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Completed

NCT Number: NCT04206241

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

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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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infant Morbidity Infections Lentivirus Infections Perinatal HIV Infection RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Beitbridge District Hospital, Beitbridge, Zimbabwe

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of care early infant diagnosis (POC EID)

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.

Other names: POC EID

Primary outcomes

  1. Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth

    Time frame: 18 months

    Number of eligible HEI who received POC EID divided by the total number of eligible HEI

Secondary outcomes

  1. Proportion of tested HEI whose caregivers receive results of the POC EID birth testing

    Time frame: 18 months

    Number of HEI whose caregivers received results of the POC EID birth testing, divided by the number of HEI who received POC EID birth testing

  2. Average number of days between sample collection of HEI and results received by caregiver

    Time frame: 18 months

    Date HEI sample collected minus date results received

  3. Proportion of HEI tested at birth who are HIV positive

    Time frame: 18 months

    Number of HEI tested at birth who are HIV positive divided by the number of HEI tested at birth

  4. Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test

    Time frame: 18 months

    Number of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test, divided by the number of HIV-infected infants tested at birth

  5. Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive

    Time frame: 18 months

    Date of sample collection of HEI minus date of date of ART initiation on ART for infants testing HIV-positive

  6. Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks

    Time frame: 18 months

    Number of infants testing HIV-negative at birth who return for testing at 6-8 weeks, divided by the number of infants who tested HIV-negative at birth

  7. Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth

    Time frame: 18 months

    Number of infants who test HIV-positive at 6-8 weeks divided by those who tested HIV-negative at birth

  8. The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life

    Time frame: 18 months

    Number of infants who tested HIV-positive at birth in care at 3 and/or 6 months of life, divided by the number who tested HIV-positive at birth

  9. Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission

    Time frame: 18 months

    Number of HEI tested at birth who meet the criteria for high risk of vertical transmission divided by the number who meet the criteria for high risk of vertical transmission

  10. Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth

    Time frame: 18 months

    Number of high-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of high-risk infants according to the risk screening tool

  11. Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth

    Time frame: 18 months

    Number of low-risk infants according to the risk screening tool who test HIV-positive at birth, divided by the number of low-risk infants according the risk screening tool

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • UNITAID

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 20, 2019
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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