potential challenges of implementing PrEP for HIV prevention

As efficacy trials of antiretroviral pre-exposure prophylaxis (PrEP) continue, a growing literature has begun anticipating the potential challenges of implementing PrEP for HIV prevention. These efforts coincide with a shift toward combination interventions for preventing HIV, which integrate biomedical, behavioural, and structural components. The optimal implementation of PrEP would exemplify this combination model, incorporating not only PrEP drugs, but also HIV testing, safety screening, behavioural interventions addressing adherence and risk behaviour, and long-term monitoring. Efforts to plan for PrEP implementation therefore present an opportunity to advance the science of implementation and delivery in HIV prevention, in order to better address the challenges of scaling up combination approaches. The authors review the published and unpublished literature on PrEP implementation, organizing themes into five categories: scientific groundwork, regulatory and policy groundwork, stakeholder and infrastructure groundwork, delivery, and long-term monitoring. The lessons from PrEP planning can benefit the scale-up of future combination interventions.

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Editors’ note: This paper on preparing for pre-exposure prophylaxis (PrEP) trial results conceptualises PrEP as being composed of biomedical, behavioural, and structural components, following the combination prevention paradigm. Planning for PrEP implementation has both a lot to learn from the experience of medical male circumcision introduction and scale-up and is an opportunity to build the emerging field of implementation and programme delivery science by documenting lessons for scaling up future combination prevention approaches. PrEP delivery will face many challenges including drug cost, active outreach to marginalized communities, provider training, education and awareness-raising strategies, safety screening, clinical monitoring for adverse events, frequent HIV testing, behavioural support, long-term follow-up, prevention of drug resistance, comparative cost-effectiveness, and ethical issues of financing antiretroviral prevention in the face of unmet treatment demand. With 5 large trials of daily oral PrEP ongoing among diverse populations (men who have sex with men, people who inject drugs, heterosexual discordant couples, and women at higher risk of HIV exposure), we need to ask how ‘PrEP works’ will be defined and are we ready to grapple with the complex implementation challenges that PrEP entails? Kenya, Tanzania, Uganda, Zambia, Zimbabwe, and Brazil have already held stakeholder consultations on PrEP. Regional consultations in West and Central Africa and East Africa, chaired by UNAIDS regional support team directors and academics, have explored the challenges and opened up dialogue between policy makers and representatives of men who have sex with men, in anticipation of the first PrEP results which will come from the 4-continent iPrEx study (Peru, Ecuador, Brazil, USA, Thailand, South Africa). Don’t just watch this space, start thinking about this.