Abstracts

Introduction

In Brazil, the national policy for HIV/AIDS control has historically been based on the articulation of preventive actions, epidemiological surveillance, monitoring, financing efforts by nongovernmental organizations and access to treatment. The law on universal access to antiretroviral drugs resulted from pressure and articulation efforts among social movements, the medical field, and the media, ending the possibility of an AIDS policy without access or with limited access to these drugs in Brazil ¹1. Barros SG. Política Nacional de Aids: a construção da resposta governamental à epidemia de HIV/aids no Brasil. Salvador: Edufba; 2018..

Until 2010, HIV/AIDS prevention actions were organized almost exclusively by encouraging the use of condoms and safe sex, and by recommending the postponement of sexual debut among adolescents ²2. Calazans G. Prevenção do HIV e da aids: a história que não se conta/a história que não te contam. https://abiaids.org.br/wp-content/uploads/2021/12/2021-Prevencao_HIV-e-AIDS-A-HISTORIA-QUE-NAO-E-CONTA_NOTA-UNESCO-1.pdf (accessed on 08/Feb/2021).
https://abiaids.org.br/wp-content/upload... . The effectiveness of new prevention methods, and proposals for an association between different methods (combined prevention) ³3. World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, 2016 update. Geneva: World Health Organization; 2016.^,44. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Villars-sous-Yens: World Health Organization; 2016.^,55. Ministério da Saúde. Prevenção combinada do HIV: bases conceituais para profissionais, trabalhadores(as) e gestores(as) de saúde. Brasília: Ministério da Saúde; 2017., expanded the HIV/AIDS prevention and control possibilities. Prevention started to rely on new technologies, not only behavioral methods, including interventions with the use of antiretroviral drugs, adopting the concept of “treatment as prevention”, and recognizing the priority of key populations exposed to situations with high vulnerability towards HIV ²2. Calazans G. Prevenção do HIV e da aids: a história que não se conta/a história que não te contam. https://abiaids.org.br/wp-content/uploads/2021/12/2021-Prevencao_HIV-e-AIDS-A-HISTORIA-QUE-NAO-E-CONTA_NOTA-UNESCO-1.pdf (accessed on 08/Feb/2021).
https://abiaids.org.br/wp-content/upload... ^,66. Grangeiro A, Couto MT, Peres MF, Luiz O, Zucchi EM, de Castilho EA, et al. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil. BMJ Open 2015; 5:e009021.. Pre-exposure prophylaxis (PrEP) has emerged as a safe, effective, and efficient alternative, especially among men who have sex with men (MSM) and transgender people ⁶6. Grangeiro A, Couto MT, Peres MF, Luiz O, Zucchi EM, de Castilho EA, et al. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil. BMJ Open 2015; 5:e009021.^,77. Holloway IW, Tan D, Gildner JL, Beougher SC, Pulsipher C, Montoya JA, et al. Facilitators and barriers to pre-exposure prophylaxis willingness among young men who have sex with men who use geosocial networking applications in California. AIDS Patient Care STDS 2017; 31:517-27.^,88. Grinsztejn B, Hoagland B, Moreira RI, Kallas EG, Madruga JV, Goulart S, et al. Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brazil: 48 week results of a demonstration study. Lancet HIV 2018; 5:e136-45..

PrEP is a prevention strategy which uses antiretroviral drugs to reduce HIV infection among population segments that are at higher risk, it was introduced in Brazil in 2017, after randomized clinical trials and studies such as PrEP-Brazil showed high efficacy and effectiveness ⁹9. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas para profilaxia pré-exposição (PrEP) de risco à infecção pelo HIV. Brasília: Ministério da Saúde; 2018.^,1010. Zucchi EM, Grangeiro A, Ferraz D, Pinheiro TF, Alencar T, Ferguson L, et al. Da evidência à ação: desafios do Sistema Único de Saúde para ofertar a profilaxia pré-exposição sexual (PrEP) ao HIV às pessoas em maior vulnerabilidade. Cad Saúde Pública 2018; 34:e00206617.^,1111. Polidoro M, Kauss B. O panorama atual da estratégia da profilaxia pré-exposição (PrEP) no Brasil e os caminhos possíveis para busca da equidade em saúde. Saúde Transform Soc 2020; 11:1-11.. Daily oral PrEP consists in the regular use of one tablet containing two antiretroviral drugs: tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Priority groups for PrEP in Brazil are gays and other MSM, sex workers, transgender people and serodiscordant couples ⁹9. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas para profilaxia pré-exposição (PrEP) de risco à infecção pelo HIV. Brasília: Ministério da Saúde; 2018.. Groups with high HIV prevalence such as drug users and adolescents were not included due to lack of scientific evidence on its effectiveness so far, but demonstrative studies with these populations have already been proposed ¹⁰10. Zucchi EM, Grangeiro A, Ferraz D, Pinheiro TF, Alencar T, Ferguson L, et al. Da evidência à ação: desafios do Sistema Único de Saúde para ofertar a profilaxia pré-exposição sexual (PrEP) ao HIV às pessoas em maior vulnerabilidade. Cad Saúde Pública 2018; 34:e00206617..

The use of PrEP among adolescents and young people is justified by the growth in the number of HIV-infected people in Brazil and worldwide among this population, especially among minority groups such as MSM, travestis and transgender women (TrTGW) ¹²12. Joint United Nations Programon HIV/AIDS. Communities at the centre: global AIDS update 2019. Geneva: Joint United Nations Programon HIV/AIDS; 2019.^,1313. Secretaria de Vigilância em Saúde, Ministério da Saúde. Boletim Epidemiológico HIV/Aids 2020; número especial. https://www.gov.br/aids/pt-br/centrais-de-conteudo/boletins-epidemiologicos/2020/hiv-aids/boletim_hiv_aids_2020_com_marcas.pdf/view.
https://www.gov.br/aids/pt-br/centrais-d... . The limited studies on PrEP access, use and effectiveness among adolescents point towards important challenges ranging from legalized access, free of charge and independently, by adolescents under 18, or those who do not have parental consent ¹⁴14. Taggart T, Bond KT, Ritchwood TD, Smith JC. Getting youth PrEPared: adolescent consent laws and implications for the availability of PrEP among youth in countries outside of the United States. J Int AIDS Soc 2019; 22:e25363.^,1515. Yusuf H, Fields E, Arrington-Sanders R, Griffith D, Agwu AL. HIV preexposure prophylaxis among adolescents in the US: a review. JAMA Pediatr 2020; 174:1102-8., the obstacles in attracting young people to use PrEP due to lack of knowledge about HIV risks among professionals or adolescents ¹⁵15. Yusuf H, Fields E, Arrington-Sanders R, Griffith D, Agwu AL. HIV preexposure prophylaxis among adolescents in the US: a review. JAMA Pediatr 2020; 174:1102-8..

The PrEP1519 Study, implemented in three Brazilian capitals, is the first cohort with Latin American adolescents, which aims to assess the effectiveness of the use of PrEP among MSM and TrTGW adolescents, contributing to the reduction of HIV incidence among this population. The study began in 2018 and was expected to be completed by June 2021 but was extended until December. This paper analyzed the genesis of the PrEP1519 Study and the conditions of possibility for its construction.

Methodology

A qualitative approach study was carried out, using the Bourdieusian sociology framework to reconstruct the dynamics of the social environment where the PrEP15-19 Study ¹⁶16. Bourdieu P. Sur l’état: cours au Collège de France (1989-1992). Paris: Seuil; 2012. emerged, based on the concept of social space, place where agents are distributed according to the different amounts of various capitals forms, especially cultural and economic, but also political, social, symbolic, bureaucratic ¹⁷17. Bourdieu P. Razões práticas: sobre a teoria da ação. Campinas: Papirus; 1996., or even militant ¹⁸18. Matonti F, Poupeau F. Le capital militant: essai de définition. Actes Rech Sci Soc 2004; (155):5-11..

The concept of capital is used against an extremely economic view, understanding that others forms of possession or not of riches can influence the benefits each agent are able to obtain in a social space ¹⁹19. Bourdieu P. The forms of capital. In: Richardson J, editor. Handbook of theory and research for the sociology of education. New York: Greenwood Press; 1986. p. 241-58.. The political capital is related to the agent’s capacity of mobilizing people, acquired in person or by the delegation of a political party or a union. It’s a capital of recognition, a kind of symbolic capital. To Bourdieu, social movements just can influence the political champ if supported by journalists and the press ²⁰20. Bourdieu P. Propos sur le champ politique. Lyon: Press Universitaires de Lyon; 2000.. So, the development of militant capital notion accounts for some aspects of the social engagement for which the political capital is not sufficient. In this sense, the militant capital, developed based on Bourdieu’s theoretical framework, is related to skills like knowing what to do during a meeting, how to talk in public, how to lead people to do something, knowledges and practices that in some cases and situations can be converted or not into political capital if associated with a capital of notoriety ¹⁸18. Matonti F, Poupeau F. Le capital militant: essai de définition. Actes Rech Sci Soc 2004; (155):5-11..

The study aimed to identify the conditions of possibility within the “Brazilian AIDS space”, considered a social space for organizing the struggle against AIDS, involving stakeholders from different fields and social subspaces ¹1. Barros SG. Política Nacional de Aids: a construção da resposta governamental à epidemia de HIV/aids no Brasil. Salvador: Edufba; 2018., the relationships between different groups and the main representatives involved in Brazil, and in international organizations, from 2015 to 2018.

Thirty-five documents related to the construction of the project were analyzed: 25 from international organizations, 8 from national institutions the original project, as well as agendas, reports and presentations related to the Brazilian National Commission of STIs, AIDS and Viral Hepatitis (CNAIDS) meetings held between 2013 and 2018, available on the Department of Chronic Conditions Diseases and Sexually Transmitted Infections of the Brazilian Ministry of Health (DCCI) website (https://www.gov.br/aids/pt-br) (Box 1).

Ten in-depth interviews were conducted with individuals related to the project coordination, who occupied leadership positions, participated in the genesis of PrEP1519 in three sites: the Brazilian Ministry of Health, the Pan American Health Organization (PAHO), and the World Health Organization (WHO). The script addressed the academic, professional, and political-institutional trajectories of the representatives, as well as issues around the process of creating and developing the project, and stages for study implementation. The snowball sampling technique was used to establish the sample with key informants from the Brazilian Ministry of Health and international organizations, beginning with I3 as the first key informant. The interviews were transcribed, revised, edited, coded, and analyzed using the NVivo 11 software (https://www.qsrinternational.com/nvivo/home).

The social and professional trajectories of the coordinators, understood as the positions occupied in different spaces and social fields, and their positions in “Brazilian AIDS Space” were analyzed based on their Lattes Curriculum and interviews. The position was characterized by the volume and composition of the different types of capital: school, scientific, political, bureaucratic, university bureaucratic, and militant (Box 2), adapted from previous studies ¹1. Barros SG. Política Nacional de Aids: a construção da resposta governamental à epidemia de HIV/aids no Brasil. Salvador: Edufba; 2018.^,2121. Vieira-da-Silva L, Pinell P. The genesis of collective health in Brazil. Sociol Health Illn 2014; 36:432-46.^,2222. Costa JB, Barros SG, Cangussu MCT, Sobral NV, Vieira-da-Silva LM. Os cirurgiões-dentistas e os Programas de Pós-graduação em Saúde Coletiva. Research, Society and Development 2021; 10:e56110716869..

A multiple correspondence analysis (MCA) was performed using the R software, version 4.0.4 (http://www.r-project.org), to understand the characteristics of the teams that were part of the project at each site during its genesis. MCA is a multivariate method that analyzes the relationship between two or more variables within the context of a phenomenon of interest ²³23. Greenacre M. La práctica del análisis de correspondencias. Bilbao: BBVA Foundation; 2008.. The following active variables were considered: undergraduate course, highest degree, and area of expertise; as well as the following supplementary variables: research site and area of the graduate program (GP) with the highest degree.

The research followed the recommendations in Resolutions n. 466/2012 and n. 510/2016 of the Brazilian National Health Council regarding ethics in research involving human beings and was approved by the Research Ethics Committee at the Collective Health Institute in the Federal University of Bahia (n. 3,224,384).

In the Results, the documents are identified by the letter “D” (Box 1) as the interviewees are identified by the letter “I” (Box 3).

Results and discussion

Background and incorporation of the youth population into the agenda

In July 2012, the WHO pointed out the effectiveness of PrEP based on clinical trials and encouraged countries to carry out demonstrative studies to better understand the safety, effectiveness and sustainability of its daily use for serodiscordant couples, MSM and TrTGW (D1). In 2013, the WHO carried out a call for demonstration studies as an important step prior to full implementation in countries (D2) and, as of 2014, the WHO began recommending the offer of oral PrEP as one of the prevention possibilities for people that have high risks of having HIV, based on a combined prevention perspective (D4). There was not a referral for use among the adolescent population (D4) (Figure 1; Box 1).

In 2015, WHO, Joint United Nations Programme on HIV/AIDS (UNAIDS) and the AIDS Vaccine Advocacy Coalition (AVAC) identified daily oral PrEP as the only option available for HIV-negative people to use outside of sexual experiences. The document highlighted its use by women, including adolescent girls, and among stable partners. Other populations at risk for HIV were not mentioned (D12). In 2016, the WHO reinforced the importance of PrEP as a strategy with strong scientific evidence towards HIV prevention ⁴4. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. Villars-sous-Yens: World Health Organization; 2016.. Subsequently, PrEP implementation strategies were published in different countries, with a specific module for adolescents and young adults (D30)(Figure 1). Figure 1 illustrates a timeline with the historical construction of this strategies in the international context and in Brazil.

While deaths caused by AIDS were rapidly decreasing in other age groups, this did not occur in the adolescent population aged 15-19 (D12). Then, the prioritization of the fight against the HIV/AIDS epidemic among adolescents began, highlighted in the agenda for several events held (D6, D7, D8) and documents published independently or jointly, especially by UNAIDS (D5, D9, D12, D17, D18, D19, D31), United Nations Children’s Fund (UNICEF) (D14, D17, D19), and WHO (D12, D20, D30). Studies that analyzed the emergence of a PrEP policy in Brazil also highlighted the debate among international organizations defending its offer as a HIV prevention strategy ²⁴24. Ferrari FC. Perseguindo uma inovadora promessa em tempos de retrocessos: o debate público sobre HIV/AIDS em Porto Alegre e a emergência da profilaxia pré-exposição [Masters Thesis]. Porto Alegre: Universidade Federal do Rio Grande do Sul; 2019.^,2525. Silva RATML. Diversidade e liberdade sexual: Defensoria Pública, movimentos sociais e a PrEP no SUS. Serv Soc Soc 2018; 132:346-61..

The Youth Pre-Conference, which preceded the International AIDS Conference in 2014, addressed topics of interest to youth and developed the Youth Action Plan, demanding their participation in discussions on HIV/AIDS policies, advocacy, and treatment (D8).

Also in 2014, along with the 69th General Assembly of the United Nations (UN), the All In! Towards Ending the AIDS Epidemic among Adolescents event happened, co-organized by UNICEF, UNAIDS and the Brazilian and Kenyan governments. In this event, representatives from six regions joined the movement to advance the response to HIV among adolescents, supporting “All In!”, which sought to reduce new HIV infections among adolescents by at least 75%, and reach treatment for at least 80% of the adolescents living with the virus, through prevention, testing, care and treatment strategies for this population (D7).

In Brazil, this theme was discussed during the CNAIDS meetings, as of 2014. Although most CNAIDS meetings between 2013 and 2018 (114th to 126th) do not have their minutes published on the Committee’s website, the meeting agendas, presentations, and documents available made it possible to identify which themes were discussed and when, as well as the positions taken by some agents. At the 119th meeting (August 26, 2014), during a presentation by the International Cooperation Office of the Department for Sexually Transmitted Diseases, HIV/AIDS and Viral Hepatitis (DDAHV), PrEP was mentioned as one of the new prevention technologies. The 120th meeting (March 30, 2015) discussed the topic of AIDS and youth; followed by representatives of the National Network for Adolescents and Youth Living with HIV/AIDS/Youth Coalition for Post-2015, and the General Coordination for Prevention and Social Articulation at the DDAHV (D34).

DDAHV management promoted changes in the technical staff and supported technological innovations related to the use of antiretroviral drugs as a preventive measure. The recruitment of gay boys and trans girls helped to reorganize the actions and a training for youth empowerment (Box 4). These evidence shows that the Brazilian Ministry of Health, its director in person but also his collaborators, was predisposed to adopt PrEP, and brought the youth to the agenda, in consonance with international bodies guidelines.

In December 2014, during a meeting in Geneva (Switzerland), led by UNAIDS and UNICEF, with the support of other organizations, a strategy to face the HIV/AIDS situation among adolescents was created. A commitment was made to work towards the fulfillment of the “All in!” agenda by February 2015 (D6). Subsequently, the All In to End Adolescent AIDS (D6, D9) initiative was launched, involving 25 countries that account for more than 80% of the HIV/AIDS cases among adolescents in the world.

As part of the agenda for this initiative, a document with guidelines was prepared (D14) to promote changes in national programs and policies, to engage adolescents and stakeholders from different sectors to accelerate the reduction in infections and deaths by HIV/AIDS among adolescents (D14), through the assessment and reorganization of national programs and prioritization of interventions among this group.

This international context supported the incorporation of PrEP in Brazil, with an emphasis on the following documents: Recommendations for Comprehensive Care for Adolescents and Youth Living with HIV/AIDS (D3), Clinical Protocol and Therapeutic Guidelines for Comprehensive Care for People with Sexually Transmitted Infections²⁶26. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas para atenção integral às pessoas com infecções sexualmente transmissíveis. Brasilia: Ministério da Saúde; 2015. and the Clinical Protocol and Therapeutic Guidelines for Post-Exposure Prophylaxis (PEP) for Populations at Risk for HIV Infection, STIs and Viral Hepatitis²⁷27. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas para profilaxia pós-exposição (PEP) de risco à infecção pelo HIV, IST e hepatites virais. Brasilia: Ministério da Saúde; 2017..

Developing the strategy for PrEP use in Brazil

PrEP use was approved for oral and daily use in the Brazilian Unified National Health System (SUS) for populations that are highly vulnerable and have an increased risk for HIV infection in May 2017 (PrEP-SUS Program) (D24), effectively made available in December 2017 ²⁸28. Ministério da Saúde. PrEP está disponível em 36 serviços do SUS a partir deste mês. http://www.aids.gov.br/pt-br/noticias/prep-esta-disponivel-em-36-servicos-do-sus-partir-deste-mes (accessed on 08/Feb/2021).
http://www.aids.gov.br/pt-br/noticias/pr... . Specific criteria were considered: having anal or vaginal sex without a condom in the last six months; having frequent episodes of sexually transmitted infections (STIs); repeated use of PEP; having many sexual partners, and the commitment to medication adherence (D29) ⁹9. Ministério da Saúde. Protocolo clínico e diretrizes terapêuticas para profilaxia pré-exposição (PrEP) de risco à infecção pelo HIV. Brasília: Ministério da Saúde; 2018.. The delay of the Brazilian response towards the incorporation of PrEP as a public policy was highlighted by two interviewees (I1,I9).

A study on the use of PrEP on a social network, between 2015/2016, pointed out that some Brazilian participants reported buying Truvada (PrEP’s trade name) on pharmacy websites in other countries, and using it without medical supervision. Defending universal access to PrEP in Brazil is also mentioned along with the discussion on government responsibilities ²⁹29. Queiroz AAFLN, Sousa AFL. Fórum PrEP: um debate on-line sobre uso da profilaxia pré-exposição no Brasil. Cad Saúde Pública 2017; 33:e00112516..

The process towards PrEP accessibility in Brazil involved the DDAHV directors and technical team, university researchers and professors, and civil society organizations (CSOs).

The Commission for Incorporation of Technologies in the SUS (CONITEC) meeting, in October 2016 (D16), integrated dolutegravir into therapeutic guidelines, and expanded the use of darunavir as a second-line treatment ³⁰30. AIDS: um passo à frente, um atrás. RADIS 2016; (170):7. (I4), it also discussed the approval of the TDF/FTC-300/200mg co-formulation as PrEP, but its use for populations at higher risk for HIV was only recommended in May 2017 by CONITEC (D25). CONITEC analyzes the effectiveness of the technology, comparing it to treatments already incorporated into the SUS.

The Oswaldo Cruz Foundation (Fiocruz) technical team and PrEP-Brasil research coordinators presented scientific evidence on the use of TDF/FTC-300/200mg among people at a high risk for HIV (D16). The drug was not authorized by the Brazilian Health Regulatory Agency (Anvisa), that has the responsibility to evaluate the safety of a medicine or health product with a view to marketing authorization in Brazil, however, the agency’s representative said that the analysis towards possibly including the package insert would be prioritized. Members in the plenary, with a more conservative point of view (I4), requested the discussions regarding this topic be suspended until approval of the prophylactic indication by Anvisa ³⁰⁰ (I4), and thus, there was no presentation of the initial proposal on the Clinical Therapeutic Guideline Protocol for Pre-Exposure Prophylaxis for HIV Infection Risk (PCDT). It is noteworthy that CONITEC could have declared public health interest in the use of Truvada for prevention, despite it being approved by Anvisa for treatment purposes ³⁰30. AIDS: um passo à frente, um atrás. RADIS 2016; (170):7..

A new assessment of the PrEP drug took place at the 52nd CONITEC meeting. The members discussed a public consultation with a preliminary favorable recommendation for PrEP, subject to the registration approval by Anvisa for this indication, and the presentation of an annual follow-up plan for the people who would receive prophylaxis (D25).

Evidence from demonstration studies and international studies supported the presentation to CONITEC and PCDT on the effectiveness of PrEP for populations such as MSM and TrTGW ³¹31. Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde. Ata da 55ª reunião da CONITEC. http://antigo-conitec.saude.gov.br/images/Reuniao_Conitec/Ata_55_Reunia_final.pdf (accessed on 08/Feb/2021).
http://antigo-conitec.saude.gov.br/image... (I3). At the 55th CONITEC meeting, the results of the public consultation on the incorporation of PrEP were presented, with unanimous approval by all who were present at the meeting (D26). Users and health professionals with experience in the field participated in the public consultation. The CONITEC report highlighted the contribution of the Brazilian Society of Infectious Diseases (SBI), UNAIDS, the Brazilian Interdisciplinary AIDS Association (ABIA), and the Public Defender’s Office in the State of São Paulo (D27). The use among adolescents was suggested, questioning the lack of discussion regarding this population (D28), however, this group was not included due to lack of scientific evidence to support the approval for its use (D27) (I3, I10). Studies highlight the absence of adolescents in the PCDT (10,20).

CSOs played an important role in the debate within the CNAIDS, especially ABIA (I3). The failure to publish the minutes of CNAIDS meetings from 2013 to 2018 did not allow us to identify the positions taken by different members. ABIA’s position was identified through the presentation made by the coordinator of the Working Group on Intellectual Property (GTPI) in the Association, who pointed out the patent system as an inequality generator, “used to promote profit and prolong monopoly”, increasing the costs for purchasing medication. At that time, the purchase of antiretroviral drugs represented approximately 73% of DDAHV expenses. Several publications on their website (https://abiaids.org.br) reinforce that the entity considered PrEP a cutting-edge prevention strategy, questioned the delay ³²32. Associação Brasileira Interdisciplinar de AIDS. ABIA critica atraso brasileiro na adoção da PrEP para a prevenção do HIV no SUS. http://abiaids.org.br/abia-critica-atraso-brasileiro-na-adocao-do-truvada-para-a-prevencao-do-hiv-no-sus/28802 (accessed on 08/Feb/2021).
http://abiaids.org.br/abia-critica-atras... and lack of political will ³³33. Associação Brasileira Interdisciplinar de AIDS. ABIA: falta de vontade política para adotar PrEP na resposta à epidemia de AIDS no Brasil. http://abiaids.org.br/abia-falta-vontade-politica-para-adotar-prep-na-resposta-epidemia-de-aids-no-brasil/29269 (accessed on 08/Feb/2021).
http://abiaids.org.br/abia-falta-vontade... towards its adoption, and, after its approval, the high cost of using a patented drug ³⁴34. Associação Brasileira Interdisciplinar de AIDS. Truvada® livre! Boletim ABIA 2018; (63). http://abiaids.org.br/wp-content/uploads/2018/10/BOLETIM_ABIA_63_PrEP_completo.pdf.
http://abiaids.org.br/wp-content/uploads... ^,3535. Associação Brasileira Interdisciplinar de AIDS. ABIA diz que Brasil precisa ir além das “promessas” e questiona alto custo anunciado para entrada da PrEP no país. http://abiaids.org.br/abia-diz-que-brasil-precisa-ir-alem-das-promessas-e-questiona-alto-custo-anunciado-para-entrada-da-prep-no-pais/30192 (accessed on 08/Feb/2021).
http://abiaids.org.br/abia-diz-que-brasi... .

Silva ²⁵25. Silva RATML. Diversidade e liberdade sexual: Defensoria Pública, movimentos sociais e a PrEP no SUS. Serv Soc Soc 2018; 132:346-61. also highlights ABIA’s role towards the development of the PrEP policy in Brazil, with support from other social movements and the Public Defender’s Office in São Paulo. The entity also criticized the smaller than expected number of people who would have access to prophylaxis, and the absence of the adolescent population in the approved PCDT, an age group with growing numbers in the epidemic ³⁶36. Buscato M. CONITEC recomenda terapia que previne aids no SUS, mas restringe oferta do medicamento. Época 2017; 17 mar. https://epoca.oglobo.globo.com/saude/noticia/2017/03/comissao-recomenda-terapia-que-previne-aids-no-sus-mas-restringe-oferta-do-medicamento.html.
https://epoca.oglobo.globo.com/saude/not... .

Castro ³⁷37. Castro CG. Sociedade civil e a política da profilaxia pré-exposição ao HIV no Brasil [Masters Thesis]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2020. highlights participation from other movements and CSOs, in addition to ABIA, for their entry into the PrEP agenda and construction of the PrEP policy for SUS, such as the Forum for AIDS Nongovernmental Organizations in the State of São Paulo (FOAESP), Gestos, Grupo de Incentivo à Vida (GIV), Grupo Arco-Íris, and the National Network of People Living with HIV (RNP+Brasil). These organizations were active during public consultations, articulated to support the DDAHV management, contributing/monitoring the clinical research and government actions, through debates and campaigns, sharing information, and activities to pressure the government ³⁷37. Castro CG. Sociedade civil e a política da profilaxia pré-exposição ao HIV no Brasil [Masters Thesis]. Rio de Janeiro: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz; 2020..

A commission produces symbolic effects, develops a (new) definition of a public problem and its solution, which becomes an authority discourse ¹⁶16. Bourdieu P. Sur l’état: cours au Collège de France (1989-1992). Paris: Seuil; 2012.. Until 1990, CNAIDS was established as a group of experts from different social subspaces and had an important technical and political role in the development of official discourse ¹1. Barros SG. Política Nacional de Aids: a construção da resposta governamental à epidemia de HIV/aids no Brasil. Salvador: Edufba; 2018.. In the first 15 years (1986 to 2001) 63 meetings were held ³⁸38. Ministério da Saúde. Comissão Nacional de Aids: 1986-1994. Brasília: Ministério da Saúde; 1994.^,3939. Ministério da Saúde. Comissão Nacional de Aids: a presença do passado na construção do futuro. https://bvsms.saude.gov.br/bvs/publicacoes/cd03_06.pdf (accessed on 08/Feb/2021).
https://bvsms.saude.gov.br/bvs/publicaco... . Over the next 18 years, there were 64 meetings, reaching the 127th meeting in 2019 (D34). The reduction in the frequency of meetings is probably related to the specialization and complexity of the “AIDS space”, with the emergence of new opportunities for participation and specific articulation. This expansion fragmented power, previously concentrated at CNAIDS, which started to be characterized more as an informative and debate environment than an actual decision-making space ¹1. Barros SG. Política Nacional de Aids: a construção da resposta governamental à epidemia de HIV/aids no Brasil. Salvador: Edufba; 2018., which is also evidenced by the non-disclosure of its minutes and attendee lists. Within the PrEP discussion, however, ABIA’s taking of a stance within CNAIDS, but also through its communication channels with society, and representative spaces, demonstrated the possibility for actual social participation.

It is noted that the composition of the DDAHV, with a director with experience in international institutions and favorable to the use the PrEP to HIV/AIDS prevention, the approval of TDF/FTC-300/200mg use to PrEP by CONITEC and Anvisa associated with CSOs demand, were the conditions of possibility to PrEP incorporation to SUS.

PrEP1519

PrEP1519 was proposed based on the issue with the large number of youth aged 15-24 infected with HIV in the world (D25) ¹³13. Secretaria de Vigilância em Saúde, Ministério da Saúde. Boletim Epidemiológico HIV/Aids 2020; número especial. https://www.gov.br/aids/pt-br/centrais-de-conteudo/boletins-epidemiologicos/2020/hiv-aids/boletim_hiv_aids_2020_com_marcas.pdf/view.
https://www.gov.br/aids/pt-br/centrais-d... , and the increase in deaths related to HIV/AIDS within this population between 2005/2012 ⁴⁰40. United Nations Children’s Fund. Towards an AIDS-free generation - children and AIDS. Stocktaking Report, 2013. https://data.unicef.org/resources/towards-an-aids-free-generation-children-and-aids-stocktaking-report-2013/ (accessed on 08/Feb/2021).
https://data.unicef.org/resources/toward... . Upon recognizing the increase in the incidence of HIV among adolescents and the lack of sufficient scientific studies to include this group in the protocol approved by CONITEC, and associated with the Unitaid proposal, a demonstration cohort study with combined HIV prevention, including PrEP, was proposed for the population aged 15-19 years, at three sites, in order to support CONITEC in expanding the supply of PrEP in SUS for this age group (I4, I10).

At the 123rd CNAIDS meeting (May 9, 2017), the proposal for the implementation of PrEP among the population at increased risk for HIV was presented, highlighting five demonstration studies on the acceptability and feasibility of PrEP carried out in the country: PrEP Brazil (Fiocruz), Project Combina! (Faculty of Medicine, University of São Paulo - FMUSP), “PreParadas” (Fiocruz), Horizonte Project (Federal University of Minas Gerais - UFMG), Project PopTrans (Federal University of Bahia - UFBA), generating evidence for the development of national policy, and two implementation studies, cofinanced by Unitaid (PrEP Adult and PrEP Youth and Adolescents), which began in 2017 (D34).

The statement of an interviewee reinforces the favorable conditions towards international organizations such as WHO and Unitaid, with funding opportunities (Box 4).

What is it?

PrEP1519 was developed between 2017/2018, after PrEP was approved as a combined prevention strategy for key populations. The main researchers in the study are a medical epidemiologist, head professor of the GP on Public Health, in a Federal University in Northeast Brazil with a research focus on Epidemiology and HIV/AIDS prevention; a sociologist, researcher in a very recognized university in the Southeast Brazil, and former director of the National STI and AIDS Program, and an immunologist and infectious disease physician, professor emeritus in a Federal University in Southeast Brazil, with research/performance in the field of Infectious and Parasitic Diseases, Clinical Immunology and Ethics, also a former director at DDAHV.

Funding was provided by Unitaid and the Brazilian Ministry of Health, which contributes with medication and supplies. Each site has ways of raising funds jointly and counts on the provision of supplies/inputs for the prevention and treatment of STIs by the state and municipal departments of health, in addition to institutional financial support from Brazilian universities.

The conditions of possibility also involved cooperation with Unitaid for PrEP1519 which was enabled through the settlement of payments due by Brazil to the international organization. Furthermore, a new director of the DDAHV, a medical doctor with a specialization, and a PhD in Public Health, with a long history of HIV/AIDS work, and responsible for proposing the first legislation in the country that advocated the free distribution of medication by the public network, with extensive experience in management positions, as well as in international organizations, contributed to this process (I10).

UNICEF was part of the international management of the project, but since it was not possible to transfer funds within the UN and there were many requirements in exchange for participation, the organization did not remain in the study. While the organization was part of the project for international management, the three sites had already been merged and there was a more focused design on the assessment of the offer and effectiveness of PrEP (I6), with greater importance for the services component. This position taken by Unitaid provided more autonomy to Brazilian researchers to redesign the project according to the current settings. Based on this perspective, the management of resources of the PrEP1519 is done by Fiocruz Support Foundation (FIOTEC), the same for the study on PrEP among adults (I4, I3, I6). This possibility ensured that PrEP1519 could generate evidence for global use and then contribute to making PrEP available to adolescents (I1, I3, I6, I10). It is noteworthy that Brazil started its PrEP public policy after other middle and high-income countries, even if it is one of the most advanced countries in Latin America, somehow it has loosed its vanguard position (I3).

The main objectives for PrEP1519 are (i) assess the effectiveness of the use of PrEP among adolescent MSM and TrTGW, between 2018 and 2020, at three sites, and (ii) to contribute to the reduction of HIV incidence among this population. To achieve the objectives, six components were outlined, namely: (1) qualitative formative research; (2) demand-building strategies for recruiting, enrolling, and attachment to PrEP clinics; (3) HIV incidence to be estimated from prevalence data on the population accessed through demand creation strategies; (4) study demonstrating the effectiveness of PrEP; (5) assessment of the distribution and use of HIV self-tests (HIVST); and (6) cost-effectiveness of PrEP among adolescents. Components 2, 3, 4 and 5 involved mixed method research projects. The study components were development at the three sites, adapting aspects related to the specificities in each municipality, and articulating the development of indicators along with the Brazilian Ministry of Health and state/municipal health departments.

PrEP1519 also provides health care and prevention actions such as quick testing for HIV and other STIs, and laboratory tests for confirmation, as well as distributing self-tests and enabling greater access. The project also offers educational materials and counseling on HIV and other STIs, in addition to other prevention strategies: condoms, lubricating gel, HIV PEP, and referral for vaccination in the municipal network against viral hepatitis (A and B) and HPV.

Choosing the research sites

The choice of sites came from the DDAHV board, between 2015/2016, based on the trajectory of “AIDS space” agents, especially in the scientific and/or bureaucratic fields, and previous experience with research projects with adolescents and about PrEP. In São Paulo, the researcher coordinated Project Combina!, aimed at analyzing the use of PrEP by MSM and TrTGW at high HIV exposure and vulnerability, and participated in the committee that structured the PrEP PCDT. In Belo Horizonte (Minas Gerais State), the Horizonte Project presented objectives related to increasing the use of PrEP and testing the population, among others. In Salvador, there was the Project PopTrans initiated in 2013, on the acceptability of PrEP among TrTGW.

Based on the decision of the sites and the principal investigators (PIs), the development of the proposal began. The PIs have relevant contributions to the fields of HIV/AIDS and are leaders of several projects financed by national and international organizations. They are professors and/or researchers at public universities. Two of them work with Public Health, while the other, works in the Medical Clinic context. He was a director at DDAHV (Box 3). The other PI was also a director of DDAHV and presented a long trajectory in the bureaucratic field (Box 3).

These differences enabled different arrangements of the research team at the three sites. The MCA (Figure 2) shows this relationship. In Belo Horizonte, the high scientific capital was related to conducting cohort studies and clinical trials in the HIV/AIDS field the team mainly includes physicians and other health professionals, with a more clinical background and postgraduate training at the master and doctoral level, in Medical GPs.

The group in São Paulo gathers a large number of individuals in the Humanities (Psychology, Sociology, or Social Sciences), with a lower number of postgraduates than in the other two sites, and, when present, it is in a Public Health GP. In Salvador, there appeared to be greater diversity in the team profile regarding undergraduate and graduate education levels, despite its proximity to the Public Health GP.

The development of the PrEP1519 project demonstrated recognition of the problem with the large youth population aged 15 to 19 infected and the increase in deaths related to HIV/AIDS for this population. The dynamics of the social environment where the problem definition was developed resulted from the interpenetration of the strategies among stakeholders interested in constructing the problem as a social problem. According to Bourdieu ⁴¹41. Bourdieu P. Meditações pascalianas. Rio de Janeiro: Bertrand Brasil; 2007., the reconstruction of a social construction process is not reduced to a pure and simple set of coincidences. It implies the search for visual logical elucidations in that environment, as intended through this study.

Final considerations

PrEP was introduced in Brazil as a public policy in 2017, after proving its effectiveness through scientific studies, although international organizations recommended access through health systems since 2014. The scarcity of scientific evidence available among the adolescent population led to the development of a demonstrative cohort study, associated with an intervention, aimed at combining the prevention and treatment of STIs in three sites in Brazil. The goal was to generate evidence for global use, and to support the Brazilian Ministry of Health with the incorporation of PrEP among the 15-19-year-old population. This work resulted from the articulation of bureaucratic, scientific, and activist stakeholders. The articulation of agents from different fields, with diverse dispositions and point of views at the three sites contributes to the formulation of broader strategies and an inclusive policy, based on clinical, collective health and social sciences knowledge. The differences on the accumulation of distinct capitals during the agents’ trajectories could be evidenced through the different composition of the research team in the different sites.

The possibilities for developing this study permeated a favorable relationship with international organizations, the favorable approach that public administrators had at the time towards new technologies and prevention strategies, the researchers’ previous experience in studies with the target population or with PrEP, articulation efforts with social movements, civil society organizations and other public bodies, and the integration between scientific institutions that enabled international resources and a response to the problem. Completing this study at a moment where conservatism advances in the country, demands that the scientific field and militant space closely monitor and take positions to ensure the availability of PrEP for adolescents as a public policy. This study had not the objective of the implementation analysis, which must be investigated in another studies.

Acknowledgments

To Unitaid and Brazilian Ministry of Health for providing financial support.

References

Publication Dates

History