Clinical trials: Early Infant HIV Diagnosis
HIV, Pregnancy
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts…
- Trial name
- NCT04571684
- Testing
- HITSystem 2.1
- Where
- 12 sites in Kenya
- Volunteers
- 1,639 people
- Sponsor
- University of Kansas Medical Center
HIV Infections
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework.
- Trial name
- NCT03435887
- Testing
- Alere q HIV-1/2 Detect for point of care infant testing, GeneXpert HIV-1 Qual for point of care infant testing, HIV DNA PCR testing (Standard of Care)
- Where
- 5 sites in United States, Kenya
- Volunteers
- 1,999 people
- Sponsor
- University of Kansas Medical Center
Medical Device Complication
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing…
- Trial name
- RMC-06 (NCT02281461)
- Testing
- Male circumcision using a non-surgical device
- Where
- Rwanda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Rwanda
HIV/AIDS, Infant Morbidity
Adaptation and Evaluation of the PMTCT CSC in Dedza and Ntcheu Districts, Malawi
This CDC-funded study sought to evaluate the effect of an adapted Community Score Card Approach on maternal retention in ART, maternal retention across the PMTCT service cascade, and the uptake of early infant diagnosis services…
- Trial name
- NCT04372667
- Testing
- Community score card approach
- Where
- Malawi
- Volunteers
- 1,233 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
HIV, Pregnancy
Maternal Determinants of HIV-exposed and HIV-unexposed Fetal Growth, Birth Outcomes and Early Infant Growth
The purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in HIV+ and HIV- pregnant women living in a semi-rural and rural region of…
- Conditions
- HIV, Pregnancy, Malnutrition, Cachexia
- Trial name
- NCT01647841
- Where
- Tanzania
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Cornell University
HIV Infections, Hiv
Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants
The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young…
- Trial name
- CDC Detect (NCT03133728)
- Testing
- Alere Q Testing
- Where
- 6 sites in Zambia
- Volunteers
- 1,682 people
- Sponsor
- University of Alabama at Birmingham
HIV Infections
Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection
This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions.
- Trial name
- NCT00000872
- Testing
- Abacavir sulfate, Nelfinavir mesylate, Nevirapine
- Where
- 12 sites in United States
- Volunteers
- 55 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus
Evaluation of Problem Management Plus in Pregnant Women With HIV in Kenya
This study includes secondary quantitative analysis, qualitative methods, and hybrid type 2 implementation-effectiveness pilot trial.
- Trial name
- Tatua (NCT05841797)
- Testing
- In-Person Program Management Plus (PM+), Mobile Program Management Plus (mHealth PM+)
- Where
- Kenya
- Volunteers
- 120 people
- Sponsor
- University of Colorado, Denver
HIV
Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya
The purpose of this study is to determine the effectiveness of the HITSystem in maximizing early infant diagnosis (EID) service utilization for HIV-exposed infants and early antiretroviral therapy (ART) initiation for infants…
- Trial name
- NCT02072603
- Testing
- HITSystem, Standard of Care
- Where
- 2 sites in United States, Kenya
- Volunteers
- 1,815 people
- Sponsor
- Sarah Kessler, PhD, MPH
HIV
Point of Care Early Infant Diagnosis Patient Impact Study
In Malawi, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories.
- Trial name
- NCT02744404
- Testing
- POC EID
- Where
- 7 sites in Malawi
- Volunteers
- 1,752 people, healthy volunteers welcome
- Sponsor
- Clinton Health Access Initiative Inc.
HIV
Early Infant Diagnosis Point of Care Pilot
In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane.
- Trial name
- NCT02634450
- Testing
- Alere q
- Where
- 8 sites in Mozambique
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Saúde, Mozambique
HIV Infections
Early Anti-Retroviral Treatment in HIV- Infected Children
EARTH study is conducted as part of the EPIICAL project. It is a prospective cohort study which aims to monitor clinical, virological and immunological features of HIV-positive, early treated children (≤90 days after diagnosis)…
- Trial name
- NCT05784584
- Testing
- Blood samples collection
- Where
- 6 sites in Mali, Mozambique and 1 more
- Volunteers
- 220 people
- Sponsor
- PENTA Foundation
HIV
Texting to Improve Testing (TextIT):
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in…
- Trial name
- TextIT (NCT02350140)
- Testing
- Text messaging from beginning, Text messaging after 6 months of control
- Where
- Kenya
- Volunteers
- 2,508 people
- Sponsor
- University of Washington
HIV, Neonatal HIV Early-Infant-Diagnosis (EID), Point-of-Care Testing (PoC)
Neonatal HIV Early Infant Diagnosis (EID) Versus Standard of Care EID- Long Term Impact on inFant hEalth (LIFE)
This study we will evaluate the benefit of HIV testing in neonates born from HIV-infected mothers in Tanzania and Mozambique. The study will use and evaluate novel point-of-care diagnostic systems, that can provide neonatal HIV…
- Trial name
- LIFE (NCT04032522)
- Testing
- point-of care (PoC) neonatal HIV early infant diagnosis (EID)
- Where
- 2 sites in Mozambique, Tanzania
- Volunteers
- 6,602 people
- Sponsor
- Michael Hoelscher
Early Infant HIV Diagnosis
Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
- Trial name
- NCT02682810
- Testing
- DNA PCR HIV diagnostic test, Alere Q
- Where
- 6 sites in Zambia
- Volunteers
- 4,000 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Exposure, HIV Infection
Early Versus Delayed BCG Vaccination of HIV-exposed Infants
In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries.
- Trial name
- NCT02062580
- Testing
- BCG
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
HIV, PMTCT
Study to Determine Impact of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention of mother-to-child transmission (PMTCT)…
- Trial name
- NCT02162498
- Testing
- Feeding buddies
- Where
- South Africa
- Volunteers
- 932 people, healthy volunteers welcome
- Sponsor
- PATH
Vertical Human Immunodeficiency Virus Transmission, HIV Infection Pediatric
Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment
This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load…
- Conditions
- Vertical Human Immunodeficiency Virus Transmission, HIV Infection Pediatric, Infant Death, Infant Morbidity
- Trial name
- LIFE2Scale (NCT06267508)
- Testing
- Maternal HIV viral load testing at delivery for VHT risk assessment
- Where
- 2 sites in Mozambique, Tanzania
- Volunteers
- 6,000 people
- Sponsor
- Michael Hoelscher
Human Immunodeficiency Virus, Mental Disorder
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya.
- Trial name
- NCT06117163
- Testing
- Collaborative Care Model
- Where
- Kenya
- Volunteers
- 900 people
- Sponsor
- University of Colorado, Denver
HIV Infections
HIV Diagnosis in Hospitalized Malawian Infants
Purpose: The purpose of this research study is to learn about two HIV tests - a clinical "presumptive diagnosis" (PD) that a trained healthcare provider can quickly use to determine if a child is likely to be HIV-infected and in…
- Trial name
- NCT01388452
- Testing
- Point of care HIV RNA PCR
- Where
- Malawi
- Volunteers
- 300 people
- Sponsor
- University of North Carolina, Chapel Hill