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PrEP: Pre-Exposure Prophylaxis

Definition: Pre-Exposure Prophylaxis, or "PrEP," is the idea that a person could take a pill once a day and be protected from catching HIV, not unlike the birth-control pill which protects from unwanted pregnancy.

PrEP and PEP, The Stigma Project
PrEP/PEP
Poster: The Stigma Project, 2014

PrEP is an emerging ARV-based HIV prevention technology. Research trials have shown that Truvada when taken daily is effective as prophylaxis. Sex workers and others engaged in commercial transactions involving sex have been identified as an at-risk population in need of PrEP to reduce HIV infection rates, particularly in countries where HIV rates are high. Internationally, sex workers in most countries have no mechanism to provide direct input into public health policies or programs for implementing PrEP in the sex workplace. This is also true in Canada.

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What's New?

Listing last updated: April 11, 2016.

Truvada: Safe as Aspirin. Photo: Shutterstock
Truvada: Safe as Aspirin
Photo: Marc Bruxelle/Shutterstock

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PrEP in the Context of Sex Work

"PreP in the Context of Sex Work: Possibilities and Limitations" is a national sex-worker group consultation to learn about, discuss and make recommendations regarding the use of PrEP in the sex workplace setting. The project has so far received three separate grants in support of this work: a $15,000 planning grant from the Canadian Institutes for Health Research (CIHR) for a pre-consultation planning meeting; $75,000 from the Elton John AIDS Foundation (EJAF) for the national consultation; and separate from these, a $33,000 CIHR Catalyst Grant to create an online survey to investigate these issues further. This is the first EJAF grant ever awarded for a national community consultation with sex-worker organizations to discuss pre-exposure prophylaxis (PrEP) in the sex industry workplace.

Project Goals

The proposed project aims to:

  • educate and empower sex workers through community dialogue, debate and advocacy with regard to PrEP in the context of sex work;
  • mobilize communities of sex workers by providing opportunity to come together to discuss the possibilities and limitations of PrEP within their communities;
  • train sex work communities to better understand clinical, behavioural and implementation aspects of PrEP;
  • engage sex work communities in local and national dialogue to help ensure that efforts to roll-out and scale-up PrEP activities can be better informed by a range of community-based voices, including those of sex workers.

Project Description

The project will:

  • build the knowledge and capacity of sex workers and advocates in the science, implementation and bioethics of PrEP for more meaningful involvement in setting PrEP implementation recommendations and identifying PrEP research gaps;
  • facilitate communication and networking among sex workers, advocates, and experts in PrEP;
  • create a community-based portal for networking and the exchange of information pertaining to PrEP in the context of sex work in Canada;
  • organize and conduct a community-based consultation among sex workers, advocates, and experts in PrEP;
  • develop recommendations for the implementation and scale up of PrEP-related activities for female, male and transgender sex workers and their clients and partners in Canada;
  • enable a lobbying mechanism to help to ensure that future PrEP-related activities within the context of sex work occur within a rights-based framework.

ARVs
Traitement préventif contre le VIH

Background

In May 2015, Andrew Sorfleet, president of Triple-X came across a petition for the use of Truvada as pre-exposure prophylaxis on Facebook. Along with the petition was a factsheet which made reference to a set of Guidelines for PrEP from the B.C. Centre for Excellence in HIV/AIDS research. These guidelines recommended prescription of PrEP for persons at risk of HIV which included those involved in commercial sex.

There has been discussion about the implications of the introduction of PrEP in the sex workplace. Particularly, there are concerns that the introduction of PrEP would add new pressures to not use condoms from clients and employers in a competitive market. It is obvious that sex workers must be involved in any determination to implement PrEP in the workplace, and that sex workers in British Columbia have not been consulted. There are also concerns about the possible side effects of Truvada, particularly since there is little information about long-term use of the medication as PrEP.

In response to a plea for help, Dan Allman and Cheryl Overs offered to assist. With Dan's help, Triple-X partnered with the Dalla Lana School of Public Health and we began submitting grant applications to hold a national sex-worker group consultation in Canada to examine the possibilities and implications of PrEP for sex workers.


References

Truvada Rotator
Truvada® (emtricitabine and tenofovir disoproxil fumarate) Tablets

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Truvada by Gilead
Truvada by Gilead
Photo: Getty Images

A Little About Pre-Exposure Prophylaxis

In December 2010, the New England Journal of Medicine published findings from the Gilead sponsored iPrEx trial examining the effectiveness of HIV pre-exposure prophylaxis (PrEP) in gay men and other men who have sex with men. The study ultimately showed that HIV was successfully prevented in up to 92% of cases in men who were adherent to a daily dose of Truvada. Similar results were demonstrated in the subsequent PROUD trial from the UK and IPERGAY in France and Canada.

In July 2012, research showing the success of Truvada as PrEP was conclusive, and a new era of HIV prevention was celebrated at the International AIDS Conference in Washington, DC. "Turning the Tide Together" was the theme. The U.S. Food and Drug Administration approved the use of Truvada for prevention of HIV in the United States.

Released at the 2014 International AIDS Conference, The iPrEx OLE study was the first demonstration project on the experience of those using pre-exposure prophylaxis (PrEP). "We had been concerned that people taking PrEP might stop using condoms or have more sexual partners, but we did not see any evidence of risk compensation," said Dr Robert Grant, Protocol Chair and Senior Investigator. The iPrEx OLE study included 1,603 men and transgender women who were offered PrEP for 72 weeks, and was conducted in cities in Peru, Brazil, the U.S., South Africa and Thailand.

A study released in 2015 reports that after 2.5 years, a group of more than 600 San Francisco men who have sex with men (MSM) taking Truvada as PrEP have had zero cases of HIV contraction. The study also found that many of these individuals are using condoms less and more than half of those in the group study had contracted at least one sexually transmitted infection (STI) within a year.

When you access PrEP through a demonstration project, you get tested for HIV every three months. You are also be asked to report any incidents which may have posed a risk for HIV exposure (such as sex without condoms, etc.) for research purposes. This research also helps determine if use of PrEP has an affect on increase or decrease in risky behaviour.

Before Truvada was approved by Health Canada for use as pre-exposure prophylaxis for HIV, some doctors prescribed Truvada for that purpose known as "off-label use." Informal reports suggest off-label use of PrEP is occurring among sex workers in Canada, with some sex workers advertising their own use of PrEP as a contextual component of the services they offer. Health Canada approved Truvada for use as PrEP in February.

Truvada is but one of many PrEP medications available or in development. Global Advocacy for HIV Prevention (AVAC) provides a monthly chart which shows all the drugs being researched, the ARV-based Prevention Pipeline.

References


ARV-Based Prevention Pipeline
Credit: Global Advocacy for HIV Prevention

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Human Immunodeficiency Virus (HIV) anatomy
Human Immunodeficiency Virus (HIV) anatomy
Photo: National High Magnetic Field Laboratory

HIV Treatment and ARV Mechanics

Viruses are not alive. They are complex organic chemicals (either DNA or RNA, usually enclosed within a protein coat) that are like cell parasites.

HIV is called a "retrovirus." A retrovirus's genetic material is in the form of RNA. HIV infects white blood cells by copying its genetic code into the cell's DNA. The infected cell then creates new copies of HIV which eventually exit the cell into the bloodstream infecting more blood cells. However, in order for HIV to infect a cell, it must first convert its genetic material from RNA into DNA. This process requires an enzyme called "reverse transcriptase."

Enzymes are very specific both in function and in chemical structure. Enzyme inhibitors are substances that interfere with amino acids and interrupt the structure of the enzyme. This alters the catalytic action of the enzyme and consequently slows down, or in some cases, stops catalysis. This makes enzyme inhibitors toxic. Herbicides and microbicides are chemical enzyme inhibitors.

The basic building blocks of DNA and RNA (nucleic acids) are called "Nucleotides." One of the main ingredients in Truvada is called Tenofovir. Tenofovir belongs to a class of drugs called Nucleotide Reverse Transcriptase Inhibitors. The first Reverse Transcriptase Inhibitor (RTI) called Zidovudine (also known as AZT) was approved for treatment of HIV in 1987.

Human Immunodeficiency Virus (HIV) anatomy
Nucleotide constituent of DNA
Illustration: Wikipedia

RTIs or NRTIs are Nucleotide or Nucleoside analogues — faulty (chain-blocker) versions of Nucleotides. (a Nucleoside becomes a Nucleotide once a phosphate group is added to the molecule.) When the reverse transcriptase enzyme binds with these faulty building blocks, HIV's DNA chain-building is halted, and it does not get incorporated in the healthy cell's DNA. This in turn slows HIV infection, eventually to the point of zero viral load in the blood. The chain-blocking affect of the the faulty Nucleotides can also affect DNA synthesis in your host cells. This is the reason for the drugs' toxicity side effects.

Unfortunately prolonged exposure to RTIs can cause HIV to mutate into strains which are resistant to the drugs. These strains compensate by removing or not using the faulty Nucleotide analogs to complete DNA synthesis. For this reason combinations of RTIs are used (sometimes referred to as "the cocktail.") Truvada is the combination of Tenofovir disoproxil fumarate and Emtricitabine. There is speculation that long-term use of NRTIs could eventually fail to prevent infection by a resistant form of HIV that would not respond to current ARV drug treatment.

HIV Illustration: The Open University
Life cycle of HIV. Illustration: The Open University

References

HIV. Photo: Corbis
HIV. Photo: Corbis

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Electron micrograph of Treponema pallidum, Public Health Image Library, U.S. CDC
Electron micrograph of Treponema pallidum
Image: Public Health Image Library, U.S. CDC

PrEP and Sexually Transmitted Diseases

PrEP (Truvada) is proven in research studies to protect against HIV only. PrEP does not provide protection from other sexually transmitted infections. One of the main concerns raised about the possibility that PrEP might be used as a replacement for condoms is the potential rise in infection rates of other sexually transmitted diseases. The rate of new sexually-transmitted infections (STIs) has been increasing — sometimes sharply — since about 2000. In particular, syphilis — including the diagnosis of later stages — has been cause for some alarm. Treponema pallidum is the causative agent of syphilis. In the United States, over 35,600 cases of syphilis were reported by health officials in 1999.

For PrEP research trials, one measurement of success is the diagnosis of other sexually-transmitted diseases. Sexually transmitted infections are evidence that there was risk for HIV. In the San Francisco study, Kaiser Permanente reported that at 12 months, 50% of PrEP users had been diagnosed with any STI (33% had a rectal STI, 33% had chlamydia, 28% had gonorrhea, and 5.5% had syphilis).

Research has shown that syphilis infections, both in primary and secondary stages, decrease CD4 counts and increase HIV viral load in patients on HAART (as well as patients who are not). Research also suggests that syphilis infection accelerates HIV replication. Treatment failure for late-stage syphilis in patients who are HIV-positive is well documented.


Syphilis... Six Out of Ten Cured Because They Did Not Wait Too Long, Federal Art Project, New York, c. 1936-1941
Six Out of Ten Cured
Poster: Work Projects Administration, New York, 1941

References

BBC History Cold Case: Crossbones Girl
BBC History Cold Case: Crossbones Girl. BBC broadcast May 27, 2010
A fascinating investigation into the identity and cause of death of a skeleton from Crossbones Cemetery. Provides incredible insight into syphilis and prostitution in Victorian London.

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Truvada Whore
#TruvadaWhore
Photo: Adam Zebowski

PrEP and Whore Stigma

It started with an article in the Huffington Post titled, "Truvada Whores?" which suggested that the U.S. Federal Drug Administration was encouraging bareback sex. The article stated that it was appropriate to prescribe Truvada for committed discordant couples, sex workers and drug addicts, "but for gay men who just like bareback sex, Truvada is just an excuse to do what they want." The AIDS Healthcare Foundation (AHF) launched a national advertising campaign against the widespread use of Truvada as PrEP, with a similar moral bent. Michael Weinstein, AHF's president and co-founder, told Buzzfeed, Truvada was a "party drug," and that its strongest advocates "have all been associated with bareback porn."

Adam Zebowski, an HIV test counsellor at San Francisco AIDS Foundation, took offence. He considered this to be "slut-shaming," not unlike the way most doctors of the 1960s refused to prescribe birth-control pills for unmarried women. Zebowski decided to appropriate the term, "Truvada Whore" and began selling T-shirts to raise funds for AIDS organizations. Zebowski's social media campaign went viral.

In March 2013, a U.S. CDC released a report finding that only one in six gay men used condoms consistently for anal sex and that 100 per cent condom use for anal sex is only 70 per cent effective in stopping HIV. The CDC study also stated that intermittent use of condoms has no effect on reducing HIV rates.


I am On Truvada, But I am Not a Whore
"I am On Truvada, But I am Not a Whore." Graphic: HIV=

References

Truvada Whore, Washington Blade
Truvada Whore cartoon
Cartoon: Ranslem, Washington Blade

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History of Biomedical Prophylaxis Research on Sex Workers

Gilead pharmaceutical studies with sex workers in Cambodia to determine the effectiveness of the HIV treatment, Viread (Tenofovir, also a main ingredient in Truvada) as PrEP were halted in August 2004. The local sex workers union stopped the study demanding decades of free health care as compensation for participants becoming HIV-positive during the study. As well, there were Tenofovir trials with sex workers in Cameroon which were likewise halted in 2005.

Medical research into preventing sexually-transmitted diseases on sex workers has a long history with serious ethical violations. For example, in April 2015 800 plaintiffs launched a $1 billion lawsuit against John Hopkins University for deliberately infecting prisoners, mental patients and orphans in Guatemala from 1945 to 1956. These medical experiments also involved infecting prostitutes and then providing them for sex to subjects for intentional transmission of the disease. These experiments were to determine the prophylactic efficacy of penicillin for syphilis and gonnorhoea.

Due to the high cost of Truvada medication (approximately $900 USD/month), programs to supplement patients' costs for the drugs usually involve on-going participation in research trials that involve routine testing, counselling and interviews.


References

Tenofovir Trials in Cambodia
Video: Tenofovir Trials in Cambodia
Women's Network for Unity & Asia Pacific Network of Sex Workers

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I PrEP for Sex
"Boyfriend for rent"
Image: Twitter, 2015

HIV Prevention Regulation and Sex Work

Pre-exposure prophylaxis in the context of the sex industry workplace is not simply about Truvada or even other once-a-day treatments. How PrEP is introduced to sex workers can set precedents for future HIV-prevention technologies. It opens larger questions about HIV prevention in the workplace, which include condom-use legislation, HIV testing sites within the workplace, periodic presumptive treatment and even vaccinations. These questions are complex when considered in the context of labour and human rights.

There have been attempts in the past of public health regulation for sex workers, in the form of enforced condom use and mandatory routine HIV and STI testing. For example, by 2003 100% Condom-Use Programs (100% CUP) were being implemented or planned in several countries in Asia, Latin America and Africa. UNAIDS and other key agencies promoted 100% CUP as a "best practice" as a result of claims made about the role of 100% CUP in reducing national HIV epidemics.

100 per cent condom use programmes
Sex-worker rights perspective on 100% condom-use programmes
Photo: Carol Jenkins, July 2002


References

  • "California Officials Vote Against Condom Rules for Porn Productions." Rhett Pardon, XBiz News Report, February 18, 2016
    "Nearly all of the adult entertainment stakeholders said that if S. 5193.1 were to come into play, it would force the business underground and might put an end to the industry's own requirement that actors be tested for sexually transmitted disease every 14 days."
  • "Global Burden of HIV among Men Who Engage in Transactional Sex: A Systematic Review and Meta-Analysis." Catherine E. Oldenburg, et al, PLOS One, July 2014.
  • "Burden of HIV among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis." Stefan Baral, et al, Lancet Infectious Diseases, March 15, 2012
  • "Periodic presumptive treatment of curable sexually transmitted infections among sex workers: recent experience with implementation." Richard Steen, et al, Co-Infectious Diseases, February 2012
  • The Report of the UNAIDS Advisory Group on HIV and Sex Work, UNAIDS and Global Network of Sex Work Projects, December 2011
    "Some countries and sub-national jurisdictions have decriminalised sex work, removing all penal code violations related to sex work, sometimes also establishing health regulations or other non-penal code regulatory frameworks for sex work. These include Germany, the Netherlands, Senegal, New Zealand, parts of Australia, and some counties in the US state of Nevada."
  • Periodic presumptive treatment for sexually transmitted infections: Experience from the field and recommendations for research. Department of Reproductive Health and Research, World Health Organization, 2008
    "In this case, periodic presumptive treatment was provided — in the absence of regular STI services — for sex workers in three provinces. Rates of gonococcal and chlamydial infections fell significantly during the intervention. The findings suggested that there is a good rationale for administering periodic presumptive treatment (as was done in this case) in situations where the prevalence of STIs is high and where STI services are lacking…"
  • Worker Health and Safety in the Adult Film Industry: Post-Hearing Report. Paul Koretz, Chair, California State Assembly Committee on Labor and Employment, July 2004
    "Dr. Coates further testified that in addition to a harm reduction strategy policy makers and the industry should also be re-conceptualizing the issue of safety in adult films to include "combination prevention" as may be necessary in order to control transmission of HIV during the risky situations that define the content of adult films."
  • "HIV Transmission in the Adult Film Industry – Los Angeles, California, 2004." Morbidity and Mortality Weekly Report, September 23, 2005
    "In April 2004, the Los Angeles County Department of Health Services (LACDHS) received reports of work-related exposure to human immunodeficiency virus (HIV) in the heterosexual segment of the adult film industry in California. This report summarizes an investigation by LACDHS into four work-related HIV-transmission cases among adult film industry workers."
  • "HIV and STI Testing and Treatment Policies." Section 9: Sex workers and clients must adopt safer sex practices, Prostitution Reform Act 2003, Reprint July 1, 2013
    "A person must not provide or receive commercial sexual services unless he or she has taken all reasonable steps to ensure a prophylactic sheath or other appropriate barrier is used if those services involve vaginal, anal, or oral penetration or another activity with a similar or greater risk of acquiring or transmitting sexually transmissible infections."
  • "Cambodia's 100% Condom-Use Program." 100% CUP Draft Report, December 23, 2002
    "The policy framework for the Cambodian 100% CUP is contained in the following Ministry of Health documents: Strategy and Guidelines for Implementation of 100% Condom Use in Cambodia; Policy for HIV/AIDS and STI Prevention and Care in the Health Sector in Cambodia; Guidelines for the Implementation of STI Services, Policy, Strategy and Guidelines for HIV/AIDS Counseling and Testing; and The Outreach Program: Strategy and Guidelines for Implementation."
  • "Sex worker rights perspective on 100% condom-use programmes." AIDS 2002 Barcelona, ACT UP New York, July, 2002
    "According to Carole Jenkins, HIV Advisor to USAID, 'the bottom line is that affected and vulnerable communities have to have a voice in the design, implementation, monitoring and evaluation of programmes. Practically speaking, when/if someone accuses a programme of abuse or misconduct, the only safeguard you have is the real and democratic participation of the affected communities.'"
  • "AIDS vaccine trials set to start in Kenya." Canadian Broadcasting Corp., December 20, 2000
    "The vaccine was developed from research on a group of prostitutes working in a Nairobi slum. The sex workers in the Majengo area never contracted HIV, despite being repeatedly exposed to infection."
  • Ethical Considerations in HIV Preventive Vaccine Research UNAIDS Guidance Document. UNAIDS, May 2000 "Guidance Point 5: To ensure the ethical and scientific quality of proposed research, its relevance to the affected community, and its acceptance by the affected community, community representatives should be involved in an early and sustained manner in the design, development, implementation, and distribution of results of HIV vaccine research."
  • "Acceptability of HIV Vaccine Trials in High-Risk Heterosexual Cohorts in Mumbasa, Kenya." Denis J. Jackson, et al. AIDS, 1995
    "A significant minority anticipated an increase in risk behavior, which emphasizes the need for intensive counseling and education throughout a vaccine trial."

Caught Between the Tiger and the Crocodile
Video: Caught Between the Tiger and the Crocodile
Asia Pacific Network of Sex Workers, 2007

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PrEParing Asia, Bangkok
PrEParing Asia
Photo: APCOM, Bangkok, 2015

PrEP and Sex Work

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Other rapid tests on the market analyze a finger-prick blood samples
Rapid tests analyze finger-prick blood samples
Photo: Daily Mail Online

Sex Work, HIV and Prevention

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Reaching Common Ground on PrEP, AIDS Health Foundation.
Reaching Common Ground on PrEP
Poster: AIDS Health Foundation

Guidelines and Policies for PrEP

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Reaching Common Ground on PrEP, AIDS Health Foundation.
Sex Workers and HIV-Focused Activism
Photo: Shutterstock

PrEP/HIV Care Resources for Women

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PrEP Resources for Transgender Women

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PrEP Basics

PrEP Literature


A bottle of antiretroviral drug Truvada
Photo: Justin Sullivan/Getty Images

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Popular PrEP Promotion

PrEP Works Social Media Kit, AIDS United Policy Action Centre
#PrEPWorks Social Media Kit
Banner: AIDS United Policy Action Centre

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En Français (In French)

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Research Tools

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Partnership Information

  • Dan Allman, PhD, Assistant Professor, Co-Director HIV Studies Unit, Dalla Lana School of Public Health, Faculty of the University of Toronto
    As a student Dan Allman studied Sociology and Public Health at Universities and Colleges in Canada, Scotland and Spain. Today he is an Assistant Professor at the Dalla Lana School of Public Health, and Co-Director of the HIV Social, Behavioural and Epidemiological Studies Unit. His scholarly work focuses on the social and structural production of risk and well-being, particularly for those considered marginal, vulnerable or peripheral to a society's core. Within Canada Dan has had leading roles in community-based, participatory and collaborative research projects in studies like the Winnipeg Men's Survey, the Ontario BiSex Survey, The Ontario Men's Survey, M-Track, and Male Call Canada. At the University of Toronto Dan teaches a popular undergraduate course in HIV Prevention Research, and a graduate course in Survey Design and Social Research Methods in Public Health.

    Academic publications specific to sex work include peer reviewed journal articles focusing on Ethical and Participatory Practices for Marginalized Populations in Biomedical HIV Prevention Trials (2014), PEPFAR's Anti-Prostitution Pledge and Its Implications for Successful HIV Prevention among Organisations Working with Sex Workers (2013) Improving Communication for Good Participatory Practice in Clinical Trials (2011); chapters on male sex work in the books Men Who Sell Sex: Global Perspectives (2015) and Men Who Sell Sex: International Perspectives on Male Prostitution and HIV/AIDS (1998); and the monographs M is for Mutual, A is for Acts: Male Sex Work and AIDS in Canada (1999) and Concepts, Definitions and Models for Community-Based HIV Prevention Research in Canada (1997).
    Web: dlsph.utoronto.ca/faculty-profile/dan-allman

  • Cheryl Overs, Senior Research Fellow
    Michael Kirby Centre For Public Health and Human Rights
    Monash University, School of Public Health and Preventive Medicine, Melbourne, Victoria, Australia

    Visiting Research Fellow, Sexuality Poverty and Law Programme, Institute of Development Studies, University of Sussex, Brighton, UK
    Resumé: oversresume-2014.pdf


Blue Ribbon Boys Campaign
The Global Forum on MSM and HIV

Last modified: April 11, 2016
Created: November 14, 2015
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