Clinical trial NCT03824067: Impact of Point-of-Care EID for HIV-Exposed Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Infant Morbidity
Pediatric HIV Infection
Transmission, Perinatal Infection
Keywords: HIV/AIDS
Point of Care
Early infant diagnosis
Health systems
Diagnostic tools
LMIC
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: UNITAID
First posted: 2019-01-31
Enrollment: 9539
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Any infant who receives an EID test, either conventional or POC, for the 4-6 week EID indication at one of the study sites (which were randomly selected from project sites in country)
* HEI under 12 weeks of age or their parents/caregivers
* Some methods will only include HEI who test positive (medical chart extraction and longitudinal follow up)
* Purposively selected caregivers of HEI for in-depth interviews
* Focus groups with community members will not require participants to have sought testing for EID

Exclusion Criteria:

* Participants not at selected study sites
* For some methods (medical chart extraction and longitudinal follow-up), HEI who test negative
* For qualitative component, excluded if unable to consent due to age, competence, or inability to speak any of the study languages

Primary outcomes:
measure: Percentage of HIV exposed infants (HEI) who have received the 4-6 week EID test result by 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Testing coverage for the 4-6 week indication
timeFrame: 18 months
measure: Time from sample collection for 4-6 week EID test indication to parent's/ caregiver notification
timeFrame: 18 months
measure: Age of patient at test result notification for 4-6 week EID test indication
timeFrame: 18 months
measure: Time from test result received for 4-6 week EID test to initiation of ART, for HIV-infected infants
timeFrame: 18 months
measure: Percentage of HIV positive infants diagnosed during 4-6 week EID testing initiated on ART
timeFrame: 18 months
measure: Number of HIV-infected infants diagnosed at the 4-6 week EID with retention in care at 6 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Elizabeth Glaser Pediatric AIDS Foundation
city: Harare
country: Zimbabwe
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: George Washington University School of Public Health
name: Emma Sacks, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric Aids Foundation - Kenya
name: Collins Odhiambo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric Aids Foundation - Zimbabwe
name: Agnes Mahomva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Jennifer Cohn, MD MPH
role: STUDY_DIRECTOR
References: