Accelerating ART initiation among Infants (AAMI Study)

Due to the need for sophisticated laboratory instruments, highly trained personnel, and the associated high costs, early infant diagnosis is one of the major barriers to large-scale uptake and timely initiation of lifesaving ARV interventions. 

There is a clear global need for improvements in early infant diagnosis of HIV to increase uptake and early iniDaDon of ARV treatment among HIV-exposed infants and consequently reduce mortality and morbidity.

The overall aim of this research is to assess the impact of a novel early infant diagnostic test to improve child health in resource-constrained and rural settings in our region by increasing uptake and timely initiation of lifesaving antiretroviral interventions for HIV-infected infants. This aim aligns with the Sustainable Development Goal to end the AIDS epidemics (3.3), and reduce under-five mortality (3.2) 

Objectives:

• To assess the impact of the novel Xpert® HIV-1 QUAL early infant diagnostic (EID) test among HIV-exposed infants in Myanmar and PNG.
• To assess performance (misclassification, sensitivity, specificity, positive predictive value, negative predictive value) of the Xpert® HIV-1 QUAL assay compared to a laboratory-based polymerase chain reaction test for HIV (standard of care).
• To assess the operaDonal feasibility and acceptability of the Xpert® HIV-1 QUAL during provision of infant care services.
• To assess the cost-effectiveness of the Xpert® HIV-1 QUAL compared with standard of care and to make recommendations on the optimal combination of each type of test at different sites for implementation beyond this study. 

Activities:
Using a cluster-randomised controlled (at health facility level) stepped-wedge design, we will assess the impact of the Xpert® HIV-1 QUAL early infant diagnosis of HIV to increase uptake of results communication and enable earlier iniDaDon of infant ARV treatment. This study will implement the Xpert® HIV-1 QUAL (intervention) in a total of 6 facilities in Myanmar (n=4) and PNG (n=2).

A total of 390 HIV-exposed infants (aged less than 28 days) and their caregivers will be enrolled across the two countries, and will be followed up unDl they receive their HIV test results up to 6 months of age. Infants enrolled in the control phase will have their blood drawn for HIV testing (at approximately six weeks post-delivery) using a dried blood spot specimen evaluated at the centralised laboratory using a PCR test for HIV (standard of care).

During the intervention phase, enrolled infants will have a blood sample drawn and tested for HIV infection using the Xpert® HIV-1 QUAL test and the standard of care PCR test. It is anticipated that the Xpert® 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. In order to assess the acceptability and feasibility of the Xpert® HIV-1 QUAL test, a short questionnaire will be administered to all caregivers whose infants are enrolled in the study at enrolment and at both follow-up visits.

In addition, in-depth interviews with study participants will be used to assess acceptability; focus groups discussions with health care workers will help assess feasibility and key informant interviews will be scheduled with facility managers, community leaders, policy makers and implementers for further qualitative assessment.

Outcomes
This study in Myanmar and PNG will provide evidence of the impact, feasibility and acceptability of the Xpert® HIV-1 QUAL assay for infants in countries with low or moderate HIV prevalence, typical of the Asia-Pacific region. Trialling this test in low-prevalence settings will provide novel data to guide implementation and enhance global coverage.

The expected outcomes of the study include an increase in the proportion of infants receiving HIV test results by 3 months of age. A decrease in the median duraDon between blood sample collection, communication of test results and iniDaDon of ARVs is also anticipated. Both quantitative and qualitative data will inform acceptability and feasibility of the Xpert® HIV-1 QUAL test.