Clinical trial NCT04206241: Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
Official title: Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Infant Morbidity
Perinatal HIV Infection
HIV Infections
Keywords: HIV
POC
EID
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: UNITAID
First posted: 2019-12-20
Enrollment: 278833
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * HIV-exposed infants newly born at the selected sites or presenting in study sites within 48 hours after birth
* Health care workers and phlebotomists who are currently employed in study sites who are involved in providing POC EID services
* Laboratory managers and program leads/focal persons at the Ministry of Health
* Mothers/caregivers of HEI delivered or presenting in study sites within 48 hours after birth

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of eligible HEI who present to pilot facilities who receive POC EID testing at birth
timeFrame: 18 months
Secondary outcomes:
measure: Proportion of tested HEI whose caregivers receive results of the POC EID birth testing
timeFrame: 18 months
measure: Average number of days between sample collection of HEI and results received by caregiver
timeFrame: 18 months
measure: Proportion of HEI tested at birth who are HIV positive
timeFrame: 18 months
measure: Proportion of HIV-infected infants tested at birth who are started on ART within 2 weeks of the birth test
timeFrame: 18 months
measure: Average number of days between sample collection of HEI and initiation on ART for infants testing HIV-positive
timeFrame: 18 months
measure: Proportion of infants testing HIV negative at birth and who return for testing at 6-8 weeks
timeFrame: 18 months
measure: Proportion of infants who test HIV-positive at 6-8 weeks of those who test negative at birth
timeFrame: 18 months
measure: The retention in care of positively-identified infants on birth testing for the first 3 and/or 6 months of life
timeFrame: 18 months
measure: Proportion of HEI tested at birth who meet criteria for high risk of vertical transmission
timeFrame: 18 months
measure: Proportion of high-risk infants according to the risk screening tool who test HIV-positive at birth
timeFrame: 18 months
measure: Proportion of low-risk infants according to the risk screening tool who test HIV-positive at birth
timeFrame: 18 months
Other outcomes:
Locations:
city: Beitbridge
country: Zimbabwe
facility: Beitbridge District Hospital
city: Bindura
country: Zimbabwe
facility: Bindura Provincial Hospital
city: Chegutu
country: Zimbabwe
facility: Chegutu District Hospital
city: Chegutu
country: Zimbabwe
facility: Norton Hospital
city: Chiredzi
country: Zimbabwe
facility: Chiredzi District Hospital
city: Gweru
country: Zimbabwe
facility: Gweru Provincial Hospital
city: Hwange
country: Zimbabwe
facility: Victoria Falls District Hospital
city: Kadoma
country: Zimbabwe
facility: Kadoma District Hospital
city: Kwekwe
country: Zimbabwe
facility: Kwekwe General Hospital
city: Masvingo
country: Zimbabwe
facility: Masvingo Provincial Hospital
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation - Zimbabwe
name: Agnes Mahomva, MBCHB, MPH
role: PRINCIPAL_INVESTIGATOR
References: