Impact of Point-of-Care EID for HIV-Exposed Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV/AIDS Infant Morbidity Pediatric HIV Infection Transmission, Perinatal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of Care Early Infant Diagnosis

Conventional laboratory based (standard of care - SOC) early infant diagnosis (EID) testing: SOC EID

Group Type ACTIVE_COMPARATOR

Standard of Care Early Infant Diagnosis

Intervention Type DIAGNOSTIC_TEST

Conventional laboratory based EID testing

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.

Group Type EXPERIMENTAL

Point of Care Early Infant Diagnosis

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Standard of Care Early Infant Diagnosis

Conventional laboratory based EID testing

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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POC EID SOC EID

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No