Country Updates


Much of PrEP advocacy is dependent on local context. Below you will find brief updates from around the globe of national updates and in-country partners working for PrEP access. If you are working in PrEP advocacy and would like your update or organization included here, please contact us.

Australia / Belgium / Botswana / Brazil / Canada / France / Germany / India / Italy / Kenya / Malawi / Netherlands / Nigeria / Norway / Peru / South Africa / Thailand / Uganda / United Kingdom / United States / Zambia / Zimbabwe

Australia

  • Research and Demonstration Projects: There are several ongoing demonstration projects in Australia—VicPrEP in MSM, transgender women, heterosexual serodiscordant couples and people who received N-PEP on more than two occasions; PRELUDE in men and women at high and ongoing risk of HIV; and EPIC-NSW enrolling high-risk, mostly gay and bisexual men in New South Wales. A fourth demonstration project, PrEPX, will start later this year. In November 2016, the South Australian government announced that it would begin a PrEP project to help enable PrEP access in the state. A proposal for a project in Western Australia is under consideration with a decision expected soon.
  • Drug Registration: The Therapeutic Goods Administration has approved daily oral Truvada for HIV prevention.
  • Policy/Regulatory: There is no national policy or guidance at present. Following Therapeutic Goods Administration review, the Pharmaceutical Benefits Scheme also needs to consider Truvada for PrEP for cost subsidization.
  • Advocacy: PrEP’D for Change and #ComePrEPd are working to increase awareness of PrEP in Australia. If you’re an Australian advocate working on PrEP, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Belgium

  • Research/Demonstration Projects: Belgium has an ongoing PrEP demonstration project for MSMs, the “Be PrEPared-The Antwerp PrEP project”.
  • Drug Registration: Currently, Gilead (the manufacturer of Truvada) has not applied to the Belgium regulatory agency for a prevention indication. The European Medicines Agency is in the process of reviewing Truvada for PrEP. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, but each member state will separately determine how, if at all, it might introduce PrEP.
  • Policy/Regulatory: There is no national policy or guidance at present.
  • Advocacy: If you’re a Belgian advocate working on PrEP, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Botswana

  • Research and Demonstration Projects: Botswana was the site of the TDF2 trial, one of the early efficacy studies substantiating proof of concept of TDF/FTC for prevention in heterosexual men and women. There was a subsequent open-label extension trial—results of which were released in 2015.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention.
  • Policy/Regulatory: In June Botswana incorporated PrEP into its 2016 HIV Clinical Care Guidelines. TDF/FTC for PrEP is technically, currently available in the private sector but will be publically available and funded April 1, 2017.
  • Advocacy: There is demand among the gay population but there is a great need for mobilization and communication campaigns among others. Thus far BOFWA, BONELA and ITPC, along with Botswana Ministry of Health and UNAIDS Botswana are participating in early stages of shaping eventual rollout.

Brazil

  • Research and Demonstration Projects: Brazil hosted three sites in the phase III iPrEx trial, and the open label extension of iPrEx. Brazil has an ongoing PrEP demonstration project in MSM and transgender women, PrEPBrasil. A second demonstration project is scheduled to start by mid-2015 and will enroll MSM, commercial sex workers and drug users.
  • Drug Registration: Gilead submitted an application for Truvada as PrEP to Brazil’s regulatory authority in 2014.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present. However, the ongoing demonstration project may be used to inform such policy.
  • Advocacy: If you’re a Brazilian advocate working on PrEP, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Canada

  • Research and Demonstration Projects: Canada hosted sites for the phase III IPERGAY study showing that "on-demand" Truvada (taken before and after sex) could be protective against HIV. Those taking Truvada reduced their HIV risk by 86 percent. Additionally, CTN 279, a pilot study of daily Truvada among high-risk Toronto MSM, is ongoing.
  • Drug Registration: Gilead applied for approval of Truvada as PrEP with Health Canada, the country’s health ministry. The application was filed in August 2015. In February 2016, following a satisfactory review of submission, Health Canada approved Truvada as prevention.
  • Policy/Regulatory: There is no national policy or guidance at present. In 2013, the Ministry of Health and Social Services in Quebec issued its own interim guidance on PrEP for those at highest risk for HIV.
  • Advocacy: Canadian civil society is organizing to ensure timely, equitable and affordable access to PrEP across Canada. Advocates are monitoring private and public health plans, both those specific to individual provinces and federal, country-wide plans. To get connected, contact Glenn Betteridge with CTAC.

France

  • Research/Demonstration Project: France is home to the IPERGAY study, which showed in 2015 that “on-demand” or “intermittent” PrEP (two Truvada tablets taken up to 24 hours before sex, one tablet 24 hours and another 48 hours after sex ) could be protective against HIV. ANRS (The French National Research Organization) is currently conducting implementation research into the efficacy of PrEP rollout.
  • Drug Registration: In November 2015, the French National Agency for Medicines and Health Products Safety (ANSM) approved Truvada as PrEP. ANSM’s authorization enabled PrEP use under an RTU (Recommendation of Temporary Use)—the provision of drugs for urgent and off-label use for up to three years. The approval places France as the second country after the US to approve Truvada as PrEP. Truvada had been previously approved only for treatment in France.
  • Policy/Regulatory: In January 2016, full reimbursement by France’s health system became available for Truvada as PrEP, along with counselling and follow-up. Daily PrEP can now be prescribed for anyone assessed as needing it or intermittent PrEP is available for MSM, as studied in the IPERGAY trial. For now, PrEP prescribing is only available from HIV specialist physicians within a hospital clinic or HIV testing site. Currently, there are 60 clinics offering PrEP. Information about the nearest clinic is available here.
  • Advocacy: The ASO, AIDES, has led civil society’s advocacy, pushing for regulatory approval and guidelines for rollout. The activist group, Nous Sommes PrEP, is working toward PrEP visibility and the ACT UP Paris website is a good source of PrEP information in France.

Germany

  • Research/Demonstration Project: To date there have been no clinical trials or demonstration projects of PrEP in Germany.
  • Drug Registration: Gilead (the manufacturer of Truvada) has not applied to the German regulatory agency for a prevention indication. The European Medicines Agency is in the process of reviewing Truvada for PrEP. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, but each member state will separately determine how, if at all, it might introduce PrEP.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present. The Ministry of Health and BZgA (Federal Center for Health Education) is awaiting the European Medicines Agency.
  • Advocacy: The national German Network Women and AIDS is advocating for PrEP and GSSG in cooperation with advocates continues to work on mobilizing community demand, experts’ support and governmental action. The Was Ist PrEP website in English and German is the country’s most comprehensive source of information and the largest national gay campaign, I Know What I’m Doing, has committed to providing PrEP information.

India

  • Research and Demonstration Projects: India is host to a PrEP demonstration project among female sex workers in Durbar Mahila Samanwaya Committee, a brothel-based project in Sonagachi, and the Ashodaya Samithi project for street-based sex workers based in Mysore. It is scheduled to run from December 2015 to early 2017.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present. However, the ongoing demonstration project may be used to inform such policy.
  • Advocacy: If you’re an advocate working on PrEP in India, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Italy

  • Recent Research/Demonstration Projects: To date there have been no clinical trials or demonstration projects of PrEP in Italy.
  • Drug Registration: Gilead (the manufacturer of Truvada) has not applied to the Italian regulatory agency for a prevention indication. The European Medicines Agency is in the process of reviewing Truvada for PrEP. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, but each member state will separately determine how, if at all, it might introduce PrEP.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present.
  • Advocacy: Lila and Plus are two activist groups working on PrEP. Plus organized a public PrEP conference in Bologna and conducted surveys on community attitudes toward PrEP.

Kenya

  • Research/Demonstration Projects: Kenya has been the site of trials and demonstration projects of daily oral PrEP in serodiscordant couples, heterosexual women, men who have sex with men and sex workers. PrEP is slated to be included in the PEPFAR-supported DREAMS initiative focused on young women and adolescent girls. Click here for a full list of planned, ongoing and completed research/demonstration projects.
  • Drug Registration: Kenya’s Pharmacy and Poisons Board (PPB)—the regulatory body that considers new drugs—approved Truvada TDF/FTC for PrEP for adults at high risk of sexually acquiring HIV-1 infection.
  • Policy/Regulatory: PrEP is incorporated into the Kenyan HIV Prevention Revolution Roadmap and is also identified as an evidence-based intervention in the most recent Kenya National Strategic Framework (KASF). PrEP is also included in the Guidelines on use of ARV drugs for treating and preventing HIV infections in Kenya – 2016 edition.
  • Advocacy: Civil society and Kenyan researchers have worked in close collaboration to advance PrEP access in country, with dialogues and advocacy among key populations and at the national stakeholder level.
  • Country Close-Up: For a more detailed look at the landscape in Kenya, click here.

Malawi

  • Research/Demonstration Projects: No research on daily oral PrEP has taken place in Malawi. There is an ongoing trial of an ARV-containing vaginal ring, slated to release data in the next year. As of mid-2015, PrEP was not included in the PEPFAR-supported DREAMS initiative.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention.
  • Policy/Regulatory: In Malawi’s National HIV Prevention Strategy 2015–2020, PrEP is a stated part of the comprehensive prevention package for MSM and serodiscordant couples but funding for PrEP has yet to be allocated.
  • Advocacy: Civil society is at the forefront of efforts to ensure a comprehensive response, including high quality ART for people living with HIV and incorporation of PrEP. See, for example, the poster Advocacy for More HIV Prevention Options for Women in Malawi.

Netherlands

  • Research/Demonstration Projects: Netherlands has an ongoing PrEP demonstration project, AMPrEP, for MSMs and transgender people.
  • Drug Registration: Currently, Gilead (the manufacturer of Truvada) has not applied to the Netherlands regulatory agency for a prevention indication. The European Medicines Agency is in the process of reviewing Truvada for PrEP. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, but each member state will separately determine how, if at all, it might introduce PrEP.
  • Policy/Regulatory: There is no national policy or guidance at present.
  • Advocacy: The advocacy group PrEPnu is advocating for PrEP in the Netherlands and have a petition. If you’re a Netherlands advocate working on PrEP, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Nigeria

  • Research and Demonstration Projects: Nigeria is host to a PrEP demonstration project among serodiscordant couples at sites in Plateau, Edo and Cross River State. It is scheduled to run from late-2015 until late-2017.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention.
  • Policy/Regulatory: PrEP is mentioned in the 2014-15 National HIV Prevention Plan as one of the new prevention technologies that should be embraced, but there is no national PrEP policy or guidance at present. However, the ongoing demonstration project may be used to inform such policy.
  • Advocacy: The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) has a long history advocating for research on and implementation of new HIV prevention options. Visit them here for more on the their work in this space. If you’re a Nigerian advocate working on PrEP, building a campaign or seeking to share insights and experience, please send info here and PrEPWatch will post it.

Norway

  • Research/Demonstration Projects: Implementation research is planned to examine how PrEP is being used and if there is any impact on sexual behaviour or HIV risk. Advocates at NorwayHIV say current planning for the study includes enrolloment of 500 people by the end of 2017.
  • Drug Registration: PrEP is licensed by the Norwegian Medicines Agency, which is responsible for setting maximum prices on prescription-only-medicines. The agency also determines if a medicine should be reimbursed by the National Insurance Scheme.
  • Policy/Regulatory: In October 2016, full reimbursement for PrEP became available under the National Insurance Scheme. PrEP has the same legal status as HIV treatment and PEP. It is available from family doctors, infectious disease clinics and Olafia, a sexual health research center and clinic in Oslo (Facebook link in English, clinic link in Norwegian).
  • Advocacy: The campaign for PrEP access was started by HivNorway and received support from many LGBTQI NGOs and infectious disease clinics.

Peru

  • Research and Demonstration Projects: Peru hosted three sites in the phase III iPrEx trial, and the open-label extension of iPrEx. Several studies have shown the cost-effectiveness of rolling out PrEP in Peru, as well as looked at delivery issues such as provider attitudes and acceptability.
  • Drug Registration: Truvada is registered for treatment. In April 2016 the Peru Ministry of Health approved the use of fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine for PrEP.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present.
  • Advocacy: Peruvian NGOs, such as Epicentro and Investigaciones Médicas en Salud (Inmensa), have worked on PrEP research and advocacy.

South Africa

  • Research/Demonstration Projects: South Africa hosted a site in the phase III iPrEx trial, and the open label extension of iPrEx in MSM and is hosting demonstration projects of daily oral PrEP in men who have sex with men and sex workers. PrEP is slated to be included in the PEPFAR-supported DREAMS initiative focused on young women and adolescent girls. Click here for a full list of planned, ongoing and completed research/demonstration projects.
  • Drug Registration: In November 2015 South Africa’s Medicines Control Council (MCC) approved the use of the fixed-dose combination of tenofovir disoproxyl fumarate and emtricitabine for PrEP.
  • Policy/Regulatory: PrEP is included in the National Strategic Plan (NSP) for HIV, STIs and TB (2012-2016). The Southern African HIV Clinicians Society published a revised and expanded set of PrEP guidelines in early 2016 advising PrEP as a highly effective and safe prevention options for HIV prevention when combined with other combination prevention strategies.
  • Advocacy: Prevention advocates are actively engaging with researchers and policy makers around revising PrEP guidelines, following the planned and ongoing PrEP demonstrations studies and discussing possible rollout plans. A recent opinion piece in the Mail & Guardian outlines advocates’ demands—a follow-up piece released after MCC announced its approval outlines what should come next. An AVAC Fellow hosted by TB-HIV Care Foundation is specifically working on these issues, as well as conducting community dialogues with a variety of stakeholders including sex-workers and young women. Through partnership work with CCISA, the ZAZI curriculum will have a new section specifically discussing the importance of new prevention options – including PrEP—for young women.
  • Country Close-Up: For a more detailed look at the landscape in South Africa, click here.

Thailand

  • Research/Demonstration Projects: Thailand has been the site of trials and demonstration projects of daily oral PrEP in men who have sex with men (MSM), transgender (TG) women, women and people who inject drugs. The Ministry of Public Health (MoPH) is conducting a demonstration project in MSM, linked to a test-and-treat study conducted by the Thai Red Cross, MoPH, USAID, GFATM, Rainbow Sky Association of Thailand and several others. The Thai Red Cross is implementing a PrEP 30 project for MSM and TG women in Bangkok.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention, but Gilead, the manufacturer of Truvada, applied for a prevention indication with the Thai FDA in 2014.
  • Policy/Regulatory: There is no national PrEP policy or guidance at present. There is anecdotal evidence of interest in developing national guidance, as per the planned demonstration project by MoPH.
  • Advocacy: National Community Advisory Board, focused on biomedical HIV prevention research, has been actively pushing for PrEP introduction, especially following positive efficacy trial results of iPrEx and BTS—two randomized-controlled studies that had sites in Thailand. This group has links to national policy making bodies such as the National AIDS Committee and its sub-committee on biomedical HIV prevention research. It is comprised primarily of civil society representatives and is managed by the Thai NGO Coalition on AIDS. There is reported openness amongst potential PrEP users, especially the LGBT community. Stakeholder consultations are being proposed as part of regional Asia-focused efforts led by WHO, UNAIDS and APCOM. An analysis of acceptability among MSM in Asia is ongoing (see below): Preparing Asia—Tell Us What You Know about PrEP survey. You can also view short educational videos on PrEP from APCOM, as part of the regional dialogue "PrEPARING ASIA: A new direction for HIV prevention among MSM in Asia".

Uganda

  • Research/Demonstration Projects: Uganda has been the site of trials and demonstration projects of daily oral PrEP in serodiscordant couples; PrEP is slated to be included in the PEPFAR-supported DREAMS initiative focused on young women and adolescent girls.
  • Drug Registration: Truvada is registered for treatment. It is not registered for prevention.
  • Policy/Regulatory: PrEP is mentioned in the National Strategic Plan, but there are no specific PrEP policies or guidance documents available to guide implementation.
  • Advocacy: A vibrant coalition of civil society groups has been working to articulate the need for PrEP as part of comprehensive combination prevention. This group has focused on the need for government leadership and on ensuring that PrEP introduction in no way diminishes the focus on access to quality ART programs for people living with HIV. Read a piece that marks the latest efforts of Ugandan civil society to secure PrEP access, Government Should Give Guidance on Drugs that Prevent HIV.

United Kingdom

  • Recent/Demonstration Projects: PROUD demonstration study, showing 86 percent risk reduction among gay men in the UK. You can watch a video documentary of the PROUD study here.
  • Drug Registration: The European Medicines Agency is in the process of reviewing Truvada for PrEP. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union, but each member state will separately determine how, if at all, it might introduce PrEP.
  • Policy/Regulatory: The National Health Service (NHS) announced on March 21st that PrEP will not be made widely available through NHS because “NHS England is not responsible for commissioning HIV prevention services”. Instead, NHS England and Public Health England will launch several test sites over the next two years to test cost-effectiveness and affordability of PrEP as part of an integrated HIV and STI prevention service. Read the full NHS statement here.
  • Advocacy: ACT UP London is a strong supporter of PrEP, organizing demonstrations in favor of access and vocal demand for PrEP is growing among gay men, with a strong local EATG presence. Also, check out prepster.info, a new PrEP website aimed to educate and agitate for PrEP access in England and beyond.

United States

  • Research/Demonstration Projects: Numerous demonstration projects and implementation pilots in a range of populations are ongoing or planned in the US, while a handful have already completed and reported results. Several iPrEx trial sites were in the US and ongoing research on non-TDF-based PrEP and alternative dosing regimens are ongoing at sites in the US.
  • Drug Registration: In July 2012, the US Food and Drug Administration approved daily oral Truvada for HIV prevention.
  • Policy/Regulatory: PrEP is part of the updated US National HIV/AIDS Strategy (NHAS), released in July 2015, as a component of HIV prevention. A federal action plan that provides information on how it will be operationalized is expected in December 2015.
  • Advocacy: Advocacy for PrEP in the US has been ongoing across a number of groups for several years, supporting the research effort, calling for early implementation, FDA approval, guidance for all populations and now expanded access. A coalition of individuals and groups continue the work on social media and via the online PrEP Access Advocates list (to join, email here).
  • US Women & PrEP Working Group: This group represents organizations and individuals pushing for programming and access to PrEP for women. Learn more.
  • United States Local Programs: For information on specific local programs in the US, click here.

Zambia

  • Research/Demonstration Projects: There are no planned or ongoing trials or demonstration projects of PrEP in Zambia. As of mid-2015, PrEP was not part of the PEPFAR-supported DREAMS plan for reducing HIV incidence in adolescent girls and young women.
  • Drug Registration: Truvada is registered as treatment. It is not registered for prevention.
  • Policy/Regulatory: Oral PrEP is included in Zambia’s Consolidated Guidelines for Treatment and Prevention of HIV Infection, published in late 2016 by the Ministry of Health. Find details on Zambia’s PrEP-related recommendations on pages 23-24.
  • Advocacy: Civil society has voiced the need for Zambia to explore what role PrEP could play in their combination prevention package. Civil society continues to push government and there are current efforts by civil society for PrEP to be included in DREAMS and for demonstration projects to be considered among young women, sero discordant couples and sex workers. Read Pre-Exposure Prophylaxis for Prevention of HIV Infection.

Zimbabwe

  • Research/Demonstration Projects: Zimbabwe is the site for the SAPPH-Ire PrEP demonstration project, looking at how best to roll out PrEP and ARV treatment to sex workers. Results are expected at the end of 2016. PrEP will also be incorporated into the PEPFAR-funded DREAMS initiative.
  • Drug Registration: Daily oral Truvada has been approved for prevention.
  • Policy/Regulatory: Zimbabwe AIDS prevention Program at the University of Zimbabwe has helped to move forward the discussion on PrEP access for serodiscordant couples, and helped ensure that couples counseling guidelines included specific information on helping HIV-negative individuals understand his or her risk. To adapt the HIV guidelines, the Ministry of Health has formed a committee with five subgroups, including one on PrEP. Guideline revisions are expected by mid-2016.
  • Advocacy: Activists are working in coalition to mobilize community demand and government action. Read New HIV Prevention Tools for Young Women. Is Zimbabwe prepared?
  • Country Close-Up: For a more detailed look at the landscape in Zimbabwe, click here.

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