Posts classified under: Adults

Los Angeles CRS for the MACS/WIHS Combined Cohort Study

Abstract: The UCLA Clinical Research Site (CRS) of the Multicenter AIDS Cohort Study (MACS) / Women’s Interagency HIV Study (WIHS) Combined Cohort Study (CCS) proposes to continue to document clinical, immunologic, physiologic, behavioral, virologic, genetic and psychosocial changes in HIV‐infected and ‐uninfected men‐who‐ have‐sex‐with‐men (MSM). This includes proposed studies to document these changes in MSM recruited previously, as well as plans to recruit new untreated and recently treated HIV‐infected MSM (primarily African‐ and Hispanic‐ Americans), to maintain the cohort. The UCLA CRS will provide leadership and participation in the working groups, CCS‐wide and local studies and research publications, as well as collaborative multi‐ cohort studies, as it has since the inception of the MACS 35 years ago. The UCLA CRS has recruited a large team of early career and established co‐investigators from a wide range of disciplines. These investigators have developed, and are continuing to develop, innovative proposals to advance our understanding of co- morbid conditions that arise in people living with treated HIV infection, as well as the pathophysiology, immunology, genetics and bio-behavioral characteristics of treated and untreated HIV infection. The breadth, enthusiasm, experience and innovation of the UCLA CRS investigators, combined with the experience and commitment of the long‐term staff, and our leadership of several areas of HIV/AIDs research, will continue to play an invaluable role in the success of the CCS over the next seven years.

Project Number: 3U01HL146333-02S1

https://reporter.nih.gov/search/2GhA0lGvQUa0Ika5JZbzxA/project-details/10125498

 

Contact PI/ Project Leader

DETELS, ROGER, PROFESSOR (DETELS@UCLA.EDU)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: This is a proposal to continue the UCLA Clinical Research Site (CRS) of the Multicenter AIDS Cohort Study (MACS) / Women’s Interagency HIV Study (WHIS) Combined Cohort Study (CCS), which studies clinical, immunologic, physiologic, behavioral, virologic, genetic and psychosocial changes in HIV‐infected and HIV‐ uninfected men‐who‐have‐sex‐with‐men (MSM). The ongoing studies of the CCS will provide key information to advance our understanding of co-morbid and iatrogenic conditions occurring in people living with HIV infection (PLWH) receiving anti-retroviral therapy (ART), as well as inform the natural history of HIV at the molecular level, psychosocial determinants of disease and treatment compliance, and factors affecting optimal treatment of PLWH.

 

FOA: PA-18-591/ Study Section: ZHL1(O2)

 

Project Start Date: 15-April-2019

Project End Date: 31-March-2026

Budget Start Date: 01-July-2020

Budget End Date: 31-March-2021

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM/ FY Total Cost by IC:$46,610

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

Expedited Partner Therapy and the HIV Prevention Cascade Among MSM in Peru

Abstract: Expedited Partner Therapy (EPT) offers a unique tool to combine HIV prevention and STI control through an integrated HIV Prevention Cascade. In providing empiric, patient-delivered antibiotic treatment to the recent sexual partners of individuals with bacterial STIs, EPT promotes partner notification, HIV/STI testing, and treatment, and triggers the critical first step of an HIV prevention cascade culminating in uptake of antiretroviral-based prevention methods (such as PrEP or pre-exposure prophylaxis), and ultimately a reduction in community-level HIV transmission risk. By targeting the sexual partners of individuals with new STI diagnoses, EPT provides an opportunity to identify nodes of active HIV and STI transmission within high-risk sexual networks, to promote HIV testing and linkage to prevention and treatment services among these individuals, and to potentially reducing the incidence of HIV/STI transmission within the larger population. Use of EPT for HIV/STI control among MSM presents three key questions for future research: i) What is the impact of EPT on biological outcomes of persistent or recurrent bacterial STIs among MSM? ii) What is the effect of EPT on prevention cascade outcomes of partner HIV/STI testing and linkage to HIV prevention/treatment services? and iii) Would any observed increases in prevention cascade outcomes lead to community-level reductions in HIV/STI transmission? Aim 1 (Individual). To determine the effect of EPT on individual-level outcomes of partner notification and persistent or recurrent GC/CT infection among MSM. Aim 2 (Partnership). To assess the impact of EPT on partner-level outcomes of notification, testing, STI treatment, and linkage to HIV prevention and treatment services. Aim 3 (Population). To use Agent Based Modeling to estimate the impact of EPT for MSM on HIV/STI transmission at network- and population-levels.

 

Project Number: 1R01MH118973-01A1

https://reporter.nih.gov/search/8uQzJnqO4kGvjo0HMuZ8FQ/project-details/9781083

 

 

Contact PI/ Project Leader

CLARK, JESSE LAWTON, ASSISTANT PROFESSOR-IN-RESIDENCE (jlclark@mednet.ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Expedited partner therapy (EPT) following STI diagnosis offers a unique strategy to integrate STI control with HIV prevention among men who have sex with men (MSM). Our study uses EPT as a tool to trigger the HIV prevention cascade among at-risk MSM in Lima, Peru.

 

 

Project Start Date: 01-June-2019

Project End Date: 31-March-2024

Budget Start Date:01-June-2019

Budget End Date:31-March-2020

 

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES + NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $561,476

Combining Positive Deviance and Implementation Science to Improve Retention in HIV Care in South Africa

Abstract:Despite notable increases in antiretroviral therapy (ART) adherence and decreases in mortality, South Africa is not close to achieving the UNAIDS goals of 90% of all people living with HIV (PLWH) diagnosed, 90% of those with a positive HIV diagnosis on antiretroviral therapy (ART), and 90% of those on ART with undetectable HIV RNA by 2020, with only 60% of all PLWH having undetectable RNA as of 2017. Moreover, in the Western Cape, the viral load suppression (VLS) rate (54.7%) is the second lowest in the country, and the average 6- month rate for retaining PLWH in primary health care clinics is 64%. Retention is critical for improving ART adherence and VLS. Clinics face myriad challenges retaining PLWH in care long enough to maintain VLS. Structural-, organizational-, and individual-level patient barriers impede retention. Nevertheless, a handful (about 8%) of health care clinics consistently have retention rates at 80% or above. Information about how these clinics manage to succeed despite pervasive barriers could help improve retention rates in clinics that are not performing as well. Positive Deviance (PD) is an approach to studying ways in which a minority of individuals or organizations succeed despite barriers that typically hinder success. The approach begins with a “discover” phase in which intensive study is undertaken to uncover unique strategies of clinics with better outcomes than those facing similar challenges, followed by an implementation phase in which the strategies are implemented. In a collaboration among the RAND Corporation, the South African Human Science Research Council, and the South African Western Cape Department of Health, we propose (1) to use a PD approach and mixed methods research (a provider survey that assesses contextual factors thought to be associated with performance; patient shadowing; semi-structured interviews with clinic leaders, and focus groups with providers and patients) to discover strategies used by primary health care clinics that retain 80% or more of PLWH in care; (2) to develop an intervention that consists of a toolkit with novel PD strategies identified in Phase 1 and implementation science methods for successfully implementing strategies; and (3) to implement the PD intervention in 3 low-performing pilot clinics and conduct a pilot cluster randomized trial to evaluate (a) feasibility (extent to which the PD strategies are implemented); (b) acceptability (clinic staff attitudes about the toolkit, the strategies, and implementation processes); and (c) preliminary effects of the intervention on PLWH retention in care and VLS. To determine feasibility, we will collect attendance logs and activity worksheets; to assess acceptability, we will conduct focus groups with providers and patients; to assess preliminary effectiveness, we will examine changes in patient retention and VLS at intervention clinics from 6-months before the intervention and during the intervention period, compared to changes in all other low- performing clinics. The proposed study would be the first to experimentally test a PD intervention to improve retention in HIV care for PLWH; if effective, it could lead to higher retention and VLS rates and lower mortality.

 

Project Number: 5R34MH119889-03

https://reporter.nih.gov/search/NOajWrXy_UCgpi4QmSgvzQ/project-details/10304143

 

 

Contact PI/ Project Leader

OBER, ALLISON, ASSOCIATE BEHAVIORAL SCIENTIST (ober@rand.org)

SKINNER, DONALD HARRY 

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Retaining people living with HIV in care in primary health care clinics in the Western Cape (WC) of South Africa, a region with high HIV prevalence and the second lowest viral load suppression (VLS) rates in the country, is an ongoing challenge. Retention is associated with greater antiretroviral therapy adherence and VLS, but clinics in the WC only retain an average of 64% of patients who begin treatment. The proposed study will combine a Positive Deviance approach with implementation science methods to identify clinics in the WC with retention rates above 80% (currently 8% of all clinics have achieved this), employ quantitative and intensive qualitative methods to discover unique strategies that might be contributing to high retention rates, and develop and implement in the lowest performing clinics a novel, clinic-level intervention to test feasibility, acceptability and preliminary effects on retention and VLS; if effective, the intervention ultimately could lead to greater retention and VLS and lower mortality in the region and elsewhere.

 

 

Project Start Date: 01-December-2019

Project End Date: 30-November-2022

Budget Start Date: 01-December-2021

Budget End Date: 30-November-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH/ FY Total Cost by IC: $250,689

Innovative HIV Testing Strategy for Middle-to-Upper Income Men in a Resource Limited Setting

Abstract:In Botswana, the setting of the proposed study, nearly one in five adults are living with HIV. Men in Botswana over age 40, the focus on the present research, show relatively high levels of HIV prevalence and risk behavior, and low levels of HIV testing. Moreover, higher income is associated with increased risk of being HIV-positive in sub-Saharan Africa (SSA). The proposed research will use mixed methods to develop an intervention that de- stigmatizes and encourages HIV testing among men of middle-to-higher socio- economic status (SES) in Gaborone, Botswana. We will focus on increasing HIV testing among men of higher SES. Fear of being stigmatized among financially secure men in employment in Botswana may contribute to low HIV testing uptake. The Specific Aims are: Aim 1: To initially conduct formative qualitative work to explore the role of stigma on low HIV testing uptake among 20 men via face to face interviews, and then to obtain feedback about potential interventions using asynchronous online focus group discussion among 40 men all with relatively high socio-economic status (SES) in Botswana. Aim 2: To develop and conduct a small pilot test of a local, culturally appropriate HIV testing strategy targeting 100 men in the higher-SES in Botswana. Hypothesis: At least 60% of men will access the new HIV testing strategy, equivalent to a ~20% point increase above testing strategies not tailored to men. Aim 3: To build capacity for HIV stigma and related behavioral research by conducting focused workshops in Botswana. To reach the remaining 10-10-10, it is essential to develop differentiated, tailored approaches for risk groups, such as men of relatively higher SES, that are untouched by existing prevention and testing frameworks in countries of high HIV prevalence.!

 

Project Number:5R21TW011069-02

https://reporter.nih.gov/search/ukRDruCWsESODyaoaOckJg/project-details/9730678

 

 

Contact PI/ Project Leader

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

MOSEPELE, MOSEPELE, SENIOR LECTURER (mosepelemosepele@gmail.com)

 

 

Organization

UNIVERSITY OF BOTSWANA

 

 

PUBLIC HEALTH RELEVANCE: In Botswana, the setting of the proposed study, nearly one in five adults are living with HIV, and men over age 40, especially those of higher income, are at particularly high HIV risk due to concurrent multiple partnerships and low rates of HIV testing. We propose to explore qualitatively how stigma in the context of masculine gender role norms may be a barrier to HIV testing among men over age 40 years of higher socioeconomic status in Botswana, and use these results to develop and pilot an innovative HIV testing strategy through major employers that is tailored to men.

 

 

Project Start Date: 01-July-2018

Project End Date:30-April-2022

Budget Start Date: 01-May-2019

Budget End Date: 30-April-2022

 

 

NIH Categorical Spending

Funding IC: FOGARTY INTERNATIONAL CENTER / FY Total Cost by IC:$106,708

Promoting Reductions in Intersectional Stigma to Improve HIV Testing and PrEP Use Among Latino Sexual Minority Men

Abstract: HIV prevention continuum disparities persist among Latinos in the U.S., especially those who are immigrants and sexual minority men (SMM). Latinos tend to be diagnosed with HIV (i.e., tested) at a later disease stage and use pre-exposure prophylaxis (PrEP) at much lower rates than do Whites. However, of the existing evidence-based HIV prevention interventions, only one was developed for Latino SMM, and none have yet been developed or assessed for PrEP uptake. Based on the scientific premise and empirical evidence that stigma contributes meaningfully to HIV disparities, we propose to conduct a randomized controlled trial (RCT) of an 8-session cognitive behavior therapy group intervention, Siempre Seguiré (“I will continue being”; named by community stakeholders after a popular song conveying gay empowerment), which aims to increase effective coping responses to stigma from intersectional identities (related to ethnicity, immigration status, and sexual minority identity) among Latino SMM, with the goal of improving HIV prevention continuum outcomes. Siempre Seguiré has a strong scientific basis in our prior pilot work, which found that the proposed intervention is acceptable to key stakeholders, feasible to conduct, and associated with improved effective coping and increased trust in providers and healthcare. The specific aims are: (1) To conduct a randomized controlled trial of Siempre Seguiré, a culturally congruent cognitive behavior therapy group intervention for immigrant Latino sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake; (2) To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma, anticipated stigma, and medical mistrust); and (3) To conduct a cost- effectiveness analysis of the intervention. In the context of an established community-academic partnership, we will conduct the RCT with 300 immigrant Latino SMM, randomizing 150 to the intervention and 150 to an attention control group (a community-based wellness-oriented support group, with sessions matched to the intervention condition in number, timing, and length). Participants will complete surveys at baseline and 3, 6, and 12 months post-baseline to assess the primary outcomes, potential mediators, covariates, and moderators. Regular HIV testing will be confirmed with official copies of HIV testing results, and PrEP uptake will be confirmed through copies of prescriptions, medical records, and urine testing. With the exception of our own work, we are not aware of any interventions that address coping with stigma from intersecting identities in order to improve health outcomes. Our research is consistent with Healthy People 2020, which recommends developing interventions to address effects of stigma among sexual minority individuals. Although structural- level interventions are critical for reducing societal stigma as a long-term strategy, individual-level interventions—such as Siempre Seguiré—are needed in tandem to reduce stigma’s immediate health effects.

 

Project Number:5R01MH121256-03

https://reporter.nih.gov/search/IFI0_tkBV0WwBnvpf1ingA/project-details/10163917

 

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Latinos in the U.S., especially those who are immigrants and sexual minority men (SMM), are highly affected by HIV-related disparities, tending to be diagnosed at a later disease stage, leading to delays in antiretroviral treatment use and lower rates of viral suppression. No culturally congruent interventions have been developed to address intersectional HIV-related stigmas, a key contributor to disparities in the HIV prevention continuum among Latino SMM. We propose a randomized controlled trial of an 8-session cognitive behavior therapy group intervention that aims to increase regular HIV testing and PrEP uptake by increasing effective coping responses to intersectional stigmas from ethnicity, immigration status, sexual minority identity, HIV, and PrEP among Latino SMM.

 

 

Project Start Date: 01-August-2019

Project End Date: 31-May-2024

Budget Start Date: 01-June-2021

Budget End Date: 31-May-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH + NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES / FY Total Cost by IC: $715,688

Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention

Abstract: HIV disparity persist among Latino men who have sex with men (MSM), especially those who are immigrants. The CDC estimates the lifetime HIV risk is 1 in 5 for Latino MSM compared to 1 in 11 for white MSM. Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy highly effective in preventing HIV acquisition, with the potential to reduce the number of new HIV infections among Latino MSM in the U.S. PrEP involves once daily dosing of medications. The FDA has approved two medications, sold under the brand names Truvada® and Descovy® for daily use as PrEP. The Centers for Disease Control and Prevention (CDC) has established clinical guidelines for administering PrEP to high-risk candidates. While evidence indicates that PrEP use is rising in the U.S., disparities persist in uptake among Latino MSM, despite their reported high levels of interest in using PrEP. To address this disparity, we propose a 2-phase project to develop a pilot PrEP intervention called Estoy PrEParado (I’m PrEPared) to facilitate initiation and adherence to PrEP among immigrant Latino MSM. The project will develop an engaging, culturally tailored intervention using the Information-Motivation-Behavioral Skills (IMB) model. The specific aims of the project are: Aim 1: based on data from a prior study, the project will elicit feedback, validation and modification to the initial content areas of the Estoy PrEParado intervention to facilitate PrEP adoption and adherence among immigrant Latino MSM; and Aim 2: the project will conduct a small randomized pilot of Estoy PrEParado to assess the feasibility, acceptability and preliminary impact of the intervention in moving immigrant Latino MSM along the PrEP cascade to initiation. In formative phase 1, the project will use the innovative and novel World Café approach to facilitate a community conversation with immigrant LMSM (n≈40) to validate, modify and refine the initial intervention content areas of the Estoy PrEParado pilot intervention. The World Café is a powerful conversational process for facilitating constructive group dialogue that produces ideas and knowledge that can be put into practice. The project will also elicit feedback and input on the contents of the intervention from a project-specific Intervention Advisory Committee (IAC) comprised of academic and community experts. In phase 2, the project will conduct a small randomized pilot of 80 participants (40 participants receiving the PrEP intervention and 40 participants receiving standard care, i.e., PrEP referrals) to establish feasibility, acceptability and preliminary impact. If the intervention shows promise, the findings will support the preparation of a larger scale R01 efficacy trial.

 

Project Number: 5R34MH121228-02

https://reporter.nih.gov/search/JhB7cXNmT0WkoNOjh9xCBQ/project-details/10239232

 

 

Contact PI/ Project Leader

BROOKS, RONALD ANDREW, ASSISTANT PROFESSOR (rabrooks@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: For Public Health, it is important to facilitate adoption of PrEP, a highly effective biomedical HIV prevention strategy that can help reduce new HIV infections among immigrant Latino MSM in the U.S. Our study will make use of HIV testing sites as an entry point to enroll participants into our pilot PrEP intervention with information tailored to address the specific needs of immigrant Latino MSM who are considering PrEP for HIV prevention. The insights from this R34 grant will serve as the basis for a subsequent R01 grant application to assess efficacy of the intervention.

 

 

Project Start Date: 15-August-2020

Project End Date: 31-July-2023

Budget Start Date: 01-August-2021

Budget End Date: 31-July-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH/ FY Total Cost by IC: $214,211

A Comprehensive Community-based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth At HIV Risk, Acutely Infected and with Established HIV Infection

Abstract: America’s increasing HIV epidemic among youth aged 12-24 and our concurrent failure to identify, link to care, and achieve viral suppression among youth living with HIV (YLH) suggests the need to identify novel community-based strategies to leverage gateways and settings where high risk and infected youth can be engaged in HIV prevention and treatment. Scientific successes reducing HIV viral reservoirs among acutely infected infants, stopping HIV transmission from HIV-infected adults with undetectable viral loads, and documenting the efficacy of Treatment as Prevention (TASP) suggest strategies to reduce the trend of increasing adolescent HIV infections. This U19 will evaluate the usefulness of these advances for youth aged 12-24 at the highest risk of acquiring HIV- gay, bisexual, transgender youth (GBTY) and homeless youth (HY) – as well as youth living with HIV (YLH) in two HIV epicenters (Los Angeles and New Orleans). All GBTY and HY at five gay-identified community-based organizations (CBO) and homeless shelters will be screened over 18 months. From these screenings, a cohort of 220 YLH and 1,500 highest risk seronegative GBTY and HY will be formed. Over 24 months, this cohort will be repeatedly tested at four month intervals for sexually transmitted infections (STI) and serious drug use, and with 4th Gen HIV tests if seronegative, in order to identify acutely infected youth, engage youth in medical care, and monitor outcomes. Youth are triaged to: Study 1: Acute infection. Using 60 ARV-naive YLH with established infection as controls, we expect to identify 36 YLH with acute infection. All youth with acute infections will be aggressively treated with at least four highly potent antiretroviral therapies (ARV) and repeatedly assessed to examine if prolonged viral suppression is achieved, with reduced viral reservoirs to potentially allow ARV- free HIV remission. Study 2: Stepped care for YLH. Adapting strategies to manage chronic illnesses, we will conduct a RCT comparing a Standard Care Arm (repeated assessments every four month and an Automated Messaging and Monitoring Intervention [AMMI]) to Stepped Care. In the Stepped Care Arm, increasingly more intense interventions are delivered if viral load is detectable: a) the Standard Care Arm; b) an AMMI that is tailored to comorbidities of the specific YLH; or c) a Coach to support during crises, make treatment referrals, and brief interventions. Dried blood spots will monitor viral load and, on a small sample, ARV adherence over time. Study 3: Engaging seronegative youth in the HIV Prevention Continuum. Youth will be randomized to either: a) an AMMI Arm; b) Peer-Support plus AMMI Arm; c) eNavigator and an AMMI arm; or d) Peer-Support plus eNavigator plus AMMI Arm. Each condition aims to optimize the HIV Prevention Continuum. An interdisciplinary team of basic, clinical, and applied researchers with expertise in HIV, STI, behavioral interventions, biomedical interventions, CURE research, perinatal HIV, and a history of participating and coordinating multi-site RCT is participating on this U19 from six universities.

 

Project Number: 3U19HD089886-05S1

https://reporter.nih.gov/search/SBBoz9XDVUyX_k7No8tfLg/project-details/10397368

 

 

Contact PI/ Project Leader

SWENDEMAN, DALLAS TRAVIS , ASSOCIATE PROFESSOR, CENTER CO-DIRECTOR (dswendeman@mednet.ucla.edu)

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: HIV among youth has doubled in the last 15 years, with incidence expected to increase 39% by 2020. If acutely infected youth can be identified and treated during the period when their infectivity to others is 5-to 10-fold, we can reduce this expected rise as well as improve youth’s long-term health, reflected in smaller viral reservoirs. The set of studies in this U19 tests a comprehensive set of strategies for acutely infected youth, youth with established infection, and seronegative youth at highest risk of acquiring and transmitting HIV –with policy implications for communities and the Centers for Disease Control and Prevention.

 

FOA: PA-20-272/ Study Section: Unavailable

 

Project Start Date: 01-June-2021

Project End Date: 31-May-2022

Budget Start Date: 01-June-2021

Budget End Date: 31-May-2022

 

 

NIH Categorical Spending

Funding IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT/ FY Total Cost by IC: $2,429,844

HPTN-077

Abstract: To evaluate the safety, tolerability, pharmacokinetics and acceptability of the injectable agent, GSK1265744 long-acting injectable (744LA), in healthy, HIV-uninfected men and women. It is a multi-site, double-blind, two-arm, randomized, placebo-controlled trial of the safety, tolerability, and acceptability of 744LA. HPTN-077 will study HIV-uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65. of approximately 176 men and women, randomized 3:1, with 132 in the active drug arm, and 44 in the placebo arm. It is anticipated that approximately 60% of the enrolled participants will be women. Participants will be randomized to receive daily oral GSK1265744 (30 mg tablets) or daily oral placebo for 4 weeks, followed by a one-week washout, to assess safety and tolerability before they receive injections. After safety and tolerability assessments from the oral phase have been completed (if no concerns are identified), participants will enter the injection phase of the study and will receive two intra-muscular (IM) gluteal injections of 744LA (800 mg, administered as two 400 mg injections) or placebo (matching vehicle control) at three study visits performed at 12-week intervals.

Project Number: 5UM1AI068619-11

Racial/Ethnic Disparities in Health Insurance Coverage Stability: Implications for Chronic Disease Management and Use of Preventative Services

Abstract:  Unstable health insurance coverage (i.e., gaining and/or losing coverage over time) affects millions of individuals in the US. The Affordable Care Act (ACA) has helped 16.4 million of the uninsured gain coverage through the expansion of Medicaid in 31 states (including the District of Columbia as of September 1, 2015) and subsidies through the Health Insurance Exchanges (HIE) and is projected to reduce racial/ethnic disparities in coverage. However, disruptions in coverage may continue to be an important post-ACA issue, as changes in eligibility are expected to continue resulting in churning (i.e., losing and/or gaining coverage over time) between coverage through Medicaid, the HIE and employer-provided health insurance. Despite the abundance of research on the uninsured, little is known about how coverage stability affects access to care, especially in terms of disease management and use of preventive services, and whether important differences exist between racial and ethnic groups. The limited amount of research that does exist on coverage stability have largely been descriptive and have relied on measures that only capture one aspect of coverage stability at a time (e.g., ever lost coverage in the past year). Additionally, few studies have made use of methods that address the influence of unobservable characteristics that may be associated with both coverage stability and access to care (i.e., endogeneity of health insurance coverage). Thus, to address these gaps in the literature, the proposed dissertation will use data on a nationally representative sample of non-elderly adults (ages 18-64) from the Medical Expenditure Panel Survey (MEPS) to: (1) Construct a coverage stability index measure that encompasses multiple aspects of coverage stability using month-to-month coverage status and principal component analysis; (2) Evaluate the effect of coverage stability on disease management among those living with a chronic condition (i.e., diabetes, hypertension, and high cholesterol) by race/ethnicity; and (3) Examine the effect of coverage stability on the use of preventive services among the near-elderly (ages 50-64) by race/ethnicity. The proposed project will contribute and improve upon the existing body of research by developing and testing a coverage stability measure that accounts for multiple aspects of the phenomenon, demonstrating the effect of coverage stability on access to care among vulnerable populations and disparities by race/ethnicity, and making use of methods that address the endogeneity of coverage to produce less biased estimates. Such a contribution would bring to light the magnitude of the issue and provoke urgency among policymakers and other stakeholders to engage in discussions and efforts geared towards identifying those at highest risk for unstable coverage and developing strategies that will make coverage transitions less burdensome on access to care, thus alleviating the perpetuation of racial/ethnic disparities in health.

 

Project Number: 1R36HS024862-01A1

https://reporter.nih.gov/search/tRh4M7PY80G_22Aco4BUqA/project-details/9379776

 

Contact PI/ Project Leader

TAN, DIANE, (diane.tan@ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE:Project Narrative Unstable health insurance coverage (i.e., gaining and/or losing coverage over time) affects millions in the US. Although the Affordable Care Act (ACA) has greatly improved access and is projected to reduce racial/ethnic disparities in coverage, disruptions in coverage may continue to be an important post-ACA issue, as changes in eligibility are expected to continue resulting in churning between the different sources of coverage (i.e., Medicaid, the health insurance exchanges, and employer-provided health insurance). The proposed project will contribute to the small albeit growing body of research by developing and testing a multi-dimensional coverage stability measure, demonstrating the effect of coverage stability on access to care among vulnerable populations, determining disparities by race/ethnicity, and using methods that address the endogenity of coverage to produce less biased estimates.

 

 

 

 

Project Start Date: 01-July-2017

Project End Date: 30-June-2018

Budget Start Date: 01-July-2017

Budget End Date: 30-June-2018

 

 

NIH Categorical Spending

Funding IC: AGENCY FOR HEALTHCARE RESEARCH AND QUALITY / FY Total Cost by IC:$41,931

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