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Introduction: Mother-to-child transmission of HIV can be reduced to <5% with appropriate antiretroviral medications. Such reductions depend on multiple health system encounters during antenatal care (ANC), delivery and breastfeeding; in countries with limited access to care, transmission remains high. In Lesotho, where 28% of women attending ANC are HIV positive but where geographic and other factors limit access to ANC and facility deliveries, a Minimum PMTCT Package was launched in 2007 as an alternative to the existing facility-based approach. Distributed at the first ANC visit, it packaged together all necessary pregnancy, delivery and early postnatal antiretroviral medications for mother and infant. Methods: To examine the availability, feasibility, acceptability and possible negative consequences of the Minimum PMTCT Package, data from a 2009 qualitative and quantitative study and a 2010 facility assessment were used. To examine the effects on ANC and facility-based delivery rates, a difference-in-differences analytic approach was applied to 2009 Demographic and Health Survey data for HIV-tested women who gave birth before and after Minimum PMTCT Package implementation. Results: The Minimum PMTCT Package was feasible and acceptable to providers and clients. Problems with test kit and medicine stock-outs occurred, and 46% of women did not receive the Minimum PMTCT Package until at least their second ANC visit. Providing adequate instruction on the use of multiple medications represented a challenge. The proportion of HIV-positive women delivering in facilities declined after Minimum PMTCT Package implementation, although it increased among HIVnegative women (difference-in-differences=14.5%, p=0.05). The mean number of ANC visits declined more among HIVpositive women than among HIV-negative women after implementation, though the difference was not statistically significant (p=0.09). Changes in the percentage of women receiving 4 ANC visits did not differ between the two groups. Conclusions: If supply issues can be resolved and adequate client educational materials provided, take-away co-packages have the potential to increase access to PMTCT commodities in countries where women have limited access to health services. However, efforts must be made to carefully monitor potential changes in ANC visits and facility deliveries, and further evaluation of adherence, safety and effectiveness are needed. © 2012 McDougal L et al; licensee International AIDS Society.
To better understand the rationale of the MPP and the required steps for its success, the authors reviewed international PMTCT recommendations [1,2,22,23] and national PMTCT guidelines for several sub-Saharan countries [19,24–27] and obtained input from staff that had been involved in the design and implementation of the MPP in Lesotho. A conceptual framework was then developed against which feasibility, acceptability, service uptake analyses, and potential detrimental effects could be examined. Based on this framework, a series of eight potential barriers for the successful functioning of the MPP was formulated, along with specific questions and data sources for each (Table 1). Conceptual framework for successful implementation of the Minimum PMTCT Package This MOHSW and UNICEF-commissioned study was designed to investigate the procurement and supply chain management of the MPP, its sociocultural acceptability, and the feasibility of scale-up. Methods are detailed in the study report [20], but briefly, data were collected in November–December 2009 using rapid, mixed-methods techniques that consisted of interviews with key informants from the MOHSW and national pharmacy services as well as other key partners; a facility checklist; interviews of service providers; and exit interviews of ANC, delivery, and postnatal visit patients. In addition, separate focus groups for men and women were conducted at community level to assess normative values regarding PMTCT and the MPP. The facility checklist and the service providers and patient interviews were conducted in 42 facilities: 17 of the 18 hospitals in the country, all five filter clinics (an interim level of service between a health centre and hospital), as well as 20 health centres that had been selected using district-level probability-proportionate-to-size sampling. The facility checklists, focus groups, and patient and staff interviewers were conducted by local teams, each of which included a nurse, and were hired and trained by the consulting firm that conducted the evaluation, with field supervision provided by the Lesotho MOHSW, WHO and the independent consulting firm. Patients were selected for exit interviews using a systematic random sampling frame. Data were available for a total of 150 providers and 214 patients, all of whom provided verbal consent [20]. Ethical approval was obtained from the Research and Ethics Committee of the Lesotho MOHSW. Data from the assessment report was used where feasible. In addition, however, the original facility checklist data was re-analysed to better describe the extent to which facilities, particularly clinics, were adequately equipped to provide services for women who may have lacked access to subsequent ANC visits and facility delivery. Finally, the open-ended answers on the individual health worker and client questionnaires were examined to better understand their knowledge of and attitudes towards the MPP. This comprehensive facility HIV services assessment, which was funded by USAID and conducted by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), was designed to evaluate the capacity of each health facility in Lesotho to fully implement comprehensive HIV/AIDS services and programs, including PMTCT. Data were collected in June 2010 using a structured questionnaire and chart data abstraction in each of Lesotho's 252 health facilities, of which 203 sites offered ANC services. In each facility, data were extracted from patient records and cards for the previous 3 months. Data collection was conducted by staff from EGPAF and the MOHSW who attended a one-day training course on correct survey procedures and data instruments use [21]. Ethical approval was obtained from the Research and Ethics Committee of the Lesotho MOHSW. For the purpose of this analysis, findings from the report were examined; EGPAF also provided supplementary analyses of facility-level availability of care, testing capacities and medications. This nationally representative, individual level survey was conducted between October 2009 and January 2010, and was implemented by the MOHSW and Bureau of Statistics, with funding from USAID and technical support from Measure DHS. Two-stage cluster sampling was used to select households, and all women age 15–49 within a selected household were eligible to be interviewed. Interviews and HIV testing were conducted by enumerators who underwent extensive training on the DHS protocols and procedures [18]. A total of 7624 women aged 15–49 were interviewed using structured questionnaires on personal data assistants, with an eligible woman response rate of 98% [18]. HIV testing was conducted in 50% of the households where women were interviewed (n=4016). Testing was anonymous and was performed on dried blood spots collected at the time of the interview. For these analyses, records from the individual questionnaires were linked with the HIV test results for all women who had received a DHS-administered HIV test and had given birth during 2005–2009 (n=1545). For women with more than one birth during this period, only the most recent birth was used. Women who were HIV-tested were not significantly different from untested women in terms of urban/rural residence, marital status, age, education level, literacy, wealth, parity and years of residency (results not shown). The linked DHS data were used to investigate the effect of the MPP implementation on maternal and child health services and service utilization. Specific outcomes examined were≥4 ANC visits, the mean number of ANC visits, the quality of ANC care, facility deliveries, and whether or not the infant was brought into a facility by 3 months of age for DPT1 (a proxy for the recommended 6-week follow-up visit for DNA PCR testing). Women were considered to have received quality care if they reported all of the following during their most recent pregnancy: being informed of signs of pregnancy complications; being weighed; having blood pressure, urine and blood samples taken. A difference-in-differences analytic approach was used to assess the percentage change in each outcome after MPP implementation. Specifically, self-reported service utilization from before and after the MPP rollout was compared between women who should have received the MPP (HIV-positive women) and those that should not have received it (HIV-negative women). The HIV-negative group provided the background trends in ANC and delivery services against which the experience of the HIV-positive women could be compared. Pre-/post-implementation of the MPP was differentially defined by district, as the program was implemented on a rolling basis. For purposes of the analysis, the pre-implementation period was 2005–2006 and post was 2007–2009 for Butha Buthe, Leribe, Berea, Mafeteng, Maseru and Mohale's Hoek. For the remaining districts of Quthing, Quacha's Nek, Mokhotlong and Thaba-Tseka, the corresponding years for analysis were 2005–2007 and 2008–2009. The logit models used for this approach contained demographic covariates independently associated with HIV status as well as the outcome in question (assessed by Rao-Scott F-adjusted Chi-square tests [categorical variables] or t-tests [continuous variables] with a 0.05 significance cut-off) as well as HIV status and a pre-/post-implementation dummy variable which were interacted to create the difference-in-difference estimator. District of residence was also included to adjust for district-specific factors not accounted for in other demographic variables, as well as possible spillover effects. No multi-collinearity between variables in any model was detected using a tolerance level of 0.10. Marginal effects at the mean were then applied to the specified logit models to calculate model adjusted predicted prevalence before and after MPP implementation in HIV-positive and HIV-negative women (HIV positive, pre-implementation [n=149]; HIV positive, post-implementation [n=250]; HIV negative, pre-implementation [n=381]; HIV negative, post-implementation [n=765]). All analyses with DHS data were weighted and adjusted for the complex survey design [28]. Data from the 2010 and 2011 Annual Joint Reports of the MOHSW [13,29] and the 2010 UNGASS Report on the Status of the National Response to the 2001 Declaration of Commitment on HIV and AIDS [30] were examined for further historical background and information on PMTCT trends. All statistical calculations were conducted using SAS v.9.2 and Stata 10.
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