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Article ; Online: Discriminatory experiences among gay, bisexual, and other men who have sex with men, and transgender and non-binary individuals: a cross sectional analysis.

Freitas, Lucilene / Torres, Thiago S / Hoagland, Brenda / Silva, Mayara S T / Veloso, Valdilea G / Grinsztejn, Beatriz / Bastos, João L / Luz, Paula M

Lancet regional health. Americas

2024 Volume 33, Page(s) 100737

Abstract: Background: Several systems of oppression combine in complex ways to impact the lives of minority populations. Following an intersectionality framework, we assessed the frequency and perceived reasons for discrimination among gay, bisexual, and other ... ...

Abstract	Background: Several systems of oppression combine in complex ways to impact the lives of minority populations. Following an intersectionality framework, we assessed the frequency and perceived reasons for discrimination among gay, bisexual, and other cisgender men who have sex with men (MSM) and transgender and non-binary individuals (TGNB), stratified by race. Methods: Online survey among MSM and TGNB ≥18 years living in Brazil, between November/2021 and January/2022. We used the 18-item Explicit Discrimination Scale to assess day-to-day experiences of differential treatment, and perceived discrimination. For each item, participants indicated their perceived reasons for differential treatment using 14 pre-defined options. Negative binomial regression models assessed if race was a significant predictor of discrimination. Subsequent models, stratified by race, examined associations of perceived reasons and number of reasons with perceived discrimination. Findings: Of 8464 MSM and TGNB, 4961 (58.6%) were White, 2173 (25.7%) Interpretation: LGBTQIA+phobia was highly prevalent among all participants. Additionally, our results indicated that Black MSM and TGNB participants were more frequently discriminated against than other racial groups, with racial discrimination uniquely contributing these experiences. Funding: Fundação Oswaldo Cruz, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro.
Language	English
Publishing date	2024-04-10
Publishing country	England
Document type	Journal Article
ISSN	2667-193X
ISSN (online)	2667-193X
DOI	10.1016/j.lana.2024.100737
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Article ; Online: Ongoing HIV-1 evolution and reservoir reseeding in two elite controllers with genetically diverse peripheral proviral quasispecies.

de Azevedo, Suwellen Sardinha Dias / Côrtes, Fernanda Heloise / Villela, Larissa M / Hoagland, Brenda / Grinsztejn, Beatriz / Veloso, Valdilea Gonçalvez / Morgado, Mariza G / Bello, Gonzalo

Memorias do Instituto Oswaldo Cruz

2023 Volume 118, Page(s) e230066

Abstract: Background: Elite controllers (EC) are human immunodeficiency virus (HIV)-positive individuals who can maintain low viral loads for extended periods without antiretroviral therapy due to multifactorial and individual characteristics. Most have a small ... ...

Abstract	Background: Elite controllers (EC) are human immunodeficiency virus (HIV)-positive individuals who can maintain low viral loads for extended periods without antiretroviral therapy due to multifactorial and individual characteristics. Most have a small HIV-1 reservoir composed of identical proviral sequences maintained by clonal expansion of infected CD4+ T cells. However, some have a more diverse peripheral blood mononuclear cell (PBMC)-associated HIV-1 reservoir with unique sequences. Objectives: To understand the turnover dynamics of the PBMC-associated viral quasispecies in ECs with relatively diverse circulating proviral reservoirs. Methods: We performed single genome amplification of the env gene at three time points during six years in two EC with high intra-host HIV DNA diversity. Findings: Both EC displayed quite diverse PBMCs-associated viral quasispecies (mean env diversity = 1.9-4.1%) across all time-points comprising both identical proviruses that are probably clonally expanded and unique proviruses with evidence of ongoing evolution. HIV-1 env glycosylation pattern suggests that ancestral and evolving proviruses may display different phenotypes of resistance to broadly neutralising antibodies consistent with persistent immune pressure. Evolving viruses may progressively replace the ancestral ones or may remain as minor variants in the circulating proviral population. Main conclusions: These findings support that the high intra-host HIV-1 diversity of some EC resulted from long-term persistence of archival proviruses combined with the continuous reservoir's reseeding and low, but measurable, viral evolution despite undetectable viremia.
MeSH term(s)	Humans ; Proviruses/genetics ; HIV-1/genetics ; Quasispecies/genetics ; Leukocytes, Mononuclear ; HIV Infections ; Viral Load ; CD4-Positive T-Lymphocytes
Language	English
Publishing date	2023-06-05
Publishing country	Brazil
Document type	Journal Article
ZDB-ID	953293-6
ISSN	1678-8060 ; 0074-0276
ISSN (online)	1678-8060
ISSN	0074-0276
DOI	10.1590/0074-02760230066
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Article ; Online: Moderating Effect of Pre-Exposure Prophylaxis Use on the Association Between Sexual Risk Behavior and Perceived Risk of HIV Among Brazilian Gay, Bisexual, and Other Men Who Have Sex With Men: Cross-Sectional Study.

Blair, Kevin James / Torres, Thiago S / Hoagland, Brenda / Bezerra, Daniel R B / Veloso, Valdilea G / Grinsztejn, Beatriz / Clark, Jesse / Luz, Paula M

JMIR public health and surveillance

2023 Volume 9, Page(s) e45134

Abstract: Background: Gay, bisexual, and other men who have sex with men (MSM) with a higher perceived risk of HIV are more aware of and willing to use pre-exposure prophylaxis (PrEP). PrEP is an effective HIV prevention strategy, but there is a lack of data on ... ...

Abstract	Background: Gay, bisexual, and other men who have sex with men (MSM) with a higher perceived risk of HIV are more aware of and willing to use pre-exposure prophylaxis (PrEP). PrEP is an effective HIV prevention strategy, but there is a lack of data on how PrEP use might moderate the relationship between sexual risk behavior and perceived risk of HIV. Moreover, most studies measure perceived risk of HIV via a single question. Objective: We estimated the moderating effect of PrEP use on the association between sexual risk behavior and perceived risk of HIV, measured with the 8-item Perceived Risk of HIV Scale (PRHS), among Brazilian MSM. Methods: A cross-sectional, web-based survey was completed by Brazilian Hornet app users aged ≥18 years between February and March 2020. We included data from cisgender men who reported sex with men in the previous 6 months. We evaluated the moderating effect of current PrEP use on the association between sexual risk behavior, measured via the HIV Incidence Risk Index for MSM (HIRI-MSM), and perceived risk of HIV, measured by the PRHS. Higher HIRI-MSM (range 0-45) and PRHS (range 10-40) scores indicate greater sexual behavioral risk and perceived risk of HIV, respectively. Both were standardized to z scores for use in multivariable linear regression models. Results: Among 4344 cisgender MSM, 448 (10.3%) were currently taking PrEP. Current PrEP users had a higher mean HIRI-MSM score (mean 21.0, SD 9.4 vs mean 13.2, SD 8.1; P<.001) and a lower mean PRHS score (mean 24.6, SD 5.1 vs mean 25.9, SD 4.9; P<.001) compared to those not currently taking PrEP. In the multivariable model, greater HIRI-MSM scores significantly predicted increased PRHS scores (β=.26, 95% CI 0.22-0.29; P<.001). PrEP use moderated the association between HIRI-MSM and PRHS score (interaction term β=-.30, 95% CI -0.39 to -0.21; P<.001), such that higher HIRI-MSM score did not predict higher PRHS score among current PrEP users. Conclusions: Our results suggest current PrEP users have confidence in PrEP's effectiveness as an HIV prevention strategy. PrEP's effectiveness, positive psychological impact, and the frequent HIV testing and interaction with health services required of PrEP users may jointly influence the relationship between sexual risk behavior and perceived risk of HIV among PrEP users.
MeSH term(s)	Male ; Humans ; Adolescent ; Adult ; Homosexuality, Male ; Sexual and Gender Minorities ; Cross-Sectional Studies ; Pre-Exposure Prophylaxis ; HIV ; Brazil/epidemiology ; HIV Infections/epidemiology ; HIV Infections/prevention & control ; Risk-Taking
Language	English
Publishing date	2023-10-05
Publishing country	Canada
Document type	Journal Article
ISSN	2369-2960
ISSN (online)	2369-2960
DOI	10.2196/45134
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Article ; Online: Comparative HIV-1 Proviral Dynamics in Two Individuals That Maintained Viral Replication Control with or without Antiretroviral Therapy following Superinfection.

de Azevedo, Suwellen Sardinha Dias / Côrtes, Fernanda H / Villela, Larissa M / Hoagland, Brenda / Grinsztejn, Beatriz / Veloso, Valdilea G / Morgado, Mariza G / Bello, Gonzalo

Viruses

2022 Volume 14, Issue 12

Abstract: The analysis of the HIV-1 proviral dynamics after superinfection in the context of both natural and antiretroviral therapy (ART)-mediated suppression could yield unique insights into understanding the persistence of viral variants that seeded the ... ...

Abstract	The analysis of the HIV-1 proviral dynamics after superinfection in the context of both natural and antiretroviral therapy (ART)-mediated suppression could yield unique insights into understanding the persistence of viral variants that seeded the infected cells at different times. In this study, we performed a longitudinal analysis of the env diversity of PBMC-associated HIV DNA quasispecies in two HIV controllers (EEC09 and VC32) that were superinfected with subtype F1 viruses several years after primoinfection with subtype B viruses. Patient EEC09 started ART soon after superinfection, while patient VC32 maintained a natural control of virus replication for at least six years following the superinfection. Our analysis revealed no significant temporal changes in the overall proportion of primo-infecting and superinfecting proviral variants over 2-3 years after superinfection in both HIV controllers. Upon the introduction of ART, individual EEC09 displayed no evidence of HIV-infected cell turnover or viral evolution, while subject VC32 displayed some level of HIV-infected cell reseeding and detectable evolution (divergence) of both viral variants. These results confirm that proviral variants that seeded the reservoir at different times throughout infection could persist for long periods under fully suppressive ART or natural viremic control, but the HIV-1 proviral dynamics could be different in both settings.
MeSH term(s)	Humans ; Proviruses/genetics ; HIV-1/genetics ; Superinfection ; Leukocytes, Mononuclear ; Virus Replication ; HIV Infections ; HIV Seropositivity ; Viral Load
Language	English
Publishing date	2022-12-15
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v14122802
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Article ; Online: Preferences for pre-exposure prophylaxis (PrEP) among sexual and gender minorities: a discrete choice experiment in Brazil.

Pereira, Claudia Cristina de Aguiar / Torres, Thiago Silva / Luz, Paula Mendes / Hoagland, Brenda / Farias, Alessandro / Brito, José David Urbaez / Lacerda, Marcus Vinícius Guimarães / Silva, Daila Alena Raenck / Benedetti, Marcos / Pimenta, Maria Cristina / Grinsztejn, Beatriz / Veloso, Valdilea Gonçalves

Lancet regional health. Americas

2023 Volume 19, Page(s) 100432

Abstract: Background: Men who have sex with men (MSM) and transgender women (TGW) are disproportionally affected by HIV infection in Latin America. This study aims to assess pre-exposure prophylaxis (PrEP) preferences among sexual and gender minorities (SGM) and ... ...

Abstract	Background: Men who have sex with men (MSM) and transgender women (TGW) are disproportionally affected by HIV infection in Latin America. This study aims to assess pre-exposure prophylaxis (PrEP) preferences among sexual and gender minorities (SGM) and identify attributes and levels that are related to PrEP uptake and adherence, both crucial for PrEP success. Methods: We conducted a discrete choice experiment (DCE) among SGM from all Brazilian regions (September-December/2020). The survey was administered face-to-face (five Brazilian capitals) and online (entire country). We used a D-efficient zero-prior blocked experimental design to select 60 paired-profile DCE choice tasks. Findings: The total sample size was 3924 (90.5% MSM; 7.2% TGW and 2.3% non-binary or gender diverse persons). In random-effects logit models, highest levels of protection and "no side effects" were the most important attribute levels. For "presentation", injectable and implant were preferred over oral. Participants were willing to accept a 4.1% protection reduction to receive injectable PrEP or a 4.2% reduction if PrEP were taken monthly. The largest class in the latent class models was defined predominantly by the preference for the highest HIV protection level (p < 0.005). Respondents in this class also preferred no side effects, injectable and implant presentations. Interpretation: Higher HIV protection, no side effects, and presentation, whether injectable or implant, were the most important attributes in PrEP preferences. Protection against HIV was the most important attribute. PrEP programs should make available technologies such as long-acting presentations that could reunite the most desired attributes, thus maximizing acceptability and user-appropriateness. Funding: Unitaid.
Language	English
Publishing date	2023-02-06
Publishing country	England
Document type	Journal Article
ISSN	2667-193X
ISSN (online)	2667-193X
DOI	10.1016/j.lana.2023.100432
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Article ; Online: Correction to: HIV Risk Perception and Pre-Exposure Prophylaxis (PrEP) Awareness Among Transgender Women from Mexico.

Guillen-Diaz-Barriga, Centli / Diaz-Sosa, Dulce / Torres, Thiago S / Konda, Kelika A / Robles-Garcia, Rebeca / Hoagland, Brenda / Benedetti, Marcos / Pimenta, Cristina / Grinsztejn, Beatriz / Caceres, Carlos F / Veloso, Valdilea G / Vega-Ramirez, Hamid

AIDS and behavior

2022 Volume 27, Issue 3, Page(s) 1003

Language	English
Publishing date	2022-10-17
Publishing country	United States
Document type	Published Erratum
ZDB-ID	1339885-4
ISSN	1573-3254 ; 1090-7165
ISSN (online)	1573-3254
ISSN	1090-7165
DOI	10.1007/s10461-022-03887-z
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Article: A Peer-Led Digital Intervention to Reduce HIV Prevention and Care Disparities Among Young Brazilian Transgender Women (The BeT Study): Protocol for an Intervention Study.

Jalil, Emilia Moreira / Wilson, Erin / Monteiro, Laylla / Varggas, Thaylla / Moura, Isabele / Torres, Thiago S / Hoagland, Brenda / Cardoso, Sandra Wagner / Ismerio Moreira, Ronaldo / Gonçalves Veloso Dos Santos, Valdilea / Grinsztejn, Beatriz

JMIR research protocols

2023 Volume 12, Page(s) e44157

Abstract: Background: The HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and ...

Abstract	Background: The HIV epidemic continues to disproportionately burden marginalized populations despite the availability of effective preventive and therapeutic interventions. Transgender women are severely affected by HIV worldwide including in Brazil and other low- and middle-income countries, with evidence of increasing new infections among young people. There is an urgent need for youth-specific HIV prevention and care interventions for young transgender women in Brazil. Objective: This study aims to (1) address stigma in the Brazilian public health system and (2) reduce barriers to HIV care and prevention with systems navigation among young transgender women aged 18-24 years in Rio de Janeiro, Brazil. Methods: The Brilhar e Transcender (BeT) study is a status-neutral, peer-led, single-arm digital intervention study enrolling 150 young transgender women in Rio de Janeiro, Brazil. The intervention was pilot tested and refined using data from a formative phase. The BeT intervention takes place over 3 months, is delivered remotely via mobile phone and in person by peers, and comprises three components: (1) BeT sessions, (2) digital interactions, and (3) automated messages. Eligibility criteria include identifying as transgender women, being aged 18-24 years, speaking in Portuguese, and living in the Rio de Janeiro metropolitan area in Brazil. The primary outcomes are HIV incidence, pre-exposure prophylaxis uptake, linkage to HIV care, and viral suppression. Primary outcomes were assessed at baseline and quarterly for 12 months. Participants respond to interviewer-based surveys and receive tests for HIV and sexually transmitted infections. Results: The study has been approved by the Brazilian and the US local institutional review boards in accordance with all applicable regulations. Study recruitment began in February 2022 and was completed in early July 2022. Plans are to complete the follow-up assessment of study participants on July 2023, analyze the study data, and disseminate intervention results by December 2023. Conclusions: Interventions to engage a new generation of transgender women in HIV prevention and care are needed to curb the epidemic. The BeT study will evaluate a digital peer-led intervention for young transgender women in Brazil, which builds on ways young people engage in systems and uses peer-led support to empower transgender youth in self-care and health promotion. A promising evaluation of the BeT intervention may lead to the availability of this rapidly scalable status-neutral HIV intervention that can be translated throughout Brazil and other low- and middle-income countries for young transgender women at high risk of or living with HIV. Trial registration: ClinicalTrials.gov NCT05299645; https://clinicaltrials.gov/ct2/show/NCT05299645. International registered report identifier (irrid): DERR1-10.2196/44157.
Language	English
Publishing date	2023-02-03
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2719222-2
ISSN	1929-0748
ISSN	1929-0748
DOI	10.2196/44157
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Article ; Online: Impact of Latent M. tuberculosis Infection Treatment on Time to CD4/CD8 Recovery in Acute, Recent, and Chronic HIV Infection.

Grinsztejn, Eduarda / Cardoso, Sandra Wagner / Velasque, Luciane / Hoagland, Brenda / Dos Santos, Desiree Gomes / Coutinho, Carolina / Cruz Silva, Simone da Costa / Nazer, Sandro Coutinho / Ferreira, Ana Cristina Garcia / Castilho, Jessica / Grinsztejn, Beatriz / Veloso, Valdilea G

Journal of acquired immune deficiency syndromes (1999)

2023 Volume 94, Issue 4, Page(s) 355–363

Abstract: Introduction: In people living with HIV, active and latent tuberculosis (TB) coinfections are associated with immune activation that correlate with HIV progression and mortality. We investigated the effect of initiating antiretroviral therapy (ART) ... ...

Abstract	Introduction: In people living with HIV, active and latent tuberculosis (TB) coinfections are associated with immune activation that correlate with HIV progression and mortality. We investigated the effect of initiating antiretroviral therapy (ART) during acute (AHI), recent (RHI), or chronic HIV infection (CHI) on CD4/CD8 ratio normalization and associated factors, the impact of latent TB infection treatment, and prior/concomitant TB diagnosis at the time of ART initiation. Methods: We included sex with men and transgender women individuals initiating ART with AHI, RHI and CHI between 2013 and 2019, from a prospective cohort in Brazil. We compared time from ART initiation to the first normal CD4/CD8 ratio (CD4/CD8 ≥1) using Kaplan-Meier curves and multivariable Cox proportional hazards models. Sociodemographic and clinical variables were explored. Variables with P -values <0.20 in univariable analyses were included in multivariable analyses. Results: Five hundred fifty participants were included, 11.8% classified as AHI and 6.4% as RHI, 46.7% with CHI-CD4 cell counts ≥350 cells/mm 3 and 35.1% with CHI-CD4 cell counts <350 cells/mm 3 . Time to normalization was shortest among AHI patients, followed by RHI and CHI individuals with higher baseline CD4. In the multivariable model, AHI was associated with a six-fold increased likelihood of achieving a CD4/CD8 ratio ≥1 (hazard ratio [HR]: 6.03; 95% confidence interval [CI]: 3.70 to 9.82; P < 0.001), RHI with HR: 4.47 (95% CI: 2.57 to 7.76; P < 0.001), and CHI CD4 ≥350 cells/mm 3 with HR: 1.87 (95% CI: 1.24 to 2.84; P = 0.003). Latent TB infection treatment was significantly associated with a higher likelihood of the outcome (HR: 1.79; 95% CI: 1.22 to 2.62; P = 0.003). Previous history or concomitant active TB at ART initiation was associated with a lower likelihood of the outcome (HR: 0.41; 95% CI: 0.16 to 1.02; P = 0.054). Conclusions: Initiating ART early during AHI may offer an opportunity to mitigate immune damage. Efforts to implement HIV diagnosis and ART initiation during AHI are critical to amplify ART benefits.
MeSH term(s)	Male ; Humans ; Female ; HIV Infections/complications ; HIV Infections/drug therapy ; Latent Tuberculosis/drug therapy ; Latent Tuberculosis/complications ; Prospective Studies ; Tuberculosis/complications ; Tuberculosis/drug therapy ; CD4 Lymphocyte Count ; Mycobacterium tuberculosis ; CD8-Positive T-Lymphocytes ; Anti-HIV Agents/therapeutic use
Chemical Substances	Anti-HIV Agents
Language	English
Publishing date	2023-10-26
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	645053-2
ISSN	1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
ISSN (online)	1944-7884 ; 1077-9450
ISSN	0897-5965 ; 0894-9255 ; 1525-4135
DOI	10.1097/QAI.0000000000003284
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Article ; Online: Evaluation of Mpox Knowledge, Stigma, and Willingness to Vaccinate for Mpox: Cross-Sectional Web-Based Survey Among Sexual and Gender Minorities.

Torres, Thiago Silva / Silva, Mayara Secco Torres / Coutinho, Carolina / Hoagland, Brenda / Jalil, Emilia Moreira / Cardoso, Sandra Wagner / Moreira, Julio / Magalhaes, Monica Avelar / Luz, Paula Mendes / Veloso, Valdilea G / Grinsztejn, Beatriz

JMIR public health and surveillance

2023 Volume 9, Page(s) e46489

Abstract: Background: The 2022 multicountry mpox outbreak positioned the condition as a public health emergency of international concern. By May 2023, Brazil ranked second globally in the cumulative number of mpox cases and deaths. The higher incidence of mpox ... ...

Abstract	Background: The 2022 multicountry mpox outbreak positioned the condition as a public health emergency of international concern. By May 2023, Brazil ranked second globally in the cumulative number of mpox cases and deaths. The higher incidence of mpox among gay and other men who have sex with men in the current mpox outbreak deepens the stigma and discrimination against sexual and gender minorities (SGM). This might worsen the structural barriers impacting access to health services, which ultimately leads to undertesting and underreporting of cases. There are no data available on mpox knowledge and stigma in Latin America. Objective: We aimed to evaluate mpox knowledge, stigma, and willingness to vaccinate for mpox among SGM, and to describe sociodemographic and behavioral characteristics according to self-reported mpox diagnosis. Methods: A cross-sectional, internet-based survey was conducted in a convenience sample of adults (aged >18 years) living in Brazil recruited through advertisements on dating apps, social media, referral institutions for infectious diseases websites, and mass media (October-November 2022). We compared participants' characteristics according to self-reported mpox diagnosis using chi-square test or Fisher exact test for qualitative variables and Kruskal-Wallis test for quantitative variables. Results: We enrolled 6236 participants: 5685 (91.2%) were cisgender men; 6032 (96.7%) were gay, bisexual, or pansexual; 3877 (62.2%) were White; 4902 (78.7%) had tertiary education; and 4070 (65.2%) reported low or middle income. Most participants (n=5258, 84.4%) agreed or strongly agreed that "LGBTQIA+ individuals are being discriminated and stigmatized due to mpox." Mpox awareness was 96.9% (n=6044), and 5008 (95.1%) were willing to get vaccinated for mpox. Overall, 324 (5.2%) reported an mpox diagnosis. Among these, 318 (98.1%) reported lesions, 178 (56%) local pain, and 316 (99.4%) sought health care. Among participants not reporting a diagnosis, 288 (4.9%) had a suspicious lesion, but only 158 (54.9%) of these had sought health care. Compared to participants with no diagnosis, those reporting an mpox diagnosis were younger (P<.001), reported more sex partners (P<.001), and changes in sexual behavior after mpox onset (P=.002). Moreover, participants diagnosed with mpox reported more frequently being tested for HIV in the prior 3 months (P<.001), living with HIV (P<.001), currently using HIV pre-exposure prophylaxis (P<.001), and previous sexually transmitted infection diagnosis (P<.001). Conclusions: Our results point to high mpox knowledge and willingness to vaccinate among SGM in Brazil. Participants self-reporting mpox diagnosis more frequently reported to be living with HIV, STI diagnosis, and current pre-exposure prophylaxis use, highlighting the importance of an mpox assessment that includes comprehensive sexual health screenings. Efforts to decrease stigma related to mpox among SGM are necessary to avoid mpox underdiagnosis.
MeSH term(s)	Adult ; Humans ; Male ; Cross-Sectional Studies ; HIV Infections/epidemiology ; Homosexuality, Male ; Mpox (monkeypox)/epidemiology ; Sexual and Gender Minorities ; Sexual Behavior ; Sexually Transmitted Diseases/epidemiology ; Sexually Transmitted Diseases/prevention & control ; Social Media ; Vaccination ; Health Knowledge, Attitudes, Practice
Language	English
Publishing date	2023-07-17
Publishing country	Canada
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2369-2960
ISSN (online)	2369-2960
DOI	10.2196/46489
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Article ; Online: Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study.

Grinsztejn, Beatriz / Torres, Thiago Silva / Hoagland, Brenda / Jalil, Emilia Moreira / Moreira, Ronaldo Ismerio / O'Malley, Gabrielle / Shade, Starley B / Benedetti, Marcos R / Moreira, Julio / Simpson, Keila / Pimenta, Maria Cristina / Veloso, Valdiléa Gonçalves

JMIR public health and surveillance

2023 Volume 9, Page(s) e44961

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Humans ; HIV Infections/prevention & control ; HIV Infections/drug therapy ; Anti-HIV Agents/therapeutic use ; Sexual Behavior ; Sexual and Gender Minorities ; Randomized Controlled Trials as Topic
Chemical Substances	cabotegravir (HMH0132Z1Q) ; Anti-HIV Agents
Language	English
Publishing date	2023-04-19
Publishing country	Canada
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2369-2960
ISSN (online)	2369-2960
DOI	10.2196/44961
Database	MEDical Literature Analysis and Retrieval System OnLINE

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