The social construction of the PrEP1519 study: conditions of possibility for advances in HIV/AIDS prevention

Barros, Sandra Garrido de; Brasil, Sandra Assis; Rossi, Thais Regis Aranha

doi:10.1590/0102-311XEN201621

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ARTIGO • Cad. Saúde Pública 39 (Suppl 1) • 2023 • https://doi.org/10.1590/0102-311XEN201621 copy

The social construction of the PrEP1519 study: conditions of possibility for advances in HIV/AIDS prevention

A construção social do estudo PrEP1519: possíveis condições para os avanços na prevenção do HIV/aids

La construcción social del estudio PrEP1519: posibles condiciones para avances en la prevención del VIH/sida

Authorship SCIMAGO INSTITUTIONS RANKINGS

This paper analyzed the genesis of the PrEP1519 study and feasibility conditions for its construction. A qualitative-approach study was conducted using the Bourdieusian sociology framework to reconstruct the dynamics of the social environment where PrEP1519 emerged during 2015-2018. A document analysis and ten in-depth interviews were carried out to analyze the trajectory of the project. Pre-exposure prophylaxis (PrEP) was introduced in Brazil as a public policy in 2017. The lack 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 sexually transmitted infections at three sites in Brazil. PrEP1519 sought to generate evidence for global use and to help the Brazilian Ministry of Health apply PrEP among adolescents. The articulation of bureaucratic, scientific, and activist stakeholders enabled this study. The feasibility conditions for developing PrEP1519 included a favorable relationship of national organizations 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 agencies, and the integration between scientific institutions, which allowed using international resources and developing a response to the problem. Completing this study at a moment when conservatism advances in Brazil demands that the scientific community and activists closely monitor and take stances on PrEP to ensure its availability for adolescents as a public policy.

Keywords:
Pre-Exposure Prophylaxis; Teenagers; Acquired Immunodeficiency Syndrome; Public Health Policies; Medical Sociology

ID	DOCUMENT	INSTITUTION (YEAR)	DOCUMENT TYPE	CONTENT
D1	Guidance on PrEP for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV. Recommendations for use in demonstration projects	WHO (2012)	Guidance	Recommendations specifically developed to address the daily use of antiretrovirals in HIV-uninfected people to block the acquisition of HIV infection (pre-exposure prophylaxis). At that stage evidence was available from studies with two groups: men and transgender women who have sex with men; and serodiscordant heterosexual couples
D2	PrEP demonstration projects: a framework for country level protocol development	WHO (2013)	Guidelines	Recruitment of the priority population for a PrEP program will be defined in each site, as well as the best methods to recruit these populations. In Brazil, adolescents who fit the profile of the population at risk were included
D3	Recommendations for comprehensive care for adolescents and youth living with HIV/AIDS	Brazilian Ministry of Health (2013)	Recommendations	The document aimed to present health professionals with aspects of comprehensive care that promote quality of life and quality of care, with themes related to the epidemiological aspects of HIV infection in this population, considerations about adolescence, diagnostic disclosure, adherence to treatment, sexual and reproductive health, nutritional assessment, and transition
D4	Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations	WHO (2014)	Guidelines	Consolidated guidelines document on HIV prevention, diagnosis, treatment, and care for key populations, the WHO brings together all existing guidance that is relevant to five key populations - MSM, people who inject drugs, people in prisons and other closed settings, sex workers, and transgender people - and updates on selected guidance and recommendations
D5	HIV prevention, treatment, care and support for adolescents and youth	UNAIDS (2014)	Guidance note	Aligns guidance with the HIV investment approach to ensure better coherence of support for HIV programs for adolescents and youth with impact evidence. Emphasizes the need to address and monitor responses for key neglected and vulnerable groups, including adolescents and key affected populations
D6	Update. All in for adolescents	UNAIDS (2014)	News/Update	Meeting held in Geneva (Switzerland), to develop strategies to face the HIV/AIDS situation among adolescents, convened by UNAIDS and UNICEF and partners, who drafted a joint action plan and were committed to fulfilling the “All In Agenda” by February 2015
D7	Update. World leaders unite towards ending the AIDS epidemic among adolescents	UNAIDS (2014)	News/Update	Parallel event to the 69th United Nations General Assembly called All In! Towards Ending the AIDS Epidemic among Adolescents, coorganized by UNICEF, UNAIDS, and the governments of Brazil and Kenya, where representatives of the six regions supported the “All In!” initiative
D8	Update. Treat, reform, educate, love: young people preparing to take the lead at AIDS 2014	UNAIDS (2014)	News/Update	The Youth Pre-Conference, which preceded AIDS 2014 in Melbourne (Australia), addressed various topics of interest to youth and created the Youth Action Plan, demanding youth participation in national, regional, and international discussions on AIDS policy, advocacy, and treatment
D9	All in to #endadolescentaids	UNAIDS (2015)	Call for action document	The “All In” strategic framework is in line with the visions of zero new HIV infections, zero AIDS-related deaths, and zero discrimination, monitoring and assessing efforts of existing national programs and expanding them to focus on results for adolescents
D10	Health blog	Brazilian Ministry of Health (2015)	Blog/Interview	Brazil leads unprecedented PrEP studies scheduled to start in 2016 in the Unitaid action in Brazil; studies on PrEP are carried out with this age group for the first time
D11	Minutes of the 22nd Executive Board Meeting	Unitaid (2015)	Minutes of the Executive Board Meeting	Meeting held in Brazil. Approves several items, including Resolution 5 Enabling Scale-up of PrEP and Linkage to Test as a New Area for Intervention
D12	PrEP - contextualizing a new option/oral PrEP - putting a new choice in context	UNAIDS, WHO, and AVAC (2015)	PrEP reference document	PrEP basic information and implementation issues
D13	WHO technical update on PrEP	WHO (2015)	Guidelines	The role of PrEP as part of a comprehensive HIV prevention package for young women needs urgent consideration and WHO plans to develop this guidance in the first half of 2015
D14	Strengthening the adolescent component of national HIV programs through country assessments and the AADM tool	UNICEF (2015)	Guidelines	All In is an initiative aimed at generating better outcomes for adolescents (10-19 years old) through critical changes in programs and policies that seeks to engage adolescents and unite stakeholders in all sectors to accelerate the reduction in deaths AIDS-related and new HIV infections among adolescents by 2020
D15	Resolution n. 9-2016-e	Unitaid (2016)	Resolution	Presents conditions for Unitaid and UNICEF to conduct the project. It appoints UNICEF as the leading organization, making funding conditional for Unitaid and UNICEF to sign a grant agreement project. Countries involved: Brazil, South Africa, and Thailand
D16	Minutes of the 49th CONITEC meeting	CONITEC (2016)	Minutes	Technical staff from Fiocruz and from the PrEP Brazil Project presented the available scientific evidence on the use of prophylactic antiretroviral (tenofovir + emtricitabine = Truvada) among people at high risk for HIV infection. Discussions on the subject were suspended until Anvisa approved prophylactic indication of the drug. The initial PCDT proposal was not presented
D17	Strengthening HIV programs for adolescents: early lessons from adolescent assessments to guide fast tracking of adolescent responses through All In	UNAIDS and UNICEF (2016)	Guidelines	Tool to help countries identify equity and performance gaps that limit the impact of investments in adolescent programs and direct countries to actions that better target adolescents at greatest risk for infections, illness, and death
D18	Ending the AIDS epidemic for adolescents, with adolescents - a practical guide to meaningfully engage adolescents in the AIDS response	UNAIDS (2016)	Guidelines	Seeks to provide guidance on adolescent involvement in the AIDS response and broader health programs among efforts to end the AIDS epidemic by 2030
D19	All In to end the adolescent aids epidemic: a progress report	UNAIDS and UNICEF (2016)	Report	It seeks to engage adolescents in rapid efforts to end the AIDS epidemic by 2030 and provides targets for 2020
D20	Appropriate medicines: options for PrEP	WHO (2016)	Guidelines	Lack of data for adolescents and transgender people [note: this is also true regarding other PrEP drugs]
D21	Resolution n. 9-2016-e	Unitaid (2016)	Resolution	Enabling scale-up of PrEP and linkage to testing among sexually active older adolescents with substantial HIV risk (Brazil, South Africa, and Thailand)
D22	Resolution n. 21-2017-e	Unitaid (2016)	Resolution	International funding document for PrEP access for adolescent women in South Africa. Integrating PrEP into comprehensive services for adolescent girls and young women in South Africa
D23	Resolution n. 7-2017-e	Unitaid (2017)	Resolution	Release of funds for PrEP project in Brazil, Peru, and Mexico
D24	Resolution n. 2-2021-e	Unitaid (2017)	Resolution	Project term extension “Preparedness for the Rollout of Effective HIV Prevention among Key Affected Populations in Brazil, Peru and Mexico”
D25	Minutes of the 52nd CONITEC meeting	CONITEC (2017)	Minutes	Scientific evidence showed that the use of PrEP reduces the risk of HIV infection with > 70% efficacy, being directly related to adherence. The group decided to submit the topic to public consultation with a favorable preliminary recommendation, with some conditions
D26	Minutes of the 55th CONITEC meeting	CONITEC (2017)	Minutes	Unanimous recommendation to incorporate the use of TDF/FTC 300/200mg as PrEP in SUS for populations at increased risk of contracting HIV. Approval of the HIV PrEP Clinical Protocol and Therapeutic Guidelines
D27	PCDT for PrEP to HIV: report recommendation	CONITEC (2017)	Report	Proposed PCDT for HIV PrEP assessed by the Technical Subcommittee for the PCDT Assessment on CONITEC and CONITEC (52nd regular meeting) that favorably recommended the use of PrEP in writing
D28	Report on the recommendations: TDF/FTC (300/200mg) as PrEP for population at higher risk of acquiring HIV	CONITEC (2017)	Report	Presented scientific and epidemiological evidence to support the analysis for the incorporation of TDF/FTC 300/200mg as PrEP for HIV infection in SUS
D29	PCDT for PrEP of risk for HIV infection	Brazilian Ministry of Health (2017)	PCDT	PCDT for PrEP for HIV infection risks
D30	WHO implementation tool for PrEP of HIV infection - module 9	WHO (2017)	Guidelines	Older adolescents and young people at substantial risk of HIV could also be included in PrEP services. It is important for providers to sensitively and non-judgmentally engage in a discussion with young people about their sexual partners and recognize and minimize risks of intimate partner violence while assessing HIV prevention options
D31	Training workshop for the implementation of PrEP and innovations in HIV testing - Asia and the Pacific	Unitaid, UNAIDS and WHO (2018)	Workshop report	Conducted in Thailand in 2018, the report highlights the challenges for implementing PrEP and using self-testing in the Asia-Pacific region. Indicates actions to be prioritized
D32	UNITAID Annual Report 2016-2017	UNITAID (2018)	Annual Report	Projects and Actions carried out in 2016-2017
D33	WHO implementation tool for PrEP of HIV infection: module 12: adolescents and young adults	WHO (2018)	Guidelines	The limited data available on young key populations suggest that they are even more disproportionately affected by HIV in most settings. Young members of key populations often face tremendous challenges, including legal and sociocultural issues related to societal attitudes about sexuality in youth
D34	Agendas and presentations from CNAIDS meetings (114th to 126th)	CNAIDS (2013 to 2018)	Documents	The website provided no documents of the 116th and 117th meetings. Since it also did not show the minutes of the other meetings, the research group decided to search for information on the discussions about PrEP using other documents
D35	Enabling scale up of PrEP and Linkage to testing among sexually active adolescents who have sex with men, transgender women and their sexual partners with substantial HIV risk in Brazil	2018	Research project	Study project financed by Unitaid, developed in three city capitals of Brazil to (a) reduce HIV incidence among MSM and TrTGW adolescents; (b) assess the effectiveness of PrEP use among MSM and TrTGW adolescents aged 15 to 19 years

TYPE OF CAPITAL	CAPITAL VOLUME
TYPE OF CAPITAL	VERY HIGH	HIGH	MEDIUM	LOW
Scientific	Research productivity scholarship 1A, 1B, 1C, 1D (CNPq - Public Health and Nutrition or Medicine) or compatible profile: Obtained Doctorate at least 8 years ago; Supervised at least 10 stricto sensu graduate students in the last 10 years, at least 2 at a doctorate level (PGP with a Doctorate for at least 5 years); Published 30 scientific papers in the last 10 years; Is active in a PGP with score 3 or higher	Research productivity scholarship 2 (CNPq - Public Health and Nutrition or Medicine) or compatible profile: Obtained Doctorate at least 3 years ago; Supervised at least 1 main stricto sensu graduate student in the last 5 years; Published 10 papers in the last 5 years; Is active in a PGP with score 3 or higher	Doctorate; Permanent staff in a PGP and supervising 1 main student in progress/completed. Coordinates research project with funding	Doctorate; Is part of a research project team
Bureaucratic **
Occupation of technical positions at different levels of management in the health system and international organizations	Management positions in international organization (UNAIDS, PAHO, WHO); Leaders of the National STI/AIDS Program or in senior positions involved in AIDS policy	Leading state programs; National STI/AIDS Program technical staff; Participation in meetings to define the Ministry of Health policy	Intermediate management positions in Municipal Health Departments (municipal programs); State program technical staff	Technical positions (advisor, consultant)
University bureaucratic	President	Unit director	Department head; GP coordinator	Deputy head of department; GP vice-coordination
Political
Occupation of administrative positions that result in specific political articulations	Minister of Health; Chairmen of the health agencies	State health secretaries	Municipal health secretaries	Other technical positions with a political appointment
Participation in political parties	National leader	State political party leader	Municipal political party leader	Affiliated to a political party
Participation in elective positions	Senator; Federal representative	State representative	City councilor
Militant
Professional and popular leaders	Leader with charismatic leadership skills capable of engaging and gathering people (high symbolic capital)	Director of NGOs or social movements	Intermediate positions in NGOs or social movements	Activists in NGOs or social movements

INTERVIEWEES	PLACE OF BIRTH	AGE (YEARS)	UNDERGRADUATE DEGREE	CAPITAL VOLUME
INTERVIEWEES	PLACE OF BIRTH	AGE (YEARS)	UNDERGRADUATE DEGREE	SCIENTIFIC	BUREAUCRATIC	UNIVERSITY BUREAUCRATIC	POLITICAL	MILITANT
I1	Brazil	52	Biological Sciences (UNICAMP, Brazil, 1986-1989)	Medium	Very high	-	-	Medium
I2	São Paulo (Brazil)	41	Psychology (USP, Brazil, 2001-2005)	Medium	-	-	-	-
I3	Salvador (Bahia State, Brazil)	62	Medical Sciences (EBMSP, Brazil, 1976-1981)	Very high	Medium	Medium	-	-
I4	Manaus (Amazonas State, Brazil)	65	Medicine (UFAM, Brazil, 1973-1978)	Very high	Very high	-	-	High
I5	NI	74	Medical Sciences (UFMG, Brazil, 1965-1969)	Very high	Very high	Medium	-	-
I6	Bragança Paulista (São Paulo State, Brazil)	55	Social Sciences (PUC-SP, Brazil, 1987-1992)	Medium	Very high	-	-	Medium
I7	NI	31	Nursing (UFBA, Brazil, 2007-2011)	Medium	-	Low	-	High
I8	NI	NI	Psychology (University of Maryland at College Park, United States, 1974-1978)	Medium	High	-	-	Medium
I9	Baltimore (Maryland, United States)	44	Health Services Administration (Auburn, United States, N/I)	-	Very high	-	-	-
I10	Itápolis (São Paulo State, Brazil)	63	Medicine (UEL, Brazil, 1975-1982)	Medium	Very high	-	Medium	High

THEME	AGENT (HIGHER CAPITAL)	INTERVIEW FRAGMENTS
Background and conditions of feasibility: national and international cooperation	I9 (Bureaucratic)	“...what Unitaid does as part of product introduction, and what they wanted to do for PrEP, we knew that PrEP was effective, but we didn’t know how to deliver it effectively, so the ideas of the projects were to see what demand-generation activities, what type of service delivery, what type of messaging, what type of support tools would users need, you know, you’re trying to reach a particular population and concentrated epidemics, who don’t access services...”
	I10 (Bureaucratic)	“...the department even had an LGBT population working there, but (...) it had nothing to do with youth (...) three gay boys and a trans girl (...) young people, very energetic who knew how to deal with youth, communicate [were recruited] And they helped (...) to organize a training (...) for youth empowerment...”
	I7 (Scientific and Militant)	“...there was a whole international and Brazilian context that brought PrEP to a leading role. Not a leading role as the only technology, but as an effective prevention technology. So, all the AIDS and HIV congresses with many studies, as a promising technology, so this whole background pushed us to study this topic. It has a favorable context, a scientific, financial, technological, favorable context for that... and social too, right? So PrEP was the focus of the study”
	I7 (Scientific and Militant)	“So, the studies (...) show the great effectiveness of PrEP for prevention and this technology stands as a promising technology for prevention. So it turns out that the governments of different countries, the international agencies have a super important role in this process, the agencies specifically the WHO or UNAIDS also have an important role in the diffusion of these prevention technologies...”
PrEP and scientific evidence	I3 (Scientific)	“...the PrEP Brazil project was fundamental in providing CONITEC with scientific evidence on the importance of evaluations to demonstrate the effectiveness of PrEP for these two key populations, men who have sex with men, travestis, and trans women...”
PrEP in Brazil - initial challenges	I1 (Bureaucratic)	“...civil society in Latin America has a lot of resistance to everything that resembles medicalization, capitalism, so it’s always received with ‘no’. So, PrEP took some time to convince civil society that this was a good thing (...) [We also] have all the councils involved and supporting and finally manage to approve antiretrovirals as prevention, etc. and the whole regulatory issue...”
The delay in the Brazilian response	I1 (Bureaucratic)	“...it was absurdly slow (...) because what happens is that, in general, any recommendation takes a long time to enter Latin America and the Caribbean (...) One is because you don't have a financing agent pushing and determining things (...) Latin America doesn’t receive many external resources (...) in Brazil, you don’t bring in a new product overnight, you have a whole bureaucratic process...”
PREP1519: strategies and innovations	I9 (Bureaucratic)	“...the creativity that these folks have, I think I’ve never seen anything like it. (...) I think [it] will turn the tide for services to the younger population. (...) how they design the different digital technologies, or the services (...), you know, you don’t see that very often, but I do think Brazil is a very special place when it comes to key populations (...). So, to do those types of services might be harder in other places, but I do think that what digital tools have been created in PrEP1519 will help in those places where these populations are more marginalized”
Choosing the research sites	I3 (Scientific)	“São Paulo has always been the epicenter of the HIV/AIDS epidemic in Brazil, and it has accumulated experience like no other municipality. (...) Belo Horizonte has [had] a tradition of [conducting] cohort studies on men who have sex with men for a long time, very concentrated in the department of infectious diseases at UFMG, where the coordinator (...) has a more clinical profile (...) [Salvador had a research project on the acceptability of PrEP between TrTGW called PopTrans]”
Choosing the research sites	I1 (Bureaucratic)	“So, in terms of choosing cities, I think honestly it was a political decision. I think this combination of meeting people who can play and play well...”

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[1] Correspondence
T. R. A. Rossi Rua dos Pintassilgos 202, apto. 1103, Salvador, BA 41720-030, Brasil. thais.aranha@gmail.com