Youth Services Navigation Intervention for HIV+ adolescents and young adults being released from incarceration: A randomized control trial

Abstract: The continuum of HIV care has forced new focus on the urgency to identify and effectively serve high-need, under-resourced, and often transient populations to facilitate their receiving the necessary ongoing care and antiretroviral therapy (ART) to suppress HIV RNA viral load (VL). Crucial target groups for improving care along the continuum are young (aged 16-25), sexual and gender minority (SGM) populations being released from jail settings. HIV prevalence among incarcerated youth living with HIV (YLWH) is three times that of the general population and one in seven of all HIV+ persons experience incarceration each year. HIV incidence, prevalence, and incarceration rates are higher for blacks and Latinos than for any other group – these disparities are especially prominent among youth. Furthermore, only an estimated 6% of HIV+ youth are virally suppressed, due to poor retention and adherence to ART. Existing linkage and retention services are insufficient to meet the acute needs of criminal justice-involved (CJI) HIV+ youth, particularly in the high-need period following release from incarceration. Moreover, because of their lack of experience, many youths may struggle to obtain needed services and stabilize their living conditions. Disparities in HIV continuum outcomes are inextricably linked to incarceration, substance use disorders (SUDs), homelessness, and mental health (MH) problems among YLWH. If HIV is to be controlled and the benefits of ART experienced broadly, the problems of CJI YLWH must be addressed with innovative, youth-, and sexual and gender minority (SGM)- sensitive approaches. We propose to enroll 240 CJI YLWH, aged 16-25, incarcerated in Los Angeles and Chicago jails and juvenile detention facilities. We will randomize participants to the YSN intervention (n=120) vs. a usual-care control group (n=120). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support. The proposed study has two Primary Specific Aims: 1. Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to SGM culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for CJI YLWH, aged 16-25 upon release from large county jails and juvenile detention systems; 2. Using a two-group RCT design, we will test the effectiveness of the new YSN, youth SGM-sensitive intervention among CJI YLWH aged 16-25, compared to controls offered standard referrals to services. We will evaluate the YSN Intervention’s effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on SUDs, mental health, services utilization, and met needs. Secondary Aims: We will assess YSN’s effects on recidivism, costs and potential cost-offset/effectiveness.

 

Project Number:1R01MD011773-01

https://reporter.nih.gov/search/WBAx0xWJNESVugqyMSVW8A/project-details/9395728

 

 

Contact PI/ Project Leader

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

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Crucial target groups for improving care along the Continuum of Care are young (aged 16-25) HIV+ sexual and gender minority youths with criminal-justice involvement (CJI) – a population that is poorly retained in HIV care. If HIV is to be controlled and the benefits of ART advances experienced broadly, the problems of CJI young people living with HIV must be addressed with innovative, youth-, and sexual and gender minority-sensitive approaches. The proposed Youth Services Navigation intervention will address this gap, testing a youth- focused approach that is adapted from our successful intervention with HIV+ CJI adults.

 

 

Project Start Date: 08-August-2017

Project End Date: 31-March-2022

Budget Start Date: 08-August-2017

Budget End Date: 31-March-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES / FY Total Cost by IC: $708,966

Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda

Abstract:In Uganda, HIV prevalence is estimated to be 6.2% among those aged 15-64, and is higher (6.9%) in Kampala, the proposed study setting. Political and cultural barriers, including limited government funding and HIV stigma, impede HIV prevention and have led to projections of rapid increases in HIV incidence. The proposed research will be a randomized controlled trial (RCT) of Game Changers, a 6-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks. By decreasing stigma among PLWH and their social network members, and training PLWH on strategies to engage social network members in discussions around HIV, Game Changers provides PLWH with the tools to do prevention advocacy. Game Changers was developed through an NIMH R34 that found high feasibility and acceptability, and preliminary intervention effects on increased HIV prevention advocacy between PLWH and their social network members, reduced internalized stigma, and increased HIV-serostatus disclosure to social network members among PLWH, and medium to large effects on increased condom use and HIV testing among a subsample of network members. The Specific Aims are: (1) To conduct an RCT of Game Changers, a peer- led group intervention for PLWH in Uganda, to test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members; (2) To test intervention effects on the secondary outcomes of reduced internalized HIV stigma, increased HIV serostatus disclosure, and increased viral load suppression among PLWH, and PrEP uptake among social network members; (3) To examine whether increased HIV prevention advocacy by PLWH mediates intervention effects on social network members’ increased condom use and HIV testing, and whether increased HIV disclosure by PLWH mediates intervention effects on social network members’ reduced enacted HIV stigma; and (4) To conduct a cost-effectiveness analysis of the intervention. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit social network members to complete assessments (736 total, 368/arm), to test intervention effects on social networks. All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline; PLWH will also complete social network assessments. The cost-effectiveness analysis will inform policymakers about whether Game Changers is a feasible intervention in which to invest. Our approach is particularly timely in the era of biomedical interventions, which require widespread penetration of effective HIV prevention messaging into communities. Positioning PLWH as central to the solution for controlling (vs. causing) the HIV epidemic has the potential to reduce HIV stigma and improve prevention outcomes at the individual, household, and network levels.

 

Project Number: 1R01MH126691-01A1

https://reporter.nih.gov/search/d28T3sYPEkSxvEsRxFXQ6Q/project-details/10319366

 

 

Contact PI/ Project Leader

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

WAGNER, GLENN JOHN, BEHAVIORAL RESEARCH SCIENTIST (GWAGNER@RAND.ORG)

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: The proposed study aims to conduct a randomized controlled trial to empower people living with HIV to be critical agents of behavior change within their social networks in Uganda, where virtually every family is touched by someone living with HIV. Positioning people living with HIV as central to the solution for controlling (vs. causing) the HIV epidemic has the potential to reduce HIV stigma and improve HIV prevention behaviors at the individual, household, and network levels.

 

 

Project Start Date: 06-July-2021

Project End Date: 31-May-2026

Budget Start Date:06-July-2021

Budget End Date: 31-May-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $804,979

SMS as an Incentive to Adhere (SITA)

Abstract: HIV care requires high medication adherence to achieve optimal clinical outcomes such as slowing the progression to AIDS. Youths face special and unique challenges to adherence. Despite a wealth of interventions designed to increase adherence outcomes, few have focused on interventions that are sustainable in resource-limited settings, or for the period of adolescence. Developing ways to increase adherence rates among adolescents is particularly important as this groups experiences the fastest growth in new HIV/AIDS cases. Existing interventions often require scarce human resources, limiting their practical use. Novel ways of adapting traditional interventions in a sustainable manner are important in resource-limited settings, where second-line therapy is often too expensive or altogether unavailable. The recent rapid rise in mobile phone coverage and ownership among developing country populations has spawned the advent of mobile-phone based interventions to improve health service delivery; short message service (SMS)-based interventions have been found to increase adherence rates to ART among adult patients. However, more knowledge about this promising technology is needed as currently no clear-cut evidence exists about the pathways through which they work. The proposed study ‘SMS as an Incentive To Adhere’ (SITA) proposes novel ways of using SMS messages that are explicitly grounded in the theoretical framework of Social Cognitive Theory (SCT). The first intervention is that of self-monitoring, i.e. providing participants with feedback about their adherence performance. Traditionally this involves clinic visits that take up provider and patient time and resources; SIT instead suggests providing objective, real-time information measured by electronic monitoring (Wisepill) devices sent to patients by weekly SMS. Such feedback builds self-efficacy, a key SCT concept and so may contribute to improved adherence. The second intervention is based on the SCT concept of social learning. Perceived group norms, and interventions that affect those perceptions, are a key influence on health behavior among youths, providing a substitute for direct learning. This approach is adapted to a mHealth environment by providing patients not only with their own adherence information but also that of a reference (peer) group. The first aim of the study is to hold focus groups with key stakeholders to tailor the SMS-intervention to the local needs of youths. The second aim planned is a small, six-month randomized controlled trial testing the two SITA intervention groups against a control condition of usual care to determine which method of informing and motivating drug adherence can best achieve its goals. The third aim is to synthesize lessons learned and discuss them with the clinics and other key stakeholders. The purpose of such capacity building and knowledge transfer activities part of this study is to build up mHealth knowledge at Mildmay and Uganda more generally to a point where ideas can be generated and implemented locally.

Project Number: 5RMH107218-02

Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam

Abstract: Globally, organizational and system interventions are needed to provide integrated services to address the needs of people living with HIV who use drugs (PLHWUD), including other comorbid conditions. Community health and service workforce can be mobilized to promote service integration, which is particularly critical in low- and middle-income countries. We develop and pilot test multilevel integration strategies in Vietnam, including structural changes for better treatment coordination, strengthening treatment provider networks for improved service collaboration, and involving community health workers to support those in need throughout the treatment cascade. The study is conducted in six provinces in Vietnam. In Phase 1, we conduct formative studies with 20 PLHWUD, 24 clinic providers from HIV and drug use treatment facilities, and six directors of Provincial AIDS Centers. Based on the findings, we establish a provincial coordination team at each participating province. In Phase 2, we implement and pilot test an agency-level intervention by training 72 service providers working at various HIV and drug treatment centers to enhance the coordination and networking among the providers and to improve interactions with their patients. Agency-level aggregated data are collected and compared at the baseline and at 12-months after the intervention. In Phase 3, we implement and pilot test our intervention strategies that focus on community health workers working at commune health centers to enhance their networking and collaboration with clinic providers at the treatment facilities. The intervention focuses on improving their communication skills to outreach and motivates PLHWUD living in the community to link them to and support them to stay in care. To assess intervention outcomes, we will recruit 80 commune health workers (CHW) and 240 PLHWUD from 40 commune health centers (CHC). Intervention outcomes on PLHWUD and CHW will be compared at baseline and every three months for one year.

 

Project Number: R01DA041008(2017)

https://reporter.nih.gov/search/1nF2mB6R7E6QQoc1W9IG1A/project-details/9276658

 

 

Contact PI/ Project Leader

LI, LI, (lililili@ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: There is an urgent need to provide integrated services for People Living with HIV who use drugs (PLHWUD). This study addresses the need by developing and implementing multilevel strategies focusing on strengthening provider networks and partnerships between HIV and drug treatment clinics, as well as between treatment agencies and community health centers. Study findings are expected to inform global efforts in service integration, as enhancing community capacity and partnerships are likely to be a relevant and sustainable strategy in other low- and middle-income countries.

 

 

FOA:  RFA-DA-15-013Study Section: ZDA1-HXO-H(10)R

 

 

Project Start Date:30-September-2015

Project End Date: 31-May-2020

Budget Start Date: 01-June-2017

Budget End Date: 31-May-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE / FY Total Cost by IC: $501,180

Improving Art Adherence Through Urban Gardening and peer Nutritional Counseling in the Dominican Republic

Abstract: In recent years, access to antiretroviral therapy (ART) for HIV has increased dramatically in Latin America and the Caribbean (LAC) and in particular in the Dominican Republic (DR); however, food insecurity and poor nutrition have emerged as barriers to ART utilization and adherence among people living with HIV (PLHIV), especially in low-resource settings. Our pilot work in the DR found that 68% of PLHIV report moderate or severe food insecurity. Most programs aimed at addressing food insecurity among PLHIV in low-resource settings have involved providing food supplementation, with positive results; however, such efforts are typically not sustainable. Further, most interventions focus primarily on PLHIV who are underweight, while overweight and obesity are also a growing concern. Sustainable approaches that increase access to food and also promote balanced nutrition among PLHIV are needed. Urban gardening together with peer nutritional counseling represents a potential solution. The purpose of this three-year study is to develop, implement, and evaluate the feasibility, acceptability, and preliminary effectiveness of a culturally appropriate, multi-component intervention that targets food insecurity and nutritional health with the ultimate goal of improving ART adherence and virologic suppression for PLHIV in the DR. The specific aims are to: (1) Use formative research on dietary patterns and locally available foods, together with our preliminary research on nutritional counseling and urban gardening, to develop a multi-component nutrition intervention to address food insecurity among PLHIV that integrates culturally-appropriate, peer-led nutritional education with a sustainable urban garden component; (2) Evaluate the feasibility, acceptability and preliminary effectiveness of urban gardening plus peer nutritional counseling on improving our primary outcomes (HIV care retention, ART adherence, and virologic suppression) in both the short (month 6) and longer terms (month 12); and (3) Explore the preliminary intervention effects on potential mediators (food security, nutritional status, internalized HIV stigma, and social support), which are secondary outcomes. The proposed study involves a partnership among researchers from RAND, University of California San Francisco (UCSF) and the Universidad Autónoma de Santo Domingo and other local partners, including program staff from the United Nations World Food Program (WFP), the Dominican Ministry of Agriculture, and the Dominican National HIV/AIDS Council. It builds on our previous work elsewhere in LAC and established relationships between RAND, WFP, and local partners in the DR. As one of the first studies to develop a sustainable food production approach with peer nutrition counseling among PLHIV, key products will include: 1) an easy-to-use peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on the feasibility, acceptability, and effects of our intervention on primary outcomes and potential mediators; and 3) if results are promising, an R01 application to conduct a fully- powered cluster RCT that examines effects across a larger number of clinics in the DR.

 

Project Number: 5R34MH110325-02

https://reporter.nih.gov/search/kumhXg8EkEWgzZAkFTBfyg/project-details/9334938

 

 

Contact PI/ Project Leader

DEROSE, KATHRYN PITKIN, PROFESSOR (kpderose@umass.edu)

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: NARRATIVE This study proposes to develop, implement, and evaluate the acceptability, feasibility, and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer-led nutrition education with sustainable urban gardening to support the goal of improving ART adherence and virologic suppression for PLHIV in the Dominican Republic (DR). If results are promising, we will follow with an R01 application to conduct a fully-powered cluster RCT examining effects across a larger number of clinics in the DR.

 

 

 

Project Start Date: 18-August-2016

Project End Date: 31-July-2019

Budget Start Date: 01-August-2017

Budget End Date: 31-July-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH/ FY Total Cost by IC:$251,550

Effect of Peer Navigation and Contingency Management on Retention in HIV Care

Abstract: Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons’ continuous visits to the health care provider, regular monitoring and regular delivery of medications, – known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low- income minorities, are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA). The interventions will then be implemented and evaluated in a fully powered Randomized Control Trial (RCT) using 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA). to examine the effect of the interventions (CM and PN) compared to one another, to their combination (CA) and to usual care. A total of 660 inadequately retained individuals (165/group) will be recruited from publically-funded clinics providing HIV Care in Los Angeles County (LAC). These 495 intervention and 165 controls will be assessed through interviews, VL tests and electronic record review for HIV care visits. The evaluation will address retention in HIV care, use of ART medications, and viral load suppression outcomes, as well as intermediate variables, such as barriers to care, substance use, mental health, social support, self-efficacy, knowledge, stigma, and other factors that may affect the effectiveness of the intervention. We will also assess the costs of the intervention and potential cost savings from long-term intervention outcomes (cost offset and cost-effectiveness). If shown to be effective and cost-effective, this study could have substantial, widespread impact on both individual and public health in Los Angeles and other major metropolitan areas.

 

Project Number: 5R01MH103076-03

https://reporter.nih.gov/search/KzBZ_y4pskitONYKOaSESw/project-details/9116020

 

 

Contact PI/ Project Leader

CUNNINGHAM, WILLIAM EMERY, PROFESSOR (WCUNNINGHAM@MEDNET.UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Prior research strongly suggests that racial and ethnic disparities substantially and persistently affect retention in HIV care rates. In order to improve both individual and community HIV prevention and care outcomes, innovative interventions are urgently needed to target the underlying factors that contribute to these disparities in care. We therefore propose to evaluate the effectiveness of two distinct and promising cognitive behavioral strategy interventions: Peer Navigation (PN) and Contingency Management (CM), and their combination to optimize retention in HIV care among a vulnerable population of HIV+ individuals served by a safety net health care system that includes the second largest epicenter of HIV+ persons in the U.S.

 

 

 

Project Start Date: 15-August-2014

Project End Date:31-July-2019

Budget Start Date:01-August-2016

Budget End Date: 31-July-2017

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH/ FY Total Cost by IC: $560,220

Bringing South African Men into HIV Counseling and Testing and Care

Abstract: The ultimate objective of this research is to provide evidence-based strategies to improve treatment of HIV+ men. Treatment as prevention (TasP) can only work through a three step process: (1) Testing a significant proportion of the population, (2) linkage to care and (3) maintaining in care a significant proportion of HIV+ individuals to the point of viral suppression. The benefits of increased testing, linkage to and maintenance in care for men would be enormous. We propose a study that combines structural and individual level interventions and integrates the results to address our overall objective of maintenance in care to the point of viral suppression. Aim 1: In a cluster-randomized study, we will investigate whether male-centered mobilization and testing increases the population-level percentage of men who have been tested (within the last 12 months) by more than 10 absolute percentage points. Aim 2: In the individually-randomized design, we will investigate whether POC CD4 testing and individualized case management improves linkage to care (immediately following diagnosis) and viral suppression (12 months later) over POC CD4 testing alone and standard of care. Aim 3: Integrate the results of the two trial components (Aims 1 and 2) to evaluate the joint effect of the interventions on the percentage of HIV+ men who are effectively tested, linked to care and maintained with undetectable VL. The benefits of increased testing, linkage to and maintenance in care for men would be enormous. Men would remain healthier longer, could work and support their families, contribute to rather than deplete household economic resources, raise their children, and they would be less likely to transmit HIV to female partners.

 

Project Number: 5R01MH105534-03

https://reporter.nih.gov/search/dlMSOWZnt0asvYbLAM9JMQ/project-details/9319824

 

 

Contact PI/ Project Leader

COATES, THOMAS J., PROFESSOR-IN-RESIDENCE (tcoates@mednet.ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, moe likely to have detectable viral load (VL), more likely to transmit HIV with unprotected intercourse and more likely to progress to AIDS and die sooner from HIV. As such, community-based HIV counseling and testing strategies that are responsive and attractive to men are urgently required. This research will evaluate innovative strategies to test for HIV and diagnose black African men and successfully link them to care and maintain them in care, which may reduce their likelihood of transmitting HIV and have a beneficial impact on their individual health, as wel as the well-being of their partners, children, families, and communities.

 

 

Project Start Date:07-July-2015

Project End Date:30-April-2020

Budget Start Date:01-May-2017

Budget End Date: 30-April-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $502,711

Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins

Abstract: Contemporary cohorts of people living with HIV (PLWH) have a ~ 2.5-fold increased relative risk of heart failure versus matched controls. The predominant type of heart failure among PLWH is heart failure with a preserved ejection fraction (HFpEF). This type of heart failure is typically preceded by diastolic dysfunction, a condition in which the left ventricle of the heart stiffens, resulting in delayed relaxation and increased filling pressures. Among PLWH, the prevalence of diastolic dysfunction is strikingly high: 43%. Once diastolic dysfunction has progressed to overt HFpEF, no good therapeutic options exist. Thus, strong imperatives exist to test rational, safe strategies which may preserve diastolic function and prevent progression to overt heart failure among aging PLWH on ART. There are two key processes which likely contribute to the development of diastolic dysfunction in HIV. The first is myocardial fibrosis, a condition in which excess collagen is deposited in the myocardial structural space. The second is myocardial steatosis, a condition in which triglycerides are ectopically deposited within cardiomyocytes. Myocardial fibrosis and myocardial steatosis are both increased among PLWH, in relation to diastolic dysfunction. We postulate that PLWH without overt heart failure, statin therapy will reduce the progression of myocardial fibrosis and myocardial steatosis, preserving cardiac function. Our primary hypothesis is that statin effects to dampen systemic immune activation and inflammation will translate to reduced in situ myocardial inflammation and, in turn, reduced myocardial fibrosis. We will also test an alternate hypothesis that statin effects to improve lipid metabolism will result in reduced ectopic fat deposition in the heart. Cardiac magnetic resonance imaging/magnetic resonance spectroscopy (MRI/MRS) represents a gold-standard approach with which to test our hypotheses. We propose an observational cardiac MRI/MRS-based study, CARDIAC-MR, integrated with an ongoing randomized trial of pitavastatin vs. placebo (REPRIEVE). From 8 REPRIEVE sites, we will co-enroll 130 PLWH aged 40-75 without known heart failure. Outside of REPRIEVE, we will orchestrate additional study visits at entry and 24 months. At these visits, participants will undergo cardiac MRI/MRS, as well as targeted metabolic and immune phenotyping. Our work will answer scientific questions relevant to heart failure prevention in HIV which will not otherwise be addressed in REPRIEVE. If we confirm our hypothesis that statins forestall progression of myocardial fibrosis and/or fat among PLWH, we will have found the first effective strategy to preserve cardiac function in HIV. Even in the case of null statin effects on fibrosis/fat, our baseline characterization of pathologic pathways predisposing to cardiac dysfunction will help identify future targeted strategies geared toward heart failure prevention in HIV. Given that heart failure is a highly morbid, age-related comorbidity to which PLWH are particularly vulnerable, our work will have significant clinical implications to improve the lives of at-risk individuals aging with HIV.

 

Project Number: 1R01HL137562-01A1

https://reporter.nih.gov/search/lk4QlpSW3k6NH9JxPR4g4Q/project-details/9409760

 

 

Contact PI/ Project Leader

NEILAN, TOMAS G, ASSISTANT PROFESSOR (tneilan@partners.org)

 

 

Organization

MASSACHUSETTS GENERAL HOSPITAL

 

 

PUBLIC HEALTH RELEVANCE: Individuals living with HIV have higher rates of heart failure than individuals without. We will identify why individuals living with HIV develop heart failure and test whether statins, a type of drug typically used to lower cholesterol, can protect the heart muscle and improve the way the heart functions among individuals with HIV.

 

 

Project Start Date: 01-July-2017

Project End Date:31-March-2021

Budget Start Date: 01-July-2017

Budget End Date: 31-March-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE/ FY Total Cost by IC: $708,470

A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

Abstract:  Compared to Whites, Black people living with HIV are less likely to adhere to antiretroviral treatment (ART) and be virally suppressed. Our research has identified culturally relevant factors contributing to disparities among HIV-positive Black Americans, including stigma and medical mistrust (e.g., “conspiracy beliefs,” that ART is poison), in addition to structural and psychosocial factors related to poverty, healthcare access, and mental health. However, ART adherence interventions have rarely been culturally congruent, which may explain why relatively few interventions have shown robust effects on adherence or viral suppression. We propose to conduct a randomized controlled trial (RCT) of Rise, a culturally congruent adherence counseling intervention for HIV-positive Black men and women. Rise counselors possess specialized HIV treatment knowledge and are trained in motivational interviewing (MI) skills to overcome culturally relevant barriers to adherence and retention in care; they also assist with linkage to social services. Rise is ideally implemented in community organizations, enabling clients to seek services in non-medical settings, which helps to overcome mistrust of healthcare, and increase readiness for adherence. In a pilot RCT, Rise led to increased adherence (measured by electronic monitoring) relative to a wait-list control group over time, showing a large effect size (Cohen’s d=.87). However, the pilot did not evaluate effects on viral suppression or include long-term follow-up. Thus, we propose to conduct an RCT of Rise that follows best practices for evidence-based HIV treatment adherence intervention design and testing. The Specific Aims are: (1) To conduct a randomized controlled trial to examine the effects of a culturally congruent adherence intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; (2) To examine culturally relevant mediators (e.g., medical mistrust, stigma) that may help to explain the effects of the intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; and (3) To conduct a cost effectiveness analysis of the intervention. A total of 350 Black men and women will be randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 12- months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 12-months post-baseline. If Rise is found to be effective, the next step would be to conduct research to determine effective and feasible methods for intervention implementation and dissemination to community settings.

 

Project Number: 1R01NR017334-01

https://reporter.nih.gov/search/PdfddKi3BUOnOnbnl4vOTw/project-details/9346334

 

 

Contact PI/ Project Leader

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

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Black people living with HIV show lower levels of antiretroviral treatment adherence than do Whites. However, few culturally congruent interventions have been developed and tested. We propose to conduct a randomized controlled trial (RCT) of Rise, an innovative, culturally congruent adherence intervention for HIV-positive Black men and women that targets cultural and structural issues contributing to health disparities. Rise facilitates improved adherence and retention in care through client-centered counseling and assistance with linkage to social services.

 

 

Project Start Date: 01-May-2017

Project End Date:28-February-2022

Budget Start Date:01-May-2017

Budget End Date: 28-February-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF NURSING RESEARCH/ FY Total Cost by IC:$647,915

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