The third quarter of 2016 saw all sorts of language about oral PrEP appear in draft or finalized guidelines throughout east and southern Africa. In June, South Africa formally launched its national PrEP program with clinics that serve sex workers but will also provide the strategy to anyone who asks for PrEP. In July, Kenya launched its new Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infections in Kenya with oral PrEP fully integrated. And ministries in Namibia, Uganda, Zambia and Zimbabwe are among those that began to draft language around PrEP.
Does all of this mean there's going to be more PrEP in sub-Saharan Africa in the near future? Not exactly. Here's what we've learned from working with advocates in countries where discussions are underway.
The Process of Updating ART Guidelines Is Propelling PrEP Into Country Documents
The most recent WHO guidelines on the use of antiretrovirals (ARVs) for treatment and prevention recommend the immediate offer of ART for all people living with HIV. This "test and offer" approach is the cornerstone of most models for ending the epidemic and countries are under pressure from many stakeholders to swap out their old guidelines -- which may have used a CD4-cell-count threshold to guide initiation -- for the new ones. Since PrEP is included in the current WHO ARV guidelines, some countries are also including it in their national adaptations. This has happened in Botswana and Lesotho and may soon happen in other countries.
Guidelines Aren't the Same as Guidance
PrEP is popping up in national guidelines that set the broad strokes for country programs. But fewer countries have developed PrEP guidance -- the more detailed, intervention-specific roadmap for implementing who should get PrEP, what tests and counseling messages should go with it and how clinicians should approach monitoring and supporting people who are taking it. Some countries are updating their ART guidelines and developing PrEP guidance at the same time. Others have done the former but aren't taking action on the latter, which means there's very little happening on the ground. So a key question for advocates tracking in-country progress is: What's the status of standalone PrEP guidance?
Guidance Language on Who Gets PrEP Can Get Tricky
Perhaps the most important thing for advocates is to help guide the language on who should be offered PrEP. While the WHO states that PrEP should be made available to "anyone at substantial risk of HIV", countries are taking various approaches to narrowing down the eligibility criteria. In some places, advocates have seen PrEP recommended for "serodiscordant couples." This could work if the term "serodiscordant couples" applied to HIV-negative people who might have sex with someone living with HIV. But typically this term is applied only to people in a regular partnership with someone who has a different serostatus, which leaves too many people without access to PrEP. This type of language may also raise questions about why the partner living with HIV isn't offered ART immediately.
One alternative, naming specific risk groups with documented high incidence such as men who have sex with men, and adolescent girls and young women, can also be tricky. In some regions cultural norms demand that adolescent girls and young women abstain from sex, and MSM aren't supposed to even exist. Yet these are the precise populations who must have access to PrEP if the strategy is going to have impact. Kenya's approach is worth studying -- their guidelines, which list risk behaviors rather than populations, avoid political minefields but recognize that it's behaviors, not identities, that put people at risk. There are also early, anecdotal indications that programs focused on sex workers are deterring some women from starting PrEP. They fear being identified as sex workers by virtue of using PrEP. This is another reason to roll out programs with broad guidance and targeted programming. Advocates can help secure broad access by focusing on risk behaviors, not identities, as the basis for eligibility within in-country guidance.
It Shouldn't Be Too Complicated
PrEP is a new tool. It hasn't been delivered at national scale anywhere in the world. And there's a lot to be learned about the best way to offer it safely and sustainably. In order to learn these lessons, PrEP guidance needs to be sensible but not so complex that the strategy becomes difficult to roll out. Creatinine tests for kidney function are nice to have in PrEP programs, but they shouldn't be a requirement, as this can slow down initiation and isn't the standard in Kenya, for example. Counseling messages should focus on the individual's sense of his or her risk and overall well-being and also support the individual's choice whether to take PrEP. And women who become pregnant while on PrEP should be able to continue PrEP use. This issue was hotly debated at the recent International AIDS Conference -- it's time to move ahead with access inclusive of pregnant women.