About 40% of the new HIV infections in Ethiopia are among children < 15 years of age. The great majority of these infections occur through Mother-to-child HIV transmission (MTCT). For prevention of MTCT, the national guidelines has been revised to incorporate scientific advances in HIV prevention, treatment and care. Since 2005, the country has been implementing a peer mentor programme called Mother Support Group (MSG), which provides psychosocial and adherence support for HIV positive mothers. This study examined implementation of PMTCT guidelines revisions and outcomes of HIV exposed babies in the MSG in Addis Ababa. Retrospective routine data were collected between 2005 and August 2013 from seven randomly selected primary health facilities. Odds ratios and 95% confidence intervals were calculated using logistic regression models. Several guidelines revisions were made between 2001 and 2013 in HIV testing approaches, prophylactic antiretroviral options, infant feeding recommendations and infant HIV testing algorithms. Revisions on the CD4 thresholds were associated with a significant increase in the proportion of women initiating antiretroviral treatment from 0 in 2005 to 62% in 2013. Revisions in infant feeding recommendations led to a 92.3% reported practice of exclusive breastfeeding in 2013 compared to 60.9% in 2005. Two and four percent of the HIV exposed babies were HIV positive by six and 18 months respectively. Not receiving prophylactic ART and receiving mixed feeding were independent predictors for babies having an HIV positive antibody test at 18 months. The rate of HIV status disclosure increased significantly year by year. Over the years, the PMTCT recommendations have moved from having a solo focus on PMTCT to holistic and inclusive approaches emphasizing survival beyond HIV prevention. The data reflect favourable outcomes of HIV exposed babies in terms of averted MTCT though serious gaps in data quality remain. For successful implementation of Option-B plus, the identified gaps in the MSG need to be addressed.
Addis Ababa, the capital of Ethiopia has the highest HIV prevalence in the country. Although the HIV incidence has been steadily declining since 2005, still approximately 5% pregnant women in the city are living with the virus [12]. For the prevention of MTCT, a free PMTCT programme was launched in 2003. In 2004, 24 primary care facilities, referred in this study as health centers started implementing the programme. Following progress in the rolling out of the PMTCT programme more and more health facilities have started implementing every year. The programme has been implemented in accordance with the national PMTCT guidelines revisions and updates that follow scientific advances and global recommendations. The first national guideline recommended voluntary HIV counselling and testing to identify and enrol HIV positive women in PMTCT programme. Single dose nevirapine (NVP) prophylaxis at birth, exclusive formula as first line infant feeding choice and antibody testing of HIV exposed babies at 18 months of age were among the recommendations. This guidelines has supported the implementation of the national PMTCT programme between 2005 and 2007 (Table 1). AFASS—affordable, feasible, acceptable sustainable and safe, ART- antiretroviral therapy, HAART—highly active antiretroviral treatment, NVP—Nevirapine, ZDV—Zidovudine, 3TC- Lamuvudine A comprehensive revision of the guideline was made in 2007 that shifted the HIV testing approach from opt-in to opt-out. This has made antenatal HIV testing a routine standard of care [4]. The prophylaxis regimen has shifted from mono-therapy to multidrug therapy. This shift was in line with the 2004 WHO recommendations on antiretroviral drug for treating pregnant women and preventing HIV infection in infants [13]. Prophylaxis ART was initiated at 28 weeks of gestation in women with CD4 count ≥ 200 cells/mm2, while those who have a CD4 cell count < 200 cells/mm3 initiate HAART. This guideline promoted exclusive breastfeeding as the preferred infant feeding method for the first six months, then follows complementary feeding until 18 months of age. The revision also incorporated Deoxyribonucleic acid (DNA) Polymerase chain reaction (PCR) infant HIV testing at six weeks from dried blood sample (DBS) followed by confirmatory HIV antibody testing at 18 months or one week following complete cessation of breastfeeding. The 2007 versions guided the national PMTCT programme implementation from 2008 to 2010 (Table 1). The 2011 revision was mainly on prophylaxis regimen in accordance with the WHO recommendations made in 2010 that introduced Option-A [5, 14, 15]. In Option-A, prophylaxis ART is initiated in early pregnancy and to be continued until cessation of breastfeeding. Pregnant women whose CD4 count is ≥ 350 cells/mm3 receive prophylaxis. Pregnant women whose count < 350 cells/mm3 irrespective of clinical stage and those in the WHO stage 3 and 4 initiate HAART (Table 1). The 2011 revision had guided the national PMTCT programme from 2011 to August 2013. In February 2013, Ethiopia officially launched Option-B plus to accelerate progress to achieve elimination of MTCT. In Option-B plus, women start lifelong ART from the time of HIV diagnosis irrespective of their CD4 cell count, viral load or WHO clinical stage. Single pill fixed dose combination of Tenofovirdisoproxilfumarate, lamuvididne and efavirenz (TDF/3TC/EFV) is the drug of choice. Option-B plus has high efficacy in reducing MTCT and horizontal transmission to sexual partners, potential to increase ART coverage, significant maternal health benefit and has high programme acceptability [2, 9]. Although, Ethiopia’s motivation to move from Option A to Option B plus was primarily to achieve its ambitious goal of eliminating MTCT by 2015, being a country with a generalized epidemic, the programmatic and operational advantages of it were also additional driving forces [9]. Since August 2013 the Option-B plus has been rolled out in public health facilities by replacing all the existing prophylactic ART options [9]. Partner involvement in PMTCT programme and HIV serostatus disclosure to partner have been an integral part of all the PMTCT guidelines in Ethiopia [4–6]. Several studies have shown improved adherence to PMTCT services among women whose partners were involved in the PMTCT programme and those who disclosed their HIV positive status to their partners [16–18]. Moreover, all the guidelines have emphasised the need for linking HIV positive women to treatment, care and support services. To optimize the effectiveness of the PMTCT programme, a MSG was launched in 2005 in public health facilities [8]. This peer mentor programme follows women who found to be HIV positive during their peri-partum visits in public health facilities. Only women who wish to participate in the programme are enrolled. The programme offers regular meetings and discussion sessions for the women to express their concerns, pose questions and clarify doubts and myths. Scheduled meetings are often accompanied by a traditional “coffee ceremony” where all women come together to share each other’s experience and to discuss psychosocial and medical issues. Mentor mothers provide peer counselling on: Moreover, the MSG providers do routine registration; link HIV positive women to appropriate services such as ART, family planning, nutrition programmes, social support and infant HIV testing services. They also dispense prophylactic cotrimoxazol for HIV exposed babies and condoms in some of the MSG sites. The MSG providers are volunteers who only receive transport allowances. The number of MSG providers in each site ranges from three to four. The MSG initiative receives support from international and local partners involved in the implementation of the PMTCT programme in the country. In the early years, IntraHealth is an international NGO used to provide consistent yet modest technical, financial and logistic supports for the coffee ceremonies, training and transportation allowance for mentor mothers [7]. Later, when Management Science for Health and John Hopkins University took over the programmes, such incentives were reduced [8]. Considering its significant contributions, the national PMTCT guidelines have incorporated the MSG activities since 2007. However, there was no direct support from the government for the programme until the launching of the Option-B plus in 2013. For the successful rollout of the Option-B plus initiative, currently the Federal HIV/AIDS prevention and control office and the Federal Ministry of health have been working jointly to fully integrate the MSG endeavour in the national PMTCT programme. This study, conducted in September 2013 had collected routine retrospective data from 2005 to August 2013 from health centers. Ten public primary care facilities were randomly selected one from each sub-city of Addis Ababa. Of these, three of the health centers were found not to have the MSG programme and hence excluded. The study also excluded hospitals, as they did not have the MSG programme. The study was ethically approved as part of a project conducted in Addis Ababa in collaboration with the Addis Ababa City Administration Health Bureau and the Addis Ababa University from 2013 to 2015. The project received Ethical approvals from the Addis Ababa City Administration, Health Bureau ethics committee and from the regional ethics committee in Western Norway. For this study, retrospective routine data was collected anonymously from logbooks using client medical registration number as unique identifier. To access the MSG logbooks; study permit was first obtained first from the Addis Ababa City Administration, Health Bureau, then from respective sub-city health bureau’s and from each health center. The principal investigator, who has been working closely with the Addis Ababa City Administration, Health Bureau and Addis Ababa University since 2009, collected all the data. In each of the selected health facilities, the MSG programme logbooks used for recording routine PMTCT data were reviewed. In the early phase of the programme, there were two major logbooks; one for recording data during pregnancy and the other for recording data after birth. The two logbooks have the mother record number as a unique code. This study used these codes to link the two logbooks. In recent years, the entries in the two logbooks were merged together with the most recent logbook recording both pre-partum and post-partum information including infant HIV testing. There were inconsistencies in the recording and reporting across the MSG sites. This was partly due to different stakeholders running the programmes at different times. Gaps in the quality of data were commonplace, and some sites were worse than others. Despite the changes in PMTCT interventions across the years, there were limited updates in the MSG logbooks. The aforementioned factors also presented challenges to ensure data quality and might have introduced bias to the study. In total, there were 1,084 women registered in the MSG logbooks in the seven health facilities from 2005 to August 2013. Of these, 321 (42%) of the data did not have complete information. Missing data is a common problem in studies using routine data collected for reporting purposes. Missing data not only introduce bias but also compromises the statistical power of a study [19–21]. It is more problematic when the missing data is related to an outcome or exposure. In the present study, the missing data appeared to be related to practical and logistic issues within the MSG programme than attrition and study outcomes. Low literacy of the mentor mothers in recording observations and their poor awareness about its significance, inconsistencies in the logbooks, poor monitoring and evaluation of the programme, limited technical and logistic supports to the programme and the challenges surrounding DBS testing (eg. drawing blood sample, taking sample to central laboratory, collecting test results, recording results on logbooks and communicating test results to mothers) had contribution for the poor quality of the MSG reports and for the missing data. To minimize bias due to missing data and to yield least biased estimates, studies use different missing data analysis methods including deletion also called conventional, nonstochastic imputation and stochastic imputation methods [19, 20, 21]. The present study has employed the conventional approach, assuming that the missing data have occurred at random. The study presented only cases with complete data on exposed babies HIV testing outcomes [19, 20]. In a review, Kang indicates, “missing at random does not mean the missing data can be ignored” [19]. In this regard, the present study undertook sensitivity analysis in addition, to account for potential bias due to the missing data. [22]. Data were analysed using the SPSS statistical package version 21. The number and percentages of women and babies who received prophylaxis in relation to PMTCT guidelines revisions, trend in infant feeding practices in relation to PMTCT guidelines revisions, percentage of babies having DNA PCR and HIV antibody testing, number and percentage of women who disclosed their HIV status to partner and partner HIV test results were calculated. Using bivariate and multivariate logistic regression analyses, odds ratio (OR) and 95% confidence interval (CI) were calculated to determine predictors for exposed infant HIV test status. The predictor variables entered in the bivariate model were year enrolled in MSG, women ART medicine, infant prophylaxis, infant feeding methods, partner HIV test status and disclosure to partner. Of these, infant prophylaxis, infant feeding methods and partner HIV test status showed a chi square statistical p-value ≤ 0.2 and hence entered into the multivariables model to control for potential confounding. A variable having CIs including one for adjusted OR was not considered as an independent predictor. Sensitivity analysis was done to account for potential bias due to missing data as described above.