Clinical Trials Logo

Clinical Trial Summary

This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers and time to initiation on treatment for HIV-infected infants. Data will be collected through longitudinal clinical follow-up and medical chart extraction of routine records and lab forms. Feasibility and acceptability data will be collected through interviews with mothers/caregivers of HIV-exposed infants, and community focus groups.


Clinical Trial Description

This study seeks to evaluate the impact of point of care (POC) early infant HIV diagnosis (EID) on turn-around time from sample collection until notification of parents/caregivers of test result, linkage to care, and time to initiation of treatment, and early retention in HIV care (3-6 months) for those infected. The study will take place in two countries, Zimbabwe and Kenya, with high HIV prevalence, and where EGPAF-supported POC EID platforms are being implemented as part of a Unitaid-funded POC EID project. As part of POC program implementation activities, in each country up to 50 EGPAF-supported sites will implement POC EID platforms. These sites may be prevention of mother-to-child transmission (PMTCT) of HIV clinics, HIV clinics or multidisciplinary health facilities. Project sites have been selected as part of the program implementation. In each country, 18 sites will be randomly selected as study sites for the impact evaluation. Using a stepped wedge design, the intervention (the POC EID platforms) will be rolled out sequentially to the study facilities over three randomly-assigned time periods. Quantitative data will be derived from routine medical and laboratory charts and longitudinal tracking and follow-up of HIV-infected infants. Qualitative data on feasibility and acceptability of POC will be derived from in-depth interviews with mothers/caregivers of HIV-exposed infants at the beginning and end of the study and community focus group discussions at the end of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03824067
Study type Interventional
Source Elizabeth Glaser Pediatric AIDS Foundation
Contact
Status Completed
Phase N/A
Start date August 1, 2017
Completion date October 31, 2019

See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A
Completed NCT03643705 - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention N/A
Completed NCT03923231 - Pharmacokinetics of Atazanavir in Special Populations