Country adaptation of the 2010 World Health Organization recommendations for the prevention of mother-to-child transmission of HIV
Elena Ghanotakis a, Lior Miller a & Allison Spensley a
a. Elizabeth Glaser Pediatric AIDS Foundation, 1140 Connecticut Ave NW (Suite 200), Washington, DC 20036, United States of America.
Correspondence to Elena Ghanotakis (e-mail: email@example.com).
(Submitted: 12 January 2012 – Revised version received: 16 September 2012 – Accepted: 18 September 2012 – Published online: 16 October 2012.)
Bulletin of the World Health Organization 2012;90:921-931. doi: 10.2471/BLT.12.102210
Considerable progress has been made by programmes for the prevention of mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV), as evidenced by the drop in the estimated annual number of children born to HIV-positive (HIV+) mothers from 570 000 in 2003 to 330 000 in 2011.1 These gains are mostly attributed to increases in PMTCT service coverage. In low- and middle-income countries, the percentage of HIV+ pregnant women receiving antiretroviral therapy (ART) for PMTCT has increased from 15% in 2005 to 57% in 2011.1 The Joint United Nations Programme on HIV/AIDS has now called for the “elimination” of mother-to-child transmission of HIV by 2015.2 Elimination necessitates lowering the risk of transmission of HIV from mother to child to less than 5% and reducing the infection rate among young children by at least 90%.3 To attain these goals, an increase in PMTCT programme coverage and a scale-up in the use of the more efficacious ART regimens currently available are needed.4
The World Health Organization (WHO) revised its global guidance on the use of ART to treat HIV+ pregnant women and prevent HIV infection in infants (herein referred to as the 2010 PMTCT recommendations) with initial draft recommendations released in November 20094 and final guidelines launched in July 2010.5 Key changes reflected in the 2010 PMTCT recommendations are summarized in Box 1.5
Box 1. Summary of key changes in the 2010 PMTCT recommendations issued by the World Health Organization
Expand access to CD4+ lymphocyte testing for all HIV+ pregnant women.
Raise the recommended CD4+ lymphocyte threshold for eligibility for treatment to < 350 cells/mm from the previous threshold of 200 cells/ mm3, irrespective of WHO stage, and provide ART to all women in WHO stages III and IV.
Provide ART to eligible HIV+ pregnant women consistent with national standard first-line treatment guidelines for adults. First-line treatment should be either AZT or a TDF-based regimen; d4t-based regimens should be phased out. Recommended regimens for pregnant women are:
- AZT + 3TC + NVP or
- AZT + 3TC + EFV or
- TDF + 3TC or FTC + EFV or
- TDF + 3TC or FTC + NVP
EFV, only after the first month of pregnancy, should replace NVP if this is not tolerated or is contraindicated.
Offer two antiretroviral prophylactic regimen options for pregnant women not eligible for treatment and provide antiretrovirals for prophylaxis starting at 14 weeks’ gestation (most likely at diagnosis) and to mother or infant during breastfeeding:
- Option A: Maternal prophylaxis includes provision of AZT from 14 weeks gestation, single-dose NVP at the onset of labour and AZT + 3TC during labour and delivery, and AZT + 3TC for 7 days post-delivery. For infants who are breastfeeding, Option A includes provision of NVP from birth until one week after cessation of breastfeeding and for non-breastfeeding infants, provision of AZT or NVP until 4–6 weeks of age.
- Option B: Maternal prophylaxis includes provision of a three-drug regimen from 14 weeks’ gestation until one week after the infant’s exposure to breast milk has ended. Infant prophylaxis includes provision of AZT or NVP until 4–6 weeks of age to all HIV-exposed infants.
ART, antiretroviral therapy; AZT, zidovudine; d4t, stavudine; EFV, efavirenz; FTC, emtricitabine; HIV, human immunodeficiency virus; HIV+, HIV-positive; NVP, nevirapine; PMTCT, prevention of mother-to-child transmission; TDF, tenofovir; 3TC, lamivudine; WHO, World Health Organization.
Implementation of the new guidelines in developing countries would allow PMTCT programmes to attain rates of mother-to-child HIV transmission comparable to those in developed countries.6 Yet putting the new recommendations into operation, especially in resource-limited settings, is complex, costly and involves significant planning, human capacity and resources. In addition, the new guidelines call for longer patient follow-up than previous guidelines. Ministries of health (MOH) therefore faced a series of challenging decisions as they revised national guidelines to make them consistent with the 2010 PMTCT recommendations and at the same time appropriate for local contexts (herein referred to as the adaptation process).
The revision of international health guidelines is a dynamic process informed by emerging scientific evidence and practical programmatic experience. This article explores perspectives on the collective adaptation process, common issues, key themes and challenges and the decisions reached in relation to adaptation of the 2010 PMTCT recommendations in the 14 African countries where the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) works. This information is being provided to inform subsequent adaptation processes in response to future guideline revisions.
Since 2000, EGPAF has provided comprehensive technical support for the delivery of PMTCT and HIV care and treatment services to more than 13.6 million women in over 5900 health-care facilities in 16 countries, 14 in sub-Saharan Africa and 2 in Asia (data from EGPAF database, available from corresponding author). Of the 16 countries where EGPAF works, 15 are among the 22 countries with the highest estimated numbers of pregnant women living with HIV. This analysis focuses on experiences in 14 EGPAF-supported countries in sub-Saharan Africa (Table 1).
Table 1. Context of prevention of mother-to-child transmission (PMTCT) of HIV in countries supported by the Elizabeth Glaser Pediatric AIDS Foundation, 2010
EGPAF staff work closely with ministries of health in supporting programme implementation, policy and advocacy, and research. Many of EGPAF’s country-based technical staff actively participate in national PMTCT technical working groups, where they provide technical assistance on national policy related to PMTCT and HIV care and treatment. Thus, they have first-hand knowledge of country experiences in adapting the 2010 PMTCT recommendations.
Tracking of adaptation process
In anticipation of the release of the 2010 PMTCT recommendations, EGPAF launched an organized effort to help ministries of health incorporate the new recommendations at the national policy level. In 2009 EGPAF formed a technical advisory group to build the capacity of its staff in light of this objective. Specific interventions are outlined in Box 2.
Box 2. EGPAF support to country programmes for the 2010 PMTCT recommendations’ adaptation process
- Coordination and communication fora, such as an internal e-mail discussion group (i.e. listserv) and a web site housing a database of country progress and resources to facilitate information synthesis and sharing across country programmes
- Three toolkits to support national level adaptation, implementation, and monitoring and evaluation of the revised guidelines
- Knowledge and capacity building of EGPAF staff, including trainings, technical assistance, and regularly scheduled discussions highlighting key issues and offering a venue for sharing early implementation experiences
- EGPAF staff travel to country programmes in need of technical assistance and/or advocacy during the adaptation process.
- Technical exchange calls among country staff to allow countries at a later stage in the adaptation process to provide assistance to those at an earlier stage
- Documentation support, including production of externally disseminated documents outlining promising practices and lessons learnt
EGPAF, Elizabeth Glaser Pediatric AIDS Foundation; PMTCT, prevention of mother-to-child transmission.
To understand common issues and to provide targeted support during this effort, EGPAF tracked the adaptation progress in 14 African countries. EGPAF headquarters staff gathered data from in-country technical staff from January 2010 to July 2011 through bimonthly queries, an online discussion forum, and three international meetings attended by representatives from the 14 countries and EGPAF headquarters. Box 3 contains the tool used to gather information on the adaptation progress from country teams.
Box 3. Tool used to gather information from countries on their progress in the 2010 PMTCT recommendations adaptation process
- What is the current status of adaptation and implementation of the revised guidelines? Have there been any developments or progress since we last spoke?
- Which aspects of this process are going well or represent successes?
- Which aspects of this process are challenging?
- Please provide feedback on the status of the following:
- Revision of national PMTCT guidelines
- Selection of maternal prophylaxis regimen
- Roll-out of trainings
- Distribution of revised tools and job-aids to facilities
- Forecasting of drugs in accordance with revised guidelines
- Revision of national indicators
- Revision of registers and national reporting forms
- Status of implementation roll-out
PMTCT, prevention of mother-to-child transmission.
Country experiences with adaptation
Of the 14 countries whose progress EGPAF tracked, 12 began the adaptation process before or immediately after WHO issued its rapid advice on the use of ART for treating HIV+ pregnant women and preventing HIV infection in infants, on the eve of World AIDS Day in 2009.4 The early release of the rapid advice and the speed with which countries responded allowed for faster adaptation of the guidelines. The total time needed for adaptation, as well as the time to implementation, varied across countries, but all 14 countries had officially revised their national guidelines within 15 months of the release of the new recommendations.
In most countries, the guideline adaptation process was quicker in 2010 than in 2006. For example, Lesotho and Uganda had just completed tools for implementing the 2006 guidelines when WHO’s rapid advice was released in 2009. By contrast, their adaptation process for the 2010 guidelines was faster, more organized and participatory due to the support of partners such as the Centers for Disease Control and Prevention, the Clinton Health Access Initiative and EGPAF. Zambia noted that in 2006 its adaptation process took over a year, whereas in 2010 it took less than half that time. The Democratic Republic of the Congo noted that in the years between the release of the 2006 and 2010 guidelines, PMTCT had become more attractive to donors and ministries of health as a strategy for tackling HIV infection and acquired immunodeficiency syndrome (AIDS). For example, the Global Fund Round 10 guidelines for proposals focused on PMTCT, and the Democratic Republic of the Congo’s application included the country’s updated PMTCT guidelines in its Round 10 application. The timing of adaptation was affected by the type of process followed in each country and by lengthy discussions and debates surrounding the choice of prophylactic ART regimen (Option A or Option B, Box 1).
Before making decisions, ministries of health consulted with stakeholders (e.g. implementation and technical assistance partners, multilateral organizations, research bodies and other groups working on HIV infection control) using a variety of methods. Kenya, Lesotho, Mozambique, Rwanda, Swaziland and Zambia gathered input through standing national PMTCT technical working groups, whereas Uganda convened participants for consultations specifically for the purpose of revising its PMTCT guidelines. Côte d’Ivoire, the Democratic Republic of the Congo and Kenya held workshops with stakeholders for several days; other countries held similar meetings over several months.
The decision-making process often involved intense lobbying to ministries of health and support from partners and donors. Although these partners expressed their preferred approach to PMTCT, ministries of health made final decisions based on what they felt was most appropriate for their countries. Technical partners actively supported the decision-making process. For example, EGPAF developed a toolkit for its in-country staff and ministry of health partners that contained an overview of the revised guidelines and guidance on effective planning for implementation and monitoring of the revised guidelines and documentation of programme experiences.
Simultaneous revision of various guidelines
Most ministries of health decided to revise other guidelines concurrently released by the WHO, such as those for adult and paediatric ART and the feeding of infants and young children in the context of HIV, while revising their PMTCT guidelines due to the overlap between guidelines.9–11 Where this occurred, it was observed that the PMTCT guideline adaptation process moved more quickly; as of July 2011, 13 of 14 MOHs had completed the revision of PMTCT guidelines, while only 11 and 12 finalized adult and paediatric HIV treatment guidelines, respectively.
Guidelines on the feeding of infants and young children in the context of HIV were sometimes incorporated into the national PMTCT guidelines or paediatric HIV care and treatment guidelines. This happened in Cameroon, the Democratic Republic of the Congo, Kenya, Mozambique, Rwanda, the United Republic of Tanzania and Zambia. However, in all other countries they exist separately.
In most of the 14 countries, activities for the prevention of HIV infection and HIV care and treatment are managed by different bodies within the health ministry, with separate national technical working groups for each area. This required additional coordination, yet countries did not report major difficulties and welcomed the opportunity to have different technical working groups collaborate among themselves and make joint decisions. In countries such as the Democratic Republic of the Congo, Kenya and Lesotho, these working groups jointly revised both sets of guidelines, whereas in the United Republic of Tanzania, PMTCT guidelines were revised first and then incorporated into adult guidelines after these were revised. In Swaziland, the technical working groups worked separately at first and then successfully harmonized their efforts through meetings. Challenges arose in Uganda and Zambia, where the technical working groups had chosen different adult first-line ART regimens. However, they were able to reconcile their differences and agree on a consistent approach.
Prophylactic regimen options
As of July 2011, 11 of the 14 countries (Cameroon, Democratic Republic of the Congo, Kenya, Lesotho, Mozambique, South Africa, Swaziland, United Republic of Tanzania, Uganda, Zambia and Zimbabwe) had officially chosen Option A for their national guidelines and 3 (Côte d’Ivoire, Malawi and Rwanda) had chosen Option B or modifications thereof. Malawi chose Option B+, which entailed initiating all HIV+ pregnant women on lifelong ART. Uganda decided to remain flexible: it adopted Option A as standard policy while allowing facilities with sufficient resources to offer Option B. Kenya, Mozambique and Zambia chose Option A for their national policies but allowed some implementing partners to pilot Option B for future consideration in case resources became available to pursue this option.
Choice of prophylactic regimen
The decision between Option A and B proved to be contentious in many countries. Although the 2010 PMTCT recommendations provide scientific evidence that both options are equally efficacious,5 many stakeholders still believed that Option B was more effective. Disagreements about the best way forward led to vigorous debate and discussions between stakeholders. This prolonged the revision process and left little time to address other critical issues, such as the logistical complexities of initiating all eligible HIV+ pregnant women on ART (e.g. limited access to CD4+ lymphocyte testing to determine treatment eligibility). Table 2 and Table 3 provide details of the decision-making processes in Lesotho (Option A) and Malawi (Option B+).
Table 2. Elements of the decision-making process surrounding the choice of antiretroviral therapy (ART) regimen for the prevention of mother-to-child transmission (PMTCT) of HIV in Lesotho and Malawi
Table 3. Factors considered by Lesotho and Malawi when selecting their antiretroviral therapy (ART) regimens for the prevention of mother-to-child transmission (PMTCT) of HIV
Common themes emerged during national-level discussions. Factors that influenced countries’ choices included: feasibility, perceived complexity of implementing a given option, potential health risks and health system capacity to incorporate the necessary changes. When WHO issued its 2010 guidelines, many countries were already offering pregnant women prophylaxis with zidovudine (AZT) at 28 weeks’ gestation and health-care providers were familiar with the regimens that most resembled Option A. On the other hand, the choice of Option B required important policy changes. In many countries, nurses were not allowed to initiate a three-drug ART regimen and HIV+ pregnant women had limited access to clinics providing ART.
Where to locate follow-up services in the postpartum period under either option had to be decided. For Option A, discussions focused on how and where to follow up infants receiving extended PMTCT prophylaxis. For Option B, the follow-up of postpartum women on three-drug prophylaxis was perceived as problematic.
Health system capacity
Various factors were considered in determining the feasibility of implementing Option A or Option B. Cameroon, the Democratic Republic of the Congo and Mozambique were already facing antiretroviral stock-outs, and concerns were raised about having sufficient drug supplies, drug and commodity quantification capabilities and the adequacy of the supply chain management systems in place as new guidelines were implemented. Lesotho, Swaziland and Uganda experienced stock-outs of nevirapine (NVP) syrup following implementation of WHO 2010 PMTCT guidelines. Kenya and Zimbabwe experienced stock-outs of AZT upon release of WHO’s rapid advice, as patients and health-care providers demanded the use of certain antiretrovirals for first-line ART in accordance with the revised recommendations. Other countries, however, did not report stock-outs in connection with the revised guidelines.
The issue of equity surfaced during discussions surrounding the selection of ART regimens. Many countries debated whether pregnant women should be prioritized for ART over other eligible adults. Ministries of health in Côte d’Ivoire and Rwanda stressed that because Option B resembled the current standard of care in developed countries more closely than Option A, it should be the standard for their countries as well.
The cost of implementing either option was a critical consideration. Many countries weighed in the funding implications of adopting extended regimens for maternal and infant prophylaxis, initiating more HIV+ pregnant women on long-term ART, the scale-up of CD4+ lymphocyte testing, and the transition from older regimens containing stavudine (d4t) to newer ones based on tenofovir (TDF). After conducting various costing exercises, the ministries of health of Cameroon, the Democratic Republic of the Congo, Kenya, Lesotho, South Africa, Swaziland, the United Republic of Tanzania, Uganda, Zambia and Zimbabwe concluded that Option B would be considerably more expensive than Option A, so they chose the latter. Even governments that believed Option B to be superior saw the increased costs of adoption would be prohibitive. Uganda and Swaziland chose to implement Option A and transition to Option B later, upon resources becoming available.
Ministries of health in Cameroon, Côte d’Ivoire Malawi and Zimbabwe were adapting their PMTCT national guidelines as they were preparing their Global Fund Round 10 proposals, anticipating that Global Fund resources would cover the increased costs associated with implementing WHO 2010 guidelines. In May 2009, the Global Fund launched an initiative to enable grant recipients to “reprogramme” leftover funding from existing grants to procure drugs and other commodities as a way to facilitate switching from a single dose of NVP to more efficacious regimens for PMTCT.
Malawi and Zimbabwe’s Global Fund proposals were rejected.15 As a result, Malawi’s ministry of health had to postpone implementing the revised adult treatment guidelines and to prioritize instead the guidelines for ART initiation in HIV+ pregnant and nursing women and in HIV+ individuals with tuberculosis.15 Similarly, Zimbabwe had to delay full implementation of revised adult ART treatment guidelines and to prioritize guidelines for the initiation of eligible pregnant women on newer, more effective ART regimens.16
For the full intended impact of the 2010 PMTCT guidelines to be achieved, several issues identified during attempts to implement these guidelines must be more closely examined. They include the acceptability of the interventions to HIV+ pregnant women and their families; the implications of adherence to prolonged drug regimens, and drug resistance among mothers and infants.
Early implementation and planning
In several countries health-care providers, patients seeking health care and members of the general public, cognizant of the key changes in the revised guidelines, advocated for their immediate implementation, before national guideline revision. In Kenya, many health-care providers began transitioning patients from d4t to AZT and TDF-based regimens and giving AZT for 28 weeks instead of 14 before national rollout of revised national guidelines. This increased AZT consumption and caused stock-outs. In Zimbabwe, providers reported cases of patients refusing to accept d4t-containing regimens and demanding alternative regimens, even though these were not widely available.
Absence of direct guidance
Ministries of health grappled with several technical issues for which no definitive guidance was given in WHO 2010 PMTCT guidelines. Many were concerned about the potential for drug resistance resulting from the use of more prolonged regimens for maternal and infant prophylaxis and about the effect such resistance might have on patients’ long-term health and on future treatment options for women and infants. The provision of AZT monotherapy for women under Option A caused concern, since a growing body of evidence points to an increased risk of resistance to NVP in women who receive a single dose of the drug during labour.16 There were also reservations about the possible detrimental impact of Option B, given evidence from the Strategies for Management of Anti-Retroviral Therapy (SMART) trial to the effect that mortality and morbidity are greater among patients on therapy causing intermittent suppression of HIV viraemia rather than continuous therapy.17,18
In several countries where HIV seroconversion during pregnancy is an important concern, ministries of health sought guidance on protocols for ART prophylaxis in infants born to HIV-negative mothers in serodiscordant relationships and for ART prophylaxis administered to mothers who seroconvert while breastfeeding. In addition, countries struggled with defining appropriate protocols for mothers and infants with interrupted ART prophylaxis.
Many countries struggled to update national monitoring and evaluation tools and registers for tracking progress in implementing WHO 2010 revised guidelines because of difficulties in defining appropriate indicators. For both Option A and Option B, EGPAF developed a comprehensive list of such indicators. Although these were shared across EGPAF-supported country PMTCT programmes, guidance issued by WHO would have reached a wider audience. WHO did release a guide for adapting WHO normative guidelines for national PMTCT programmes,19 but this was not published until July 2011, one full year after its revised guidelines were released.
Limitations of this analysis
The collective experience summarized in this article stems from only 14 countries, located in sub-Saharan Africa. This limits the generalizability of the lessons learnt. Country experiences were gathered from in-country EGPAF technical staff working directly with ministries of health and supplemented by direct discussions with ministry of health programme managers in various fora. The information in this manuscript was also submitted for review and approval by health ministry staff in all countries included in this analysis.
Some informants may not have been aware of all aspects of the adaptation process and their feedback may reflect their own subjective views. The authors were not always able to obtain the same information across all countries, and some countries asked not to be mentioned in association with certain data. Furthermore, it was not possible to objectively assess the main driving factor(s) behind national policy decisions or whether undue pressure from donors or other lobby groups may have been among them. The literature shows that Africa’s health policies and priorities have been highly influenced, even distorted, by the international donor community, often because global health funding mechanisms prioritize vertical interventions over national health priorities.20,21 However, the potential impact of these influences within specific country adaptation processes was difficult to document and discern.
It is critical to explore country perspectives on the process of adapting national PMTCT guidelines in accordance with WHO revised 2010 recommendations. Knowledge of these country-level processes and the common factors that drive them can be used by WHO and other stakeholders to inform future international guideline revisions and to anticipate and address country needs during subsequent national adaptation processes.
While exploring country experiences in implementing their revised national guidelines is beyond the scope of this paper, recent publications have highlighted some of the challenges associated with implementing Option A in Uganda,22 Zambia23,24 and Zimbabwe,25 particularly with regard to extended infant NVP prophylaxis. Hence, continued monitoring of these challenges is essential. Future research should explore in greater depth the national policy adaptation process in the broader context of donor aid and development.
At the time of writing, the executive team of the Interagency Task Team on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and their Children had initiated meetings to discuss the next changes to WHO’s new PMTCT guidelines, which will most likely favour Option B or B+. In light of these imminent changes, understanding the lessons learnt so far and the challenges faced when adapting international guidelines to national contexts is especially critical.
The contents are solely the responsibility of the authors and do not necessarily represent the official views of the CDC, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), the US Government or Johnson & Johnson.
The authors thank the following EGPAF and ministry of health staff in the countries for their kind collaboration: In EGPAF, Cathrien Alons (Mozambique); Aida Yemane Berhan (Malawi); Edward Bitarakwate (Uganda); Caspian Chouraya (Swaziland); John Ditekemena (Democratic Republic of the Congo); Patricia Fassinou (Côte d’Ivoire); Diane Gashumba (Rwanda); Mohammed Ali Mahdi (Swaziland); Lucy Matu (Kenya); Silvia Mikusova (Mozambique); Martha Mukaminega (Rwanda); Tichaona Nyamundaya (Zimbabwe); Christian Pitter (Global Technical Policy); RJ Simonds (Innovation and Policy); Susan Strasser (Zambia); Appolinaire Tiam (Lesotho); Sara Teitelman (Global Technical Policy); Roland Van de Ven (United Republic of Tanzania); Cornelia Van Zyl (Rwanda); Paula Vaz (Mozambique) and Moses Walakira (Uganda). In ministries of health, Ebogo Mesmey Bertrand (Cameroon); Max Bweupe (Zambia); Frank Chimbwandira (Malawi); Esiru Godfrey (Uganda); Virginie Ettiegne-Traore (Côte d’Ivoire); Deborah Kajoka (United Republic of Tanzania); Linda Kisakye (Uganda); Malisebo Mphale (Lesotho); Placidie Mugwaneza (Rwanda); Angela Mushavi (Zimbabwe); Bonisile Nhlabatsi (Swaziland); Nidia Remane (Mozambique); Kanhon Serges (Côte d’Ivoire); Martin Sirengo (Kenya) and Pulane Tlebere (Lesotho).
The authors also acknowledge the valuable assistance of Eveline Mboh Khan, Esther Kuni and Godlove Nkuoh, of the Cameroon Baptist Convention Health Services, and of Casimir Manzengo Mingiedi of WHO’s Country Office in the Democratic Republic of the Congo.
EG, LM and AS are supported by EGPAF through a grant (number U62/CCU123541) from the Centers for Disease Control and Prevention under the US President’s Emergency Plan for AIDS Relief and Johnson & Johnson.
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