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Showing 48 out of 48 studies

 
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects (SNP2)

Study Description: A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued.

A Prospective, Observational Study of HIV-Exposed and HIV-Infected Children at Clinical Sites in Latin American and Caribbean Countries (NISDI Pediatric)

Study Description: Describes the demographic, clinical, immunologic, and virologic characteristics of HIV-exposed uninfected infants and HIV-infected infants, children, and adolescents at clinical sites in Latin America. Biospecimens are available.

A Prospective, Observational Study of HIV-Infected Pregnant Women and HIV-Exposed, Uninfected Children at Clinical Sites in Latin American Countries (NISDI LILAC)

Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed, uninfected children at clinical sites in Latin America, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available.

A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries (NISDI Perinatal)

Study Description: Describes the characteristics of HIV-infected pregnant women and their HIV-exposed infants at participating clinical sites in Latin America and the Caribbean, including the utilization of interventions related to decreasing the risk of mother-to-child transmission. Biospecimens are available.

Acceptability and Feasibility of a Pre-Exposure Prophylaxis Trial With Young Men Who Have Sex With Men (ATN 082)

Study 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.

Antenatal Corticosteroids Trial in Preterm Births to Increase Neonatal Survival in Developing Countries (ACT)

Study Description: ACT, funded by the NICHD, studied the feasibility, effectiveness and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids (ACS) at all levels of health care in low- and middle-income countries. Investigators conducted a two-arm parallel cluster randomized trial of women enrolled in the Global Network Maternal Newborn Health Registry. Intervention clusters received health-provider training, posters, pregnancy disc, and uterine height tape to facilitate identification of women at risk of preterm birth, and ACS kits. All health providers in intervention clusters were trained to identify women presenting before 36 weeks’ gestation with signs of labor, PPROM, pre-eclampsia/eclampsia, or obstetric hemorrhage as at high risk of preterm birth and potential candidates for ACS. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birth weight (a proxy for preterm birth).

Assessment of Inflammatory Markers Associated with Neurocognitive Impairment in HIV-infected Adolescents, a Sub-study of ATN 071 (ATN 101)

Study Description: A sub-study of ATN 071 ("Neurocognitive Assessment in Youth Initiating HAART"), ATN 101 was an exploratory assessment comparing the results of a comprehensive neurocognitive evaluation carried out through ATN 071 to biomarkers within the plasma that correlate with immune activation, inflammation, and microbial translocation among study participants. Neurocognitive evaluations from ATN 071 were available for three years of follow-up; blood samples for ATN 101 were collected at the final ATN 071 study visit. In a subset of participants co-enrolled in ATN 061 ("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), biomarkers were evaluated before and after the initiation of HAART.

Behavioral, Immunologic, and Virologic Correlates of Oral Human Papillomavirus Infection in Adolescents and Young Adults with Behaviorally Acquired HIV-Infection (ATN 114)

Study Description: A cross-sectional sub-study of ATN 106 ("Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III"). In addition to sharing data collected in ATN 106, an oral rinse sample, the subject’s self reported history and medical chart abstraction of HPV vaccination status and history of oral condylomata, oral dysplasia and oral tumor viruses were collected. Oral rinse specimens were tested for HPV, EBV and KSHV viruses.

Bone Mineral Density in Childhood Study (BMDCS)

Study Description: A multi-center, six year longitudinal study examining bone accretion in a racially diverse cohort of 2014 healthy boys and girls ages 5-20 years at 5 clinical centers in the US. The BMDCS cohort included children with height, weight, and body mass index (BMI) between the 3rd and 97th percentile and with no previous or current conditions that might affect bone acquisition. Recruitment occurred in two phases: 1554 subjects ages 6 to 17 years were enrolled during 2002-2003; during 2006-2007 younger (5y) and older (19y) subjects were enrolled to extend the reference percentiles to ages 5-20 years. The second wave of participants were followed for 2 years.  Annual assessments included linear growth, weight gain, pubertal maturation, nutritional status, exercise, bone mineral density (DXA by Hologic) and bone age comprised the main study measures. A subset of patients underwent pQCT and qCT.  The reference curves generated by this carefully executed study are the gold standard for normal bone accrual.

Characterization of human trophoblastic extracellular vesicles (EV)

Study Description: Primary human trophoblasts release a repertoire of extracellular vesicles (EVs). Among them are nano-sized exosomes, which we found to suppress the replication of a wide range of DNA and RNA viruses. We report here our investigation of protein cargo of placental EVs including exosomes, microvesicles, and apoptotic blebs. We isolated EVs using ultracentrifugation and defined their purity using western analysis, electron microscopy, and nanoparticle tracking. We found that trophoblastic exosomes harbor a protein profile that is distinct from that of microvesicles or apoptotic blebs. Functionally, trophoblastic exosomes exhibit the highest anti-viral activity among the EVs. Our work suggests that human trophoblastic EVs may play a key role in maternal-placental-fetal communication.

Cholesterol in Autism Spectrum Disorder (ASD): Characterization and Treatment (CASD)

Study Description: Initially designed as a randomized, double-blind, placebo-controlled clinical trial for children with autism spectrum disorder (ASD), enrollment ceased early due to lack of funding for extramural collaborators. One of the primary aims of the study was to establish the prevalence of hypocholesterolemia and hypercholesterolemia in idiopathic ASD. Available in DASH are laboratory results collected at multiple time points, including cholesterol levels, on 42 children enrolled during the first three years of the study

Clinical Trial of Low-Dose Aspirin (60 mg) as a Preventive of Preeclampsia (MFMU LRA)

Study Description: A randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of daily low-dose aspirin in preventing preeclampsia in nulliparous women who begin treatment at 13 to 25 weeks gestation

Clinical Trial of Low-Dose Aspirin to Prevent Preeclampsia in High Risk Women (MFMU HRA)

Study Description: A randomized, double-blind, placebo-controlled trial to examine whether daily administration of 60 mg of aspirin beginning at 13 to 26 weeks gestation will decrease the incidence of preeclampsia in pregnant women at high risk for developing the disease. High risk women enrolled were those with chronic hypertension, insulin-dependent diabetes, past history of preeclampsia, or multifetal pregnancy.

Community and Child Health Network (CCHN)

Study Description: A five-year, multi-site, prospective cohort study about stress and resilience and their influence on maternal allostatic load as a mediator of birth outcomes and child health and development. Biospecimens are available.

Connect To Protect Partnerships For Youth Prevention Interventions Phase III Evaluation Sub-Study: Changes In HIV-Related Risk Among High-Risk Youth At Congregation Venues (ATN 040b)

Study Description: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the overall goal of ultimately reducing HIV incidence and prevalence among youth through a community mobilization intervention. In Phase III of C2P (ATN 040) a community mobilization intervention that consisted of guiding C2P coalitions through a strategic planning process for the development and implementation of a local action plan was initiated and completed. As the evaluation sub-study of ATN 040, ATN 040b measured changes In HIV-related risk among high-risk youth at congregation venues, i.e., locations identified by youth, community partners, and C2P site staff as places where members of the population of focus "hang out." This study is a sub-study of another ATN study or studies. Please refer to the protocol for information regarding ATN study connections.

Connect To Protect Partnerships For Youth Prevention Interventions: Phase III Community Mobilization Intervention With Public Health Surveillance Data Assessments (ATN 040)

Study Description: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions was a multi-site, three-phase project with the goal of reducing HIV incidence and prevalence among youth through a community mobilization intervention. The objective of ATN 040 (Part One of Phase III) was to initiate and complete an intervention that consisted of guiding C2P coalitions through a strategic planning process resulting in the development and implementation of a local action plan. The action plan focus was to change structural elements of affected communities believed to be associated with youth HIV acquisition and transmission. Each coalition's plan included: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) selection of community-level Centers for Disease Control and Prevention (CDC)-endorsed HIV prevention program. This study is a component of other ATN phased studies. Please refer to the protocol for information regarding the other phases.

Consortium on Safe Labor (CSL)

Study Description: Collected detailed information from electronic medical records for 228,438 deliveries in 19 U.S. hospitals. Primary objectives were to explore the underlying causes of the high cesarean rate in the U.S. population, describe contemporary labor progression at the national level, and determine when is the more appropriate time to perform a cesarean delivery in women with labor protraction and arrest. NOTE: Data requesters should refer to the "CSL Read Me" PDF describing data caveats.

Extremity Constraint Induced Therapy Evaluation Trial (EXCITE)

Study Description: The first national, randomized, single-blind study to systematically test a neurorehabilitation therapy - constraint induced movement therapy (CIMT) - among patients with the ability to initiate extension movements at the wrist and fingers and who had experienced a first stroke within 3 to 9 months prior to enrollment. Participants recruited from 247 clinics nationwide were randomized to receive CIMT to the more impaired upper extremity for two weeks upon enrollment or to receive the identical intervention 15-21 months post-stroke. Outcome measures were the Wolf Motor Function Test (WMFT) and Motor Activity Log (MAL) for functional improvements and the Stroke Impact Scale (SIS) for health-related quality of life.

Family Management of Diabetes (FMOD)

Study Description: The study employed a randomized experimental design in which youth with type 1 diabetes and parents attending one of four clinical sites were stratified by degree of glycemic control and randomized to receive either standard care or a clinic-integrated behavioral intervention. The intervention provided experiential training for families in the use of a problem-solving approach for improving diabetes management. It was designed to be applicable to the broad population of youth with diabetes and their families, flexibly implemented and tailored to the varying needs of families, and delivered at a low intensity over time to meet the changing needs and roles of families during the period in which responsibility for diabetes management typically undergoes transition. A combination of in-person assessments, telephone assessments, and in-clinic data collection were utilized to assess glycemic control, adherence, quality of life, psychological status, and hypothesized mediators of these outcomes.

Genomic and Proteomic Network for Preterm Birth Research Expression Profiling Study (GPN-PBR EP)

Study Description: An observational study of 60 women enrolled at the time of preterm or term cesarean delivery, when maternal and neonatal specimens were collected for DNA, RNA expression profiling, proteomic and metabolomic analyses, measurements of markers of pregnancy exposure, epigenetics, and histology. Participants were further grouped according to presence or absence of spontaneous onset of labor either in the presence or absence of premature rupture of membranes (preterm or term). Only data from participants who consented to secondary use of their data are included in this archive (49 women). Biospecimens are available.

Genomic and Proteomic Network for Preterm Birth Research GWAS Case Control Study (GPN-PBR CC)

Study Description: A multi-center observational genome-wide association study (GWAS) designed to determine if there is a genetic predisposition to idiopathic preterm birth. Maternal and neonatal DNA from 743 spontaneous preterm births (20 to less than 34 weeks gestation), and 752 controls (39 to less than 42 weeks gestation) were analyzed. Phenotype data and clinical data have been uploaded in dbGaP. Cases were 1:1 matched with controls according to race and ethnicity, maternal age, and parity. Biospecimens are available.

Genomic and Proteomic Network for Preterm Birth Research Longitudinal Cohort Study (GPN-PBR LS)

Study Description: A study to identify analytical biomarkers (proteins, DNA, etc.) that might help predict a pending preterm birth. Blood (whole blood & serum), urine, saliva and vaginal swab specimens were obtained from high risk women (with a history of previous spontaneous preterm birth) at different times during their current pregnancy to look for changes over time that would be predictive of a pending preterm delivery. Biospecimens are available.

Hemophilia Growth and Development Study (HGDS)

Study Description: A multicenter study of hemophilia and its complications, HGDS was established in 1988. Data were prospectively collected in 14 U.S. hemophilia treatment centers through 1996/97. The HGDS investigated the effects of hemophilia and HIV on physical growth and maturation; immunological, neurological, and neuropsychological functioning; and the pathophysiology of HIV and hepatitis C. Research using the clinical data and stored samples continues and includes the genetic research that paved the way for development of the protease inhibitors currently used to treat HIV; studies that provided clues to viral characteristics of HIV and hepatitis B and C; research to identify genetic factors associated with the development of inhibitory antibodies to factor VIII; the relationship of inhibitors to cognitive development and academic achievement; studies of viral factors and how they relate to progression of HIV and hepatitis C; and research on the parenteral transmission of human viruses. Biospecimens are available.

Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults (ATN 096)

Study 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.

Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women (ATN 064)

Study Description: A Phase II, open-label, multi-center study that evaluated the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women. The vaccine was administered at the recommended dose and schedule (Day 0, Week 8, and Week 24) with safety assessments after each vaccination and reactive antibody measurements pre- and post-vaccination. Attitudes and behaviors were measured using self-administered questionnaires.

Intervention Development for Newly Diagnosed Youth With HIV (ATN 068)

Study Description: Pilot test of an HIV intervention to aid in the psychosocial adjustment of newly diagnosed youth (diagnosed for less than 15 months) to assess its acceptability and feasibility preliminary to and leading up to a full-scale, randomized trial. Individual sessions and focus groups were conducted across three ATN sites in order to identify the challenges, strengths, and needed areas of support/assistance associated with receiving an HIV diagnosis. These data were used to guide the development of an intervention manual.

Mid-Trimester Endovaginal Sonography in Women at High Risk for Spontaneous Preterm Delivery (MFMU CRVUS)

Study Description: Examined whether endovaginal sonography can identify a group of high risk women whose mid-trimester cervical characteristics define them as candidates for a future clinical trial of cerclage or other intervention strategies. Cervical length was the primary variable of interest.

Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 days) with Suspected or Complicated Intra-abdominal Infections (BPCA Meropenem)

Study Description: An open-label, multiple-dose study to determine the safety, tolerability, and pharmacokinetics of meropenem in preterm and term infants less than 91 days of age with suspected or confirmed intra-abdominal infections. Biospecimens are available.

National Infant Sleep Position Study (NISP)

Study Description: National observational study to examine infant sleep practices and factors associated with adherence to the American Academy of Pediatrics back-to-sleep recommendations and related infant care practices. Nighttime caregivers of infants less than eight months of age were surveyed during 1992 to 2010 about their infant's sleep position, reasons for their choice of sleep position, specific sources of sleep position recommendations, and other practices, such as bed sharing, bedding used, and use of pacifiers.

Network-Wide Assessment of Current Health Status and Behavioral Risk Factors (ATN 086)

Study Description: A cross sectional study that enrolled youth, ages 12 through 24, who received care for HIV infection at sites participating in the ATN during the study period. The study was conducted in one visit and examined a broad spectrum of youth engaged in care at ATN sites 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.

Network-Wide Assessment of Current Health Status and Behavioral Risk Factors: An Expanded Study for New Sites in ATN III (ATN 106)

Study 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.

Neurocognitive Assessment in Youth Initiating HAART (ATN 071 )

Study 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.

NISDI Pediatric Latin American Countries Epidemiological Study: A Prospective, Observational Study of HIV-infected Children at Clinical Sites in Latin American Countries (NISDI PLACES)

Study Description: Describes the demographic, clinical, immunologic, and virologic characteristics of children who acquired HIV infection through mother-to-child transmission. Subjects were evaluated every six months for up to five years for complications of both the disease and its treatments. Biospecimens are available.

Obstetrical Determinants of Neonatal Survival (MFMU ODNS)

Study Description: A pilot observational study to examine the effectiveness of using selected obstetrical factors to predict the survival of extremely low birth weight infants. Attitudes of physicians, estimated gestational age, estimated fetal weight, and ultrasound data were among the factors examined.

Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens For Prevention Of Intrapartum HIV-1 Transmission (HPTN 040/P1043)

Study Description: Compared the efficacy and safety of three antiretroviral regimens [standard zidovudine (ZDV) regimen vs. ZDV and nevirapine (NVP) vs. ZDV, lamivudine (3TC) and nelfinavir (NFV)] administered for the prevention of vertical HIV-1 transmission to infants born to HIV-1-infected women who did not receive antiretroviral therapy during the current pregnancy. Primary outcome measure was HIV-1 infection at 3 months in infants uninfected at birth. This study was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HPTN). Biospecimens are available.

Posttraumatic Stress Disorder and Risk Behavior in HIV Positive Female Adolescents (ATN 053)

Study Description: A qualitative study that explored the interrelationships between 1) abuse and sexual risk behavior, and 2) abuse, sexual risk behavior, and substance use in 18 to 24 year-old females with behaviorally-acquired HIV infection. An open-ended in-depth interview, occurring over one to two sessions, was conducted with each participant.

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 (ATN 061)

Study 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 or to begin treatment under current DHHS guidelines. 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.

Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women (ATN 021a)

Study 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.

Prospective Study of Perinatal Transmission of HIV Infection and Developmental Outcome of Children Infected with HIV: Mothers and Infants Cohort Study (MICS)

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 (RVs) to offspring of HIV+ pregnant women; 2) determine if RV infection in the mother increases the likelihood of adverse pregnancy outcomes; 3) quantitate the spectrum of immunologic and clinical 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 RVs; and 8) assist in planning the allocation of healthcare resources for HIV-infected children. Biospecimens are available.

Psychosocial Needs of HIV+ Young Men Who Have Sex With Men (ATN 070)

Study Description: A mix-method study that investigated associations among HIV-positive YMSM's racial identities, sexual orientation identities, and identities as HIV-positive young men with their stressors, coping mechanisms, and health behaviors. Phase 1 of the study involved an in-depth qualitative interview with 54 participants. Phase 2 of the study involved completion of one assessment battery administered on a laptop computer via Audio Computer Assisted Self Interview (ACASI) with 200 participants

Screening for Risk Factors for Spontaneous Preterm Delivery (MFMU PREDS)

Study Description: A prospective, observational study of women with singleton pregnancies to identify and evaluate tests which could define a group of patients with at least a twofold increase in risk of spontaneous preterm delivery. Primary outcome was delivery from 23 to 34 weeks gestation following spontaneous preterm labor or premature rupture of membranes.

Short-Cycle Therapy in Adolescents Following Continuous Therapy with Established Viral Suppression: The Impact on Viral Load Suppression (ATN 015)

Study 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).

The BioCycle Study (BioCycle)

Study Description: The BioCycle Study is a prospective cohort study completed at the University at Buffalo and offers a unique and comprehensive assessment of menstrual cycle function. The primary goal of the BioCycle Study was to better understand the intricate relationship between reproductive hormone levels and oxidative stress during the menstrual cycle. Multiple markers of oxidative stress, reproductive hormones, inflammation, and metabolic biomarkers were measured in a cohort of 259 women of reproductive age over the course of two menstrual cycles. Fertility monitors were utilized to time the subjects' visits to ensure appropriate timing of biospecimen collection. Additional information regarding diet, lifestyle, and physical measurements was obtained throughout the study via standardized questionnaires, anthropometric assessments, and daily diaries. Participants were highly adherent to the study protocol, with 94% of all women completing seven or eight visits per cycle.

The Child Health and Development Studies Original Cohort (CHDS OC)

Study Description: A prospective, longitudinal study of women, their pregnancies and deliveries, and the health and development of the children born from these pregnancies. Families who were members of the Kaiser Foundation Health Plan in Oakland, California were enrolled between 1959 and 1966. Children born to the enrolled women were followed through 1972. Mothers provided information about fathers. Biospecimens are available, including father specimens. Please contact Dr. Barbara Cohn (bcohn@chdstudies.org) to obtain biospecimens. Additional data files from follow-up studies in the CHDS are available to researchers who would like to set up collaborations to access them. Please send an email to supportdash@mail.nih.gov for more information.

The Impact of Grade Retention: A Developmental Approach (Project Achieve)

Study 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.

Transgender Research Youth Project (ATN 039)

Study Description: An exploratory, cross-sectional research study to examine HIV risk behaviors of male-to-female transgender youth 15 to 24 years of age in two large U.S. cities. Surveys were conducted at club/bar venues and on the street. Semi-structured in-depth qualitative interviews were conducted with a subset of participants; data from those interviews are not available.

Treatment De-Intensification and Residual HIV-1 in Adolescents and Young Adults: A Sub-Study of ATN 061 and ATN 071 (ATN 081)

Study 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. Biospecimens are available.

Validation of the HIV Treatment Readiness Measure (ATN 065)

Study 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.