Implementing primary health care-based PMTCT interventions: operational perspectives from Muhima cohort analysis (Rwanda)

INTRODUCTION: In countries with high burden of HIV, major programmatic challenges have been identified to preventing new infections among children and scaling up of treatment for pregnant mothers. We initiated this study to examine operational approaches that were used to enhance implementation of PMTCT interventions in Muhima health Centre (Kigali/Rwanda) from 2007 to 2010. The prospective cohort study was conducted at Muhima health centre (Kigali/Rwanda). All pregnant women diagnosed with HIV-1 and attending PMTCT service at Muhima health centre were invited to participate in the study, between May 2007 and April 2010. Eligible participants were pregnant HIV-1 infected women, consenting to the study, who had attended antenatal visits or delivered at Muhima maternity and had benefited from PMTCT interventions in line with the national guidelines. Additional inclusion criteria was for participants to be registered as residents within the specific catchment area of Muhima health centre and expected to attend postnatal follow up as required. All HIV negative pregnant women, those whose consent was not obtained and those living outside Muhima catchment area were excluded from the study. We estimated the sample size based on anticipated HIV-1 infection of 4% at 6 weeks and absolute precision in% points of 1.5, with a confidence interval (CI) of 95%. A sample size of 656 was the minimum number required for the study. During the study period, of 8,669 pregnant women who attended antenatal visits and screened for HIV-1 in Muhima health centre, 736 were found to be infected with HIV-1 and among them 700 were eligible study participants. At enrolment, these were interviewed by three trained PMTCT providers (2 data collectors supervised by 1 medical doctor) until the determined sample size of 700 women was reached. Information was collected from each mother – infant pair, including specific socioeconomic characteristics, clinical and biological features. For twins, one member randomly selected from each twin pair was included in the study. Follow up data for eligible mother-infant pairs, about pregnancy, childbirth and postnatal period were obtained from women themselves and log books in Muhima health centre, using a structured questionnaire, translated into Kinyarwanda by the principal investigator. Those data included medical records and laboratory tests results. Required data were collected anonymously, using participant’s unique identifier, nationally provided by the National Centre for Treatment and Research on AIDS, Malaria, Tuberculosis and other epidemics (Rwanda TRAC plus/Rwanda Ministry of Health). The study was designed to allow for periodic re-questioning of study participants, at birth and 6 weeks after childbirth [10]. Study participants were considered lost to follow up if they have not shown up for regular visits and the study team unable to find HIV-1 test results for their infants at 6 weeks (Dried Blood Spot method using PCR technique) [11]. Baseline data on known variables, namely age, marital status, maternal education, residence, wealth index were found to be sufficiently similar to those of participants (679) who remained in the study. The data were double entered for all 700 questionnaires, by a team of 2 data entry clerks supervised by a lecturer from the University of Rwanda / School of Public Health. The quality control was meant for checking data consistency between the study questionnaires and medical records from the health facility where childbirth took place. The main outcome was cumulative incidence of mother – to – child transmission of HIV-1 measured at 6 weeks of life among live born children [11]. Background data were summarized with descriptive statistics of the following socioeconomic characteristics: mother’s age in years (< =24 years / > 24 years); marital status (married/unmarried); mother’s education (no education/primary education; secondary school and more); wealth index re-categorized in 5 quintiles (poorest/second/middle/fourth/richest) (Demographic Health Survey wealth index model) [12]; parity (primiparous/multiparous). Univariate analysis of associations was performed using the chi squared test, Fisher’s test as appropriate. For this, key PMTCT-related indicators were considered as covariates, including: disclosed HIV status to partner (no/yes); type of ARV treatment (prophylactic/curative); duration of ARV treatment prior to delivery (< 6 weeks / > = 6 weeks); place of delivery (home/facility); mode of delivery (vaginal/instrument assisted/cesarean section); CD4 count (< 350 cells/µL > = 350 cells/µL); child sex (male/female) and infant feeding choices (mixed feeding /artificial feeding /exclusive breastfeeding) [11]. A predictive modelling was applied with predictors of mother-to-child transmission of HIV-1 assessed by multivariable logistic regression. All variables with potential association with the main outcome – HIV-1 transmission, were entered into the logistic regression model. Hosmer and Lemeshow test was applied to check for how well the model fit. Variables were held in the model if they reached a significance level of P Based on the national key policies that were implemented in the country, with effects on implementation of PMTCT-related interventions [13], specific Operational considerations (service delivery, service providers, financial access; laboratory tests, data management) were discussed, in relation to the analysed PMTCT indicators (Figure 1). Conceptual framework of socio-economic, clinical and biological risk factors for mother – to – child transmission of HIV-1 The study protocol was reviewed and approved by the Rwanda national ethical committee and the research commission of University Teaching Hospital of Kigali, in February 2007, with annual evaluation of the study progress. An informed consent has been obtained, with a written and signed document for each study participant.