Impact of Point-of-Care EID for HIV-Exposed Infants (POC-EID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03824067|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : May 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Infant Morbidity Pediatric HIV Infection Transmission, Perinatal Infection||Diagnostic Test: Point of Care Early Infant Diagnosis Diagnostic Test: Standard of Care Early Infant Diagnosis||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9276 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The design of this study is a cluster-randomized stepped wedge trial. This is whereby an intervention is rolled out sequentially to the study facilities over a number of time periods. The order in which the different clusters receive the intervention is determined at random and by the end of random allocation, all facilities will have received the intervention. Testing sites (determined from the list of all project facilities excluding pilot sites) will be randomized regarding timing of POC implementation; sites that serve as "hub" sites and their associated "spoke" sites will be given the same designation. The study will use a mixed method approach in data collection, and a qualitative component will also be conducted, including interviews and focus groups.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of the Impact of Point-of-Care Early Infant Diagnostic (EID) Testing on Timely Receipt of EID Results and Treatment Initiation in HIV-Exposed Children in Kenya and Zimbabwe|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Standard of Care Early Infant Diagnosis
Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID
Diagnostic Test: Standard of Care Early Infant Diagnosis
Conventional laboratory based EID testing
Other Name: SOC EID
Experimental: Point of Care Early Infant Diagnosis
The intervention is Point of Care (POC) early infant diagnosis (EID) testing, where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Diagnostic Test: Point of Care Early Infant Diagnosis
HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
Other Name: POC EID
- Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks [ Time Frame: 12 weeks ]The number of children for whom a sample was drawn for the 4-6-week indication receiving EID result by 12 weeks, divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
- Testing coverage for the 4-6 week indication [ Time Frame: 18 months ]Number of EID samples collected for 4-6 week indication divided by the number of HEI who presented to the clinic and had an indication for 4-6 week EID testing
- Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification [ Time Frame: 18 months ]Date of sample collection to the date that results were given to care giver
- Age of patient at test result notification for 4-6 week EID test indication [ Time Frame: 18 months ]HEIs date of birth, date of sample collection and date of result notification to care giver
- Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants [ Time Frame: 18 months ]Date positive result received at facility to the date the result was communicated to mother and date of ART initiation
- Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART [ Time Frame: 18 months ]Number of HIV-infected infants initiated on ART after 4-6 week EID test divided by the number of HIV-infected infants identified after 4-6 week EID test
- Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months [ Time Frame: 24 months ]Total number of infants initiated on ART 6 months ago and number of active on ART at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824067
|Elizabeth Glaser Pediatric AIDS Foundation|
|Elizabeth Glaser Pediatric AIDS Foundation|
|Principal Investigator:||Emma Sacks, PhD||Elizabeth Glaser Pediatric AIDS Foundation|
|Principal Investigator:||Collins Odhiambo, MD||Elizabeth Glaser Pediatric AIDS Foundation|
|Principal Investigator:||Agnes Mahomva, MD||Elizabeth Glaser Pediatric AIDS Foundation|
|Study Director:||Jennifer Cohn, MD MPH||Elizabeth Glaser Pediatric AIDS Foundation|