Diagnostic performance and acceptability of Saliva-Based HIV Testing (SBT) in children
Anjuli Wagner, MPH, PhD
BACKGROUND: Rapid saliva-based tests (SBT) have been used in adult populations with high acceptability and test performance (sensitivity and specificity) relative to rapid blood-based tests (BBT), but have not yet been validated in pediatric populations ages 18 months to 12 years. SBT may be particularly acceptable in children because sample collection does not require blood draw and may facilitate scale up and expand provision of routine pediatric HIV testing, expediting pediatric HIV diagnosis.
GAP: This study will assess the test performance of SBT relative to BBT and assess the acceptability of SBT by caregivers and healthcare workers (HCW).
HYPOTHESIS: Aim 1: Among an HIV-exposed (with reported maternal HIV infection) pediatric population (18 months to 12 years old) already receiving HIV testing by BBT, to determine uptake, sensitivity, specificity, positive predictive value and negative predictive value of SBT using rapid BBT as a gold standard. Hypothesis 1: We hypothesize that SBT will be highly sensitive and specific in comparison to rapid BBT in this age range and will have high uptake.
Aim 2: To determine acceptability of SBT for pediatric HIV testing in home-based self-testing for children and outpatient clinic settings, among health care workers and caregivers. Hypothesis 2: We hypothesize that health care workers and caregivers will find SBT acceptable in both hypothetical scenarios due to ease of use of SBT.
METHODS: Aim 1 will utilize a cross-sectional design where children who are undergoing routine HIV testing by BBT are offered a concurrent SBT; Aim 2 will use a series of focus group discussions (FGDs). Aim 1 will enroll HIV-exposed children ages 18 months to 12 years in pediatric inpatient wards who receive parallel rapid BBT as part of universal inpatient HIV testing; Aim 2 will enroll caregivers of children in the pediatric wards undergoing HIV testing and HCW who perform HIV testing.
IMPACT: If acceptability, sensitivity and specificity are high, SBT could replace rapid BBT to increase uptake of pediatric HIV testing, enabling earlier diagnosis and treatment, in turn limiting HIV-associated morbidity and mortality. The findings of this study will be disseminated directly to Kenyan Ministry of Health policymakers to potentially expand their endorsement of SBT to a pediatric population.