Clinical outcomes among HIV positive babies below 18 months of age, diagnosed under the Early Infant Diagnosis (EID) programme, India: a mixed-methods study

Abstract

Background

Early Anti-Retroviral Therapy (ART) initiation among infants with perinatally acquired HIV is known to impact clinical outcomes and survival. Early Infant Diagnosis (EID) was initiated in programme settings in India in 2010. Its impact on the clinical outcomes of infants covered under the programme and associated determinants have not been reported.

Methods

This was a mixed-methods study. Quantitative clinical data of 310 children on ART with HIV diagnosis before 18 months of age was collected from the treatment cards across 30 ART centres from 11 states of India using a retrospective cohort design. A total of 67 In-depth interviews with healthcare providers and managers helped to understand the underlying causes.

Findings

Out of 310 infants, 200 (64.5%) were on ART, and 36 (11.6%) were lost to follow-up, and 25 (8.1%) had died. The median age at HIV diagnosis was 231.5 (130, 405) days, and the median age at ART initiation was 309 (198, 456) days. Three-year survival was 91%. Baseline CD4 count less than 1500 cells/mm³ had a higher hazard for mortality (hazard ratio 11.39 (CI: 1.45, 89.45), p = 0.021) as well as for either mortality or development of opportunistic infections (hazard ratio 4.87 (CI: 1.56, 15.15), p = 0.006). WHO clinical stages III and IV had hazard ratios of 2.42 ((CI: 1.43, 4.09), p = 0.001) for mortality and 1.92 ((CI: 1.28, 2.88), p = 0.001) for death or development of opportunistic infections. Demand-side issues such as stigma and discrimination at family, community, and societal levels, desperation about the survival of the child, supply-side factors such as remote access to paediatric ART centres, and lack of paediatric ART medicine formulations were associated with ART treatment.

Interpretation

Overall survival was good for those who continued on treatment, but mortality was high for those with poor immunological and clinical parameters. Retention in care needs to be ensured for better clinical outcomes.

Funding

The study was commissioned by the National AIDS Control Programme (T.11020/98/2014-NACO (R&D)) and funded through The Global Fund Against AIDS, TB and Malaria (GFATM) grant.