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Very early infant diagnosis (VEID) (testing within two weeks of life), combined with rapid treatment initiation, could reduce early infant mortality. Our study evaluated turnaround time (TAT) to receipt of infants’ HIV test results and ART initiation if HIV-infected, with and without birth testing availability. Data from facility records and national databases were collected for 12 facilities offering VEID, as part of an observational prospective cohort study, and 10 noncohort facilities. HIV-exposed infants born in January-June 2016 and any cohort infant diagnosed as HIV-infected at birth or six weeks were included. The median TAT from blood draw to caregiver result receipt was 76.5 days at birth and 63 and 70 days at six weeks at cohort and noncohort facilities, respectively. HIV-exposed infants tested at birth were approximately one month younger when their caregivers received results versus those tested at six weeks. Infants diagnosed at birth initiated ART about two months earlier (median 6.4 weeks old) than those identified at six weeks (median 14.8 weeks). However, the long TAT for testing at both birth and six weeks illustrates the prolonged process for specimen transport and result return that could compromise the effectiveness of adding VEID to existing overburdened EID systems.
Birth DNA-PCR testing was added prospectively to the standard EID testing algorithm at ages 6 and 14 weeks at 13 facilities in three districts of Lesotho. These facilities were participating in an observational prospective cohort study evaluating the effectiveness of PMTCT service delivery. DBS collection was conducted at birth and 6 and 14 weeks using similar procedures. Infant blood collection took place at delivery wards and maternal-child health (MCH) clinics at health centers and hospitals. If the district lab and MCH clinic were located on the same hospital campus, nurses would hand-deliver specimens to the district lab; for most health centers, specimens were transported to district laboratories via motorbike. Because district laboratories do not perform DNA-PCR testing, district laboratories registered specimens and compiled them with others, before transporting the samples to the national reference laboratory (NRL). Specimens were tested at NRL as they were received, without prioritizing samples based on date of blood draw. Printouts of test results generated by the laboratory information system were then returned to district laboratories and then transported back typically by motorbike to health centers. Cohort study nurses or HIV counselors delivered results to caregivers. Results were often delivered at the next postnatal visit for infants with HIV-negative test results. For infants with HIV-positive test results, MCH staff and community health workers contacted women by phone or home visit to invite them back to the clinic to receive the results. The study to evaluate test turnaround time took place in 12 out of 13 cohort facilities (excluding one which was no longer operational at the time of this study) and 10 noncohort facilities in three out of 10 districts of Lesotho. The three districts represented the geographical regions of the country: highlands (Thaba-Tseka), foothills (Butha-Buthe), and lowlands (Mohale’s Hoek). All five hospitals in the three districts and seven medium- and high-volume lower level health centers that participated in the cohort were included in this study. All of the remaining 10 medium-volume health centers that conducted only standard-of-care six-week testing in the same districts were also included in the study (the noncohort facilities). We included noncohort facilities to determine if there was shorter TAT at cohort facilities due to the additional support from cohort study nurses who may have conducted more follow-up on results than what might typically be done. All HIV-exposed infants in the 12 cohort facilities with documentation of a birth or six-week test and in the 10 noncohort facilities with documentation of a six-week test born between January and June 2016 were included in the analysis. A birth test was defined as testing before two weeks of life and a six-week test was defined as testing between four and nine weeks of age. Data were collected from July to September 2016 using paper-based forms. Trained study staff abstracted data from study and facility records related to infants’ birth and six-week DNA-PCR tests including dates of blood draw, dates results were returned to the facility, dates results were returned to the caregiver, HIV test results, and dates of ART initiation (HIV-infected infants only). Additional data were extracted from national EID and laboratory databases, including dates the specimen was received and tested at the NRL. Infants’ records were included even if their information was missing from the national database. Because information contained in the EID database was limited, any infants in the database who could not be located in facility records and verified with clinic staff were excluded. Because so few HIV-infected infants were captured during the January–June 2016 timeframe, we also collected the same data for all live-born infants enrolled in the cohort who were diagnosed as infected at birth (N = 5) or six weeks (N = 2) from the start of the cohort in July 2014 to contribute additional data to the time to ART initiation outcome. All completed data were reviewed by the study coordinator before entry into an MS Access database. Total TAT from blood draw to caregiver result receipt or ART initiation for HIV-exposed and infected infants, respectively, was calculated. Infant age at the time the caregiver received the results or at the time of ART initiation and the length of time (in days) it took to complete interim steps along the V/EID pathway were also determined. Interim steps were as follows: (1) from blood draw to specimen receipt at NRL; (2) from receipt of specimen at NRL to testing at NRL; (3) from testing at NRL to result receipt at facility; (4) from result receipt at health facility to receipt by caregiver; and (5) from result receipt by caregiver to treatment initiation. Infants’ data were included if dates were available to calculate at least one step; the number of infants contributing to each step varied as some dates were not available to calculate all steps for each infant. Using SAS/STAT software, descriptive statistics were calculated for all variables of interest using frequencies and percentages for categorical variables and medians (interquartile ranges) and minimum and maximum ranges for continuous variables. Wilcoxon rank sum tests were used to examine differences in TAT from blood draw to caregiver result receipt between cohort and noncohort facilities and TAT from blood draw to caregiver result receipt between infants tested at birth and infants tested at six weeks at study facilities. Differences in the number of days for the interim steps (1–4 above) between three groups (birth test/cohort facility, six-week test/cohort facility, and six-week test/noncohort facility) were examined with Kruskal-Wallis tests. Ethical approvals were received from the institutional review boards of the Lesotho Ministry of Health and the George Washington University. We received a waiver of informed consent. All study staff involved in data collection were trained in human subjects’ research ethics and signed a research confidentiality agreement.
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