WHO recommendation on pre-exposure prophylaxis for HIV prevention

WHO recommendation on pre-exposure prophylaxis for HIV prevention



Oral pre-exposure prophylaxis (PrEP) containing tenofovir disoproxil fumarate (TDF) should be offered as an additional prevention choice for pregnant women at substantial risk of HIV infection as part of combination prevention approaches.

(Context-specific recommendation)


Publication history

First published: December 2016

Updated: No update planned

Assessed as up-to-date: December 2016



  • This recommendation should be considered alongside the recommendation on ASB diagnosis
  • This recommendation has been integrated from the WHO guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV (2015), where it is considered to be a strong recommendation based on high-quality evidence (1). The evidence and further guidance related to the recommendation can be found in this guideline.
  • “Substantial risk” is provisionally defined as HIV incidence greater than 3 per 100 person-years in the absence of PrEP, but individual risk varies within this group depending on individual behaviour and the characteristics of sexual partners. Local epidemiological evidence concerning risk factors and HIV incidence should be used to inform implementation.
  • Thresholds for offering PrEP may vary depending on a variety of considerations, including resources, feasibility and demand.
  • The level of protection is strongly correlated with adherence.
  • Detailed evidence and guidance related to this recommendation can be found in the 2015 guideline (1), available at:
  • http://www.who.int/hiv/pub/guidelines/earlyrelease-arv/en/



ART (antiretroviral therapy) refers to the use of a combination of three or more ARV drugs for treating HIV infection. ART involves lifelong treatment. Use of ARV drugs for HIV prevention refers to the HIV prevention benefits of ARV drugs and includes ARV drugs given to the mother or infant for preventing the mother-to-child transmission of HIV (PMTCT), ARV drugs to reduce the transmission of HIV among serodiscordant couples and ARV drugs to prevent people from acquiring HIV when they are exposed (postexposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). (1)



The ANC recommendations are intended to inform the development of relevant health-care policies and clinical protocols. These recommendations were developed in accordance with the methods described in the WHO handbook for guideline development (2). In summary, the process included: identification of priority questions and outcomes, retrieval of evidence, assessment and synthesis of the evidence, formulation of recommendations, and planning for the implementation, dissemination, impact evaluation and updating of the guideline.

The quality of the scientific evidence underpinning the recommendations was graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) (3) and Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) (4) approaches, for quantitative and qualitative evidence, respectively. Up-to-date systematic reviews were used to prepare evidence profiles for priority questions. The DECIDE (Developing and Evaluating Communication Strategies to support Informed Decisions and Practice based on Evidence) (5) framework, an evidence-to-decision tool that includes intervention effects, values, resources, equity, acceptability and feasibility criteria, was used to guide the formulation and approval of recommendations by the Guideline Development Group (GDG) – an international group of experts assembled for the purpose of developing this guideline – at three Technical Consultations between October 2015 and March 2016.

To ensure that each recommendation is correctly understood and applied in practice, the context of all context-specific recommendations is clearly stated within each recommendation, and the contributing experts provided additional remarks where needed.

In accordance with WHO guideline development standards, these recommendations will be reviewed and updated following the identification of new evidence, with major reviews and updates at least every five years.

Further information on procedures for developing this recommendation are available here.


Recommendation question

For this recommendation, we aimed to answer the following question:

  • For pregnant women (P), does PrEP for HIV prevention (I) compared with no PreP (C) reduce HIV infection (O)?


Evidence summary

Detailed evidence and guidance related to the recommendation can be found in the 2015 guideline (1), available at:



Implementation considerations

  • The successful introduction of evidence-based policies related to antenatal care into national programmes and health care services depends on well-planned and participatory consensus-driven processes of adaptation and implementation. These processes may include the development or revision of national guidelines or protocols based on this recommendation.
  • The recommendation should be adapted into locally-appropriate documents and tools that are able to meet the specific needs of each country and health service. Modifications to the recommendation, where necessary, should be justified in an explicit and transparent manner.
  • An enabling environment should be created for the use of this recommendation, including changes in the behaviour of health care practitioners to enable the use of evidence-based practices.
  • Local professional societies may play important roles in this process and an all-inclusive and participatory process should be encouraged.
  • Antenatal care models with a minimum of eight contacts are recommended to reduce perinatal mortality and improve women’s experience of care. Taking this as a foundation, the GDG reviewed how ANC should be delivered in terms of both the timing and content of each of the ANC contacts, and arrived at a new model – the 2016 WHO ANC model – which replaces the previous four-visit focused ANC (FANC) model. For the purpose of developing this new ANC model, the ANC recommendations were mapped to the eight contacts based on the evidence supporting each recommendation and the optimal timing of delivery of the recommended interventions to achieve maximal impact.


Research implications

The GDG did not identify any priority question related to this recommendation


Related links

WHO recommendations on antenatal care for a positive pregnancy experience

(2016) - full document and evidence tables

Managing Complications in Pregnancy and Childbirth: A guide for midwives and doctors

Pregnancy, Childbirth, Postpartum and Newborn Care: A guide for essential practice

WHO Programmes: Sexual and Reproductive health

Maternal Health





  1. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Geneva: World Health Organization; 2015 (http://apps.who.int/iris/ bitstream/10665/186275/1/9789241509565_ eng.pdf, accessed 4 October 2016).
  2. WHO handbook for guideline development, 2nd edition. Geneva: World Health Organization; 2014 (http://www.who.int/kms/handbook_2nd_ ed.pdf, accessed 6 October 2016).
  3. GRADE [website]. The GRADE Working Group; 2016 (http://gradeworkinggroup.org/, accessed 27 October 2016).
  4. GRADE-CERQual [website]. The GRADECERQual Project Group; 2016 (https://cerqual. org/, accessed 27 October 2016).
  5. The DECIDE Project; 2016 (http://www.decide-collaboration.eu/, accessed 27 October 2016).


Citation: WHO Reproductive Health Library. WHO recommendation on pre-exposure prophylaxis for HIV prevention. (December 2016). The WHO Reproductive Health Library; Geneva: World Health Organization.