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NICHD DASH Migration

DASH is currently being migrated to the NIH BRICS platform. This migration will enhance NICHD data stewardship and increase DASH functionality and efficiency to meet NICHD researcher and staff needs. Please check back soon for updates. If questions arise, please contact SupportDASH@mail.nih.gov.

Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living with HIV through Text Messaging and Cell Phone Support Embedded within the Sequential Multiple Assignment Randomized Trial (SMART) Design (ATN 144)

Submission Date: August 21, 2025
 

Study Description: This project tested an adaptive adherence intervention to improve self-management and achieve/maintain viral load suppression while understanding the context for wide-scale implementation in an effectiveness-implementation Type 1 Hybrid trial. Primary aims: 1) Compare cell phone support (CPS) vs. text messaging (SMS) for youth living with HIV (YLH) not virally suppressed; 2) Understand the benefits of incentives for non-responders (NRsp), identify how to taper interventions for responders (Rsp), and describe potential moderators of treatment effect; 3) Study barriers and facilitators to wide-spread implementation and cost-effectiveness of treatment sequences. We hypothesized that youth randomized to CPS will have significantly greater viral load suppression (primary outcome) and self-reported medication adherence (secondary outcome) than those in the SMS group.

Investigating Donor Human Milk Composition Globally to Develop Effective Strategies for the Nutritional Care of Preterm Infants (Global DHM Study)

Submission Date: August 15, 2025
 

Study Description: Donor human milk (DHM) is the recommended food for small vulnerable infants when mother's milk is not available, due to evidence that it protects against NEC. While DHM use is increasing around the world, there are significant knowledge gaps about DHM that imped clinical care. This project addresses DHM knowledge gaps through a study conducted with eight geographically diverse milk bank partners in high, middle, and low-income settings. We examine and compare a broad range of nutrients in milk from 600 approved milk bank donors around the world to create comprehensive, geographically diverse nutrient profiles for DHM (Aim 1). Milk bank-level practices for pooling donors are evaluated using simulation to identify effective strategies that can be used by milk banks to create more consistent nutrient profiles in DHM (Aim 2). Finally, we evaluate whether currently available commercial fortifiers meet nutrient recommendations when used with DHM and identify nutrients to enhance in the development of a DHM-specific fortifiers (Aim 3).

Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite, PH400 (AMP Up Lite)

Submission Date: August 11, 2025
 

Study Description: This study investigated the long-term outcomes of perinatal HIV (PHIV) and its treatment on young adults with perinatally acquired HIV (YAPHIV). The primary objectives were to: 1) identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART; 2) define the impact of HIV infection and ART on the long-term clinical outcomes in YAPHIV; and 3) define the impact of perinatal HIV infection, its concomitant risk factors, and ART on long-term mental and behavioral health outcomes. Data collection included clinical assessments, online surveys, interviews, specimen collection, and medical chart abstraction, designed to achieve the primary objectives, as well as the domain specific study aims. Results can be used to help design intervention strategies to improve the quality of life of young adults with perinatal HIV.

Adolescent Master Protocol for Participants 18 Years of Age and Older, PH300 (AMP Up)

Submission Date: July 8, 2025
 

Study Description: This study investigated the long-term outcomes of perinatal HIV (PHIV) and its treatment on young adults with perinatally acquired HIV (YAPHIV). Young adults living with perinatal HIV exposure without perinatally acquired HIV (YAPHEU) were also enrolled. The primary objectives were to: 1) identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART; 2) define the impact of HIV infection and ART on the long-term clinical outcomes in YAPHIV; and 3) define the impact of perinatal HIV infection, its concomitant risk factors, and ART on long-term neurocognitive and behavioral health outcomes. Data collection included clinical assessments, online surveys, interviews, laboratory testing, specimen collection, and medical chart abstraction, designed to achieve the primary objectives and domain specific study aims. Results can be used to help design intervention strategies to improve the quality of life of young adults with perinatal HIV.

The Impact of Early Medical Treatment on Transgender Youth- Gender Affirming Hormone Cohort (TYCUS)

Submission Date: June 30, 2025
 

Study Description: The study used a longitudinal observational design to examine the outcomes of existing medical treatment protocols for gender dysphoria in youth pursuing a phenotypic gender change through gender affirming hormones. Routinely collected anthropometric and physiologic parameters were collected through chart abstraction throughout the 9-year study period. Research Electronic Data Capture (REDCap), ASEBA, and individual interview survey instruments were used to collect demographic, mental health, psychosocial, and behavioral data from youth in the gender-affirming hormone cohort at baseline and 6, 12, 18 months, and every year for 2-9 years.

Pharmacokinetics and Safety Profile of Digoxin in Infants with Single-Ventricle Congenital Heart Disease (BPCA DGX01)

Submission Date: June 13, 2025
 

Study Description: This study was a prospective, multi-center, open-label, pharmacokinetic (PK) and safety profile study. The study was designed to gather population-specific PK data to identify the optimal dose in a population of infants with single-ventricle (SV) congenital heart disease (CHD) and to obtain the safety profile of digoxin in infants age ≤ 30 days of life at time of stage 1 palliation. PK analysis was primarily performed using population PK methodologies. Simulations suggested that to maximize the proportion of infants with SV CHD achieving a minimum concentration on steady state between 0.5 and 2 ng/mL, as recommended in the current digoxin package insert, doses should be optimized based on weight, estimated glomerular filtration rate, and postnatal age. Two fatal serious adverse events (both resulting from hypoplastic left heart syndrome) were reported, but they were not related to study drug. Based on these data, digoxin appears safe in infants with SV CHD.

International Cohort Study of Children Born to Women Infected with Zika Virus During Pregnancy (ZIP 2.0)

Submission Date: May 22, 2025
 

Study Description: This study was an extension of the International Prospective Observational Cohort Study of Zika in Infants and Pregnancy (ZIP Study). It was a prospective longitudinal cohort study that enrolled participants from the ZIP Study and other-approved studies and followed them for up to 3.5 years of age. Participants included children with confirmed or presumptive in-utero exposure to Zika virus and children matched by site, birth sex, and age (based on age at enrollment +/- 6 weeks) without confirmed or presumptive in-utero exposed to Zika virus. The primary aims were to determine the long-term neurodevelopmental outcomes among children born to women with documented ZIKV infection during their pregnancy and compare the long-term effects (e.g. on growth, vision, hearing and neurodevelopment) of confirmed in utero ZIKV-exposure compared to ZIKV-unexposed children. A total of 5 evaluations occurred about every 6 months over about a 2-year period beginning at approximately 18 months of age through 42 months of age.

International Prospective Observational Cohort Study of Zika in Infants and Pregnancy (ZIP)

Submission Date: May 22, 2025
 

Study Description: The overall objective of this study was to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. At research sites in ZIKV endemic regions pregnant women were recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants were followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV were also enrolled, regardless of gestational age. Maternal participants were tested monthly for ZIKV infection; additional demographic, clinical, laboratory and environmental data were collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, were obtained.

Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE)

Submission Date: May 5, 2025
 

Study Description: The Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) study investigates physical and mental health outcomes and health related behaviors of women living with HIV of reproductive age, including women living with HIV since birth. Health outcomes include HIV disease course, engagement in care, mental health, pregnancy, reproductive health and choices, and cardiometabolic health as well as multi-level social and structural determinants of health and sources of resilience. The framework is informed by a social ecological model, life course perspective, and community engagement. Data collection consists of clinical assessments, online surveys, health interviews, collection of specimens and medical chart abstraction designed to achieve the primary objectives and domain specific aims of the study, as outlined in the protocol. Results from HOPE aim to advance the health of women living with HIV, inform clinical guidelines and shape supportive interventions and policies that address the needs and priorities of women living with HIV and their families.

Technology-Based Stepped Care to Stem Transgender Adolescent (TechStep) Risk Transmission (ATN 160)

Submission Date: May 5, 2025
 

Study Description: TechStep was a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake. Participants were randomized into one of three conditions for a 6-month intervention: Group 1: culturally relevant theory-based text messages (Text+Step); or, Group 2: culturally relevant mobile-enhanced website (WebApp+Step); or, Group 3: informational website control condition with no theoretically based text messages or WebApp.

ATN 138 - Connecting Youth and Young Adults to Optimize ART Adherence: Testing the Efficacy of the YouTHrive Intervention (AIM 3) (ATN 138)

Submission Date: May 5, 2025
 

Study Description: YouTHrive (YT) was a two-arm randomized control trial (RCT) that tested the efficacy of an adapted version of the Thrive With Me (TWM) intervention for youth living with HIV (YLWH). In the RCT, intervention participants had access to the full YouTHrive (YT) website- a mobile-enhanced private social networking website aimed at improving medication adherence for YLWH. We enrolled 208 youth (15-24 years old) of all genders living in eight cities and randomized them to either the intervention condition or control condition. Assessments were collected at baseline and month 5 for all participants. Additionally XX participants also were asked to complete assessments at month 8 and month 11.

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) (ACT NOW Weaning Trial)

Submission Date: May 5, 2025
 

Study Description: ACT NOW Weaning Trial was a pragmatic, randomized, blinded trial conducted to compare a rapid-wean intervention (15% decrements from the stabilization dose) with a slow-wean intervention (10% decrements from the stabilization dose) to determine whether rapid weaning reduces the number of treatment days among infants receiving morphine or methadone orally as the primary treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). Hospitals could change use of these opioids during trial period. Randomization was stratified by hospital. Study protocol commenced after NOWS signs were controlled with an opioid (stabilization) and weaning of pharmacologic treatment was to be started. At or before each 24-hour interval, clinical team members evaluated and scored infants, per hospital practice, for signs of NOWS to determine if infant would tolerate weaning of study drug. After study drug cessation, clinical team observed infants for at least 48 hours prior to discharge. A trained examiner administered the NeoNatal Neurobehavioral Scale, 2nd edition (NNNS-II) to assess neurobehavioral profiles after ceasing study drug prior to discharge.

Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA)

Submission Date: May 5, 2025
 

Study Description: The MUSA trial was a randomized 2-arm clinical trial conducted to determine whether intradetrusor onabotulinumtoxinA was more effective than midurethral sling for the treatment of mixed urinary incontinence in females. Participants had at least moderately bothersome stress and urge urinary incontinence and had failed one or more conservative treatments. The primary outcome was change at 6 months in mixed incontinence symptoms as measured by the Urogenital Distress Inventory total score. Secondary outcomes included stress and irritative UDI subscores. Among 150 females randomized, 137 were treated and included in the primary analysis. There was no observed difference in UDI total score improvement at 6 months between the onabotulinumtoxinA and midurethral sling groups in females with moderate to severe mixed urinary incontinence who previously did not respond to conservative treatments.