Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

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

Total Enrollment

278833 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

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This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

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Detailed Description

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This Unitaid-funded study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings. Outcomes measures will include age at uptake of testing, turnaround time from testing to caregiver result receipt, HIV positivity rate, and timing of ART initiation for HIV-positive infants. This study will compare outcomes between HIV-exposed at high vs low risk of maternal HIV transmission. The study will also assess the impact of POC birth testing on retention in care and impact on subsequent testing at 6 weeks.

Conditions

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HIV/AIDS Infant Morbidity Perinatal HIV Infection HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High-risk infants

Mother answered yes to any of the following questions on a risk-screening tool:

* Mother diagnosed with HIV in labor and delivery?
* Mother start ART after 32 weeks' gestation?
* Maternal viral load above 1000 copies/ml in the 3rd trimester?
* Mother seroconvert during pregnancy?
* Was the mother not adhering to ART during pregnancy?

Point of care early infant diagnosis (POC EID)

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.

Low-risk infants

Mothers did not answer affirmatively to any of the four screening questions

Point of care early infant diagnosis (POC EID)

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 (POC EID)

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

Other Intervention Names

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POC EID

Eligibility Criteria

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Inclusion Criteria

HIV-exposed infants (HEI)

* All HEI who access maternity/post-natal services within 48 hours of life
* Tested for HIV at birth using the POC NAT platform
* Caregiver provides informed consent for participation

Caregivers

* Mother/caregiver of an HEI who was offered POC EID at birth
* Able to provide informed consent to participate in the study

Health workers

* All health workers working in maternity services in the study sites
* Provides informed consent to be interviewed

Key informants (laboratory managers and program leads/focal persons)

* Health managers working in the field of pediatric HIV services or PMTCT
* Provides informed consent to be interviewed

Exclusion Criteria

HIV-exposed infants (HEI)

* HEI tested for HIV using conventional EID at project sites
* HEI whose caregivers refuse birth testing
* HEI where the clinician deems there is a contra-indication for sample collection for birth testing (e.g. severe hemophilia)

Caregivers

* Caregivers of HEI who cannot legally provide consent to participate in the study

Health workers

* Healthcare workers who do not make use of EID or results of EID

Key informants

* Key informants who cannot legally provide consent to participate in the study

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes