Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study.

BACKGROUND: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs). OBJECTIVE: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services. METHODS: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively. RESULTS: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023. CONCLUSIONS: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South. TRIAL REGISTRATION: Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44961.

Gravando: desafios para (re)contar narrativas do(no) movimento social de travestis brasileiras / Recording: challenges to (re)tell narratives of(in) the social movement of Brazilian transvestites

A produção de um documentário como estratégia de pesquisa no campo das ciências humanas ainda gera debate significativo. Buscando contribuir para esse debate, o objetivo deste artigo é apontar alguns desafios metodológicos que marcaram o processo de pesquisar/registrar/narrar um filme documentário sobre a trajetória de vida de Keila Simpson e seus entrelaçamentos com(na) história do movimento de travestis no Brasil. Assim, por meio de uma análise teórica, inicialmente, discutimos as disputas sobre o real e o verdadeiro que se (re)produzem na interação com as imagens. A partir de uma perspectiva etnográfica, então, refletimos sobre nosso percurso de realização do documentário, nas etapas de exploração e produção de esboços, apresentando possibilidades e limites de fazer/pensar/negociar um filme etnográfico sendo pesquisador/cineasta em interação com a interlocutora/narradora. Entendemos que o filme permitirá entender aspectos sensíveis da protagonista e suas relações de sociabilidade e, de forma indireta, compreender o sensível não diretamente abordado pelas imagens.(AU)

The documentary as a research strategy in the field of human sciences still generates significant debate. Aiming to contribute to this debate, the objective of this article is to point out some methodological challenges that marked the process of researching/ recording/narrating a documentary film about the life trajectory of Keila Simpson and its interweavings with(in) the history of the transvestite movement in Brazil. Thus, through a theoretical analysis, we initially discuss the disputes over the real and the truth that (re)produce in the interaction with the images. From an ethnographic perspective, then, we reflect on our journey of making a documentary, in the stages of exploration and production of sketches, presenting possibilities and limits to make/think/negotiate an ethnographic film being a researcher/filmmaker in interaction with the interlocutor/narrator. We understand that the film will allow us to understand sensitive aspects of the protagonist and her sociability and, indirectly, to understand the sensitive not directly addressed by the images.(AU)