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Testing the specificity, operational feasibility and acceptability of point-of-care (POC) HIV testing compared to conventional laboratory testing for early infant diagnosis (EID) in Durban, South Africa

Testing the specificity, operational feasibility and acceptability of point-of-care (POC) HIV testing compared to conventional laboratory testing for early infant diagnosis (EID) in Durban, South Africa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38911104
Enrollment
452
Registered
2018-01-09
Start date
2017-02-07
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-exposed infants and their mothers Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

Point-of-care HIV PCR testing is performed on HIV exposed infants around birth in Addington hospital and at Lancers rd primary health care clinic using the Alere™q HIV-1/2 Detect test which is perform

Sponsors

University of KwaZulu-Natal, School of Clinical Medicine, Department of Paediatrics and Child Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants delivered to HIV infected mothers at Addington hospital 2. Infants presenting for HIV PCR testing at Lancers rd clinic

Exclusion criteria

Exclusion criteria: 1. HIV unexposed infants 2. Infants whose mothers do not give written, informed consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the point of care testing compared to the standard of care laboratory testing, measured at the time of testing

Secondary

MeasureTime frame
Acceptability of POC testing to mothers and health care workers and operational feasibility of POC testing in both settings, measured using a quantitative/qualitative questionnaire that the mothers are asked at an interview on the day of testing with open and closed ended questions. The staff were interviewed after study completion and a quantitative/qualitative questionnaire with open and closed ended questions is completed at one timepoint.

Countries

South Africa

Contacts

Public ContactElizabeth Spooner
bethspoons@ukan.ac.za+27 (0)723510284

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026