Document text
Principal Investigator: Diana Montserrat Sheehan
Organization: FLORIDA INTERNATIONAL UNIVERSITY
Fiscal Year: 2024
Award: $544,510
Funding agency: National Institute on Minority Health and Health Disparities
PROJECT SUMMARY
Approximately 40% of Latino MSM with HIV do not achieve viral suppression—an estimate that has likely
worsened due to COVID-19 Pandemic stressors such as unemployment, loss of health insurance,
homelessness, and exacerbated mental health and substance use disorders caused by the COVID-19
pandemic. Antiretroviral therapy (ART) adherence is associated with decreased viral load, increased CD4
counts, fewer hospital days, slower disease progression, and longer survival. Adherence also helps prevent
drug resistance and reduces HIV transmission risk. The primary objective of this study is to evaluate the
efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a
sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of
delivering TXTXT first and stepping up to remote patient navigation for non-responders vs. a stepped care
strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-
responders. Both, TXTXT (“Treatment Text”) and the foundations of the e-Navigation interventions are CDC
evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building,
testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three
specific aims: Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static
(non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral
suppression among Latino MSM with HIV. Aim 2. Compare the immediate (6-month) and sustained (9- and
12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs.
TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression
among Latino MSM with HIV. Aim 3. Identify baseline and time-varying moderators on the association
between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. The
proposed study is innovative by culturally adapting and combining two EBIs, using a stepped care approach,
remote patient navigators, adaptive EMA components, and a SMART design. The proposed study is significant
because it provides data on the efficacy of two scalable EBIs in one efficient design and provides data on
enhanced treatment options for non-responders. The study is also significant because it targets an NIH health
disparity population (Latino MSM) and addresses multiple domains and levels of influence on health and health
disparities. It also targets people living in an Ending the HIV Epidemic geographic focus area with the highest
HIV diagnosis rate in the nation (South Florida), thereby supporting the objectives of reducing HIV disparities in
populations at high risk and living in the Southern US.
Terms: <2 way SMS><2 way text messaging><2 way texting><21+ years old><AIDS Virus><Access to Care><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Address><Adherence><Adult><Adult Human><Advocacy><Area><Belief><CD4 Lymphocyte Count><CD4+ Cell Counts><CD4+ Counts><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><Case Management><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Client><Data><Disease Progression><Drug resistance><Ecological momentary assessment><Epidemic><Evidence based intervention><Florida><Foundations><Geography><HIV><HIV diagnosis><HIV disparities><HIV inequalities><HIV inequities><HIV related disparities><HIV related inequities><HIV/AIDS disparities><HIV/AIDS inequities><HIV/AIDS related disparities><Health><Health Instruction><Health Insurance><Health Services Accessibility><Health Tutoring><Health education><Homelessness><Human Immunodeficiency Viruses><Individual><Informal Social Control><Interpersonal Interaction><Interpersonal Relations><Intervention><Intervention Strategies><LAV-HTLV-III><Latino><Latino Population><Latino group><Latino individual><Latino people><Latinos><Length of Stay><Life><Lymphadenopathy-Associated Virus><MSM><Mental Health><Mental Hygiene><NIH><National Institutes of Health><Number of Days in Hospital><Outcome><Patients><Persons><Population><Psychological Health><Randomized><Randomized, Controlled Trials><Relationship-Building><Reporting><Risk><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><Sampling><Self Efficacy><Self Management><Self Regulation><Sequential Multiple Assignment Randomized Trial><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><Social Service><Social Work><Substance Use Disorder><T4 Lymphocyte Count><Testing><Text><Time><Transmission><Treatment Protocols><Treatment Regimen><Treatment Schedule><Trust><Unemployment><United States><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><United States National Institutes of Health><Viral><Viral Burden><Viral Load><Viral Load result><Virus-HIV><access to health services><access to services><access to treatment><accessibility to health services><adulthood><antiretroviral therapy><antiretroviral treatment><arm><availability of services><bi-directional SMS><bidirectional SMS><care access><care coordination><coordinating care><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><cost effectiveness><design><designing><determine efficacy><disparity in health><drug resistant><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><evaluate efficacy><examine efficacy><forgetting><health disparity><health disparity community><health disparity group><health disparity populations><health insurance plan><health service access><health services availability><high risk><homeless><hospital days><hospital length of stay><hospital stay><improved><improved outcome><innovate><innovation><innovative><interpersonal relationship><interventional strategy><jobless><joblessness><m-Health><mHealth><mHealth therapeutic><mHealth therapy><mHealth treatment><men><men having sex with men><men who have sex with men><men who have sex with other men><mhealth interventions><mobile health><mobile health intervention><mobile health therapeutic><mobile health therapy><mobile health treatment><out of work><pandemic associated stressor><pandemic related stressor><pandemic stressor><patient navigation><patient navigator><pill><post intervention><prevent><preventing><programs><psychosocial><randomisation><randomization><randomized control trial><randomly assigned><resistance to Drug><resistant to Drug><service availability><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><social cognitive theory><social learning theory><substance use and disorder><success><therapy adherence><therapy compliance><transmission process><treatment access><treatment adherence><treatment compliance><trial design><two way SMS><two way text messaging><two way texting><unemployed><unhoused>