Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.

BACKGROUND: Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age. METHODS: This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation. FINDINGS: Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. CONCLUSIONS: POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.

"We Need it the Same Day": A Qualitative Study of Caregivers and Community Members' Perspectives Toward the Use of Point-of-Care Early Infant Diagnosis.

BACKGROUND: Only half of the infants tested for HIV ever receive results, leading to low uptake of treatment and increased mortality and morbidity rates. Point-of-care (POC) nucleic acid diagnostic machines allow for the possibility of same-day results. In Kenya and Zimbabwe, as part of an evaluation comparing standard of care with POC testing for early infant diagnosis, a qualitative substudy was undertaken to understand the acceptability of POC among caregivers of HIV-exposed infants and community members. SETTING: Kenya and Zimbabwe. METHODS: In Kenya, 74 interviews were conducted with caregivers, and 6 focus group discussions were conducted with male and female community members and elders. In Zimbabwe, we conducted 85 interviews and 8 focus group discussions. Data were collected in 2 rounds: 1 before the introduction of POC platforms and 1 after the platforms had been in use for at least 3 months. Interviews were conducted in local languages, and content analysis and constant comparison were used to identify key themes. RESULTS: Reduced time to receive test results lowered caregiver anxiety about the child's HIV status and allowed families to put children on treatment earlier. Printed POC results were seen by some as more trustworthy than conventional handwritten results, believing this reduced the chance of human error; a few distrusted HIV results were generated too quickly. Community awareness of POC was lower among caregivers of HIV-exposed infants. CONCLUSION: Caregivers are generally very accepting of receiving POC HIV test results; however, additional sensitization among influential community members about the benefits of POC testing is needed.

Point-of-Care Early Infant Diagnosis Improves Adherence to the Testing Algorithm in Kenya.

INTRODUCTION: We determine the level of adherence to the revised Kenya early infant diagnosis (EID) algorithm during implementation of a point-of-care (POC) EID project. METHODS: Data before (August 2016 to July 2017) and after (August 2017 to July 2018) introduction of POC EID were collected retrospectively from the national EID database and registers for 33 health facilities. We assessed the number of HIV-infected infants who underwent confirmatory testing and received baseline viral load test and proportion of infants with an initial negative result who had a subsequent test. RESULTS AND DISCUSSION: Significantly higher number of infants accessed confirmatory testing (94.2% versus 38.6%; P < .0001) with POC EID. Baseline viral load test and follow-up testing at 6 months, although higher with POC EID, were not significantly different from the pre-POC EID intervention period. CONCLUSION: The POC EID implementation has the potential to increase proportion of infants who receive confirmatory testing, thus reducing the risk of false-positive results.

Impact of a Comprehensive Adolescent-Focused Case Finding Intervention on Uptake of HIV Testing and Linkage to Care Among Adolescents in Western Kenya.

BACKGROUND: Low HIV testing uptake prevents identification of adolescents living with HIV and linkage to care and treatment. We implemented an innovative service package at health care facilities to improve HIV testing uptake and linkage to care among adolescents aged 10-19 years in Western Kenya. METHODS: This quasi-experimental study used preintervention and postintervention data at 139 health care facilities (hospitals, health centers, and dispensaries). The package included health worker capacity building, program performance monitoring tools, adolescent-focused HIV risk screening tool, and adolescent-friendly hours.The study population was divided into early (10-14 years) and late (15-19 years) age cohorts. Implementation began in July 2016, with preintervention data collected during January-March 2016 and postintervention data collected during January-March 2017. Descriptive statistics were used to analyze the numbers of adolescents tested for HIV, testing HIV-positive, and linked to care services. Preintervention and postintervention demographic and testing data were compared using the Poisson mean test. χ testing was used to compare the linkage to care rates. RESULTS: During the preintervention period, 25,520 adolescents were tested, 198 testing HIV-positive (0.8%) compared with 77,644 adolescents tested with 534 testing HIV-positive (0.7%) during the postintervention period (both P-values <0.001). The proportion of HIV-positive adolescents linked to care increased from 61.6% to 94.0% (P < 0.001). The increase in linkage to care was observed among both age cohorts and within each facility type (both P-values <0.001). CONCLUSIONS: The adolescent-focused case finding intervention package led to a significant increase in both HIV testing uptake and linkage to care services among adolescents in Western Kenya.