Daily Pill Research Articles

Functional status and caregiver burden of patients on maintenance haemodialysis in Cameroon: a two-centre cross-sectional study

BackgroundData on the functional status (FS) of patients on maintenance haemodialysis (MHD) and their caregiver burden (CGB) in SSA where patients have fewer weekly dialysis sessions and pay out-of-pocket for dialysis-related costs is sparse. ObjectivesTo assess the functional status of Patients on MHD in Cameroon, and the burden of their Caregivers, and to determine the factors associated with functional status impairment (FSI), and high caregiver burden (HCGB). MethodsWe consecutively enrolled patients on MHD at the Bamenda Regional, and Yaounde General Hospitals over a period of 3 months. We included patients on MHD for ≥ 3 months and their caregivers. Patients and/or caregivers with documented dementia were excluded. Through a face-to-face interview, FS was assessed by combining self-reports of 8 instrumental, and 5 basic activities of daily living using the Lawton-Brody and the Katz (LBKQ) scales, and CGB was assessed using the Zarit Caregiver Burden Scale (ZCGBS). We defined functional status impairment (FSI) as a score ≥ 1 on the LBKQ scale, and a high CGB as a ZCGBS score ≥ 41. Data were analysed using the IBM-SPSS version 26.0ResultsA total of 115 patients and 51 caregivers (CGs) were enrolled. The mean age of the patients was 46.9 ± 15.0 years, and 54.8% (n = 63) were males, whereas the mean age of the CGs was 38.30 ± 13.10 years with 72.5% (n = 39) being females. A total of 90 (78.3%) patients had functional status impairment (FSI), while 78.4% (n = 40) of caregivers experienced a burden (41.2% classified as moderate, and 37.2% as high). Anaemia (aOR = 9.2, CI = 3.9–29.4, p < 0.001), and a high daily pill burden (aOR = 4.4, CI = 1.1–18.5, p = 0.043) were independently associated with FSI, while age of caregiver ≥ 45 years (aOR 9.9, CI = 1.7–56.8, P = 0.01) was independently associated with a high CGB. There was a strong positive correlation between FS and CGB.ConclusionThere is a high prevalence of functional status impairment in patients on maintenance haemodialysis in Cameroon, resulting in high a physical and psychological burden on their caregivers.

The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study

ObjectivesTo estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. Study designIn a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. ResultsOf 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. ConclusionsDelayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. ImplicationsThis biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

"She is the one who knows": A qualitative exploration of oral and injectable PrEP as part of a community empowerment approach to HIV prevention among female sex workers in the Dominican Republic and Tanzania.

Despite documented interest among female sex workers (FSW), uptake of oral pre-exposure prophylaxis (PrEP) for HIV prevention has been low. Recent trials and regulatory approval of long-acting injectable (LAI) PrEP offer new hope for the potential of this biomedical intervention. We examined FSW's PrEP-related interest and preferences regarding both oral and LAI PrEP situating these dynamics within their specific social and occupational realities. We conducted this work using qualitative methods across two distinct contexts by conducting 40 in-depth interviews with FSW in Tanzania and the Dominican Republic. Textual data was coded using iterative thematic content analysis. Analytic summaries were developed and reviewed to identify recurring themes. We systematically organized themes within each country and then compared across settings. Women in both settings expressed strong interest in PrEP seeing it as an important option to protect themselves in their work. Most participants preferred LAI PrEP due to expectations of reduced stigma and concerns about daily pill adherence and side effects. Occupational factors such as alcohol use, overnight dates with clients, and fear of violence from clients were identified as barriers to daily oral PrEP. LAI PrEP was seen as having the potential to reduce stress related to oral PrEP. Women who preferred pills discussed fear of needles, skepticism about the injections, and others relayed that taking a daily pill would not be challenging for them. There was a pre-dominant sentiment that women know best whether they are better suited for oral or LAI PrEP. Participants stressed the importance of FSW understanding both options to ensure informed decision-making around PrEP and described community-led peer education as key to delivering trusted information. Community empowerment approaches led by FSW which address structural and psychosocial constraints and promote safe work environments may facilitate equitable access and uptake of PrEP among FSW across settings.

A Patient Decision Aid (i.ARTs) to Facilitate Women's Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial.

BackgroundMany women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women’s adherence and long-term HIV outcomes.ObjectiveThis study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment.MethodsThe study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance.ResultsThis study was funded in March 2021. Columbia University’s IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023.ConclusionsThis study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting.International Registered Report Identifier (IRRID)DERR1-10.2196/35646

Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study

Background and aimsIn this study, we show the results of the subset of Spanish patients of the VERIFIE study, the first post-marketing study assessing the long-term safety and effectiveness of sucroferric oxyhydroxide (SFOH) in patients with hyperphosphatemia undergoing dialysis during clinical practice. Patients and methodsPatients undergoing hemodialysis and peritoneal dialysis with indication of SFOH treatment were included. Follow-up duration was 12–36 months after SFOH initiation. Primary safety variables were the incidence of adverse drug reactions (ADRs), medical events of special interest (MESIs), and variations in iron-related parameters. SFOH effectiveness was evaluated by the change in serum phosphorus levels. ResultsA total of 286 patients were recruited and data from 282 were analyzed. Among those 282 patients, 161 (57.1%) withdrew the study prematurely and 52.5% received concomitant treatment with other phosphate binders. ADRs were observed in 35.1% of patients, the most common of which were gastrointestinal disorders (77.1%) and mild/moderate in severity (83.7%). MESIs were reported in 14.2% of patients, and 93.7% were mild/moderate. An increase in ferritin (386.66ng/mL vs 447.55ng/mL; p=0.0013) and transferrin saturation (28.07% vs 30.34%; p=0.043) was observed from baseline to the last visit (p=0.0013). Serum phosphorus levels progressively decreased from 5.69mg/dL at baseline to 4.84mg/dL at the last visit (p<0.0001), increasing by 32.2% the proportion of patients who achieved serum phosphorus levels ≤5.5mg/dL, with a mean daily SFOH dose of 1.98 pills/day. ConclusionsSFOH showed a favorable effectiveness profile, a similar safety profile to that observed in the international study with most adverse events of mild/moderate severity, and a low daily pill burden in Spanish patients in dialysis.

A real-world analysis of the influence of age on maintenance hemodialysis patients: managing serum phosphorus with sucroferric oxyhydroxide as part of routine clinical care

ObjectiveDespite the growing number of elderly hemodialysis patients, the influence of age on nutritional parameters, serum phosphorus (sP), and use of phosphate-binder (PB) medications has not been well characterized. We aimed to describe age-related differences in patient characteristics in a large, real-world cohort of maintenance hemodialysis patients, and to examine the impact of age on sP management with sucroferric oxyhydroxide (SO).MethodsWe retrospectively analyzed de-identified data from 2017 adult, in-center hemodialysis patients who switched from another PB to SO monotherapy as part of routine clinical care. Changes in baseline PB pill burden, sP levels, and nutritional and dialytic clearance parameters were assessed across varying age groups through 6 months.ResultsAt baseline, older patients had lower mean sP, serum albumin, and pre-dialysis weights compared with younger patients. Prescription of SO was associated with a 62% increase in the proportion of patients achieving sP ≤ 5.5 mg/dl and a 42% reduction in daily pill burden. The proportion of patients achieving sP ≤ 5.5 mg/dl after transitioning to SO increased by 113, 96, 68, 77, 61, 37 and 40% among those aged 19–29, 30–39, 40–49, 50–59, 60–69, 70–79, and ≥ 80 years, respectively.ConclusionsOlder patients had worse nutritional parameters, lower pill burden, and lower sP at baseline versus younger counterparts. Prescription of SO was associated with improved sP control and reduced pill burden across all ages.

Acceptability of multiple modalities of pre-exposure prophylaxis (PrEP) among female sex workers in Tanzania: a mixed-methods study

ObjectivesModalities of pre-exposure prophylaxis (PrEP) for HIV prevention offer options to women at high risk including female sex workers (FSW). This study aimed to explore FSW’s acceptability and preferences for...

Assessing acceptability of pre-exposure prophylaxis (PrEP) among participants in an HIV vaccine preparedness study in southwestern Uganda.

BackgroundDaily oral pre-exposure prophylaxis (PrEP) use is highly effective against HIV infection. However, the uptake of PrEP among individuals at high-risk of HIV acquisition in sub-Saharan Africa varies because of availability and acceptability. We assessed the acceptability of PrEP among participants in a prospective HIV vaccine preparedness study in Masaka, southwestern Uganda.MethodsFrom November 2018 to August 2019, 20 participants (10 female) were purposively selected for in-depth interviews (IDIs) at 3 and 9 months’ post-enrolment in the vaccine preparedness study. Four focus group discussions (FGD) (two among men) were conducted with 29 individuals categorized as: younger (18–24 years) men, younger (18–24 years) women, older (≥30 years) men, and older (≥30 years) women. Apart from IDI specific questions on recent life history including work experience, relationship history and places lived, topics for IDIs and FGDs included knowledge of HIV, perceptions of HIV risk (including own risk), knowledge of and use of PrEP. The Theoretical Framework of Acceptability was used to structure a thematic framework approach for data analysis.ResultsParticipants understood that PrEP was an oral pill taken daily by HIV negative individuals to prevent acquisition of HIV. Overall, interest in and acceptability of PrEP was high, more than half expressed positivity towards PrEP but were not ready to initiate taking it citing the burden of daily oral pill taking, related side effects, stigma and distrust of PrEP. Fourteen participants (from IDI and FGD) initiated PrEP, although some (one FGD and two IDI participants) stopped taking it due to side effects or perceived reduced risk.ConclusionWe observed a keen interest in PrEP initiation among our study participants. However, a limited understanding of PrEP and associated concerns impeded uptake and sustained use. Hence, interventions are needed to address end-user challenges to increase uptake and support adherence.

Long-Acting Injectable Drugs for HIV-1 Pre-Exposure Prophylaxis: Considerations for Africa.

Sub-Saharan Africa carries the highest burden of HIV-1 and AIDS. About 39% of all new infections in the world in 2020 were in this region. Oral PrEP was found to be very effective in reducing the risk of HIV-1 transmission. However, its effectiveness is highly dependent on users adhering to the drugs. The availability of long-acting injectable PrEP that eliminates the need for a daily pill may increase PrEP uptake and adherence in people who struggle to adhere to oral PrEP. The USA’s FDA approved long-acting cabotegravir (CAB-LA) for PrEP of HIV-1 in December 2021. In this review, we discussed the implementation challenges to the successful roll-out of CAB-LA in Africa and measures to address these implementation challenges. Some health system-level challenges include the cost of the drug, its refrigeration requirement, and the shortage of healthcare providers trained to administer parenteral medicines. In contrast, client challenges include lack of knowledge, accessibility of the drug, side effects, stigma, and lack of family and community support. These challenges can be addressed by several measures emanating from lessons learned from the successful implementation of ART, oral PrEP, and immunization in the continent. Some steps include advocating for waiving of CAB-LA patent licence, conducting demonstration projects in Africa, promoting the use of renewable energy sources such as solar energy, healthcare provider training, task shifting, community engagement, client education, and implementing adherence promotion strategies.

Preferences of Healthcare Professionals on 3D-Printed Tablets: A Pilot Study.

Highlights1) What are the main findings? More than 70% of the respondents agreed about the benefits of 3D printed tablets.More than 60% of the respondents were willing to prescribe 3D printed tablets.Many of the respondents were concerned about formulation considerations, manufacturing processes, and administrative issues. 2) What is the implication of the main finding? Healthcare professionals are receptive to adopting 3D printed tablets.Addressing formulation, manufacturing process and administrative concerns is important for technology adoption.3D printing companies, healthcare professionals and regulators should closely collaborate to advance the benefits of 3D printed tablets. An inaugural study was performed to understand the perceptions of healthcare professionals toward the potential benefits of 3D printing in Singapore. This study sought to increase awareness of 3D printing applications for viable clinical applications and to elucidate the current gaps in therapy where 3D printing could play a role. A common example would be the use of 3D printing to manufacture polypills, thereby reducing the daily pill burden of patients and possibly improving medication adherence. A qualitative descriptive survey with a single-centered cross-sectional design was performed at Tan Tock Seng Hospital, a tertiary referral hospital with 1700 beds. This study had a total of 55 respondents comprising doctors and pharmacists. Most of the respondents viewed the 3D printing of oral dosage forms favorably and agreed about the potential advantages this technology could offer. More than 60% of the respondents were also willing to prescribe 3D printed tablets to patients. Respondents’ concerns were grouped into three main categories: formulation considerations, manufacturing processes, and administrative issues. Viewed in its entirety, this study provides a valuable starting point for understanding the perceptions of healthcare professionals in adopting 3D printing technology.

Texting Lost-to-follow-up PrEP Patients from a San Francisco Sexual Health Clinic

It is critical to understand what happens when PrEP patients are lost-to-follow-up (LTFU) and, where appropriate, attempt to re-engage them in care with the goal of preventing future human immunodeficiency virus (HIV) acquisition. We evaluated the benefits and limitations of using text-based outreach to re-engage with LTFU PrEP patients and offer re-initiation of PrEP care. Using text-messaging, we surveyed San Francisco City Clinic patients who started PrEP from January 2015 to October 2019 and were LTFU by October 1, 2020. Our goals were to better understand (1) whether our patients remained on PrEP through another provider or source, (2) why patients choose to discontinue PrEP, and (3) whether text-based outreach could successfully re-engage such patients in care. Multiple-choice survey questions were analyzed quantitatively to determine the proportion of respondents selecting each option; free-text responses were analyzed qualitatively using an inductive approach to identify any additional recurring themes. Of 846 eligible survey recipients, 130 responded (overall response rate 15.4%). Forty-two respondents (32.3%) were still on PrEP through another provider while 88 (67.7%) were not. Common reasons for stopping PrEP included: COVID-19–related changes in sex life (32.3% of responses), concerns regarding side effects (17.7%), and the need to take a daily pill (8.3%). Free text responses revealed additional concerns regarding risk compensation. While 32 participants agreed to be contacted by City clinic staff for PrEP counseling, only 6 were reached by phone and none of the six subsequently restarted PrEP. We learned that text messaging is a possible approach to survey certain PrEP program participants to determine who is truly LTFU and off PrEP, and to better understand reasons for PrEP discontinuation. While such information could prove valuable as programs seek to address barriers to PrEP retention, efforts to improve acceptability and increase response rates would be necessary. We were less successful in re-engaging LTFU patients in PrEP care, suggesting that text-messaging may not be the optimal strategy for this purpose.

Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Lilly arthritis drug approved for alopecia

An Eli Lilly and Company rheumatoid arthritis drug has been approved to treat severe alopecia areata, an autoimmune condition marked by hair loss. Olumiant (baricitinib) is a daily pill, and Lilly says it is the first systemic treatment to be approved for the condition. Olumiant also received an emergency use authorization from the US Food and Drug Administration in May as a treatment for some people hospitalized with COVID-19.

URCHOICE: Preferences for Pre-Exposure Prophylaxis (PrEP) Options for HIV Prevention Among Kenyan men who have sex with men and Transgender Women in Nairobi, Kisumu and the Coast.

HIV prevention method preferences were evaluated among Kenyan men who have sex with men (MSM) and transgender women (TW) from three sites: Kisumu, Nairobi and the Coast. Information sessions detailing the attributes, duration of protection, route of administration and probable visibility were attended by 464 HIV negative participants, of whom 423 (median age: 24 years) agreed to be interviewed. Across pairwise comparisons daily PrEP was by far the least preferred (1%); quarterly injections (26%) and monthly pills (23%) were most preferred, followed by yearly implant (19%) and condoms (12%). When participants were "forced" to choose their most preferred PrEP option, only 10 (2.4%) chose the daily pill; more (37.1%) chose the quarterly injection than the monthly pill (34.8%) and the yearly implant (25.8%). TW preferred the yearly implant over the quarterly injection. To achieve the rates of PrEP uptake and adherence necessary for protecting large proportions of vulnerable MSM and TW, a variety of long-acting products should be developed and made accessible to appeal to a diversity of preferences.

PATIENT PREFERENCES FOR PHARMACEUTICAL AND INTERVENTIONAL HYPERTENSION TREATMENTS: RESULTS FROM A DISCRETE CHOICE EXPERIMENT

Objective: To quantify patient benefit-risk preferences for interventional and pharmaceutical treatments for hypertension (HTN) using discrete choice experiment (DCE) methods. Design and method: A DCE is an established survey method commonly used to quantify preference for selected treatment attributes in hypothetical profiles, allowing estimation of tradeoffs that are acceptable when evaluating several attributes together. Respondents with physician confirmed uncontrolled HTN were presented with a series of questions with hypothetical HTN treatments with differing levels of treatment risk and benefit. Respondents could also choose no HTN treatment. A random parameters logit analysis of the survey treatment choices was used to estimate the relative preferences and importance for each attribute. Results: 400 patients completed the survey, with 52% female, mean age 59 ± 13 years, systolic blood pressure (BP) 155 ± 12 mmHg and 1.8 ± 0.9 average prescribed antihypertensive medications. Reduction in office systolic blood pressure (BP) was the most influential treatment attribute. The remaining attributes were less impactful on respondents’ treatment choice (i.e., duration of effect, whether treatment was interventional, number of daily pills, risk of vascular injury, risk of medication side effects, and risk of temporary pain and bruising). When given a choice between no HTN treatment and an interventional treatment with a 20% risk of procedure side effects, the likelihood of selecting the interventional treatment increased with the magnitude of blood pressure reduction. No more than a 2.5 mmHg reduction in office systolic BP was sufficient to offset treatment risks associated with an interventional procedure like RDN. Conclusions: Among U.S. patients with HTN, a DCE study demonstrated that BP reduction was the most important driver of choice, risks were less important, and a minimal BP reduction was sufficient to offset treatment risks associated with an interventional procedure like RDN.

PEP for HIV prevention: are we missing opportunities to reduce new infections?

PEP for HIV prevention: are we missing opportunities to reduce new infections?

Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure.

Antiretroviral post-exposure prophylaxis (PEP) is recommended to prevent HIV infection after a high-risk exposure, but current regimens have presented challenges in tolerability, regimen completion, and potential drug-drug interactions. Because coformulated bictegravir, emtricitabine, and tenofovir alafenamide [BIC/FTC/tenofovir alafenamide (TAF)] is effective for HIV treatment, it was evaluated for use for PEP. Boston community health center. Individuals accessing PEP were enrolled in an open-label study of coformulated BIC/FTC/TAF, taken as one pill daily for 28 days. Pearson's χ2 and Fisher's exact tests were used to assess whether BIC/FTC/TAF differed with respect to side effects and regimen completion rates compared with historical PEP regimens. Between August, 2018 and March, 2020, 52 individuals enrolled in the study. Most identified as cisgender gay (67.3%) or bisexual (11.5%) men, but 7.7% identified as cisgender heterosexual men and 3.8% cisgender heterosexual women. The most common regimen side effects were nausea or vomiting (15.4%), fatigue (9.6%), and diarrhea/loose stools (7.7%), which were less common than historical controls using other PEP regimens, including those containing other integrase strand transfer inhibitors. Only 1 participant discontinued the regimen because of fatigue, and all other side effects were self-limited. Almost all participants (90.4%) completed the indicated regimen, which was a higher completion rate compared with earlier PEP regimens, and none became HIV-positive. BIC/FTC/TAF coformulated as a single daily pill was found to be safe, well-tolerated, and highly acceptable when used for PEP, and compared more favorably than historical PEP regimens used at an urban health center.

Adherence among a cohort taking progestin-only pills prescribed by a healthcare provider: Results of the BENCHMARK study

ObjectivesTo measure adherence over six months of progestin-only pill (POP) use. Study DesignProspective observational cohort study measuring adherence to daily dosing and timing of dose in patients prescribed a POP, with up to six months of follow-up, conducted from January to October 2020. A pharmacy benefit manager identified potential participants with a newly prescribed POP and extended an invitation to participate. We enrolled qualified respondents by telephone, trained them to use an electronic diary to report daily whether they had taken their POP and at what time. We followed participants for up to six months. We calculated adherence to daily pill taking as the proportion of evaluable days in which a participant took a POP, and the proportion of participants reporting ≥85% adherence. We calculated adherence to same time each day as the proportion of doses taken no later than three hours after the previous dose time of day. ResultsThe user population comprised 199 participants, 154 (77.4%) of whom completed six months of follow-up. The majority (n = 170, 85.4%) were taking norethindrone. Norethindrone users reported POP intake on 22,327 (96.4%) of 23,156 evaluable days, with 155 (91.2%) participants reporting ≥85% adherence; less than half (n = 73, 42.9%) reported 100% adherence. Participants reported adherence to same time each day on 21,698 of 22,157 (97.9%) evaluable days. ConclusionsAmong participants taking a prescribed POP, participants demonstrated high adherence for daily pill taking and the same time of day, though the majority were not 100% adherent. ImplicationsThis study reports data specific to adherence among those taking a progestin-only pill (POP) in the prescription setting. Clinicians who counsel patients about POP use should be aware that majority of patients were not 100% adherent, although most report ≥85% adherence.

Serum Phosphorus and Pill Burden Among Hemodialysis Patients Prescribed Sucroferric Oxyhydroxide: One-Year Follow-Up on a Contemporary Cohort.

PurposeIn prior analyses of real-world cohorts of hemodialysis patients switched from one phosphate binder (PB) to sucroferric oxyhydroxide (SO), SO therapy has been associated with improvements in serum phosphorus (sP) and reductions in daily PB pill burden. To characterize how SO initiation patterns have changed over time, we examined the long-term effectiveness of SO in a contemporary (2018–2019) cohort.Patients and MethodsAdult Fresenius Kidney Care hemodialysis patients first prescribed SO monotherapy as part of routine care between May 2018 and May 2019 (N = 1792) were followed for 1 year. All patients received a non-SO PB during a 91-day baseline period before SO prescription. Mean PB pills/day and laboratory parameters were compared before and during SO treatment. Results were divided into consecutive 91-day intervals (Q1–Q4) and analyzed using linear mixed-effects regression and Cochran’s Q test. These results were contrasted with findings from a historical (2014–2015) cohort (N = 530).ResultsThe proportion of patients achieving sP ≤5.5 mg/dl increased after switching to SO (from 27.0% at baseline to 37.8%, 45.1%, 44.7%, and 44.0% at Q1, Q2, Q3, and Q4, respectively; P < 0.0001 for all). The mean daily PB pill burden decreased from a baseline of 7.7 to 4.4, 4.6, 4.8, and 4.9, respectively, across quarters (P < 0.0001 for all). Patients in the contemporary cohort had improved sP control (27.0% achieving sP ≤5.5 mg/dl vs 17.7%) and lower daily PB pill burden (mean 7.7 vs 8.5 pills/day) at baseline than those in the historical cohort. Overall use of active vitamin D was similar between cohorts, although higher use of oral active vitamin D (63.9% vs 15.7%) and lower use of IV active vitamin D lower (23.4% vs 74.2%) was observed in the contemporary cohort.ConclusionDespite evolving treatment patterns, switching to SO resulted in improved sP control with fewer pills per day in this contemporary hemodialysis cohort.

Long-acting injections for HIV prevention among women in sub-Saharan Africa

Women in sub-Saharan Africa are one of the groups at highest risk of HIV in the world, encompassing 38% of new cases globally.1 Multiple HIV prevention modalities have been developed and trialled in women in sub-Saharan Africa with limited success. Tenofovir vaginal gels showed initial promise with a 39% overall reduction in HIV infection,2 but later trials showed no evidence of protection.3 Two clinical trials of dapivirine vaginal rings showed an overall 27–31% risk reduction.4,5 Daily oral pills containing tenofovir disoproxil fumarate are currently the standard for pre-exposure prophylaxis (PrEP).