The effect of the Xpert HIV-1 Qual test on early infant diagnosis of HIV in Myanmar and Papua New Guinea: a pragmatic, cluster-randomised, stepped-wedge, open-label trial.

BACKGROUND: Despite proven benefits for child health, coverage of early infant diagnosis of HIV remains suboptimal in many settings. We aimed to assess the effect of a point-of-care early infant diagnosis test on time-to-results communication for infants vertically exposed to HIV. METHODS: This pragmatic, cluster-randomised, stepped-wedge, open-label trial assessed the effect of the Xpert HIV-1 Qual early infant diagnosis test (Cepheid) on time-to-results communication, compared with standard care laboratory-based testing of dried blood spots using PCR. Hospitals were the unit of randomisation for one-way crossover from control to intervention phase. Each site had between 1 month and 10 months of control phase before transitioning to the intervention, with a total of 33 hospital-months in the control phase and 45 hospital-months in the intervention phase. We enrolled infants vertically exposed to HIV at six public hospitals: four in Myanmar and two in Papua New Guinea. Infants had to have mothers with confirmed HIV infection, be younger than 28 days, and required HIV testing to be eligible for enrolment. Health-care facilities providing prevention of vertical transmission services were eligible for participation. The primary outcome was communication of early infant diagnosis results to the infant's caregiver by 3 months of age, assessed by intention to treat. This completed trial was registered with the Australian and New Zealand Clinical Trials Registry, 12616000734460. FINDINGS: In Myanmar, recruitment took place between Oct 1, 2016, and June 30, 2018; in Papua New Guinea, recruitment was between Dec 1, 2016, and Aug 31, 2018. A total of 393 caregiver-infant pairs were enrolled in the study across both countries. Independent of study time, the Xpert test reduced time to early infant diagnosis results communication by 60%, compared with the standard of care (adjusted time ratio 0·40, 95% CI 0·29-0·53, p<0·0001). In the control phase, two (2%) of 102 study participants received an early infant diagnosis test result by 3 months of age compared with 214 (74%) of 291 in the intervention phase. No safety and adverse events were reported related to the diagnostic testing intervention. INTERPRETATION: This study reinforces the importance of scaling up point-of-care early infant diagnosis testing in resource-constrained and low HIV-prevalence settings, typical of the UNICEF East Asia and Pacific region. FUNDING: National Health and Medical Research Council of Australia.

Uptake of routine viral load testing among people living with HIV and its implementation challenges in Yangon region of Myanmar: a mixed-methods study.

OBJECTIVES: In 2017, Myanmar implemented routine viral load (VL) monitoring for assessing the response to antiretroviral therapy (ART) among people living with HIV (PLHIV). The performance of routine VL testing and implementation challenges has not yet assessed. We aimed to determine the uptake of VL testing and factors associated with it among PLHIV initiated on ART during 2017 in ART clinics of Yangon region and to explore the implementation challenges as perceived by the healthcare providers. DESIGN: An explanatory mixed-methods study was conducted. The quantitative component was a cohort study, and the qualitative part was a descriptive study with in-depth interviews. SETTING: Six ART clinics operated by AIDS/sexually transmitted infection teams under the National AIDS Programme. PRIMARY OUTCOME MEASURES: (1) The proportion who underwent VL testing by 30 March 2019 and the proportion with virological suppression (plasma VL <1000 copies/mL); (2) association between patient characteristics and 'not tested' was assessed using log binomial regression and (3) qualitative codes on implementation challenges. RESULTS: Of the 567 PLHIV started on ART, 498 (87.8%) retained in care for more than 6 months and were eligible for VL testing. 288 (57.8%, 95% CI: 53.3% to 62.2%) PLHIV underwent VL testing, of which 263 (91.3%, 95% CI: 87.1% to 94.4%) had virological suppression. PLHIV with WHO clinical stage 4 had significantly higher rates of 'not being tested' for VL. Collection of sample for VL testing only twice a month, difficulties in sample collection and transportation, limited trained workforce, wage loss and out-of-pocket expenditure for patients due to added visits were major implementation challenges. CONCLUSIONS: The VL test uptake was low, with only six out of ten PLHIV tested. The VL testing uptake needs to be improved by strengthening sample collection and transportation, adopting point-of-care VL tests, increasing trained workforce, providing compensation to patients for wage loss and travel costs for additional visits.