What do you do when the people responsible for implementing PrEP education programs don’t trust the science? What if the outreach workers and HIV test counselors believe they’re required to “push” PrEP at the expense of behavioral interventions that have been the focus of prevention programs for years? These are people in prime positions to provide PrEP education to key populations, but suggesting that otherwise healthy clients start a daily medication for prevention is a tough pill for some front-line staff to swallow.

I am a black MSM. I serve at a community-based organization where a large percentage of both the clients and employees are black MSM. One of the known barriers to PrEP implementation among black MSM is medical mistrust. Those barriers don’t just exist among clients; they also exist among members of the HIV workforce tasked with increasing PrEP awareness in their communities. If members of the HIV workforce don’t trust the medical establishment or clinical research or pharmaceutical companies or government agencies, how do we expect them to provide unbiased information about PrEP to the people who need it most?

With all of the good work HIV prevention research advocates have done educating the public about PrEP, there has been more than enough misinformation disseminated about PrEP to create and encourage lingering doubt in the minds of those who are already mistrustful of the medicalization of HIV and the perceived influence of pharmaceutical companies on the HIV prevention agenda. After the 2015 National HIV Prevention Conference in Atlanta, I listened to staff members who had attended as they reported back to staff that stayed behind:

• “There are lots of things we still don’t know.” (Never mind that we know HIV incidence in our Black MSM community is an overall 32 percent, surpassing rates in many populations in sub-Saharan Africa.)
• “We need more information.” (Never mind clinical trials and real-world evidence showing that PrEP is safe and effective and therefore FDA-approved and WHO-recommended.)
• “There are still questions about the long-term effects of the drug.” (Never mind that we have more than a decade of experience of Truvada in people who are HIV positive.)
• “People who take PrEP stop using condoms, and STI rates are increasing.” (Never mind the fact that STI rates started increasing before most people had even heard of PrEP. Furthermore, CDC PrEP protocol recommends STI screening, and treatment if necessary, every three months.)

So what do we do when the people responsible for implementing PrEP education programs don’t trust the science?

If I could talk to all of the PrEP-hater educators, I’d tell them that I wish Truvada had been available for HIV prevention when I was treated for syphilis in 2003. It took several months to get to a syphilis diagnosis because I was treated for a skin rash and gout and had a sigmoidoscopy (an invasive large-intestine probe) before the doctor even ordered an HIV test. (This was before rapid testing was widely available, so I had to think about all of my risky behaviors for a couple of weeks before I got the call that the test was negative.) It was the only time I had ever been worried about HIV infection. It took a while longer before the doctor ordered an STI screening, discovered the syphilis, and ordered the appropriate treatment.

After dodging that bullet, I would have jumped at the chance to protect myself from HIV infection by taking a pill every day. I was in my early thirties; I was a personal fitness trainer in Washington, DC with a good day job; and I had a fairly active sex life. Sometimes I used condoms. Sometimes I didn’t. I had never had any concerns before, but that syphilis scared the hell out of me. It didn’t scare me after I found out what it was because syphilis is totally treatable. It scared me when I thought that I might have been infected with HIV. (It didn’t, however, scare me enough to make me increase my condom use to 100 percent consistently and correctly.) If a pill a day could take the worry of HIV infection from me, I would have been all for it. I wouldn’t have been concerned about long-term side effects or toxicities. I was concerned about living.

If Truvada had been available as PrEP when I tested positive for syphilis in 2003, I probably wouldn’t have tested positive for HIV in 2005. The silver lining is that PrEP is available now. There are black MSM now – who like me then – would jump at the chance to protect themselves from HIV infection by taking one pill every day during their season of risk if they could have accurate, unbiased information about PrEP.

To all of the people responsible for implementing and educating communities about PrEP who don’t like PrEP, I say, “It’s not about you.” Your questions have been asked and answered. PrEP works (and is safe and effective) when it is taken according to the prescribing guidelines. Don’t let your personal or professional biases and misinformation become a barrier to key populations like black MSM accessing an HIV prevention option that might be right for them. PrEP is not appropriate for everybody, but everybody needs to know about PrEP. Get out of the way.

Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay; he is minister and founder of the the HIV program at Imani Community Church in Oakland and is a PxROAR member since 2012.

Less than a month after South Africa’s national regulatory authority, the Medicines Control Council, approved tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or trade name Truvada) for PrEP, Kenya took the same step. The country’s Pharmacy and Poisons Board (PPB)—the regulatory body that considers new drugs—also approved TDF/FTC for PrEP for adults at high risk of sexually acquiring HIV-1 infection.

Notably, the PPB made this decision within 30 days of receiving a submission from Gilead, the drug’s manufacturer. This swift approval sets a strong precedent for other countries and should spur other countries and global health organizations to quickly follow suit.

Both countries’ approvals of TDF/FTC as PrEP is the capstone on a transformational year for PrEP. The French Ministry of Health granted provisional approval of TDF/FTC as PrEP in November; the World Health Organization recommended PrEP as an additional prevention option for all people at substantial risk of HIV infection worldwide in September; and the PEPFAR Scientific Advisory Board recommended swift integration of PrEP into comprehensive HIV prevention programs in PEPFAR countries. This October recommendation came with a particular focus on young women at high risk as well as gay men and other men who have sex with men, and recommended steps to overcome regulatory barriers in countries where PrEP is not yet approved.

Daily oral PrEP is finally beginning to take its place as a core element of global HIV prevention.

But PrEP rollout is still happening far too slowly for millions of women and men at risk for HIV. Other countries need to follow the leadership of Kenya and South Africa and find ways to deliver this life-saving option today.

Young women, especially, are in desperate need of new prevention options they can control. While regulatory approval in these two countries should help accelerate access to oral PrEP, additional work is needed to ensure that millions of women, and men, from across the globe are able to benefit from a breakthrough that was developed expressly for them.

To elevate this from rhetoric to on-the-ground access and impact, a coordinated, global push to secure additional regulatory approvals, mobilize funding, raise awareness, generate demand and establish systems to get PrEP into the hands of all people most likely to benefit is needed. South Africa and Kenya’s experiences may offer a model for other nations, but there is no reason to wait. PEPFAR, the Global Fund and other key stakeholders (including Gilead Sciences and the generic manufacturers of TDF/FTC) should be working with countries to break down barriers to PrEP access within the next year.

For more information:

• Map: Regulatory Status of TDF/FTC for PrEP
• Release from South African Medicines Control Council
• South African PrEP Advocates Applaud the Approval of Truvada for PrEP and Call for Accelerated Action from South African Government to follow the WHO PrEP Guidelines
• The Desmond Tutu HIV Foundation Hails Approval of PrEP to Combat HIV Infections in South Africa
• Give Us ARVs So We Don’t Get HIV, commentary in the South African Mail & Guardian
• www.prepwatch.org

In this Mail and Guardian editorial, South African advocates call on the South African government and health department to do its part to expand the provision of PrEP and integrate it into combination treatment and prevention programs before “people are agitated and take to the streets to demand these tools”.

South Africa has rolled out the largest antiretroviral treatment program in the world—about 3.1 million people are now on treatment, according to health department figures.

This is a remarkable, given the earlier years of poor political response. But South Africa still has unacceptably high rates of infections and HIV remains a public health emergency.

Within the general epidemic in South Africa, some specific population groups—such as sex workers, gay men and other men who have sex with men (MSM), discordant couples (where one partner is HIV-positive and one HIV-negative), truckers and people who inject drugs—have higher rates of HIV and require specialised interventions.

The disease takes a particularly devastating toll on the lives of adolescent girls and young women between the ages of 15 and 24, a rate more than four times that of their male counterparts, according to the Human Sciences Research Council’s 2012 National HIV Prevalence, Incidence and Behaviour Survey.

The HSRC survey, also found that more than 400,000 new HIV infections occurred in 2012, bringing the number of people infected in South Africa to 6.8 million in 2014.

A disturbing picture
These statistics present a disturbing picture of the HIV epidemic and our response. In delaying the implementation of pre-exposure prophylaxis (PrEP), has South Africa failed to embrace the wisdom of science?

This new option for HIV-negative people at substantial risk of HIV infection is a combination antiretroviral drug, TDF/FTC, taken once a day, which can drastically reduce their chances of becoming infected. Research studies show that, when this two-in-one pill is taken correctly and consistently, it is more than 90 percent effective.

There have been unexplained delays by the Medicine Control Council to approve and license TDF/FTC as pre-exposure prophylaxis and the department of health’s response to South Africans voicing their demand for this action has been silence. The council should approve TDF/FTC before the end of this year.

New guidelines
Advocates welcomed the World Health Organisation’s (WHO) new guidelines for HIV treatment, released in September. These recommend that: “Oral PrEP… should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV prevention approaches”.

The new guidelines have broken the silence among policymakers on the future of pre-exposure prophylaxis in South Africa. Following their release, Yogan Pillay, the health department’s deputy director-general for HIV, endorsed the WHO guidelines in an article in the Mail & Guardian. This demonstration of commitment is an important step in realising our dreams about providing pre-exposure prophylaxis.

As HIV prevention advocates, we talk to many people, including potential users of TDF/FTC. We hear from a host of people from all walks of life who are demanding pre-exposure prophylaxis. They want to know when the drug will be available in South Africa and how they can get access to it. These questions have been previously been impossible to answer, but now we hope to work with health department. Will the department follow through on its commitment and the ethical imperative to provide medicine that is a crucial step in confronting the HIV epidemic?

We would like to see such a programme rolled out in the shortest possible time, and through existing structures, where possible.

We know that implementation of this new intervention will not be easy. It requires political will, dedicated advocacy, domestic sources of funding and international donor commitment.

More importantly, investment must be based on decisions that are driven by evidence rather than sentiment. The health department will need support from a variety of stakeholders—much of which can and will come from the huge groundswell of civil society support for the implementation of a pre-exposure prophylaxis programme.

Timeline
As we prepare to support the department in planning and executing such a roll-out, we have questions. What are the department’s plans for this? What are the timelines? Has the department started seriously with advocates in the provinces? What are the advocacy issues that civil society can push?

We need effective models to deliver PrEP. Demonstration or pilot projects in South Africa and around the world will provide us with the knowledge to guide a roll-out in real-world settings. The health department can also take advantage of data on existing public health programmes that can be adapted for providing TDF/FTC.

Some organisations that already provide comprehensive HIV prevention services are suggesting that the department use existing structures and services to start and expand the provision of PrEP and integrate it into combination treatment and prevention programs.

Within these organisations, there are champions who have already established positive working relationships in communities. They can help to identify barriers to implementing and recommend strategies to address the barriers.

Recommendations
Young women tell us, “We recommend that youth-friendly clinics be established and that health staff be sensitised about the unique needs and problems that young people face.” Similarly, sex workers have suggested that TDF/FTC should be provided “within user-sensitised facilities” and, where possible, through mobile clinics. Men who have sex with men are calling for the medicine and some are already getting it from private clinicians through “off label” prescriptions.

As advocates, we will continue our work to educate the public about TDF/FTC, how to get it and how it can further strengthen existing HIV prevention efforts. But we know that there is more to be done through working closely with people and with social marketers.

We will also continue preparing for the results of a vaginal microbicide ring study expected early next year. The vaginal ring, another form of PrEP, slowly releases the antiretroviral drug dapivirine over the course of a month. If proven safe and effective, the vaginal ring could expand options for women-initiated HIV prevention methods.

Civil society is working with the International Partnership for Microbicides, the organisation which developed this technology, and other partners who conducted microbicide research among South Africans to plan for the results and introduce the product if it is proven effective. No microbicide has yet been licensed for use.

We acknowledge South Africa’s remarkable success in fighting HIV. There is now opportunity to build on these successes by taking advantage of new innovations such as TDF/FTC to reduce the chance of infections and save on treatment costs. HIV-negative South Africans have a right to use this life-saving intervention now.

We should not have to wait until people are agitated and take to the streets to demand these tools.

Will South Africa show global leadership and take immediate action to get PrEP into people’s hands? Or will our collective conscience be haunted in years to come, knowing we could have averted new infections and saved on costs of lifetime HIV treatment and sickness? The science is clear that TDF/FTC works when taken correctly and consistently; now we must follow this evidence and act on it.

John Mutsambi is an AVAC Fellow. AVAC is a US based organisation that advocates for HIV prevention to end AIDS. Brian Kanyemba, Yvette Raphael and Ntando Yola are the leaders in PrEP advocacy in South Africa.