Study design
This was a cross sectional study involving secondary analysis of patient records.
Setting
The study was conducted in five health facilities providing PMTCT services and are jointly operated by the National AIDS Programme (NAP), the township medical team and the International Union Against Tuberculosis and Lung Disease (The Union). The Union is an international non-governmental organization and has been implementing integrated HIV care programme (IHC) since 2005 in collaboration with NAP, Department of Public Health, Ministry of Health and Sports, in Myanmar. The IHC clinic has been providing PMTCT services in Central Women Hospital (CWH) and Mandalay Teaching Hospital (MTH) in Mandalay since March 2011. Pregnant women from THD are referred to CWH or MTH for HIV care including ART/antiretroviral prophylaxis.
There is a responsible medical doctor assigned by The Union to support PMTCT focal person at THD for documenting linkage of HIV positive pregnant mother to HIV care. The medical doctor visits THD every week, gets the list of HIV positive women newly registered in township PMTCT register and searches those patients in electronic database of IHC clinic at CWH or MTH. Then the information on enrolment to HIV care and ART/antiretroviral prophylaxis initiation status of pregnant women is shared back to the PMTCT focal person of THD and the linkage information such as IHC code and ART/antiretroviral prophylaxis initiation date are recorded in PMTCT register. The routine procedure of updating the women’s ART status is shown in Fig. 1.
The PMTCT focal person of THD does the following activities. During first ANC visit in THD, pregnant women are given ANC code and baseline demographic characteristics along with previous medical history are recorded in the ANC registers. The women undergo HIV counselling and testing if they have not undergone this test within the past 3 months or if they have undergone this test from non-National Health Laboratory (NHL) accredited laboratories. The pregnant women who test positive were referred to CWH or MTH for enrolment to HIV care, CD4 testing and provision of ART/antiretroviral prophylaxis according to national guidelines prevailing during the study period [2, 14,15,16]. A diagram illustrating the flow of patients is shown in Fig. 2.
The ART was provided if the CD4 cell count was < 350 cells/mm3 before 2015, < 500 cells/mm3 from 2015 to 2016 and it was changed to ‘all’ regardless of CD4 count after 2016. In different time periods, different antiretroviral prophylaxis was provided to women with CD4 count higher than cutoff points: 1) Before 2013: PMTCT option A wherein eligible pregnant women received Zidovudine (AZT) only; 2) Between 2011 and 2014: PMTCT option B wherein eligible pregnant women received triple drug ART throughout pregnancy, at the time of delivery and stopped ART a week after discontinuation of breast feeding, 3) Between 2014 and 2016: PMTCT option B+ wherein eligible pregnant women received triple drug ART during pregnancy, delivery and then continued the ART for life. Between 2011 and 2013, the attending physicians based on their own discretion either proved option A or option B to the eligible pregnant women.
The description of care and services provided in IHC clinic at CWH has been reported elsewhere [17]. In brief, comprehensive PMTCT services include care and treatment provided by specialists from the hospital, medical officers employed by The Union, PLHIV network and medical social workers from the hospital. Pregnant women are scheduled for follow up visit periodically. After delivery, mother and infant(s) are followed up until 18th month post-partum. If the exposed infant is diagnosed as HIV positive, then the infant is transferred out to pediatric IHC clinic for ART initiation and the mother to adult clinic for further follow-up. If the infant is declared to have no infection, the mother is then transferred to the adult ART clinic, and the infant is discharged from further follow-up.
In THD ANC clinics, the responsible PMTCT focal person records patient information in standardized PMTCT register. At IHC clinic, the visit forms are filled by trained medical doctors and these forms are transcribed into an electronic database of NAP and The Union’s IHC programme after each clinic by trained data entry staff.
Study population
Pregnant women living with HIV enrolled in five study sites at THDs were included. From the first two study sites, pregnant women who were enrolled between January 2012 and December 2017 were included. From the other two study sites, those who were enrolled between January 2013 to December 2017 and from the last study site, those who enrolled between January 2015 and December 2017 were included in the study. The study cohort was followed up until 31st March 2018 (censor date).
Source of data, data variables
Data from the paper-based PMTCT registers was single entered into EpiData database (version 3.1) by trained data staff in April 2018. Information related to HIV care at IHC clinic (CWH and MTH) was available in the NAP-Union database. The study variables included: name, registered township, age, HIV diagnosis date, ART/antiretroviral prophylaxis initiation date, date of delivery, baseline CD4 count, baseline WHO staging, last menstrual period (LMP), employment status.
The two electronic databases were linked using IHC code. The women who did not have IHC programme code in PMTCT register were manually searched in IHC electronic database using name and age. The distances in google map were used to calculate the distance between enrolled PMTCT clinics and registered townships for women enrolled in HIV care. The last menstrual date was calculated from date of delivery by subtracting 280 days from date of delivery for those whose LMP was not recorded in electronic database. Delayed initiation of ART/antiretroviral prophylaxis was defined as being initiated on ART/antiretroviral prophylaxis after 2 weeks from the date of HIV diagnosis.
Statistical Analysis
Electronic databases were imported into STATA version 14.2 (Stata Corp. College Station, TX, USA). Data were anonymized and de-identified prior to analysis. Median (interquartile range-IQR) was used for summarizing continuous variables and numbers and proportions were used for summarizing categorical variables. Time to ART initiation was calculated by subtracting the date of HIV diagnosis and date of treatment initiation among women diagnosed with HIV during current pregnancy and initiated on ART/antiretroviral prophylaxis.
To depict the distribution of time to event, Kaplan-Meier curves were plotted. The unadjusted and adjusted prevalence ratio (PR) were calculated for the delay in initiation of ART/antiretroviral prophylaxis by multivariable binomial log regression models (multivariable Poisson regression models with robust standard error estimates if the binomial models failed to achieve convergence). A P-value of less than 0.05 was considered statistically significant for all analyses.