Posts classified under: Biomedical

Battling Stigma for Service Engagement among Women with HIV in Vietnam

Abstract:Women living with HIV/AIDS (WLHA) bear a higher level of stigma because of their socio-cultural vulnerabilities. Women are more likely to internalize social stigma and produce a sense of shame and loss of self-worth, which results in a delay in health service seeking and compromised health outcomes. In Vietnam, stigma towards WLHA is exacerbated by the deeply rooted female inferiority culture. However, research targeting WLHA is generally lacking. We propose this study to address stigma among WLHA and explore the use of virtual support system in WLHA’s service engagement in Vietnam. The 2-year study will proceed in two phases in Hanoi, Vietnam. Phase 1 will be formative studies, including in-depth interviews with 30 WLHA and focus groups with 20 service providers and community stakeholders. This phase aims to investigate the cultural and contextual background of HIV and gender roles in Vietnam and to identify effective strategies to support and engage WLHA in healthcare. These formative findings will inform the development of an intervention to be pilot tested in the next phase. Phase 2 will be a 6-month intervention pilot with 90 WLHA using an online/offline hybrid approach. During Month 1 of the pilot, WLHA will participate in an in-person section to form mutual support groups and prepare for the following online components. During Month 2-4 of the pilot, study investigators will teach WLHA a series of empowerment strategies to cope with stigma and utilize social support to seek healthcare services. These skills will be taught via interactive online group activities. During Month 4-6, WLHA will self-administer the online groups without the intervention of study investigators. WLHA’s multidimensional stigma measures, mental health burdens, and service use self- efficacy will be assessed at baseline, month 4, and month 6. Progress data of the intervention will be documented to inform the feasibility and sustainability of the online support approach. Acceptability data and feedback will be collected from the WLHA participants upon completion of the 6-month pilot period.

Project Number: 1R21TW012018-01

https://reporter.nih.gov/search/9c5dRBJyvkGOpSB3l9HRSw/project-details/10302007

 

Contact PI/ Project Leader

LIN, CHUNQING,  (lincq@ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV stigma and discrimination have enormous negative impacts on women, and reducing internalized stigma has significant implications for the effort to engage women in HIV prevention and care. This proposed study will devise strategies to empower women living with HIV in Vietnam to combat HIV and gender intersectional stigma. This study will lead to implementable and scalable approaches to promote women living with HIV’s mental health and service seeking not only in Vietnam but also globally.

 

 

Project Start Date: 17-September-2021

Project End Date: 31-May-2023

Budget Start Date: 17-September-2021

Budget End Date: 31-May-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF DRUG ABUSE + FOGARTY INTERNATIONAL CENTER / FY Total Cost by IC: $219,421

Evaluation of pre-exposure prophylaxis cascade in pregnant and breastfeeding women in Cape Town, South Africa

Abstract: HIV-uninfected pregnant and breastfeeding women in South Africa are at high risk of HIV acquisition despite increased uptake of antiretroviral therapy (ART) and maternal seroconversion during pregnancy and breastfeeding contributes significantly toward pediatric HIV infections. Comprehensive HIV prevention programs that include biomedical interventions, such as pre-exposure prophylaxis (PrEP), could dramatically reduce HIV incidence in pregnant and breastfeeding women in high HIV incidence areas and reduce vertical HIV transmission. The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women Candidate: I am an HIV epidemiologist with a background in HIV research and program development, implementation in Africa. I am applying for a five-year Fogarty IRSDA K01 award to obtain training, mentorship, and research experience to become an independent investigator capable of obtaining R01 funding. Mentoring: I have put together an exceptional multi-disciplinary mentoring team with extensive experience in HIV prevention research in South Africa that integrates clinical research, epidemiology, PrEP and qualitative methods. Drs. Thomas Coates (UCLA) and Landon Myer (University of Cape Town, South Africa) will serve as co-Primary mentors and bring complementary expertise in behavioral science and clinical trials. In addition to my two Primary mentors, my co-mentors provide expertise in specific content areas and methodologies and are based in both the U.S. and South Africa. My co-mentorship team includes: Dr. Pamina Gorbach (U.S.-based, behavioural epidemiologist with significant experience in mixed methods research, Dr. Linda-Gail Bekker (SA-based, clinical trials, PrEP and research in young women). Training: Specific training in clinical trials, advanced biostatistics, behavioural science and mixed methods analysis, will be achieved through intensive mentored training, coursework, workshops and and primary research in South Africa. Guided by my mentorship team, these training and research experiences will establish my independent investigator career as an expert in research in pregnant and breastfeeding women in low resource settings. Research: The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade. The results from our study will provide a model to implement WHO guidance and scale-up PrEP delivery in pregnant and breastfeeding women at risk of HIV and contribute to the elimination of vertical HIV transmission. We will use the formative research to apply for a R01 grant to evaluate interventions to improve retention in the PrEP cascade in a larger cohort of pregnant and breastfeeding women.

Project Number: 5K01TW011187-02

https://reporter.nih.gov/search/07mRB8oPokuMg0OWfAXBVA/project-details/9789716

 

Contact PI/ Project Leader

JOSEPH DAVEY, DVORA POSTDOCTORAL FELLOW (dvoradavey@ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV-negative pregnant and breastfeeding women in South Africa are at high-risk of HIV. Pre-exposure prophylaxis (PrEP) is safe and effective at preventing HIV. Our study will evaluate: (1) Acceptability & feasibility of integrating PrEP into ante and postnatal care, (2) the PrEP cascade (initiation, retention, adherence) and (3) Loss to follow up and factors associated with loss in a cascade in 200 pregnant/breastfeeding women.

 

 

Project Start Date: 21-September-2018

Project End Date: 31-January-2023

Budget Start Date: 01-April-2019

Budget End Date: 31-January-2020

 

NIH Categorical Spending

Funding IC:  FOGARTY INTERNATIONAL CENTER/ FY Total Cost by IC: $139,018

Innovative strategies to increase ART Initiation and viral suppression among HIV+ men in Malawi

Abstract: Men continue to be missed by HIV testing and treatment services. Index partner testing is a critical strategy for reaching men. Index HIV self-testing (HIVST), whereby ART clients take HIVST kits home to their sexual partners for testing, is a new strategy that dramatically increases index testing among men, and is being taken to scale across Malawi. However, only 25% of men identified as HIV-positive through Index HIVST initiate ART after 6- months. Innovative strategies to increase ART initiation and retention among men are urgently needed. The overarching goal of the proposed K01 is to develop and pilot a home-based ART intervention (ART initiation + 3-months ART care) to increase ART initiation (primary outcome) and 6-month viral suppression (secondary outcome) among men who test HIV-positive through Index HIVST in Malawi. Candidate: I am a social scientist with a background in HIV research in sub-Saharan Africa. My long-term goal is to transition from observational social science to clinical trials research in innovative HIV service delivery models among hard-to-reach populations, such as men. I am applying for a five-year K01 award to obtain training, mentorship, and research experience. Mentoring: I have an exceptional multi-disciplinary mentoring team with extensive experience in HIV care and management and clinical trials in the region. The team has complementary expertise in social science and clinical trials in HIV service delivery models (Dr. Thomas Coates – Primary Mentor), best practices in HIV care and management and differentiated models of care in Malawi (Drs. Judith Currier and Risa Hoffman), scalability and sustainability of interventions (Dr. Sundeep Gupta – Malawi-based), and advanced biostatistics (Dr. Ron Brookmyer). Career Development: To achieve my long-term goals, we have developed a detail plan to build skills in four additional areas: (1) best clinical practices for ART care and maintenance; (2) clinical trials in novel approaches to HIV service delivery; (3) advanced statistical methods; and (4) ethics in clinical trials research in low-resource settings. Research Activities: The specific aims accompanying the career development plan are to: (1) Develop a home-based ART intervention for male partners tested through Index HIVST, using in-depth interviews with male Index HIVST users (n=15-20) and their partners (n=15-20), and focus group discussions with key informants (n=18-30). (2) Determine the potential effectiveness of home-based ART versus standard facility-based ART (on ART initiation (primary outcome) and 6-month viral suppression (secondary outcome) among male Index HIVST users in a pilot trial with 200 HIV-positive men. Expected Outcomes: Results from this study will inform definitive trial to test home-based ART services for men identified as HIV-positive through index HIVST strategies. The project will also give me the additional skillsets needed to become an independent investigator in clinical trials.

Project Number: 1K01TW011484-01

https://reporter.nih.gov/search/lzNvPVXZdEyO9lcrU7nKLQ/project-details/9889473

 

Contact PI/ Project Leader

DOVEL, KATHRYN L, POSTDOCTORAL FELLOW (KDovel@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: Men in sub-Saharan Africa who test HIV-positive continue to have poor ART initiation and retention outcomes. By developing and piloting a home-based ART intervention for men who use index HIV self-testing (HIVST) strategies, the proposed project will provide additional knowledge on how to best reach men with HIV services across the testing and treatment continuum. The project has the potential to improve public health by engaging HIV-positive men across the cascade, a critical population to curbing the HIV epidemic.

 

 

Project Start Date: 16-September-2019

Project End Date: 30-June-2024

Budget Start Date: 16-September-2019

Budget End Date:30-June-2020

 

NIH Categorical Spending

Funding IC:  FOGARTY INTERNATIONAL CENTER/ FY Total Cost by IC: $145,233

Collaborative care teams for hospitalized patients with opioid use disorders: Translating evidence into practice

Abstract: The underuse of effective behavioral health treatments during the hospital stay is a translational science problem that has important consequences. Behavioral health comorbidities are common among hospitalized patients, and are associated with longer lengths of stay, higher costs and worse outcomes. Treatment for opioid use disorder (OUD) is an exemplar of this problem. Patients with OUD are frequently hospitalized, and while treatment is effective, it is dramatically underutilized, leaving patients at high-risk of continued misuse, future overdose, and readmission. There are multiple reasons for this translational inefficiency. While inpatient physicians frequently treat acute overdose and withdrawal, they have limited knowledge and training in behavioral health. Given pressures to minimize length of stay, the team usually prioritizes addressing the acute reason for admission. Moreover, few hospitals have the organizational infrastructure needed to treat behavioral health conditions effectively, such as dedicated teams, evidence-based protocols, or the ability to coordinate transitions of care such that patients can be linked to outpatient and community resources. Interdisciplinary, collaborative care teams (CCT) are a new approach to address translational roadblocks in OUD treatment delivery and have the potential to make a significant contribution to narrowing the treatment gap. Our prior work demonstrated the effectiveness of CCT when used with primary care patients with addiction, but CCT have never been tested as a translational approach in the inpatient setting. If effective, CCT could completely change the paradigm for addressing behavioral health disorders in the inpatient setting. We propose a mixed- methods, multi-site, randomized pragmatic trial in three sites to evaluate whether CCT increase translational efficiency, among hospitalized patients with OUD. We will randomize 414 patients total from Cedars Sinai Medical Center in Los Angeles, the University of New Mexico Hospital, and Baystate Health in Massachusetts to receive either CCT or usual care. Our primary outcomes are inpatient MAT initiation and linkage with post- discharge OUD treatment; secondary outcomes include days spent alive and in the community, treatment engagement, and opioid misuse. To inform future dissemination efforts, we also evaluate contextual factors affecting implementation, the sustainability of the CCT post-implementation, and costs. By blending components of clinical effectiveness and implementation research, leveraging the CTSA consortium including the Treatment Innovation Network and Recruitment Innovation Center, this innovative approach to translational research can generate more rapid translational gains, more effective downstream implementation, and will enhance the efficiency and science of translational research. The CCT offers expertise that most hospital-based physicians lack, creates an organized system of care, and addresses barriers to follow-up care. Knowledge from this study could transform the hospital experience into an opportunity to engage patients with OUD in MAT, resulting in reduced suffering, immediate and long-term gains in patient health, and decreased healthcare costs.

Project Number: 1U01TR002756-01A1

https://reporter.nih.gov/search/_lRWQTJNeEWI9778ibwMLw/project-details/9890409

 

Contact PI/ Project Leader

DANOVITCH, ITAI, CHAIRMAN, DEPARTMENT OF PSYCHIATRY (itai.danovitch@cshs.org)

 

Organization

CEDARS-SINAI MEDICAL CENTER

 

PUBLIC HEALTH RELEVANCE: Despite frequent hospitalizations, patients with opioid use disorders (OUD) are rarely started on effective pharmacotherapy and linked with aftercare, leaving them at high-risk of continued misuse, future overdose, and readmission. We will test the effectiveness of an interdisciplinary, collaborative care, addiction consult team, on increasing the initiation of opioid pharmacotherapy in the hospital and linking patients with post-discharge care. Knowledge from this study could transform the inpatient hospital experience into an opportunity to engage patients with OUD in effective care, resulting in immediate and lasting gains in health and functioning.

 

 

Project Start Date: 01-June-2020

Project End Date: 31-May-2024

Budget Start Date: 01-June-2020

Budget End Date:31-May-2021

 

NIH Categorical Spending

Funding IC:  NATIONAL CENTER FOR ADVACNING TRANSLATIONAL SCIENCES/ FY Total Cost by IC: $1,315,300

Syphilis immunology and biology to improve clinical management and vaccine design

Abstract: The proposed study will help substantially advance understanding of the immunology, biology, and detection of syphilis, through studying newly identified cases of in Lima, Peru, where syphilis is hyper-endemic. Syphilis remains a serious disease with significant adverse clinical outcomes including neurological, ophthalmic, and cardiovascular disease. Furthermore, despite over 100 years of research in the biology of Treponema pallidum, the agent of syphilis, little has been done recently with modern biological methods. Our study builds on the research infrastructure created through a previously-funded NIH capacity-building grant, the “PICASSO Study” (NIH/NIAID 5R01AI09972), to more deeply investigate the human host immune response to T. pallidum, and fill critical gaps in the understanding of syphilis. There are three specific aims to our proposal. Aim 1: Clinical epidemiology — Hypothesizing that those with de novo versus repeat syphilis infection will demonstrate different immunological profiles, we will conduct a prospective study of syphilis cases, comparing those with and without a history of prior syphilis infection. We will a) recruit, treat and follow 100 individuals with incident syphilis without prior infection (recently TP seronegative) and 100 individuals with repeat syphilis infection (recently TP seropositive); b) Compare markers of immunobiologic response over time in those 2 cohorts, including RPR and TPPA titers, prototypical inflammatory serum cytokines, and immunologic epitope serum TP antibody assays accounting for HIV- infection status, CD4 T-cell count and HIV viral load. We will also compare cytokine profiles and novel TP antibody expression at the time of serofast status versus new infection among those with similar RPR titers. Aim 2: Biological — Hypothesizing that the clinical manifestations and immunologic responses (cytokine profiles and antibody responses to TP surface proteins and lipoproteins) will differ between individuals with repeat infection versus de novo incident syphilis infection, active versus treated infection, HIV-associated immunosuppression and TP strain type, we will investigate whether a relationship exists during early syphilis between differential gene expression in TP, development of the immune response to treponemal antigens, host cytokine profiles of disease pathogenesis and immune correlates of infection. Aim 3: Rapid test evaluation — Using our current biobank (n > 3000 serological and clinical specimens from primary and secondary syphilis- diagnosed patients) and new specimens from study participants from Aim 1, we will evaluate new rapid dual HIV/syphilis rapid tests including combination RPR/TP tests, treponemal self-test kits, and a 10-minute oral mucosal fluid treponemal rapid test. This innovative program will help accelerate syphilis research and potentially clinical practice worldwide, illuminating new insights into syphilis immunology and enhancing opportunities for early detection and clinical management, while informing vaccine development.

Project Number: 1R01AI139265-01

https://reporter.nih.gov/search/NbWeAJGnR0ua_V2XfTTUnA/project-details/9576245

 

Contact PI/ Project Leader

KLAUSNER, JEFFREY DAVID, CLINICAL PROFESSOR (jdklausner@med.usc.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: This longitudinal cohort study will increase the understanding of the immunological aspects of syphilis and the biologic properties of the Treponema (T.) pallidum bacterium. The results from our proposed research will inform syphilis research and practice worldwide, and potentially illuminate new areas in the pathogenesis of syphilis, early detection, treatment and vaccine development.

 

 

Project Start Date: 01-September-2018

Project End Date: 31-August-2022

Budget Start Date: 01-September-2018

Budget End Date:31-August-2019

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES/ FY Total Cost by IC: $666,190

Trajectories of socially regulated gene expression, methamphetamine use, and viral load among HIV-positive men who have sex with men (MSM) receiving contingency management

Abstract: he K01 Mentored Research Scientist Development Award will provide Dr. Michael Li with invaluable research experience, mentored training from interdisciplinary faculty, and training activities in a combination of behavioral and basic sciences, which will prepare him well in his career as a biobehavioral researcher in addiction medicine and HIV treatment/prevention. This K01 mechanism will support Dr. Li’s research and training efforts to develop expertise in the following areas: (1) neurally regulated “stress” gene expression markers and links to addiction and HIV disease progression; (2) cultural competence and ethical conduct; (3) technical assay and substantive analytic methods in gene expression research; (4) clinical trial methods; and (5) professional development. Dr. Li has assembled an interdisciplinary mentorship team who will support key aspects of his training and research. Dr. Steven Shoptaw is a highly productive and influential researcher in addiction medicine, and he has an extensive track-record mentoring people who later became successful independent researchers. Co-mentor Dr. Steven Cole has pioneered the field of social genomics, and will direct Dr. Li’s training in transcriptomic methods. Dr. Jesse Clark will guide Dr. Li in clinical trial operations and safety procedures, and Dr. Thomas Belin will provide extensive mentoring in advanced statistical methods and inferential frameworks in clinical trials. Dr. Li proposes to investigate whether a neurally regulated “stress” gene expression pattern can serve as a clinically meaningful, non-abstinence-based endpoint for contingency management for methamphetamine (METH) use disorder (MUD) in MSM living with HIV. Abstinence determined by urine testing has been the only standard clinical outcome for MUD treatment, but provides an incomplete picture of patient recovery. The gene expression pattern called the conserved transcription response to adversity (CTRA) may provide insight into changes in both psychosocial health and pathogenesis over the course of MUD treatment. The CTRA is marked by upregulated expression of pro-inflammatory genes and downregulated expression of Type I interferon genes in response to negative psychosocial experiences such as depression, anxiety, and violence, problems also comorbid with METH use. The CTRA also involves some of same gene regulatory pathways that contribute to METH-related pathogenesis, such as those involving inflammation and innate antiviral responses (relevant to PLWH). My proposed research will use a two-arm clinical trial design (N=55) with 35 HIV-positive MSM with MUD receiving contingency management for METH reduction, and 20 HIV-positive MSM who qualify as a non-substance-using control to accomplish the following aims: 1) to investigate whether CTRA gene expression coincides with METH use and viral load; 2) to investigate whether psychosocial indicators of addiction are associated with CTRA; and 3) to conduct an exploratory pilot investigation to determine the degree to which CTRA mediates the association between METH use and viral load. Together, this K01 research project and training plan will play a fundamental role in my early success as an independent substance use and HIV researcher.

Project Number: 1K01DA051329-01A1

https://reporter.nih.gov/search/P51IV4WiG0m3UfJ8wdV_1w/project-details/10161548

 

Contact PI/ Project Leader

LI, MICHAEL JONATHAN, POSTDOCTORAL SCHOLAR (mjli@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: Determining whether a patient is both feeling better and improving physiologically when treating people living with HIV (PLWH) for methamphetamine use disorder (MUD) requires identification of a clinically significant measure separate from abstinence. My proposed K01 activities open the exciting opportunity to address this challenge by testing a gene expression pattern identified by the field of social genomics, which may provide insight into both psychosocial health and biological processes that impact chronic disease risk in PLWH receiving MUD treatment. Support from this K01 will facilitate my training in transcriptomics, clinical trial methods, and ethical/culturally competent practices, all of which will help me achieve my long-term career goal—to be a leading researcher of biomarker assessment tools for PLWH receiving addiction treatment.

 

 

Project Start Date: 01-April-2021

Project End Date: 31-March-2026

Budget Start Date: 01-April-2021

Budget End Date:31-March-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE ON DRUG ABUSE/ FY Total Cost by IC: $189,401

The impact of cannabinoids on inflammation, HIV viral load and symptoms of distress among persons living with HIV

Abstract: This Mentored Research Scientist Development Award (K01) will provide Dr. Chukwuemeka N. Okafor with training and expertise needed to facilitate his transition toward research independence in HIV and drug use prevention research. Dr. Okafor’s proposed training plan is designed to build upon his previous work in HIV and drug use epidemiology to increase his knowledge and expertise in: (1) the design, implementation and analysis of clinical trials and behavioral interventions for drug use prevention in the context of HIV (2) addiction research and research that integrates behavioral science and biological markers in the context of drug use and HIV (3) training in the ethical conduct of research and (4) career skills necessary for academic research. Dr. Okafor will achieve these training goals via didactic coursework, directed readings, workshops, scientific conferences, fieldwork and mentoring from an expert multidisciplinary panel of mentors led by Dr. Steve Shoptaw (primary mentor). The proposed research activities addresses an important public health issue regarding the impact of cannabis on health outcomes among persons living with HIV (PLWH). Majority of the few studies of the consequences of cannabis use in PLWH have produced mixed findings. Potential explanations for lack of clear evidence of the health consequences of cannabis might be due to the different active constituents (cannabinoids) in the cannabis products used. Tetrahydrocannabidiol (THC) and cannabidiol (CBD) are the most frequently studied cannabinoids and growing evidence suggest that they have opposing effects on symptoms of distress (e.g. depression and anxiety) and HIV relevant health outcomes (inflammation and HIV viral load). Specifically, THC is associated with mood altering and negative health effects, while CBD does not alter mood and may have therapeutic properties. Therefore, whether quantifiable biomarkers of THC and CBD in PLWH who use cannabis can provide clarification on the consequences of cannabinoids in PLWH has not being determined. The proposed project will employ two approaches to address this question including a secondary analysis of existing data from a cohort study and a pilot feasibility study involving PLWH who use cannabis. Specifically, the proposed project aims to: 1) determine relationships between measured concentrations of THC and CBD in urine with biomarkers of inflammation and HIV viral load in PLWH, (2) investigate associations between measured concentrations of THC and CBD in urine with symptoms of distress among PLWH and 3) To determine feasibility of and impact of a 28-day cannabis abstinence based contingency management (CM) program on changes in symptoms of distress, inflammation and HIV viral load. Completing the proposed project will provide an excellent pedestal for Dr. Okafor to transition into an independent research career.

Project Number: 1K01DA047912-01A1

https://reporter.nih.gov/search/DNeos6ubMUitt9tNVrm4Lg/project-details/9779460

 

Contact PI/ Project Leader

SHOPTAW, STEVEN J, PROFESSOR (sshoptaw@mednet.ucla.edu)

 

Organization

BAYLOR UNIVERSITY

 

PUBLIC HEALTH RELEVANCE: With the evolving state laws governing cannabis use in the United States, there is a need for sound scientific evidence on the impact of the different active constituents in cannabis on the health outcomes of vulnerable populations particularly persons living with HIV (PLWH). Through this K01 award, I will develop skills and knowledge in clinical trials, behavioral interventions for drug use, addiction research and research integrating biological markers in HIV and drug use research. Findings from this study will provide timely data on the impact of THC and CBD on symptoms of distress, inflammation and HIV viral load in PLWH.

 

 

Project Start Date: 01-August-2019

Project End Date: 31-July-2024

Budget Start Date: 01-August-2019

Budget End Date:31-July-2020

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE ON DRUG ABUSE/ FY Total Cost by IC:  $156,368

Linking Refugees to HIV Clinical Care in Uganda

Abstract: There are an estimated 3.4 million refugees living in sub-Saharan Africa, a region of the world which hosts 71% of the global population living with HIV. Displaced for an average of 17 years, refugees are a vulnerable population at risk of exposure to HIV due to violence and persecution. With competing survival needs, language and cultural barriers, and disrupted social networks, refugees face unique challenges accessing HIV care. HIV prevalence in refugee settlements in sub-Saharan Africa is often unknown and HIV research in this population is limited. Candidate: During my research fellowship, I conducted a clinic-based routine HIV testing study in Nakivale Refugee Settlement in Uganda demonstrating that only 54% of newly diagnosed HIV-infected clients linked to care. I am applying for a K23 Career Development Award to acquire the skills to become an independent investigator focused on understanding linkage to HIV care for refugees and developing interventions to improve engagement in care for this unique population. Mentoring: Dr. Ingrid Bassett (Mentor) is an expert on linkage to HIV care in resource-limited settings and winner of the Harvard Medical School Young Mentor Award. I will also be guided by Co-Mentors, Dr. Paul Spiegel (the Deputy Director of the Division of Programme Support and Management at the United Nations High Commissioner for Refugees [UNCHR], expert in the structural dimensions of refugee health), Dr. Edgar Mulogo (HIV researcher, faculty in Uganda), and Dr. Laura Bogart (expert in behavioral science, HIV intervention research, and qualitative methods). Committed advisors include Dr. Richard Mollica (Director of the Harvard Program in Refugee Trauma), Dr. Alexander Tsai (psychiatrist, expert on psychosocial intervention research for HIV- infected people in Uganda), Dr. Julius Kasozi (UNHCR in Uganda, expert in refugee health and Uganda health policy), Dr. Michael VanRooyen (Director of the Harvard Humanitarian Initiative), Dr. Norma Ware (qualitative methods), and Dr. Robert Parker (biostatistics, HIV trial design). Research: Within the social-ecological framework, I will 1) use qualitative methods to understand barriers to HIV care and means to overcome barriers for refugees in Nakivale; 2) prospectively enroll a cohort of HIV-infected refugees to assess which social-ecological factors correlate with failure to link to HIV care in Nakivale; and 3) use intervention mapping methodology to develop, implement, and evaluate a pilot intervention to improve linkage to HIV care in Nakivale. Training: The research is supported by training in health behavior theory and ecologic context of HIV care in resource-limited settings with an in-depth focus on mental health, analytic techniques including survey and geographic information system methods, and intervention development. The project will provide training and pilot data needed to develop an R01 application for a randomized HIV linkage intervention trial in three refugee settlements in Uganda. With my dedication to evaluating interventions to improve care for refugees, support from an exceptional mentoring team, strong institutional commitment, and an innovative research plan, I am well-positioned to become an independent clinical investigator focused on refugee health.

Project Number: 5K23MH108440-06

https://reporter.nih.gov/search/qs4MWlGAxUeMKzbgrNfMIA/project-details/9935159

 

Contact PI/ Project Leader

BOGART, LAURA M, SENIOR BEHAVIORAL SCIENTIST (LBOGART@RAND.ORG)

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: Refugees in sub-Saharan Africa face considerable hardships accessing HIV clinical care. I propose to evaluate barriers to linkage to HIV care and potential means to overcome those barriers in Nakivale Refugee Settlement in Uganda. I will develop and pilot a refugee-specific linkage intervention to assess whether this strategy improves engagement in care for newly diagnosed HIV-infected clients in the settlement.

 

 

Project Start Date: 01-August-2019

Project End Date: 31-May-2022

Budget Start Date: 01-June-2020

Budget End Date: 31-May-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $186,192

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Abstract: It is imperative to find ways to improve retention boost ART adherence in sub-Saharan Africa where adherence rates have been found to decline over time, and where treatment options such as second-line regimens are very limited. A promising tool is the Lottery Incentives to Facility Treatment Adherence (LIFT) program suggested in this proposal, i.e. the use of small prizes for healthy HIV-related behavior allocated by a drawing. LIFT is based on the results of the applicant’s R34 `Rewarding Adherence Program (RAP)’ [R34 MH096609] that demonstrated feasibility and acceptability of lottery incentives for HIV-related behaviors, and established preliminary efficacy. The current R01 application will build on these promising results with the aim to a) use viral loads as biological endpoints that were not included in the R34 for cost reasons; b) establish efficacy in a fully powered intervention including comparative efficacy of two different ways of implementing the lottery incentives (incentivization of adherence; incentivization of timely clinic visits and viral suppression) and; c) establish the cost effectiveness of these two implementation modes as a further input for policy-makers. The intervention is targeted at increasing the motivation of treatment-mature clients who have been on ART for several years through the added benefit and joy of potentially winning a prize, thereby attempting to overcome the treatment `fatigue’ that can develop in the context of mundane, daily pill taking over the course of life-long treatment. Insights from behavioral economics suggest that such an intervention may be particularly effective for people with present bias (i.e. those who have a tendency to give in to short-term temptation at the cost of more long-term benefits) that was found to be prevalent among HIV clients in the R34 study. LIFT will be implemented among 330 adult clients who have been on ART for at least two years in three groups: for the first intervention group, timely clinic attendance will determine the number of entries they receive for winning a monthly prize, and participants are eligible for an annual lottery based on viral suppression. The second treatment group will be incentivized on high demonstrated ART adherence, including at an additional annual lottery. The control group will receive the usual standard of care. All participants will receive MEMS caps to record adherence and five study assessments over 24 months (at baseline and every 6 months thereafter). The first Specific Aim will be to evaluate the effectiveness of LIFT; the second aim is to compare the effectiveness of the adherence-based arm and the revised arm directly incentivizing viral suppression that subsequently could be incorporated into clinical care as it does not require costly devices and instead relies only on information available in the clinic. The third Specific Aims is to perform a comparative cost- effectiveness analysis of the two LIFT intervention arms as a further policy input.

Project Number: 5R01MH110350-05

https://reporter.nih.gov/search/3MnscHY5qkaP-H3GhQ-H-A/project-details/10205950

 

Contact PI/ Project Leader

LINNEMAYR, SEBASTIAN, ECONOMIST (slinnema@rand.org)

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: For public health it is important to improve adherence to antiretroviral drugs and support viral suppression, especially in resource-constrained countries in which treatment options are limited, and for an increasing number of treatment-mature clients who have been on ART for several years. Our study will investigate the role of small lottery incentives in improving these HIV-related behaviors and health outcomes that can be used in combination with other strategies. The current R01 application builds on the promising results of an earlier R34 study that demonstrated acceptability, feasibility, and preliminary efficacy of such incentives.

 

 

Project Start Date: 13-September-2017

Project End Date: 30-June-2022

Budget Start Date: 01-July-2021

Budget End Date: 30-June-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $290,065

Understanding and Engaging Families in HIV Biomedical Prevention for Latino Men Who Have Sex with Men

Abstract: This K01 is submitted by Dr. del Pino, Associate Professor, from Charles R. Drew University of Medicine and Science (CDU). This proposal is the next step in his transition from philosophy to public health research. He seeks to reduce HIV disparities among Latino men who have sex with men (MSM) by analyzing family support data from three prospective cohort studies in Los Angeles and Chicago and by conducting formative research to leverage the siblings of Latino MSM in an HIV biomedical prevention intervention. He has published qualitative and quantitative papers on family support, substance use, and HIV. He is currently supported by the CDU Emerging Scholars Award and CRECD. Career Development and Training Plan: Dr. del Pino’s mentoring team includes Dr. Steve Shoptaw (expert in substance use and biomedical interventions), Dr. Nina Harawa (expert in the development of culturally responsive HIV-prevention interventions for MSM of color), and Dr. Arun Karlamangla (expert in complex biostatistical data analysis and longitudinal clinical epidemiology research). The training goals (advanced biostatistics, families and stigma, and intervention development) will be achieved through coursework and individual tutorials with each mentor. He will have access to the UCLA CTSI (NCATS); UCLA CHIPTS (NIMH); and to AXIS, CDU’s center for clinical and translational research resources and trainings (NIMHD). Research Plan: Despite the prevention and treatment efforts of the past 30 years, Latino MSM continue to be disproportionately impacted by HIV. Yet a powerful cultural source of motivation has been underutilized: the family. This project seeks to address HIV disparities by addressing gaps in our knowledge of (a) how family support affects the behaviors and health of Latino MSM over time and (b) how to engage siblings in the development and delivery of PrEP-use messages. Aim 1: Determine how family support and mental health affect the HIV-related behaviors (e.g., substance use, sexual risk) and HIV-related health (e.g., STI, HIV viral load) of Latino MSM over time. Hypothesis: Latino MSM with greater family support over time will report better HIV-related risk behaviors and health outcomes than Latino MSM who report little to no family support. Aim 2: Identify barriers and facilitators to engaging Latino MSM and siblings in HIV biomedical interventions. Aim 3: Develop and pilot test sibling-delivered messages to increase PrEP use in high-risk Latino MSM to gather feasibility and acceptability data and to refine the intervention processes and messages. Summary: The Career Development and Training Plan and the Research Plan will prepare Dr. del Pino to submit an R01 to test the efficacy and effectiveness of a culturally-specific, sibling-based intervention to reduce HIV disparities among Latino MSM. His mentorship team has the required expertise and established record of mentoring junior researchers to ensure that he becomes an independently-funded investigator.

 

Project Number: 1K01MD015002-01

https://reporter.nih.gov/search/XxIAVWiEEUW3kw7szt9ZIg/project-details/9926760

 

 

Contact PI/ Project Leader

HARAWA, NINA THAWATA , PROFESSOR (NHarawa@mednet.ucla.edu)

 

 

Organization

CHARLES R. DREW UNIVERSITY OF MED & SCI

 

 

PUBLIC HEALTH RELEVANCE: Despite the prevention and treatment efforts of the past 30 years, Latino men who have sex with men (MSM) continue to be disproportionately impacted by HIV nationally, and is particularly a problem in Los Angeles, which is a predominantly Latino minority city. Yet a powerful cultural source of motivation for behavior change has been underutilized: the family. The long-term goal of this K01 is for Dr. del Pino to become an independent investigator and national thought leader (1) to expand our understanding of the impact of family relationships on Latino MSM and how to include them in the development and testing of HIV biomedical interventions and (2) to address HIV and other health disparities in diverse sexual and gender minority communities.

 

 

Project Start Date: 29-January-2020

Project End Date: 30-November-2024

Budget Start Date: 29-January-2020

Budget End Date: 30-November-2020

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES / FY Total Cost by IC:$129,465

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