Document text
Principal Investigator: Katia Bruxvoort
Organization: UNIVERSITY OF ALABAMA AT BIRMINGHAM
Fiscal Year: 2024
Award: $619,863
Funding agency: National Institute of Mental Health
SUMMARY/ABSTRACT
HIV is declining in many parts of the world, but rising in Latin America, including Brazil. From 2010 to 2019, the
number of new HIV infections in Latin America increased 21%, compared to a global reduction of 23%. The
number of reported HIV cases in Brazil increased from 13,719 in 2011 to 40,880 in 2021, with increases driven
by sexual and gender minority youth aged 15-24 years (SGM youth). Among men aged 15-24 years, HIV
incidence per 100,000 increased from 37.8 in 2000 to 66.5 in 2018 – a 75% increase. HIV pre-exposure
prophylaxis (PrEP) was approved in Brazil in 2021 for adolescents aged 15-17 years, but PrEP uptake has been
<1% among SGM youth. Our team conducted the first and largest PrEP demonstration study among adolescents
in Latin America (PrEP1519), in which we implemented peer navigation strategies that linked 1174 SGM youth
(20% of 5870 recruited) to PrEP services at SGM-affirming health facilities. In qualitative interviews, SGM youth
articulated positive relationships with peer navigators but reluctance to engage with facility-based services due
to past experiences with stigma and logistical and structural challenges accessing care. These data suggest that
programs featuring peers were welcomed, but alternatives to facility-based services are urgently needed to scale
up PrEP among SGM youth. We hypothesize that equipping peer lay workers – trained SGM youth who are part
of SGM-affirming health care teams – to deliver PrEP to SGM youth in community venues will increase PrEP
uptake among SGM youth. The goal of this project is to conduct a series of studies to refine, test, and understand
experiences with a peer-led community-based intervention (CommunityPrEP, “COMPrEP”). In Aim 1, we will
conduct qualitative interviews guided by the Consolidated Framework for Implementation Research to identify
key modifications for the PrEP1519 peer navigator intervention to adapt it for community delivery by peer lay
workers. In Aim 2, we will randomize 1400 SGM youth to access PrEP through peer lay workers at community
venues (COMPrEP intervention) or health providers at SGM-affirming health facilities (standard care). We will
conduct intent-to-treat analyses with modified Poisson regression to compare PrEP uptake (primary outcome)
across randomized arms. We will follow the subset that initiates PrEP (expected to be N~385) for 12 months to
compare secondary outcomes (1-month adherence, 3-month and 12-month persistence). Throughout the trial,
we will monitor participant safety through our study team and an external monitoring board. In Aim 3, we will use
the RE-AIM framework to explore experiences with the COMPrEP intervention through qualitative interviews with
SGM youth, peer lay workers and health providers, and local and national policymakers to develop next steps.
The proposed work will provide robust evidence about whether PrEP delivery facilitated by peer lay workers in
community settings increases PrEP uptake, adherence, and persistence among SGM youth in Brazil. With
members of the National HIV Program in Brazil as our collaborators, we will be well-positioned to provide results
to guide programming for this population and scale up the intervention if effective.
Terms: <AIDS Virus><Access to Care><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Adherence><Adolescent><Adolescent Medicine><Adolescent Youth><Approaches to prevention><Articulation><Behavioral Sciences><Brazil><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Clinical Trials><Communities><Consolidated Framework for Implementation Research><Consolidated Framework for Implementation Science><Consolidated Framework for Implementing Change><Data><Eligibility><Eligibility Determination><Ensure><Epidemic><Epidemiology><Evaluation><Foundations><Gender and Sexual Minorities><General Population><General Public><Goals><HIV><HIV Infections><HTLV-III Infections><HTLV-III-LAV Infections><Health Care Providers><Health Care Team><Health Facilities><Health Personnel><Health Services Accessibility><Health care facility><Health system><Healthcare Facility><Healthcare Providers><Healthcare Team><Healthcare worker><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Incidence><Intervention><Intervention Strategies><Interview><Investigators><LAV-HTLV-III><Latin America><Libido><Link><Lymphadenopathy-Associated Virus><MSM><Medical Care Team><Modification><Monitor><Municipalities><Nurses><Personalized medical approach><Physicians><Policy Maker><Population><Position><Positioning Attribute><PrEP><Prevalence><Preventative care><Prevention><Prevention approach><Preventive care><Primary Care><Process Assessment><Protocol Screening><Provider><RE-AIM><Randomization trial><Randomized><Randomized, Controlled Trials><Reach, Effectiveness, Adoption, Implementation, and Maintenance><Reporting><Research><Research Personnel><Researchers><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Series><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Sexual and Gender Minorities><Social Sciences><Structure><Testing><Training><United Nations><Update><Virus-HIV><Work><YMSM><access to health services><access to services><access to treatment><accessibility to health services><aged><arm><authority><availability of services><care access><care facilities><clinical care><community intervention><community level intervention><community setting><community-based intervention><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><effective intervention><epidemiologic><epidemiological><experience><gender minority adolescent><gender minority children><gender minority youth><health care personnel><health care worker><health provider><health service access><health services availability><health workforce><healthcare personnel><implementation science><individualized approach><innovate><innovation><innovative><interest><interventional strategy><juvenile><juvenile human><medical personnel><member><men><men having sex with men><men who have sex with men><men who have sex with other men><navigator intervention><nurse><participant safety><peer><personalized approach><pre-exposure prophylaxis><precision approach><primary outcome><programs><randomisation><randomization><randomized control trial><randomized trial><randomly assigned><reach, efficacy, adoption, implementation, and maintenance><recruit><scale up><secondary outcome><service availability><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sex drive><sexual drive><sexual minority adolescent><sexual minority children><sexual minority youth><social stigma><sound><standard care><standard treatment><stigma><subject safety><tailored approach><trans-women><transgender women><transwoman><transwomen><treatment access><treatment provider><trend><uptake><young MSM><young men who have sex with men>