None listed
Conditions
Brief summary
The overall aim of the study is to improve child health in resource-constrained and rural settings in the Asia and Pacific region by increasing uptake and timely initiation of lifesaving antiretroviral interventions for HIV-exposed infants through the use of a novel point-of-care (POC) early infant diagnostic test. The use of this novel POC test will enable caregivers of HIV-exposed infants to receive HIV test results sooner, and consequently result in HIV-infected infants starting on lifesaving treatment faster.
Interventions
During the intervention phase, HIV-infected women and their infants aged less than 28 days presenting at the health facility will be invited to participate. At approximately six weeks post-delivery, enrolled infants will have either a heel prick or venous blood sample taken – depending on the local hospital guidelines - and tested for HIV infection using the Xpert (Registered Trademark) HIV-1 QUAL test. In addition, up to six dried blood spot circles (from the same blood draw as for the Xpert (R
During the intervention phase, HIV-infected women and their infants aged less than 28 days presenting at the health facility will be invited to participate. At approximately six weeks post-delivery, enrolled infants will have either a heel prick or venous blood sample taken – depending on the local hospital guidelines - and tested for HIV infection using the Xpert (Registered Trademark) HIV-1 QUAL test. In addition, up to six dried blood spot circles (from the same blood draw as for the Xpert (Registered Trademark) HIV-1 QUAL test) will be collected, up to five for the HIV PCR laboratory-based assay to assess Xpert (Registered Trademark) HIV-1 QUAL test performance and confirm diagnosis, and one to be stored for quality assurance purposes. In total, 300 microlitres will be collected from each infant for standard of care and storage, and 100 microlitres for the Xpert (Registered Trademark) HIV-1 QUAL test (total 400 microlitres). It is anticipated that the Xpert (Registered Trademark) HIV-1 QUAL test will be performed the same day by a trained health worker or assigned clinic staff member. Test results will be communicated to the parent / caregiver as soon as the test result is available or soon thereafter. The Xpert (Registered Trademark) HIV-1 QUAL test takes 90 minutes to complete, therefore it is anticipated that results will be conveyed to the parent/caregiver after 90 minutes. Infants testing positive on the Xpert (Registered Trademark) HIV-1 QUAL test (or once confirmed by the HIV PCR laboratory-based assay if indicated by the in-country regulations) will receive antiretroviral (ARV) treatment as soon as possible according to WHO guidelines. HIV-exposed infants testing HIV negative will receive standard care as per national guidelines. In both arms, ARV treatment and prophylaxis will be provided as per national and WHO guidelines ensuring intervention sustainability. Across the 6 sites, 45 cumulative enrolment months are allocated to the intervention phase.
Sponsors
Burnet Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 28 Days
Healthy volunteers
No
Inclusion criteria
i) Infants born to confirmed HIV-infected mothers (i.e. with documentation of prior counselling and HIV testing, with a confirmed positive HIV test result) and requiring HIV testing; ii) Newborn infants within the first 28 days of life; iii) Parent/caregiver residing, and planning to continue to reside, within the site-specific catchment area for the next six months; iv) Parent/caregiver able and willing to give informed consent for enrolment of their infant in the study. v) Parent/caregiver providing consent is aged 18 years or older vi) Parent/caregiver is willing to provide reliable contact information (e.g. mobile phone number, home address, description of how to find their house if they live in a rural area), and consent to be contacted by a member of the research team in the community to remind them to re-attend for follow-up.
Exclusion criteria
i) Participant is enrolled in another research study which interferes with this study, or previously enrolled in this study; ii) Parent/caregiver and/or participant has a medical or non-medical issue incapacitating participation in the research as decided by the local Principal Investigator.
Outcome results
None listed