cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.57982/sf5p-h581
title: Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

description: A Phase 3, randomized clinical trial to assess the efficacy and safety of tenofovir disoproxil fumarate (TDF) in hepatitis B virus (HBV) infected, s and e antigen positive, pregnant women to prevent perinatal transmission despite infant passive-active HB immunization.
The hypothesis was that TDF would decrease HBV DNA load in chronically HBV infected pregnant women and therefore reduce the risk of perinatal transmission.
From January 2013 to August 2015, 168 women were assigned to the TDF group and 163 to the placebo group. There were 322 deliveries on study, 324 infants. None of the 147 infants in the TDF group were infected, as compared with 3 of 147 in the placebo group (P = 0.12). The rate of adverse events did not differ significantly between groups. The incidence of a maternal alanine aminotransferase level of more than 300 IU per liter after discontinuation of the trial regimen was 6% in the TDF group and 3% in the placebo group (P = 0.29).
DOI: 10.57982/v659-y740
title: A Secondary Prevention Empowerment Intervention for Young Women Living with HIV

description: This study developed a culturally appropriate secondary prevention intervention for young HIV+ women through focus groups. Focus groups were digitally recorded and transcribed. Focus groups informed the development of the intervention's framework and content areas. The intervention aimed to reduce the risk of young women infected with HIV transmitting the virus to their sexual partners, and to prevent young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease.
DOI: 10.57982/hcjc-c673
title: Clinician Attitudes and Behaviors Regarding Use of Pre-Exposure Prophylaxis (PrEP) for Primary HIV Prevention

description: A study in three phases that examined clinician behaviors with regard to recommending and prescribing pre-exposure prophylaxis (PrEP) as a primary HIV prevention strategy, and to identify knowledge-related and attitudinal factors associated with these behaviors. Through three phases, researchers used semi-structured interviews with ATN-affiliated clinicians to develop a new theory-based survey instrument, and administered the newly developed survey to clinicians. The primary objectives were to explore clinician attitudes and prescribing behaviors of PrEP for men who have sex with men (MSM) and heterosexually active adults and adolescents, and to identify factors associated with prescribing PrEP.
DOI: 10.57982/f1b3-kz10
title: CATCH: Comprehensive Assessment of Transition and Coordination for HIV-Positive Youth as They Move from Adolescent to Adult Care

description: A multi-method, prospective study that assessed the transition process of behaviorally-infected HIV-positive youth, aged 18 to 24, as they transitioned from pediatric and adolescent-specific care to adult care. The transition process was characterized from the perspectives of HIV-positive youth, Adolescent Medicine Trials Unit (AMTU) clinic staff, and receiving adult clinic staff. Data on individual psychosocial, behavioral, and clinical factors affecting transition for adolescent and young adult participants were measured through ACASI surveys. Demographic, biomedical, antiretroviral therapy, and healthcare utilization visit information was collected through medical chart abstraction. Information on transition protocols was collected through semi-structured interviews with AMTU and adult clinic staff.
DOI: 10.57982/6m16-5r50
title: Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex with Men

description: This study sought to construct and modify a culturally-based secondary prevention intervention targeted toward HIV-positive black young men who have sex with men. The feasibility and acceptability of the intervention were explored in Trial 1 and Trial 2; the potential efficacy of the intervention was assessed in Trial 2. Primary outcomes examined were health promotion behaviors (i.e., treatment adherence, sexual risk reduction, reduction in substance use behaviors, and HIV status disclosure). Psychosocial factors (i.e., self-esteem, critical consciousness, and socio-political awareness) were examined as secondary outcomes.
DOI: 10.57982/16dy-yk79
title: Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

description: A two-group randomized repeated measures design that examined the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) compared with an attention-controlled health education comparison intervention (HEALTH). Goals of the intervention were to improve engagement in care, decrease psychosocial barriers to care, and decrease sexual risk for youth newly diagnosed with HIV. Data were primarily collected through Audio Computer-Assisted Self-Interview (ACASI) questionnaires and medical record abstraction.
DOI: 10.57982/wqnc-6t37
title: Assessing the Engagement of Transgender and Other Gender Minority Youth Across the HIV Continuum of Care

description: A mixed-methods study to characterize the HIV prevention and care continua among Transgender and Other Gender Minority Youth (TGMY) ages 16-24. Quantitative surveys and qualitative interviews were conducted with TGMY in care and TGMY not in care. In addition, qualitative interviews were conducted with health care and social service providers who work with TGMY. This study assessed transgender youth experiences with accessing services along the HIV prevention and care continua, including barriers and facilitators to service engagement.
DOI: 10.57982/c94k-ts07
title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 Supplement to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in HIV Positive Youth Treated with ART Containing Tenofovir

description: A randomized, double-blind, placebo-controlled trial of directly observed vitamin D versus placebo every 4 weeks for 48 weeks. Participants included HIV-infected youth ages 16-24 with viral load <200 copies/mL, and taking TDF-containing combination antiretroviral therapy for >180 days. Whole-body, spine, and hip BMD and BMC were assessed using DXA at baseline and at study weeks 24 and 48.
DOI: 10.57982/njys-dv21
title: Pharmacokinetics of Diazepam in Children with Status Epilepticus

description: Analysis of diazepam data and pharmacokinetic (PK) samples obtained from the NICHD-2003-10-2 (BPCA Status 2) study, a double-blinded, randomized, controlled trial comparing efficacy and short-term safety of lorazepam versus diazepam in pediatric status epilepticus (SE). The primary objective of the NICHD-2015-DZP01 (BPCA DZP01) study was to determine the PK of diazepam for pediatric SE using sparse sampling. The secondary objective was to determine the safety and efficacy of diazepam for pediatric SE. The Status 2 and DZP01 studies were both conducted under the Best Pharmaceuticals for Children Act (BPCA).
DOI: 10.57982/fyzg-2f45
title: Use of Lorazepam for the Treatment of Pediatric Status Epilepticus

description: An open-label, multi-center study to evaluate the single dose pharmacokinetics of intravenous lorazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. Cohort assignment was based on medical history: Cohort 1 included Emergency Department or hospital patients in SE receiving lorazepam; Cohort 2 included patients with epilepsy admitted for an elective dose of lorazepam. Subjects were stratified by age in each cohort. Participants in Cohort 1 received lorazepam 0.1 mg/kg up to a maximum dose of 4 mg/kg. Participants in Cohort 2 received lorazepam 0.05 mg/kg up to a maximum dose of 2 mg/kg. This study was conducted under the Best Pharmaceuticals for Children Act Program.
DOI: 10.57982/857e-cw34
title: Use of Lorazepam for the Treatment of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial of Lorazepam and Diazepam

description: A randomized, double-blinded trial comparing the efficacy and safety of intravenous lorazepam to diazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. For patients in whom SE was not terminated by benzodiazepines, data were collected prospectively regarding subsequent medications, dosing, and effectiveness. Cohort assignment was based on medical history: Cohort 1 included patients presenting to the Emergency Department (ED) in SE with prior informed consent; Cohort 2 included patients presenting to the ED in SE without prior informed consent and enrolled under Exemption from Informed Consent (EFIC). Subjects were stratified by age in each cohort and randomized to receive lorazepam 0.1 mg/kg up to maximum dose 4 mg or diazepam 0.2 mg/kg up to maximum dose 8 mg. A second dose, if required for ongoing convulsions, was half of the first dose. This study was conducted under the Best Pharmaceuticals for Children Act Program.
DOI: 10.57982/hfy2-zz97
title: Correlates of HBV-Specific B Cell Memory Following Vaccination in HIV-Infected Adolescents and HIV-Uninfected Adolescents: A Substudy of ATN 024 and ATN 025

description: An exploratory laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This sub-study of ATN 024 and ATN 025 compared cellular immune response in responders and non-responders to immunization and evaluated the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.
DOI: 10.57982/na77-qb54
title: Microbicide-Use Adherence, Acceptability, and Attitudes among Sexually Active Young Women Participating in a Phase I Microbicide Trial (MTN-004) "Tell Juliana"

description: ATN 062 was a descriptive study of young women's adherence, acceptability and attitudes towards microbicide use and took place in parallel to the MTN-004 study, "Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel?) Applied Vaginally in Sexually Active Young Women." Participants used a computerized phone diary during the 14 day MTN-004 gel trial, and emailed messages to a research assistant as a supplement to the diaries. Participants also took part in in-depth interviews through teleconferences to contextualize the recorded events.
DOI: 10.57982/5q26-jy39
title: Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025

description: A laboratory-based substudy of ATN 024 and ATN 025 that evaluated the genetic contribution of highly individualized immune responses to the hepatitis B vaccine in individuals. The correlation of specific human leukocyte antigen (HLA) alleles and haplotypes with hepatitis B virus (HBV) antibody concentrations and antibody decay kinetics in vaccinated adolescents was also investigated.
DOI: 10.57982/peg2-rr82
title: Evaluation of an Intervention to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

description: A randomized, preliminary proof of concept study evaluating two types of supplemental information that would serve as an adjunct to the traditional informed consent in an HIV vaccine clinical trial. Participants were administered a standard HIV vaccine trial consent form and were then randomized into three conditions: no supplemental information provided, supplemental information with 1-sided messages provided, and supplemental information with 2-sided messages provided. Interviewers administered Part 1 of a two-part questionnaire before the informed consent was reviewed with participants. Part 2 of the questionnaire was administered either directly after the informed consent in the control condition, or after participants read through supplemental materials in the other two conditions. A debriefing interview was conducted with selected participants to review their understanding of the study procedures and reactions to the supplemental materials and/or questionnaires.
DOI: 10.57982/pvzp-5w06
title: Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline

description: Aim: Characterize the PK of doxycycline administered to children per standard of care as prescribed by their treating caregiver.

Methods: The PK and safety analyses was conducted for doxycycline data from NICHD-2011-POP01, a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including doxycycline, and is actively enrolling participants.

Results: A one-compartment model offered the best fit to characterize doxycycline PK data based on model selection criteria. No AEs or SAEs related to study procedures were reported.
DOI: 10.57982/dhny-2b90
title: Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Trimethoprim-Sulfamethoxazole

description: Aim:  Characterize the pharmacokinetics (PK) of enteral TMP and SMX administered to children per standard of care (SOC) as prescribed by their treating caregiver.

Methods: The PK analyses include plasma TMP-SMX data following enteral administration from NICHD-2011-POP01, a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who received drugs per SOC, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including TMP-SMX, and is actively enrolling participants for other DOIs. 

Results: A one-compartment model with first-order absorption and elimination described the PK data for both TMP and SMX. No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to TMP-SMX were reported.
DOI: 10.57982/66ds-7s05
title: Hepatitis B Vaccination in Youth at Adolescent Trials Network Sites: Effectiveness of Two Strategies and Evaluation of Tools to be Used in Future HIV Prevention Trials

description: A randomized, single-blinded trial evaluating two licensed vaccine products, Recombivax and Twinrix, given in a two-dose schedule to youth at risk for HIV and hepatitis B infection. Primary objectives were to determine immunogenicity of the products in the study population and to determine safety and tolerability of the vaccines given in the two regimens.
DOI: 10.57982/9314-3f44
title: Feasibility of Using a Structured Daily Diary to Assess Mood, Stressful Events, Support, Substance Use, and Sexual Behavior in HIV-Positive Young Men who have Sex with Men

description: This study tested the feasibility and acceptability of daily diary use among 16 to 24 year old HIV positive men who have sex with men to measure HIV risk behaviors and other psychosocial variables. Relationships among daily mood, stressful events, social support, substance use, sexual behavior, and adherence to antiretroviral therapy (ART) among youth who were prescribed to take medication were examined. The feasibility and acceptability of using daily diaries for data collection and to provide personalized feedback and/or assist with self-monitoring was also explored. Two daily diary modalities were tested: internet diaries accessible via any web-enabled device and voice diaries accessible by phone. Participants were randomized to complete one diary modality for 33 days before switching to the second modality for 33 days.
DOI: 10.57982/14pr-ze37
title: Safety and Efficacy of Caffeine Citrate in Premature Infants

description: The primary objective of the study is to characterize safety, efficacy and exposure-response relationship of caffeine citrate. The study included the retrospective analysis of clinical data for premature infants who received caffeine citrate per standard of care (SOC), gathered from three sources. Caffeine citrate used at greater doses for longer durations in more immature (e.g., lower Gestational Age) infants than the FDA label appears to be a safe therapy for the treatment of Apnea of Prematurity. Caffeine citrate use is not associated with an increased risk for Necrotizing Enterocolitis.
DOI: 10.57982/8t1q-jn35
title: A Pilot Study Using Cell Phone Interactions to Improve Medication Adherence in Adolescents Who Have Previously Failed Antiretroviral Therapy Due to Non-Adherence

description: A randomized, behavioral trial examining whether HIV-infected youth ages 15 to 24 receiving cell phone support with study funded phone plans demonstrated improved ART adherence and viral control during the 24 week intervention and 24 week post-intervention periods, compared to controls. Participants were randomized to either the intervention or control group. Intervention group participants received Monday through Friday cell phone support from an Adherence Facilitator, including reminders, assessment of barriers to adherence, problem solving and referrals to services. Control group participants completed all on-study evaluations, except intervention exit interviews.
DOI: 10.57982/hjg1-1r22
title: Safety and Pharmacokinetics of Fluconazole in Children Supported with Extracorporeal Membrane Oxygenation

description: Evaluate the safety and pharmacokinetics of intravenous fluconazole in children supported with ECMO who may benefit from fluconazole prophylaxis.This is a prospective, open-label, single center, PK study of fluconazole in children <= 17.85 years of age supported with ECMO. There will be up to 36 subjects enrolled; each will receive fluconazole. The patients will be divided in 3 groups based on age: 0-30 days; 31 days-1 year; >1 year-17 years.
DOI: 10.57982/04gk-kd23
title: A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

description: Suboptimal response to hepatitis B vaccination in HIV-positive adults and children has been well documented in the literature. This Phase 4 trial compared the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age. The three vaccination schemas were the standard adult dosing of hepatitis B virus (HBV)-only vaccine (Engerix 20mcg), the increased adult dosing of HBV-only vaccine (Engerix 40 mcg), and the standard adult dosing of combined HBV/hepatitis A virus vaccine (Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg), all at Entry, Week 4, and Week 24. Primary sero-reponses were evaluated at Week 28, and primary non-responders (antibody response of < 10 IU/ml) were provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48.
DOI: 10.57982/xhta-wv85
title: Healthy Choices: Motivational Enhancement to Promote Health and Reduce Risk in HIV-Infected Youth

description: In this Phase II multi-site clinical trial, HIV+ youth were randomized to receive either a four-session motivational enhancement intervention and referrals or standard care plus referrals. Participants randomized to the intervention group participated in four sessions of Healthy Choices, a motivational enhancement intervention specifically designed to target multiple risk behaviors in HIV+ youth. Participants received individualized referrals at the fourth session. Participants randomized to standard care also received individualized referrals. Interviews, self-report, chart review and blood tests were used to measure substance use, condom use, adherence to medications, and health outcomes, as well as hypothesized mediators and moderators of the intervention. The primary objective was to determine the efficacy of a motivational enhancement intervention in reducing health risk behaviors (drug and alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.
DOI: 10.57982/brh7-tj70
title: Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Ondansetron

description: Aim: Characterize the pharmacokinetics (PK) of ondansetron administered to children per standard of care as prescribed by their treating caregiver. Methods: The PK and safety analyses in this report include ondansetron data from NICHD-2011-POP01 (“Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including ondansetron, and continues to enroll participants under other DOIs. 
Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ondansetron were reported.
DOI: 10.57982/qmvr-mr13
title: Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers

description: This was a prospective, single-center, open-label, PK and safety study of fluconazole loading dose in infants <2 years of age for the treatment of suspected fungal infections. Subjects were given an intravenous loading dose (25 mg/kg administered over 2 hours via a syringe pump) followed by maintenance therapy (12 mg/kg/d over 1 hour). Study objectives included determining the optimal loading dose and maintenance dose of fluconazole in infants with suspected invasive candidiasis, as well as the safety of these doses in infants.
DOI: 10.57982/fqfd-ze19
title: Safety of Fluconazole Prophylaxis in Infants

description: This is a secondary analysis of clinical trials involving fluconazole prophylaxis in very low birthweight and extremely low birth weight infants. The objective of this study is to evaluate the safety of prophylactic fluconazole in premature infants. The prophylaxis trial observed gastrointestinal safety signals that have not been previously reported for fluconazole. Based on this observation additional information was obtained from the subjects enrolled in the prophylaxis trial. The fluconazole safety study analyzed the data to better evaluate these safety signals.
DOI: 10.57982/xcc3-4r53
title: Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants <750 Grams Birth Weight

description: This was a prospective, randomized, double-blind, multi-center, efficacy study comparing fluconazole prophylaxis to placebo. The study objective was to determine the safety and efficacy of fluconazole for the prevention of candidiasis in infants <750 grams birth weight. The primary endpoint was death or candidiasis prior to study day 49. The prophylaxis trial observed gastrointestinal safety signals that have not been previously reported for fluconazole. Based on this observation additional information was obtained from the subjects enrolled in the prophylaxis trial. The fluconazole safety study analyzed the data to better evaluate these safety signals.
DOI: 10.57982/wcv5-c904
title: Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I

description: An exploratory study that adapted and tested an integrated cognitive behavioral and contingency management (CBT/CM) intervention for decreasing alcohol and/or marijuana use or abuse in HIV-positive adolescents. HIV-infected youth between 16 and 24 years of age with an alcohol and/or marijuana use or abuse disorder participated in focus groups and one of two intervention trials, with revision and adaptation of the intervention between trials. The CBT/CM intervention was delivered in fifteen one-hour individual sessions over the course of four months. The sessions aimed to promote decreased alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior, as well as increased adherence to medical treatment. Participants had the option of including parents and/or a significant other in treatment sessions.