cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.57982/5sk5-2s15
title: Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 cells/mm3 Initiating HAART

description: A randomized, proof-of-concept study of adolescents and young adults aged 18-24 years with confirmed HIV acquired after age 9 with CD4+ T cells above 350 cells/mm3 who were randomized 3:1 to begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone with ATV/r upon entry. Subjects in the experimental group who achieved virologic control by week 24 and maintained good control through 48 weeks would de-intensify to ATV/r alone and be followed for an additional two years. Subjects randomized to the standard care arm began HAART with TDF/FTC/ATV/r, AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen and followed for a total of three years. Subjects on the standard care arm would begin therapy when the CD4+ T cell count dropped below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman (john.sleasman@duke.edu).
DOI: 10.57982/65h7-1e78
title: Acceptability and Feasibility of a Pre-Exposure Prophylaxis Trial With Young Men Who Have Sex With Men

description: An exploratory mixed-methods study comparing a behavioral HIV-prevention intervention (Many Men, Many Voices or 3MV) alone to 3MV combined with a biomedical intervention (Pre-exposure Prophylaxis or PrEP). After completing the 3MV intervention, participants were randomly assigned to one of three study arms: 1) daily PrEP with emtricitabine and tenofovir (FTC/TDF); 2) placebo pill control; or 3) “no pill” control. Behavioral and biomedical data were collected at baseline and every 4 weeks for 24 weeks. Qualitative interviews with a subset of participants were completed at the end of the study to explore the feasibility and acceptability of the trial. Eligible youth who declined to participate were asked to complete a brief opinion survey about PrEP.  In addition, a focus group was conducted with young men ages 16-17 years who have sex with men and who met all eligibility requirements except for age to discuss issues of feasibility and acceptability should they be eligible to enroll in a future similar trial.
DOI: 10.57982/e4w5-9k85
title: Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults

description: A multi-site study of 13-24 year-old Hispanic/Latino men who have sex with men, heterosexual men, and heterosexual women. Comparisons were made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies, assessing the most effective means for identifying undiagnosed HIV infection in young, at-risk Hispanics/Latinos. Study participants completed an audio computer-assisted self-interview (ACASI) and HIV screening. All participants with presumptive HIV+ screening results were referred for confirmatory testing and linkage to HIV medical care. In addition, a subset of SSNIT participants went on to recruit members of their social and sexual network who were eligible for study participation.
DOI: 10.57982/zqnx-mj55
title: Neurocognitive Assessment in Youth Initiating HAART

description: A prospective cohort study comparing neurocognitive functioning in four groups of youth, ages 18-24 years, with behaviorally acquired HIV infection: two groups with CD4+ T-cells greater than 350 cells/mm3 and HIV RNA equal to or greater than 1,000 copies/ml - one initiating early highly active antiretroviral therapy (HAART) (Group 1), the other not initiating treatment (Group 2); and two groups with CD4+ T-cells less than 350 cells/mm3 -  one initiating HAART according to then current DHHS guidelines (Group 3), the other not initiating treatment (Group 4). Groups 2 and 3 represented standard of care. The study provided preliminary data to test the hypothesis that initiating HAART earlier than DHHS guidelines suggested at that time resulted in better neurocognitive function in comparison with no treatment or treatment initiated according to DHHS recommendations.
DOI: 10.57982/pqf8-kj71
title: Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III

description: A cross sectional study that enrolled youth ages 12-24 years who received care during the study period for HIV infection at five newly participating ATN Adolescent Medicine Trials Units (AMTUs). The study was conducted in one visit and examined a broad spectrum of youth engaged in care at the AMTUs, including those newly enrolled in care. Information was collected on rates of adherence to medical regimens, sexual risk behaviors, substance use and mental health concerns, and basic demographic and biomedical data to understand risk behaviors, risk and protective factors, and relationships between factors in adolescents and young adults with HIV infection.
DOI: 10.57982/rsh3-tn90
title: Validation of the HIV Treatment Readiness Measure

description: A multi-site study that assessed the reliability of the HIV Treatment Readiness Measure (HTRM). The psychometric properties of the HTRM and test-retest reliability were assessed with a sample of HIV positive youth between 13 and 24 years of age that were highly active antiretroviral therapy (HAART) naive (never having taken HAART) or HAART experienced (at least one experience taking HAART and not taken HAART 30 days prior to study entry). The HTRM is a tool to assist clinicians in determining whether youth living with HIV are ready to initiate HAART, and to identify youth in need of additional support services to facilitate their adherence to HAART.
DOI: 10.57982/z73t-cw13
title: The Impact of Grade Retention:  A Developmental Approach

description: 784 ethnically diverse students, first grade students were recruited and followed with annual assessments of academic, behavioral, and social functioning for 14 years. Aim 1 was to use a bilingual, prospective longitudinal methodology to test the effects of grade retention on students’ subsequent academic, social, emotional, and behavioral outcomes and to examine the social processes that mediate retention’s effects at different ages and grades.  Aim 2 was to test theoretical models of child and environmental factors that influence academic trajectories of academically at-risk children, with a specific focus on social-relational processes. Aim 3 was to investigate the role of ethnicity, language, and culture as they relate to the first two specific aims.  Over 50 journal articles reports results. Grade retention does not impair academic achievement but negatively impacts high school graduation.  Peer and teacher relationships are key to students’ school engagement and achievement.
DOI: 10.57982/n3fa-px71
title: Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women

description: A cross-sectional study that enrolled adolescent and young women, ages 12 through 24, to evaluate the prevalence and severity of morphologic and metabolic abnormalities and to assess the drug and non-drug factors related to these abnormalities. The study assessed differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV infected and uninfected young women  to understand the pathophysiological effects of protease inhibitor (PI)- and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young females. One study visit conducted over 1 or more days included survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism. Biospecimens are available.
DOI: 10.57982/qqp0-3z47
title: Child/Adolescent Longitudinal Predictors of Young Adult Outcome

description: Two longitudinal studies were conducted for third generation subjects from pedigrees that were either at high risk for developing alcohol use disorders and related substance use disorders or were from control pedigrees. Approximately annual assessment in childhood and adolescence provided information on childhood problems.  Interview in young adulthood provided information on substance use disorder outcome as well as other DSM-IV diagnoses.
DOI: 10.57982/bpjd-4578
title: Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression

description: A prospective proof of concept study of subjects who had successfully suppressed their HIV-1 RNA levels for a minimum of 6 months prior to study entry on highly active antiretroviral therapy (HAART) including a protease inhibitor (PI). The study assessed the impact of switching from continuous HAART with a PI to short-cycle therapy (SCT).  The primary objective was to show that the rate of viral load rebound on SCT does not exceed that which would be expected in subjects on continuous therapy.  While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial was construed as an assessment of safety. The study was co-endorsed by the Pediatric AIDS Clinical Trials Group (PACTG).
DOI: 10.57982/pwvm-7s10
title: Treatment De-Intensification and Residual HIV-1 in Adolescents and Young Adults: A Sub-Study of ATN 061 and ATN 071

description: A laboratory-based sub-study of ATN 061 and ATN 071 that examined the effect of early treatment (HAART at CD4+ T cells > 350 cells/mm3) followed by treatment de-intensification to atazanavir/ritonavir (ATV/r) monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent low-level viremia (LLV), and their contribution to successful long-term control of HIV-1 replication among HIV-1 infected adolescents and young adults, ages 18 to 24 years. Some biospecimens are available; for inquiries, please contact Dr. John Sleasman (john.sleasman@duke.edu).
DOI: 10.57982/swpr-dx74
title: Prospective Study of Perinatal Transmission of HIV Infection and Developmental Outcome of Children Infected with HIV: Mothers and Infants Cohort Study

description: A prospective cohort study that enrolled both HIV+ and HIV- pregnant women (n=450) at 5 obstetric clinics in New York City between 1986-1991. Of those that were HIV+, few had been exposed to antiretroviral therapy. Objectives were to: 1) ascertain the probability of perinatal transmission of retroviruses (RV) to offspring of HIV+ pregnant women; 2) determine if RV increases adverse pregnancy outcomes; 3) quantitate the spectrum of disorders up to age four for children at risk for RV infection; 4) determine the effect of HIV status on pregnancy; 5) develop a serum bank as a resource for new serologic markers of RV infectivity and exposure; 6) obtain prolonged follow-up of RV-infected women and children; 7) have a population available for possible studies of heterosexual or household transmission of RV; and 8) assist in planning the allocation of healthcare resources for HIV-infected children. Biospecimens are available for request through DASH. Please navigate to Explore Biospecimens at the top of this page.
DOI: 10.57982/jd9t-f626
title: Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Men

description: A multi-center, cross-sectional study of HIV infected and uninfected males, ages 12 to 24, that evaluated the prevalence and severity of morphologic and metabolic abnormalities in HIV-infected young men and assessed the drug and non-drug factors related to these abnormalities. Differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV infected and uninfected young men were assessed to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapies in young men. One study visit conducted over 1 or more days included survey questionnaires, DEXA scanning, collection of blood and urine specimens, anthropometric measurements, and blood tests examining glucose and lipid metabolism and levels of C-Reactive protein and lactate. Biospecimens are available.
DOI: 10.57982/3c58-8531
title: A Pilot Study to Identify Undiagnosed Asymptomatic HIV Infections in Adolescent and Young Adult Women

description: A cross-sectional pilot study that enrolled sexually experienced Hispanic/Latina and African American adolescent and young adult women to serve as index recruiters, who in turn recruited members of their female friendship network to undergo HIV screening. Participants were stratified into three groups based on self-reported HIV infection status. The feasibility and acceptability of identifying and recruiting young women who self-disclose their HIV status to serve as index recruiters were examined. Factors facilitating and hindering recruitment of friendship network members to undergo HIV screening, friendship network members undergoing HIV screening, and HIV negative and HIV status unknown index recruiters undergoing HIV screening were also examined.
DOI: 10.57982/zqhr-3t26
title: A Pilot Study to Identify and Describe the Male Networks of Adolescent and Young Adult Women Enrolled in ATN 067

description: The primary goal of ATN 084, a pilot study and sub-study of ATN 067, was to explore the feasibility and acceptability of index female recruiters identifying and recruiting their past and present male sexual partners to undergo HIV screening. In addition, the study  included female friendship network members of the index recruiters who were enrolled in ATN 067 and were diagnosed with HIV. These young women were asked to recruit their past and present male sex partners to undergo HIV screening. Factors facilitating and hindering HIV screening of the male sexual partners were also examined.
DOI: 10.57982/r90r-hj35
title: Stillbirth Collaborative Research Network Study 

description: Population-based case–control study of the causes and extent of stillbirth (SB) in the United States. Participants were recruited at delivery between March 2006 and September 2008 from 59 urban and rural hospitals in 5 geographic areas. All women with SB and a representative sample of women with live births, oversampled for those delivering at <32 weeks gestation and those of African descent delivering at =32 weeks gestation, were approached for enrollment. Pregnancy terminations were excluded. The study included maternal interview, chart abstraction, placental exam, and postmortem (SB only).  Data collection focused on surveillance and epidemiology, maternal disease, immunology and infections, placental pathology, and genetics.  A subset of SCRN participants consented to re-contact which examined subsequent pregnancies and pregnancy complications, grief resolution, and whether life-course stresses and environmental factors were associated with an increased risk of SB.  Biospecimens are available.
DOI: 10.57982/e6h7-p462
title: Structural and Partnership Factors Affecting Adherence to Pre-Exposure Prophylaxis (PrEP) Among Young Men Who Have Sex With Men

description: A longitudinal pilot sub-study of ATN 110 and ATN 113 assessing how structural (physical settings) and partnership factors affect adherence of young men who have sex with men to Pre-Exposure Prophylaxis (PrEP). The study compared levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by ACASI, Wisepill, and drug concentration levels in blood and hair. The iQS was administered at study entry (ATN 110 or ATN 113 week 24) and week 24 (ATN 110 or ATN 113 week 48) visits.
DOI: 10.57982/5ede-a454
title: Evaluation of SMILE in CARING for YOUTH: CDC-ATN/NICHD HIV Testing and Linkage-to-Care Collaboration 

description: This study determined program-level factors associated with the effectiveness of SMILE in CARING for YOUTH Linkage-to-Care (LTC) program networks at 15 Adolescent Medicine Trial Units (AMTUs). The various LTC programs at the AMTUs were evaluated and categorized. The study then examined associations between LTC program characteristics (providers, practices, and systems) and the proportion of Human Immunodeficiency Virus (HIV)-infected youth, ages 12-24 years old, inclusive, linked to care and maintained in care. This study focused on LTC programs at the AMTUs as the unit of analysis and not the youth themselves.
DOI: 10.57982/3gyq-4927
title: PROJECT �R�: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females

description: A group-randomized controlled design to test the efficacy of the Project �R� intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) were randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females recruited members of their friendship group for the five-hour program. In the experimental condition, the intervention group received the half-day Project �R� intervention. The attention control group received a standard health promotion control program which had been used previously with similar populations. All participants completed pre-, post-, and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups participated in a process evaluation focus group immediately following the program.
DOI: 10.57982/rx3b-sh14
title: Ovarian Follicle Function in Patients with Premature Ovarian Failure

description: No proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. We know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. This is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with premature ovarian failure. The findings will determine patients' suitability for specifically focused therapeutic research protocols. Whole exome sequences (WXS), phenotype, and clinical data for a subset of patients are available in dbGaP repository.
DOI: 10.57982/q2x7-5x65
title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss 

description: The objectives of the Optimal Trial are to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.
DOI: 10.57982/wa02-gp03
title: Safety and Efficacy of High-Dose Acyclovir in Infants with HSV or Suspected HSV

description: An observational, retrospective study that included analysis of safety data on infants who had been admitted to intensive care nurseries who received acyclovir as standard of care for confirmed herpes simplex virus (HSV) infection. Sources of data were the Pediatrix Medical Group database and medical charts from four clinical sites (n=49).  Publications from two major clinical trials of acyclovir in neonatal HSV infection were also reviewed for safety data. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program.
DOI: 10.57982/7ce5-2h15
title: Pregnancy in Polycystic Ovary Syndrome II: A 25 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women with Polycystic Ovary Syndrome

description: In this study published in NEJM, 750 infertile women diagnosed with PCOS were enrolled, and we found that letrozole is better than the current standard therapy in increasing live births for women with polycystic ovary syndrome, which is a leading cause of female infertility.
DOI: 10.57982/ce5c-dk43
title: An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants

description: An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four groups, with GA 23-42 weeks and PNA up to 60 days; version 2.0 (n=19) included three groups, with GA 23-34 weeks and PNA <45 days. Acyclovir was administered every 8-12 hours for up to 3 days and was well tolerated. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program. Biospecimens were collected but are not currently available.
DOI: 10.57982/jq4x-e077
title: Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation

description: In this multicenter, randomized trial published in NEJM, 900 couples with unexplained infertility were enrolled to test the standard therapy of gonadotropin or clomiphene citrate for women with unexplained infertility against ovarian stimulation with letrozole to reduce multiple gestations while maintaining live birth rates.  The primary outcome was the rate of multiple gestations among women with clinical pregnancies, and we found that in women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene.
DOI: 10.57982/s9rb-rd70
title: Pediatric Pharmacokinetic and Tolerability Study of Lithium for the Treatment of Pediatric Mania followed by an Open Label Long Term Safety Period, Discontinuation Phase, and Restabilization Period

description: A multi-phase, multi-center trial that examined lithium in the treatment of pediatric patients (ages 7-17 years) with bipolar I disorder. There were four phases: 1) the Pharmacokinetic Phase included 8 weeks of open label treatment to determine empirically based dosing strategies for children and adolescents with bipolar disorder; 2) after completing the Pharmacokinetic Phase, eligible participants continued in the Long-Term Effectiveness Phase for a maximum of 16 weeks of lithium treatment; 3) participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks; and 4) participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an open label Restabilization Phase and treated with lithium for up to 8 weeks.
DOI: 10.57982/4x6x-sd62
title: A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for Treatment of Pediatric Mania followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase and Open Label Restabilization Period

description: The second of two multiphase, multicenter trials that comprehensively examined lithium in the treatment of pediatric patients with bipolar I disorder. In the first phase, the Efficacy Phase, participants were randomized to either lithium or placebo for 8 weeks to determine efficacy. Eligible participants then continued in the Long-Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.