scholarly journals 883. Qualitative Patient-Participant Perspectives on Implementation of Monthly Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) Injectable in the United States (CUSTOMIZE)

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S533-S533
Author(s):  
Cindy Garris ◽  
Larissa Stassek ◽  
Ronald D’Amico ◽  
Marybeth Dalessandro ◽  
Sheila Adkins ◽  
...  
Keyword(s):  
Side Effects ◽  
The United States ◽  
Hiv Treatment ◽  
Early Implementation ◽  
Patient Participant ◽  
One Year ◽  
Long Acting ◽  
Hiv Status Disclosure ◽  
Participant Perspectives ◽  
Status Disclosure

Abstract Background CAB+RPV LA administered monthly for HIV treatment is non-inferior to daily oral ART at maintaining viral suppression and preferred by most participants in clinical trials over daily ART. CUSTOMIZE, an implementation-effectiveness study, evaluated facilitators and barriers to clinic implementation of CAB+RPV LA from the patient perspective. Methods 115 participants were enrolled across 8 HIV clinics. Semi-structured phone interviews were conducted with a randomized subgroup of 3-6 participants per site, prior to the 1st (Baseline [BL], N=34) and 12th CAB+RPV LA injections (Month 12 [M12], N=31). Consolidated Framework for Implementation Research-guided interviews were recorded, transcribed, and coded using ATLAS.ti. Results At BL, 97% (n=33) of those interviewed indicated ≥1 challenge taking daily oral ART, including concerns about adherence (n=19; 56%), dosing frequency (n=13; 38%) and side effects (n=12; 35%). Twenty-seven (79%) reported anticipated challenges of CAB+RPV LA such as worry about side effects (n=15; 44%) and discomfort from injections (n=14; 41%). Participants reported at BL that CAB+RPV LA may help with adherence (n=17; 50%) or reduce fears of HIV status disclosure (n=10; 29%). At M12, 35% (n=11) reported some pain/discomfort from injections, but 87% (n=27) reported satisfaction with CAB+RPV LA, most commonly due to preferring the monthly regimen over the daily pill (n=15; 48%). Facilitators reported by participants as most helpful during early implementation were verbal education by clinic staff (14%), reminder texts/calls (13%), and an educational video about the regimen (6%). Most (n=25; 81%) indicated clinic hours were not a barrier, but 19% (n=6) noted taking time off work for the visits. Many participants (n=21; 68%) described positive aspects of going to the clinic each month, none complained about visit length, and 94% (n=29) reported intent to continue CAB+RPV LA after the study. Conclusion Interviewed participants reported several challenges with daily oral ART that monthly CAB+RPV LA may help overcome. Some initial concerns about receiving CAB+RPV LA were reported at BL, but most participants were satisfied with the regimen after one year and plan to continue receiving CAB+RPV LA following the study. Disclosures Cindy Garris, MS, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Larissa Stassek, MPH, GlaxoSmithKline (Consultant, Other Financial or Material Support, My company (Evidera) received funding from GSK to conduct this research. We did not receive funding for work on this abstract.) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Marybeth Dalessandro, BS, ViiV Healthcare (Employee, Shareholder) Sheila Adkins, BS, GSK (Employee)GSK (Employee, Stock) Maggie Czarnogorski, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Reasons to choose a long acting antipsychotic and tolerability

2017 ◽  
Vol 41 (S1) ◽  
pp. s822-s822
Author(s):  
I. Martínez Molina ◽  
N. Gómez-Coronado Suárez de Venegas ◽  
P. Blanco Ramón
Keyword(s):  
Side Effects ◽  
Sexual Dysfunction ◽  
Negative Symptoms ◽  
Descriptive Analysis ◽  
Hypertensive Crisis ◽  
Antipsychotic Treatment ◽  
Competing Interest ◽  
One Year ◽  
Long Acting ◽  
Positive And Negative Symptoms

IntroductionAripiprazole depot is an atypical antipshycotic used to treat positive and negative symptoms of psychosis or acute mania.AimDescribe the reason why psychiatrists switch the current antipsychotic treatment on to aripiprazol depot, its tolerability and the reasons to stop aripiprazol depot treatment.MethodsDescriptive analysis based on a sample of 37 patients, aged 18–65 years, treated during one year with antipsychotics at two community mental health units.ResultsSwitching on to aripiprazole depot principal reasons: promote adherence (25%), persistence of symptoms (25%) and high levels of prolactin or sexual dysfunction (16.66%):– side effects of aripiprazole depot: insomnia (11.11%), inquietude (8.33%), sexual dysfunction (2.77%) and hypertensive crisis during administration (2.77%);– 83.33% of the patients are still taking it after one year. The most common reasons to stop or change it were the presence of secondaries (11.11%) and clinical exacerbation (5.55%).ConclusionsAripiprazole depot is well tolerated (even better than other antipsychotics). Common side effects are not severe and appear in a small percent of patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Trends in HIV Treatment Adherence Before and After HIV Status Disclosure to Adolescents in Botswana

2020 ◽  
Vol 67 (4) ◽  
pp. 502-508 ◽  
Author(s):  
Harriet Okatch ◽  
Knashawn Morales ◽  
Rachel Rogers ◽  
Jennifer Chapman ◽  
Tafireyi Marukutira ◽  
...  
Keyword(s):  
Treatment Adherence ◽  
Hiv Treatment ◽  
Hiv Status ◽  
Before And After ◽  
Hiv Status Disclosure ◽  
Status Disclosure

scholarly journals Frequency of Early Refills for Opioids in the United States

Pain Medicine ◽  
2020 ◽  
Vol 21 (9) ◽  
pp. 1818-1824
Author(s):  
David M Kern ◽  
M Soledad Cepeda ◽  
Maribel Salas ◽  
Syd Phillips ◽  
Matthew H Secrest ◽  
...  
Keyword(s):  
Patient Characteristics ◽  
Immediate Release ◽  
The United States ◽  
Prescription Opioid ◽  
Opioid Prescription ◽  
National Drug ◽  
One Year ◽  
Long Acting ◽  
Opioid Users

Abstract Objective Refilling an opioid prescription early is an important risk factor of prescription opioid abuse and misuse; we aimed to understand the scope of this behavior. This study was conducted to quantify the prevalence and distribution of early refills among patients prescribed opioids. Methods We conducted a retrospective cohort study utilizing dispensed prescription records. Patients filling one or more prescription opioids were identified and followed for one year. Early refills were defined as having a second prescription filled ≥15% early relative to the days’ supply of the previous prescription for the same opioid (according to the National Drug Code [NDC]). The distribution of the number of early refills and patient characteristics were assessed. Results A total of 60.6 million patients met the study criteria; 28.8% had two or more opioid prescriptions for the same opioid during follow-up. Less than 3% of all patients receiving an opioid had an early refill. Approximately 10% of those with two or more opioid prescriptions for the same drug had an early refill. For patients with multiple fills (N = 1.5 million with extended-release long-acting [ER/LA] opioids; N = 17.1 million with immediate-release short-acting [IR/SA] opioids), early refills were more common among patients with an ER/LA opioid (18.5%) compared with an IR/SA opioid (8.7%). Three-quarters of patients with an early refill had only one (70.9% and 78.4% for ER/LA and IR/SA, respectively). Conclusion Refilling an opioid prescription with the same opioid early is an infrequent behavior within all opioid users, but more common in ER/LA users. Patients who refilled early tended to do so just once.

scholarly journals Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs

2021 ◽  
Vol 12 ◽  
Author(s):  
Kevin C. J. Yuen ◽  
Bradley S. Miller ◽  
Cesar L. Boguszewski ◽  
Andrew R. Hoffman
Keyword(s):  
Side Effects ◽  
The United States ◽  
Molecular Structures ◽  
Therapeutic Monitoring ◽  
Patient Acceptance ◽  
Trough Serum ◽  
Igf I ◽  
Hormone Analogs ◽  
Long Acting

Daily recombinant human GH (rhGH) is currently approved for use in children and adults with GH deficiency (GHD) in many countries with relatively few side-effects. Nevertheless, daily injections can be painful and distressing for some patients, often resulting in non-adherence and reduction of treatment outcomes. This has prompted the development of numerous long-acting GH (LAGH) analogs that allow for decreased injection frequency, ranging from weekly, bi-weekly to monthly. These LAGH analogs are attractive as they may theoretically offer increased patient acceptance, tolerability, and therapeutic flexibility. Conversely, there may also be pitfalls to these LAGH analogs, including an unphysiological GH profile and differing molecular structures that pose potential clinical issues in terms of dose initiation, therapeutic monitoring, incidence and duration of side-effects, and long-term safety. Furthermore, fluctuations of peak and trough serum GH and IGF-I levels and variations in therapeutic efficacy may depend on the technology used to prolong GH action. Previous studies of some LAGH analogs have demonstrated non-inferiority compared to daily rhGH in terms of increased growth velocity and improved body composition in children and adults with GHD, respectively, with no significant unanticipated adverse events. Currently, two LAGH analogs are marketed in Asia, one recently approved in the United States, another previously approved but not marketed in Europe, and several others proceeding through various stages of clinical development. Nevertheless, several practical questions still remain, including possible differences in dose initiation between naïve and switch-over patients, methodology of dose adjustment/s, timing of measuring serum IGF-I levels, safety, durability of efficacy and cost-effectiveness. Long-term surveillance of safety and efficacy of LAGH analogs are needed to answer these important questions.

scholarly journals The act of telling: South African women’s narratives of HIV status disclosure to intimate partners in the HPTN 071 (PopART) HIV prevention trial

2021 ◽  
Vol 17 ◽  
pp. 174550652199820
Author(s):  
Lario Viljoen ◽  
Dillon Wademan ◽  
Graeme Hoddinott ◽  
Virginia Bond ◽  
Janet Seeley ◽  
...  
Keyword(s):  
Public Health ◽  
Hiv Prevention ◽  
Hiv Testing ◽  
Hiv Treatment ◽  
Treatment As Prevention ◽  
Hiv Status ◽  
Women Living With Hiv ◽  
Adherence Support ◽  
Hiv Status Disclosure ◽  
Status Disclosure

Background: Public health programming often frames HIV status disclosure as a means to negotiate condom- and abstinence-based prevention or to involve intimate partners in HIV care to garner treatment adherence support. HIV treatment can be used to ensure viral suppression and prevent onward transmission, which provides strong evidence to encourage disclosure. The ideological shift towards HIV treatment as prevention is expected to facilitate disclosure. Purpose: There is a lack of research on how the scale-up of universal HIV testing and treatment influences disclosure practices in high burden settings. In this manuscript, we aim to address this gap. Methods: To this end, we conducted a two-phased narrative performative analysis of the disclosure scripts of 15 women living with HIV in three communities of Western Cape, South Africa where the HPTN 071 (PopART) HIV prevention trial implemented a universal HIV testing and treatment model as part of the intervention. The women were part of a larger cohort nested in the trial. We use Goffman’s dramaturgical metaphor, which understands social interactions as ‘performances’ by ‘actors’ (people) guided by ‘scripts’ (anticipated dialogues/interactions), to explore how women living with HIV manage their status disclosure. Conclusion: We describe how these women perform HIV status disclosure (or deliberate non-disclosure) to retain, reaffirm or redefine existing social scripts with partners. Their performances reveal priorities other than those imagined by public health programmes driving HIV disclosure (or non-disclosure): establishing trust, resenting betrayal and ensuring self-preservation while simultaneously (re)constructing self-identity. None of the women engaged with the concept of treatment as prevention in their disclosure narratives, either to facilitate disclosure or to ‘justify’ non-disclosure. HIV prevention, in general, and treatment adherence support were rarely mentioned as a reason for disclosure. To date, there has been a missed opportunity to ease and support disclosure in health programmes by tapping into existing social scripts, impeding potential patient and public health benefits of universal HIV testing and treatment.

scholarly journals Ultra-long-acting tunable biodegradable and removable controlled release implants for drug delivery

2019 ◽  
Vol 10 (1) ◽  
Author(s):  
S. Rahima Benhabbour ◽  
Martina Kovarova ◽  
Clinton Jones ◽  
Daijha J. Copeland ◽  
Roopali Shrivastava ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Plasma Concentrations ◽  
Chemical Properties ◽  
Antiretroviral Drugs ◽  
Hiv Treatment ◽  
Sustained Drug Delivery ◽  
Wide Range ◽  
One Year ◽  
Long Acting ◽  
Multiple Drugs

Abstract Here we report an ultra-long-acting tunable, biodegradable, and removable polymer-based delivery system that offers sustained drug delivery for up to one year for HIV treatment or prophylaxis. This robust formulation offers the ability to integrate multiple drugs in a single injection, which is particularly important to address the potential for drug resistance with monotherapy. Six antiretroviral drugs were selected based on their solubility in N-methyl-2-pyrrolidone and relevance as a combination therapy for HIV treatment or prevention. All drugs released with concentrations above their protein-adjusted inhibitory concentration and retained their physical and chemical properties within the formulation and upon release. The versatility of this formulation to integrate multiple drugs and provide sustained plasma concentrations from several weeks to up to one year, combined with its ability to be removed to terminate the treatment if necessary, makes it attractive as a drug delivery platform technology for a wide range of applications.

Barriers to adolescent contraception use and adherence

2016 ◽  
Vol 30 (4) ◽  
Author(s):  
Camille Clare ◽  
Mary-Beatrice Squire ◽  
Karem Alvarez ◽  
Julia Meisler ◽  
Candice Fraser
Keyword(s):  
Side Effects ◽  
Contraceptive Use ◽  
Ethnically Diverse ◽  
The United States ◽  
Patient Demographics ◽  
Contraception Use ◽  
Contingency Coefficient ◽  
Metropolitan Hospital ◽  
Long Acting ◽  
Patient Barriers

Abstract Objective: The United States has the highest rate of adolescent pregnancy of the industrialized nations. Previously reported patient barriers to the use of contraception included an ambivalence about pregnancy; method side effects; difficulty using methods; lack of satisfaction with methods; concerns about safety; expense; and a lack of knowledge about long-acting reversible contraception (LARC). This survey aims to determine if there are additional barriers to contraception use and adherence among an ethnically diverse urban population. Methods: A 16-item survey with good interrater reliability was utilized in a pilot study to assess patient demographics, and contraceptive methods was distributed to female patients aged 13–21 years at Metropolitan Hospital Center from January to October of 2014. Data analysis was performed using the χ2-square analysis, ϕ-coefficient, Contingency Coefficient, Cramer’s V, and Satterthwaite methods of analyses. Results: Concerns about contraceptive method side effects, more specifically, weight gain, irregular bleeding and long-term health risks, and worries about parents discovering their contraceptive habits were the major barriers to contraceptive use. Conclusion: The identification of these barriers is critical in order to reduce the high rates of pregnancy in adolescents. Educating parents and their teenagers regarding the most effective methods may increase compliance and adherence. This study offers further support for the use of LARC to overcome perceived patient barriers.

scholarly journals Study of depot medroxyprogesterone acetate as an extended postpartum contraceptive at SCB medical college and hospital, Cuttack

2021 ◽  
Vol 10 (4) ◽  
pp. 1484
Author(s):  
Sagarika Samal ◽  
Lucy Das
Keyword(s):  
Side Effects ◽  
Infant Mortality ◽  
Medroxyprogesterone Acetate ◽  
Contraceptive Use ◽  
Age Groups ◽  
Socioeconomic Group ◽  
Medical College ◽  
Unwanted Pregnancies ◽  
One Year ◽  
Long Acting

Background: Increase in contraceptive use during the postpartum period substantially reduces the rate of maternal and infant mortality by preventing unplanned and unwanted pregnancies. Injectable Medroxy Progesterone acetate (DMPA) is one long acting reversible safe and effective method for postpartm contraception. Aims and Objectives to study the acceptance, efficacy, side effects and compliance of DMPA as an extended postpartum contraceptive at SCB Medical College, Cuttack.Methods: The study includes 76 women between 6weeks to 1year postpartum who had chosen DMPA as contraceptive after counseling regarding the basket of choices. DMPA injection was given within 7 days of menstruation if it has returned or at any time after being confirmed that woman is not pregnant with a back up for first 7days. Subsequent injections were given at three monthly intervals and followed up for one year after the first injection for pregnancy rate, side-effects, discontinuation and patient satisfaction.Results: Maximum females were from the combined age groups 25-29 (39.47%) and 20-24 years (35.52%). 46.1% women belong to lower middle socioeconomic group. The most common menstrual problem was amenorrhea in 47.36% followed by scanty bleeding in 22.36%. 25% discontinued after 1st dose of injection, which is the maximum. The commonest reason for discontinuation observed was menstrual problems (37.93%) followed by use of other methods of contraception (17.24%). Out of 76, 23 women were not satisfied (30.26%), main reason of dissatisfaction being menstrual problems. Failure rate was nil.Conclusions: The study concludes that DMPA is a very effective, safe, and long acting contraceptive with no effect on lactation. Proper counseling can improve the acceptance and compliance.

Effect in antipsychotic-induced hyperprolactinemia after switching to long-acting injectable aripiprazole: A 1-year study

2017 ◽  
Vol 41 (S1) ◽  
pp. s815-s816
Author(s):  
M. Juncal Ruiz ◽  
B. Fernández-Abascal Puente ◽  
O. Porta Olivares ◽  
M. Gómez Revuelta ◽  
R. Landera Rodríguez ◽  
...  
Keyword(s):  
Side Effects ◽  
Sexual Dysfunction ◽  
Clinical Improvement ◽  
Drug Induced ◽  
Oral Olanzapine ◽  
Competing Interest ◽  
One Year ◽  
Long Acting ◽  
Almost All

IntroductionAntipsychotic-induced hyperprolactinemia is associated with relevant side effects: short-term as hypogonadism, gynecomastia, amenorrhoea, sexual dysfunction and galactorrhoea; long-term as cardiovascular disease, bone demineralization and breast and prostate tumors.AimsTo evaluate the effect of switching to long-acting injectable aripiprazole on long-lasting antypsychotic-induced hyperprolactinemia.MethodsThis was a prospective observational 1-year study carried out in 125 outpatients with schizophrenia who were clinically stabilized but a switching to another antipsychotic was indicated. We measured the basal prolactine at the start of the study and 1 year after switching to long acting injecatable (LAI) aripiprazole.ResultsIn basal analytic, 48% had hyperprolactinemia (21.8–306.2 ng/mL) and 66.5% of them described side effects: 78% sexual dysfunction (72% men), 11% galactorrhoea (100% women), 5.5% amenorrhoea and 5.5% bone pain (100% women). In 48% of patients with hyperprolactinemia, the previous antipsychotics comprised: LAI-paliperidone (65,7%), oral-risperidone (7%), oral-olanzapine (6.1%), oral-paliperidone (5.2%), LAI-risperidone (4%) and others (12%). One year after switching to LAI-aripiprazole, prolactine levels were lower in all patients and in 85% prolactine levels were normalized. Overall, 72% described a clinical improvement, especially in terms of sexual dysfunction.ConclusionsSeveral studies have described an improvement of drug-induced hyperprolactinemia after switching to or adding oral aripiprazole. In our study, we observed that levels of prolactine were normalized in 85% of patients with a clinical improvement in almost all of cases. These findings suggest that switching to LAI aripiprazole may be an effective alternative for managing antipsychotic-induced hyperprolactinemia due to its partial agonism in D2 brain receptors, especially in tuberoinfundibular pathway.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Developing acceptable contraceptive methods: Mixed-method findings on preferred method characteristics from Burkina Faso and Uganda

2019 ◽  
Vol 3 ◽  
pp. 1205
Author(s):  
Aurélie Brunie ◽  
Rebecca L. Callahan ◽  
Amelia Mackenzie ◽  
Simon P.S. Kibira ◽  
Madeleine Wayack-Pambè
Keyword(s):  
Side Effects ◽  
Burkina Faso ◽  
Unmet Need ◽  
User Preferences ◽  
Product Characteristics ◽  
Group Discussions ◽  
Pelvic Exam ◽  
Ranking Exercise ◽  
One Year ◽  
Long Acting

Background: Unmet need remains high in developing regions. New contraceptive technologies may improve uptake and use. This study examines desirable product characteristics. Methods: We added a module to the female questionnaire of the PMA2020 surveys in Burkina Faso and Uganda and conducted 50 focus group discussions (FGDs) with women, 10 FGDs with men, and 37 in-depth interviews (IDIs) with providers across the two countries. FGDs with women and IDIs with providers included a semi-structured ranking exercise on pre-selected product characteristics. Results: Effectiveness, duration, few side effects, cost, and access were the characteristics most commonly reported as important in choosing a method by survey respondents across both countries. Half or more of women surveyed in each country would like a method that lasts at least one year, while 65% in Burkina Faso and 40% in Uganda said they would use a method causing amenorrhea. Qualitative findings show that women want methods with minimal and predictable side effects. Reactions to increased bleeding were negative, especially in Burkina Faso, but perspectives on reduced bleeding were more mixed. Women and providers preferred methods that are discreet and not user-dependent, and associate duration with convenience of use. Some women in Uganda expressed concerns about the invasive nature of long-acting methods, and cost was an important consideration in both countries. In the ranking exercise, discreet use and few side effects often ranked high, while causing amenorrhea and not requiring a pelvic exam often ranked low. Conclusion: Product development should consider user preferences for success in these settings.

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