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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206241
• Other study ID #: EG0219
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278833
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• HIV/AIDS
• Infant Morbidity
• Infection
• Perinatal HIV Infection

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Zimbabwe	Beitbridge District Hospital	Beitbridge
Zimbabwe	Bindura Provincial Hospital	Bindura
Zimbabwe	Chegutu District Hospital	Chegutu
Zimbabwe	Norton Hospital	Chegutu
Zimbabwe	Chiredzi District Hospital	Chiredzi
Zimbabwe	Gweru Provincial Hospital	Gweru
Zimbabwe	Victoria Falls District Hospital	Hwange
Zimbabwe	Kadoma District Hospital	Kadoma
Zimbabwe	Kwekwe General Hospital	Kwekwe
Zimbabwe	Masvingo Provincial Hospital	Masvingo

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	UNITAID

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth	Number of eligible HEI who received POC EID divided by the total number of eligible HEI	18 months
Secondary	Proportion of tested HEI whose caregivers receive results of the POC EID birth testing	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	18 months
Secondary	Average number of days between sample collection of HEI and results received by caregiver	Date HEI sample collected minus date results received	18 months
Secondary	Proportion of HEI tested at birth who are HIV positive	Number of HEI tested at birth who are HIV positive divided by the number of HEI tested at birth	18 months
Secondary	Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test	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	18 months
Secondary	Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive	Date of sample collection of HEI minus date of date of ART initiation on ART for infants testing HIV-positive	18 months
Secondary	Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks	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	18 months
Secondary	Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth	Number of infants who test HIV-positive at 6-8 weeks divided by those who tested HIV-negative at birth	18 months
Secondary	The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life	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	18 months
Secondary	Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission	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	18 months
Secondary	Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth	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	18 months
Secondary	Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth	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	18 months