackgroundHIV endpoint-driven clinical trials provide oral pre-exposure prophylaxis (PrEP) as HIV prevention standard of care. We evaluated quantifiable plasma tenofovir among South African women who used oral PrEP during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial.MethodsECHO, a randomized trial conducted in 4 African countries between 2015 and 2018, assessed HIV incidence among HIV-uninfected women, aged 16-35 years, randomized to 1 of 3 contraceptives. Oral PrEP was offered onsite as part of the HIV prevention package at the South African trial sites. We measured tenofovir in plasma samples collected at the final trial visit among women reporting ongoing PrEP use. We used bivariate and multivariate logistical regression to assess demographic and sexual risk factors associated with plasma tenofovir quantification.ResultsOf 260 women included, 52% were ≤24 years and 22% had Chlamydia trachomatis at enrollment. At PrEP initiation, 68% reported inconsistent/nonuse of condoms. The median duration of PrEP use was 90 days (IQR: 83-104). Tenofovir was quantified in 36% (n = 94) of samples. Women >24 years had twice the odds of having tenofovir quantified vs younger women (OR = 2.12; 95% confidence interval = 1.27 to 3.56). Women who reported inconsistent/nonuse of condoms had lower odds of tenofovir quantification (age-adjusted OR = 0.47; 95% confidence interval = 0.26 to 0.83).ConclusionsOver a third of women initiating PrEP and reporting ongoing use at the final trial visit had evidence of recent drug exposure. Clinical trials may serve as an entry point for PrEP initiation among women at substantial risk for HIV infection with referral to local facilities for ongoing access at trial end.Clinical trial numberNCT02550067.

BackgroundOral anti-cancer treatments such as adjuvant endocrine therapies (AET) for breast cancer survivors are commonly used but adherence is a challenge. Few low-touch, scalable interventions exist to increase ET adherence.PurposeTo evaluate the acceptability, feasibility, and initial efficacy of a low-touch, remotely-delivered values plus AET education intervention (REACH) to promote AET adherence.MethodsA mixed-methods trial randomized 88 breast cancer survivors 1:1 to REACH or Education alone. Wisepill real-time electronic adherence monitoring tracked monthly AET adherence during a 1-month baseline through 6-month follow-up (FU) (primary outcome). Patient-reported outcomes were evaluated through 3- and 6-month FU (secondary). Multiple indices of intervention feasibility and acceptability were evaluated. Qualitative exit interviews (n = 38) further assessed participants' perceptions of feasibility/acceptability and recommendations for intervention adaptation.ResultsThe trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention sessions, and "good" intervention satisfaction ratings on average. For Wisepill-assessed AET adherence, REACH outperformed Education for Month 1 of FU (p = .027) and not thereafter. Participants in REACH maintained high adherence until Month 4 of FU, whereas in Education, adherence declined significantly in Month 1. Conditions did not differ in self-reported adherence, positive affective attitudes, future intentions, or necessity beliefs. REACH trended toward less negative AET attitudes than Education at 3-month FU (p = .057) reflecting improvement in REACH (p = .004) but not Education (p = .809). Exploratory moderator analyses showed that average to highly positive baseline AET affective attitudes and oncologist-patient communication each predicted higher adherence following REACH than Education; low levels did not. Participants identified recommendations to strengthen the interventions.ConclusionsREACH, a low-touch values intervention, showed good feasibility and acceptability, and initial promise in improving objectively-assessed AET adherence among breast cancer survivors (relative to education alone). Future research should target improving REACH's tailoring and endurance.

In order to understand HIV-positive Malawian adults' experiences with hypertension management, we conducted qualitative interviews with 30 hypertensive adults who were also taking antiretroviral therapy. These interviews regarding hypertension management behaviours and beliefs were audio-recorded, transcribed, translated into English, and coded in Atlas.ti. Despite acknowledging the dangers of hypertension and the benefits of medication, many respondents missed their antihypertensive medication. Primary reasons included feeling healthy, health workers' advice to stop taking medicine when blood pressure normalised, side effects, and using herbs or non-prescription medicines to manage hypertension. Women highlighted difficulties with dietary modifications, and changes in their social relationships. Both men and women spoke about hypertension-related challenges with employment and household economics. These results suggest numerous challenges among adults managing hypertension and HIV in Malawi, and frequent suboptimal adherence to medication. We identified new key themes - the quality of adherence counselling for antihypertensive medication, the effects of hypertension on financial stability, and the role of social relationships in self-care - and encourage further investigation into these topics in low-income, high-burden countries.

PurposeThis study aimed to evaluate associations between outpatient low-density lipoprotein cholesterol (LDL-C) testing and subsequent statin adherence and intensification in patients after an atherosclerotic cardiovascular (ASCVD) event.MethodsThis was a longitudinal study of adult members of Kaiser Permanente Northern California hospitalized with an ASCVD event (myocardial infarction or stroke) during January 01, 2016, to December 31, 2017, with follow-up through December 31, 2019. Outcomes were statin adherence (estimated using continuous medication gap [CMG]) and intensification (defined by an increased dose or switch to a higher-intensity statin) based on pharmacy dispensing. The exposure of interest was first outpatient LDL-C test after an ASCVD event. Baseline for follow-up was LDL-C test date or a date assigned using incidence density sampling. Multivariate logistic regression models were specified to estimate the odds ratios for statin adherence or intensification among those with vs without an LDL-C test, with adjustment for age, sex, race/ethnicity, smoking, hypertension, diabetes, body mass index, and estimated glomerular filtration rate.ResultsThere were 19,604 adults hospitalized with ASCVD, including 7054 adults not on high-intensity statins. The mean age was 69.5 years and 33.0% were female. Prevalence of good adherence (continuous medication gap ≤20%) was significantly higher (80.2% vs 75.9%; odds ratio 1.38; 95% confidence interval, 1.28-1.49; P

Introduction: Effective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub‐Saharan Africa. The MTN‐034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings. Methods: REACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV‐negative AGYW (ages 16–21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug‐level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check‐ins, peer support clubs, "peer buddies" and additional counselling. Counsellors documented adherence support choices and counselling content on standardized forms. Through focus groups, serial in‐depth interviews (IDIs) and single IDIs (n = 119 total), we explored participants' experiences with adherence support and how it encouraged product use. Results: Participants received counselling at nearly all visits. DLF was provided at 54.3% of sessions and, across sites, 49%–68% received results showing high adherence for oral PrEP, and 73%–89% for the ring. The most popular support strategies were in‐person clubs and weekly calls, followed by online clubs, additional counselling and SMS. Preferences differed across sites but were similar for both products. Qualitative results demonstrated that the REACH strategies supported adherence by providing information about HIV and PrEP, continually motivating participants, and supporting the development of behavioural skills and self‐efficacy, aligning with the Information, Motivation, and Behavioural Skills (IMB) model. Effectiveness was supported by three foundational pillars: strong interpersonal relationships with counsellors; ongoing, easily accessible support and resources; and establishing trust in the counsellors and study products through counsellor relationships, peer‐to‐peer exchange and DLF. Conclusions: Implementation programmes could support effective PrEP use by offering a small menu of counsellor‐ and peer‐based support options that are youth‐friendly and developmentally appropriate. The same menu options can support both ring and oral PrEP users, though content should be tailored to the individual products. [ABSTRACT FROM AUTHOR]

IntroductionInnovations are needed for preventing cardiovascular disease (CVD) and for reaching diverse communities in remote regions. The current study reports on a telemedicine-delivered intervention promoting a traditional heart-healthy diet and medication adherence with Alaska Native men and women residing in the Norton Sound region of Alaska.MethodsParticipants were 299 men and women with high blood pressure or high cholesterol smoking daily who were randomized to receive telemedicine-delivered counseling and printed materials on diet and medication adherence or on smoking and physical activity. Intervention contacts were at baseline and 3-, 6-, and 12-months follow-up, with a final assessment at 18 months. Nutrition outcomes were the ratio of heart-healthy foods and traditional heart-healthy foods relative to all foods reported on a 34-item food frequency questionnaire. Recent and typical adherence for heart medications were self-reported.ResultsIntervention effects were significant for the heart-healthy foods ratio at 6 months only (p = 0.014) and significant for the traditional heart-healthy foods ratio at 6 months only for those aged 47+ (p = 0.031). For recent and typical medication adherence, there were no significant group differences by time.DiscussionIn a remote region of Alaska, telemedicine proved feasible and acceptable for engaging Alaska Native men and women in counseling on CVD risk behaviors. The findings indicate that more touchpoints may be necessary to impart comprehensive lasting change in heart-healthy eating patterns. Medication adherence group differences were not significant; however, medication adherence was high overall.

BackgroundMother-to-infant transmission of HIV is a major problem in Sub-Saharan Africa despite free or subsidized antiretroviral treatment (ART), but is significantly reduced when mothers adhere to ART. Because potable water access is limited in low-resource countries, we investigated water access and ART adherence intention among HIV-positive pregnant women and new mothers in Zambia.MethodsOur convenience sample consisted of 150 pregnant or postpartum women receiving ART. Descriptive statistics compared type of water access by low and high levels of ART adherence intention.ResultsMost (71%) had access to piped water, but 36% of the low-adherence intention group obtained water from a well, borehole, lake or stream, compared to only 22% of the high-adherence intention group. The low-adherence intention group was more rural (62%) than urban (38%) women but not statistically significant [unadjusted Prevalence Ratio (PR) 0.73, 95% CI: 0.52-1.02; adjusted PR 1.06, 95% CI: 0.78-1.45].ConclusionProviding potable water may improve ART adherence. Assessing available water sources in both rural and urban locations is critical when educating women initiating ART.

BackgroundAdherence to antiretroviral treatment (ART) among postpartum women with HIV is essential for optimal health and prevention of perinatal transmission. However, suboptimal adherence with subsequent viremia is common, and adherence challenges are often underreported. We aimed to predict viremia to facilitate targeted adherence support in sub-Saharan Africa during this critical period.MethodsData are from PROMISE 1077BF/FF, which enrolled perinatal women between 2011 and 2014. This analysis includes postpartum women receiving ART per study randomization or country-specific criteria to continue from pregnancy. We aimed to predict viremia (single and confirmed events) after 3 months on ART at >50, >400, and >1000 copies/mL within 6-month intervals through 24 months. We built models with routine clinical and demographic data using the least absolute shrinkage and selection operator and SuperLearner (which incorporates multiple algorithms).ResultsAmong 1321 women included, the median age was 26 years and 96% were in WHO stage 1. Between 0 and 24 months postpartum, 42%, 31%, and 28% of women experienced viremia >50, >400, and >1000 copies/mL, respectively, at least once. Across models, the cross-validated area under the receiver operating curve ranged from 0.74 [95% confidence interval (CI): 0.72 to 0.76] to 0.78 (95% CI: 0.76 to 0.80). To achieve 90% sensitivity predicting confirmed viremia >50 copies/mL, 64% of women would be classified as high risk.ConclusionsUsing routinely collected data to predict viremia in >1300 postpartum women with HIV, we achieved moderate model discrimination, but insufficient to inform targeted adherence support. Psychosocial characteristics or objective adherence metrics may be required for improved prediction of viremia in this population.

BackgroundTRIUMPH (Trans Research-Informed communities United in Mobilization for the Prevention of HIV) was a community-led, transgender-specific pre-exposure prophylaxis (PrEP) demonstration project at 2 community-based clinical sites in California. TRIUMPH used peer health education, community mobilization, and clinical integration of PrEP with hormone therapy to promote PrEP knowledge and acceptability. The goal of this study was to evaluate PrEP uptake, retention, and adherence among TRIUMPH participants and examine site-based differences.MethodsEligible participants were adult transgender and gender diverse people interested in PrEP. Participants were seen at baseline and at 1, 3, 6, 9, and 12 months for PrEP provision, clinical visits, and HIV testing. PrEP uptake was defined as dispensation of PrEP, PrEP retention was defined as proportion of expected visits completed among those who initiated PrEP, and PrEP adherence was assessed by measuring tenofovir diphosphate concentrations in dried blood spots. Logistic regression models quantified the association of variables with PrEP outcomes.ResultsTRIUMPH enrolled 185 participants; the median age was 28 years (interquartile range: 23-35), 7% was Black, and 58% was Latinx. PrEP uptake was as follows: 78% in Oakland and 98% in Sacramento; 91% among trans women, 96% among trans men, and 70% among nonbinary participants. Almost half (47%) rarely/never believed about HIV, and 42% reported condomless sex act in the past 3 months. Participants who reported higher numbers of sex partners were more likely to be retained and adherent; other predictors of adherence included not having a primary partner and not experiencing violence in the past 3 months.ConclusionsThis community-led, trans-specific PrEP demonstration project documents high levels of PrEP initiation in a young transgender and gender diverse cohort at risk of HIV acquisition.

PrEP is safe and effective but requires adherence during potential HIV exposure, yet the facilitators of long-term maternal adherence are not well understood. We conducted semi-structured interviews with 25 postpartum women who reported high adherence (PrEP use ≥ 25 days in last 30-days and never missed a PrEP prescription in pregnancy/postpartum period) within a PrEP service for pregnant and postpartum women. A thematic approach guided an iterative process of coding and analysis. Themes identified as drivers of optimal PrEP use were HIV risk perception, mainly because of partner's behaviors and unknown serostatus, and a strong desire to have a baby free of HIV. Reported disclosure of PrEP use facilitated PrEP adherence. Women discussed having partner and family support, which included reminders to take PrEP daily. Primary barriers were anticipated or experienced stigma, overcome through education of partners and family about PrEP. Pregnant women experienced transient side-effects, but found ways to continue, including taking PrEP at night. PrEP programs for pregnant and postpartum women should integrate strategies to assist women with realistic appraisals of risk and teach skills for disclosure and securing support from significant others.

Little information is known about the cisgender women who seek and initiate pre-exposure prophylaxis (PrEP) for HIV prevention in the United States. Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week single-arm open-label demonstration study of daily oral tenofovir disoproxil fumaratel emtricitabine (TDF/FTC) in cisgender women ≥ 18 years old at risk for HIV. Participants were surveyed at screening and enrollment about sociodemographics, HIV risk perception and behaviors, and PrEP perspectives and aggregated into three risk groups according to HIV sexual risk behavior: being in a serodiscordant partnership (SD), engaging in sex work (SW), and having partners with unknown HIV status at risk for HIV (UP). One hundred sixty-seven women presented for screening with n = 31 screen failures. Of the 162 women completing enrollment, mean age was 40 (standard deviation 11), with 41% non-Hispanic Black, 22% non-Hispanic White, and 19% Latina. Compared with those who screened ineligible, enrolled participants were more likely to have heard of PrEP, had higher HIV risk perception, and reported higher perceived PrEP efficacy. Sixty-four women (47%) were categorized as SD, 21 (15%) as SW, and 51 (38%) as UP. The SW were more likely to report higher levels of drinking and drug use (p = 0.002) and history of intimate partner violence in the past year (p

Individuals with sickle cell disease (SCD) experience neurocognitive decline, low medication adherence, increased unemployment, and difficulty with instrumental activities of daily living (IADL). The relationship between self-perceived cognitive difficulties and IADLs, including employment, school enrollment, independence, engagement in leisure activities, and medication adherence is unknown. We hypothesized that self-reported difficulties across neurocognitive areas would predict lower IADL skills. Adolescent and adult participants of the multi-site Sickle Cell Disease Implementation Consortium (SCDIC) (n = 2436) completed patient-reported outcome (PRO) measures of attention, executive functioning, processing speed, learning, and comprehension. Cognitive symptoms were analyzed as predictors in multivariable modeling. Outcome variables included 1) an IADL composite that consisted of employment, participation in school, reliance on others, and leisure pursuits, and 2) hydroxyurea adherence. Participants reported cognitive difficulty across areas of attention (55%), executive functioning (51%), processing speed (57%), and reading comprehension (65%). Executive dysfunction (p

BackgroundTuberculosis (TB) disproportionately affects marginalized and impoverished homeless adults. Although active TB can be prevented by treating latent TB infection (LTBI), individual factors, such as high prevalence of depression and anxiety, drug and alcohol use, and unstable housing, lead to poor LTBI treatment adherence and completion among homeless adults.ObjectivesWe hypothesized that the delivery of a tailored nurse-led, community health worker (RN/CHW) program across the LTBI continuum of care (e.g., screening, diagnosis, and treatment) that delivers 3HP treatment (3HP: rifapentine plus isoniazid) for homeless adults (e.g., sheltered and unsheltered) and is tailored to their health and social service needs will overcome existing treatment completion barriers. We also hypothesized that mental health symptoms (e.g., depression and anxiety), drug use score, and problematic alcohol use will decline over time among clients receiving this treatment.MethodsWe assessed the effect of delivering a theoretically guided, RN/CHW-based, single-arm study among eligible LTBI-positive homeless adults (N = 50) on completion of a weekly, directly observed, 12-dose 3HP LTBI treatment in Central City East (Skid Row). Completing 3HP treatment was compared to the only known historical, clinic-based control that obtained 65% completion among homeless adults. Secondary outcomes included drug and alcohol use, depression, and anxiety.ResultsThe RN/CHW program achieved a 91.8% 3HP treatment completion rate among homeless adults. Younger homeless adults (

Stigma in health care settings can have negative consequences on women living with HIV, such as increasing the likelihood of missed visits and reducing trust in their clinical providers. Informed by prior stigma research and considering knowledge gaps related to the effect of patient-provider race concordance, we conducted this study to assess if patient-provider race concordance moderates the expected association between HIV-related stigma in health care settings and patients' trust in their providers. Moderation analyses were conducted using Women's Interagency HIV Study data (N = 931). We found significant main effects for patient-provider race concordance. Higher experienced stigma was associated with lower trust in providers in all patient-provider race combinations [White-White: B = -0.89, standard error (SE) = 0.14, p = 0.000, 95% confidence interval, CI (-1.161 to -0.624); Black patient-White provider: B = -0.19, SE = 0.06, p = 0.003, 95% CI (-0.309 to -0.062); and Black-Black: B = -0.30, SE = 0.14, p = 0.037, 95% CI (-0.575 to -0.017)]. Higher anticipated stigma was also associated with lower trust in providers [White-White: B = -0.42, SE = 0.07, p = 0.000, 95% CI (-0.552 to -0.289); Black patient-White provider: B = -0.17, SE = 0.03, p = 0.000, 95% CI (-0.232 to -0.106); and Black-Black: B = -0.18, SE = 0.06, p = 0.002, 95% CI (-0.293 to -0.066)]. Significant interaction effects indicated that the negative associations between experienced and anticipated HIV-related stigma and trust in providers were stronger for the White-White combination compared with the others. Thus, we found that significant relationships between HIV-related experienced and anticipated stigma in health care settings and trust in providers exist and that these associations vary across different patient-provider race combinations. Given that reduced trust in providers is associated with antiretroviral medication nonadherence and higher rates of missed clinical visits, interventions to address HIV-related stigma in health care settings may improve continuum of care outcomes.

BackgroundDaily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women.MethodsAdherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence.ResultsFrom June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections.ConclusionAdequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.

BackgroundThe postpartum year is a vulnerable period for women with opioid use disorder, with increased rates of fatal and nonfatal overdose; however, data on the continuation of medications for opioid use disorder on a population level are limited.ObjectiveThis study aimed to examine the effect of discontinuing methadone and buprenorphine in women with opioid use disorder in the year following delivery and determine the extent to which maternal and infant characteristics are associated with time to discontinuation of medications for opioid use disorder.Study designThis population-based retrospective cohort study used linked administrative data of 211,096 deliveries in Massachusetts between 2011 and 2014 to examine the adherence to medications for opioid use disorder. Individuals receiving medications for opioid use disorder after delivery were included in the study. Here, demographic, psychosocial, prenatal, and delivery characteristics are described. Kaplan-Meier survival analysis and Cox regression modeling were used to examine factors associated with medication discontinuation.ResultsA total of 2314 women who received medications for opioid use disorder at delivery were included in our study. Overall, 1484 women (64.1%) continued receiving medications for opioid use disorder for a full 12 months following delivery. The rate of continued medication use varied from 34% if women started on medications for opioid use disorder the month before delivery to 80% if the medications were used throughout pregnancy. Kaplan-Meier survival curves differed by maternal race and ethnicity (the 12-month continuation probability was .65 for White non-Hispanic women and .51 for non-White women; P

ObjectiveTo estimate the prevalence, risk factors, and consequences of cost-related medication nonadherence (CRN) in individuals with chronic liver diseases (CLDs) in the United States.Patients and methodsUsing the National Health Interview Survey from January 1, 2014, to December 31, 2018, we identified individuals with CLDs. Using complex weighted survey analysis, we obtained national estimates and risk factors for CRN and its association with cost-reducing behaviors and measures of financial toxicity. We evaluated the association of CRN with unplanned health care use, adjusting for age, sex, race/ethnicity, insurance, income, education, and comorbid conditions.ResultsOf 3237 respondents (representing 4.6 million) US adults with CLDs, 813 (representing 1.2 million adults, or 25%; 95% CI, 23% to 27%) reported CRN, of whom 68% (n=554/813) reported maladaptive cost-reducing behaviors. Younger age, female sex, low income, and multimorbidity were associated with a higher prevalence of CRN. Compared with patients without CRN, patients experiencing CRN had 5.1 times higher odds of financial hardship from medical bills (adjusted odds ratio [aOR], 5.05; 95% CI, 3.73 to 6.83) and 2.9 times higher odds of food insecurity (aOR, 2.85; 95% CI, 2.02 to 4.01). The CRN was also associated with 1.5 times higher odds of emergency department visits (aOR, 1.46; 95% CI, 1.11 to 1.94).ConclusionWe observed a high prevalence of CRN and associated consequences such as high financial distress, financial hardship from medical bills, food insecurity, engagement in maladaptive cost-reducing strategies, increased health care use, and work absenteeism among patients with CLD. These financial determinants of health have important implications in the context of value-based care.

Objective methods of measuring antiretroviral adherence are limited. We assessed the relationship between tenofovir disoproxil fumarate (TDF) hair concentrations, self-reported adherence, and virological outcomes in HIV-infected adolescents in Harare, Zimbabwe. HIV-infected adolescents on atazanavir/ritonavir-based second-line treatment for >6 months with viral load (VL) ≥1,000 copies/mL were randomized to either modified directly administered antiretroviral therapy (mDAART) or standard of care. Hair and VL samples were collected at baseline and after 90 days. Treatment outcome was defined as TDF concentrations in hair. Virological suppression was defined as VL

BackgroundTenofovir alafenamide (TAF) is increasingly used in HIV treatment, with or without agents that require pharmacologic boosters such as ritonavir/cobicistat. Boosters increase TAF levels, so the TAF dose is lowered in single-pill combinations. We hypothesized that individuals on dose-adjusted boosted TAF would have similar urine tenofovir (TFV) concentrations to those on unboosted TAF.Setting/methodsWe collected urine samples from patients with HIV on TAF, with evidence of virologic suppression and high self-reported adherence at 2 San Francisco clinics from June 2019 to January 2020. We measured urine TFV levels by liquid chromatography/tandem mass spectrometry and used linear regression to compare natural log-transformed urine TFV levels for patients on boosted versus unboosted TAF.ResultsOur analysis included 30 patients on unboosted TAF (25 mg daily TAF) and 15 on boosted TAF (12 on 10 mg daily TAF and 3 on 25 mg daily TAF). Patients on unboosted vs. boosted TAF had similar baseline age, weight, sex, and creatinine. In unadjusted univariate linear regression, there were no significant differences in urine TFV levels based on presence/absence of boosting after TAF dose reduction to 10 mg (geometric mean ratio 1.07; 95% confidence interval: 0.53 to 2.16). This finding was unchanged in adjusted analysis.ConclusionsNo significant differences in urine TFV levels were seen for patients on unboosted vs. boosted dose-reduced TAF. These results have important implications for our forthcoming point-of-care urine immunoassay for TAF, implying that separate adherence cutoffs will not be necessary for patients on boosters and dose-reduced TAF. A single POC TAF immunoassay will, thus, support monitoring on most TAF-based antiretroviral therapy.

BackgroundSafe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection.MethodsWe conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection.ResultsThe intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified.ConclusionsCAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).

ObjectiveThis study aims to assess the product-related, relationship-related, and sex-related factors that act as facilitators and barriers to the acceptability of a vaginal ring (VR) for HIV prevention among adolescent girls.DesignQualitative study.MethodsNinety-six girls aged 15-17 years from 6 urban US sites were enrolled in MTN-023/IPM 030, a 24-week randomized controlled trial, for assessing the safety and acceptability of a dapivirine VR for HIV prevention. At week 24, 21 girls were randomly selected to participate in in-depth interviews. Interviews were transcribed verbatim and data analyzed using a thematic analysis approach. Facilitators and barriers to VR acceptability related to participants' relationships, sexual activity, and characteristics of the VR product were identified.ResultsFactors related to relationships rarely seemed to act as barriers to VR acceptability; most participants disclosed VR use to sexual partners, and positive reactions from sexual partners, which were common, seemed to facilitate VR acceptability. Emotional and/or physical discomfort surrounding VR use during sex was mentioned occasionally as a barrier to VR acceptability. Product characteristics were most frequently mentioned as barriers to VR acceptability. Many participants reported concerns about the large size of the VR on first impression. Although most found the VR comfortable, some reported pain with VR insertion. Several participants were concerned about VR cleanliness, particularly during menstruation.ConclusionProduct considerations, specifically size and use during menstruation, were the most commonly reported barriers to VR acceptability in this study. Adolescent girls may require additional counseling to assuage product concerns regarding a VR for HIV prevention.

Abstract Introduction Effective use of pre‐exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub‐Saharan Africa. The MTN‐034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings. Methods REACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV‐negative AGYW (ages 16–21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug‐level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check‐ins, peer support clubs, “peer buddies” and additional counselling. Counsellors documented adherence support choices and counselling content on standardized forms. Through focus groups, serial in‐depth interviews (IDIs) and single IDIs (n = 119 total), we explored participants’ experiences with adherence support and how it encouraged product use. Results Participants received counselling at nearly all visits. DLF was provided at 54.3% of sessions and, across sites, 49%–68% received results showing high adherence for oral PrEP, and 73%–89% for the ring. The most popular support strategies were in‐person clubs and weekly calls, followed by online clubs, additional counselling and SMS. Preferences differed across sites but were similar for both products. Qualitative results demonstrated that the REACH strategies supported adherence by providing information about HIV and PrEP, continually motivating participants, and supporting the development of behavioural skills and self‐efficacy, aligning with the Information, Motivation, and Behavioural Skills (IMB) model. Effectiveness was supported by three foundational pillars: strong interpersonal relationships with counsellors; ongoing, easily accessible support and resources; and establishing trust in the counsellors and study products through counsellor relationships, peer‐to‐peer exchange and DLF. Conclusions Implementation programmes could support effective PrEP use by offering a small menu of counsellor‐ and peer‐based support options that are youth‐friendly and developmentally appropriate. The same menu options can support both ring and oral PrEP users, though content should be tailored to the individual products.

We conducted a pilot randomized controlled trial of a social network-based intervention to promote PrEP adherence among transgender women (TW) in Lima, Peru. We enrolled 89 TW from six social networks and cluster-randomized them 1:1 to standard of care (n = 44) or the TransPrEP intervention (n = 45). Core workshops discussed strategies to support PrEP adherence and defined group adherence objectives. Maintenance workshops discussed participants' experiences taking PrEP and collective adherence goals. At 3-month follow-up, we evaluated 40 participants and obtained 29 hair samples for tenofovir level measurements. Though no significant differences were observed, 36.4% (4/11) of participants of TransPrEP participants and 10.0% (1/10) of control participants had tenofovir levels > 0.023 ng/mg, consistent with ≥ 4 doses per week. 81.8% (9/11) of intervention and 40.0% (4/10) of control participants had any detectable tenofovir in their hair. Pilot assessment of our network-based intervention suggested a trend towards improved PrEP adherence, measured objectively, for TW in Peru.

BackgroundThe appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.MethodsUsing an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis.ResultsA total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQR], 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]).ConclusionsIn this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.).

Suboptimal adherence to Antiretroviral Therapy (ART) regimens can lead to the development of drug resistance, virologic and clinical failure, and, on the community level, the spread of drug-resistant HIV. To design effective interventions, it is crucial to understand locally specific barriers to optimal adherence. Self-report data from a cross-sectional sample of 527 adherence-challenged people living with HIV (PLWH) in the South-Indian state of Karnataka showed that they took on average 68% of prescribed doses in the past month. Large majorities of participants encountered individual (95%), social/structural (88%), and clinic/regimen (80%) adherence barriers. Multivariate linear regression analyses of past month adherence showed that disclosure to all adults in the household was positively related to adherence, as was employing a larger number of adherence strategies, perceiving more benefits of ART, and having been on ART for longer. Fears of stigmatization upon disclosure of HIV-status to friends and people at work were negatively related to adherence. These results suggest that some barriers, especially individual-level barriers like forgetfulness are very common and can be targeted with relatively simple individual-level strategies. Other barriers, related to fear of stigma and lack of disclosure may require family- or community-level interventions.

Background and purposeWe investigated the prevalence, awareness, and control of vascular risk factors (VRFs) and the use of antithrombotic and statin agents in HCHS (Hispanic Community Health Study)/SOL (Study of Latinos) participants with self-reported history of stroke or transient ischemic attack.MethodsSociodemographic characteristics, medications, and prevalence of different VRFs were recorded. VRF diagnoses and goals were based on the recommendations of professional organizations. Factors associated with optimal VRF control and use of antithrombotic and statin agents were investigated using multivariate logistic regression.ResultsThe analysis included 404 participants (39% men). The prevalences of hypertension, dyslipidemia, and diabetes were 59%, 65%, and 39%, respectively. Among those who met the diagnostic criteria for these diagnoses, the frequencies of awareness were 90%, 75%, and 83%, respectively. In participants who were aware of their VRFs, the prevalences of controlled hypertension, dyslipidemia, and diabetes were 46%, 32%, and 54%. Approximately 46% of the participants were on antithrombotics, 39% on statins, and 26% on both. Only 38% of those with atrial fibrillation received anticoagulation. In multivariate analyses adjusted for baseline sociodemographic characteristics, older age was associated with uncontrolled hypertension and diabetes. Residing in the United States for ≥10 years and born in the United States were associated with uncontrolled diabetes, female sex with uncontrolled dyslipidemia, and lack of health insurance with decreased use of statins and hyperlipidemia.ConclusionsHispanic/Latino adults in the United States have high prevalence and awareness of VRFs but low adherence to secondary stroke prevention strategies. Older adults, women, and uninsured people are vulnerable groups that may benefit from targeted interventions. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02060344.

BackgroundResearch on how disclosure concerns affect health outcomes for people living with HIV (PLWH) has yielded inconsistent results. Theoretically, disclosure concerns could predict either poorer antiretroviral therapy (ART) adherence (PLWH worried about disclosure may not want to take their medication in front of others) or better ART adherence (stronger concerns may enhance treatment adherence to avoid unintentional disclosure). Furthermore, internalized stigma (which is positively associated with disclosure concerns) predicts worse ART adherence (an effect potentially in the opposite direction of the direct effect of disclosure concerns).Setting/methodsOne hundred eighty-six PLWH initiating HIV care at 4 US clinics completed measures of disclosure concerns, internalized stigma, and ART adherence. Viral load data were obtained from medical records. We examined the indirect effect of disclosure concerns on outcomes, adjusting for the suppressor effect of internalized stigma. That is, we examined whether the association between disclosure concerns and ART adherence/viral suppression is stronger and positive when controlling for the effect of internalized stigma.ResultsDisclosure concerns were more strongly associated with better viral suppression and ART adherence when internalized stigma was in the model, suggesting that internalized stigma suppressed this association. Similarly, internalized stigma led to higher disclosure concerns, which in turn led to better ART adherence and higher likelihood of viral suppression. However, internalized stigma also had a direct effect in the opposite direction of this indirect effect.ConclusionsFindings highlight the importance of addressing effects of internalized stigma and disclosure concerns jointly when attempting to understand effects on health outcomes among new-to-care PLWH.

We investigated the influence of toilet access on intention to adhere to antiretroviral therapy (ART) among women who are HIV-positive and enrolled in Option B+. A convenience sample of 150 women residing in Lusaka (urban) and Sinazongwe (rural) Districts of Zambia were recruited. if they were seeking pre- or post-natal care and were enrolled in Option B+. Intention to adhere to ART was assessed using four questions based on the Theory of Planned Behavior; the median score was used to distinguish high intention from low intention. Descriptive statistics were used to characterize access to toilet facilities and ART adherence intention in the entire sample and by rural and urban districts in Zambia. There was no significant difference (p = .19) between rural and urban women's access to a flush toilet. After adjusting for toilet access, however, rural women were significantly less likely to be in the high adherence intention group (PR = 0.80, 95% CI 0.71-0.90, p < .001) but access to a flush toilet was associated with adherence intention (PR = 1.14, 95% CI (1.00 - 1.30). Community-led total sanitation in Zambia could increase ART adherence intention.

BackgroundOral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but data are limited on HIV incidence among PrEP users in generalized epidemic settings, particularly outside of selected risk groups. We performed a population-based PrEP study in rural Kenya and Uganda and sought to evaluate both changes in HIV incidence and clinical and virologic outcomes following seroconversion on PrEP.Methods and findingsDuring population-level HIV testing of individuals ≥15 years in 16 communities in the Sustainable East Africa Research in Community Health (SEARCH) study (NCT01864603), we offered universal access to PrEP with enhanced counseling for persons at elevated HIV risk (based on serodifferent partnership, machine learning-based risk score, or self-identified HIV risk). We offered rapid or same-day PrEP initiation and flexible service delivery with follow-up visits at facilities or community-based sites at 4, 12, and every 12 weeks up to week 144. Among participants with incident HIV infection after PrEP initiation, we offered same-day antiretroviral therapy (ART) initiation and analyzed HIV RNA, tenofovir hair concentrations, drug resistance, and viral suppression (

PurposeMany patients with hormone receptor-positive (HR+) breast cancer do not adhere to endocrine therapy (ET), and treatment-related side effects are often discussed by participants in online breast cancer forums. Our aim was to survey this unique group of patients about their ET-related experiences.MethodsWe partnered with patients active in breast cancer social media communities to develop a survey assessing ET-related side effects and medical team communication. Patients with a history of HR+ breast cancer who had received a recommendation to take ET were eligible to participate in the anonymous, online survey.ResultsRespondents included 2353 women and 54 men. Aromatase inhibitors were the most commonly used medication. Side effects were reported by 91.2%, were more often experienced by women than men (p