Posts classified under: Adults

Combating Craving with Contingency Management: Neuroplasticity and Methamphetamine Abuse in South Africa

Abstract: Methamphetamine (MA) dependence is a significant health problem in South Africa and the U.S. In South Africa, a shift in policy focus is required away from allocating health resources primarily to HIV/AIDS and TB and toward the financial, social and personal consequences of untreated stimulant addiction. In response to PAR 14-331, this application proposes to build capacity for a new linkage of productive teams of clinical researchers at UCLA and the University of Cape Town to conduct studies on the neurobiological foundation of treatment for stimulant dependence. The research direction is innovative in linking findings from neuroscience with clinical outcomes using contingency management (CM) to identify changes in brain structure and function that emerge during purely behavioral therapy. The knowledge gained may guide development of optimally effective behavioral and/or medication therapies. The application design will correlate MA-abstinence outcomes from an 8-week program of voucher-based incentives using an escalating schedule for 30 treatment-seeking, MA-dependent individuals with scores on tasks of working memory and assessments of neuropsychological and demographic status. At the beginning and end of the CM program, participants will participate in MRI scans while performing a working memory task, and will complete a battery of select neurocognitive and psychological assays to address two specific aims: (1) to determine whether changes in neural function within front striatal circuitry from baseline to end of the 8- week CM program are associated with parallel changes in measures of cognitive control and impulsivity and with MA abstinence outcomes; (2) to determine whether structural changes in front striatal circuitry over the 8-week CM intervention correspond with neurocognitive, psychological and MA abstinence measures. Findings from this study will describe associations between: (1) functional and structural indices of brain areas that support working memory, cognitive control/inhibition; (2) performance on select neurocognitive and psychological assessments; and (3) associations between these with MA abstinence outcomes. Study activities and the neuroscience data generated will provide preliminary data for a larger, adequately powered study that will test ways to optimize behavioral therapies for treating stimulant use disorder.

 

Project Number: 3R21DA040492-02S1 (2017); 5R21DA040492-02 (2016)

https://reporter.nih.gov/search/WrJtBSqGgUKo9EPZYXxZsA/project-details/9480137

 

 

Contact PI/ Project Leader

SHOPTAW, STEVEN J, PROFESSOR (SSHOPTAW@MEDNET.UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: Statement Methamphetamine addiction (MA) is a global health problem with high prevalence and great social and health costs in the United States and in the Republic of South Africa and there is a strong need for development and implementation of effective MA treatment approaches. This project will correlate outcomes from an 8-week program of contingency management with findings from pre- and post- treatment neuroimaging and neurocognitive assessments to identify structures and/or processes that may represent targets for development of novel behavioral and/or medication therapies. The public health relevance of this application is enhanced by its effort to develop capacity for a productive and impactful neuroscience research agenda between groups of strong clinical scientists in the U.S. and in the Republic of South Africa.

 

 

 

 

Project Start Date: 01-September-2015

Project End Date: 31-August-2018

Budget Start Date: 01-September-2016

Budget End Date: 31-August-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE / FY Total Cost by IC: $9,353

MSM and Substances Cohort at UCLA Linking Infections Noting Effects (Masculine)

Abstract: This application in response to NIDA PAR 12-222 Cohort Studies of HIV/AIDS and Substance Use (U01) seeks to leverage extensive existing infrastructure and cohorts at the University of California, Los Angeles to launch a new cohort of substance using minority (Black or Hispanic) men who have sex with men (MMSM). The epidemic of HIV among MMSM in the US and locally in Los Angeles County (LAC) may be driven by effects of substance use on adherence to treatment regimens and bio-behavioral prevention and enhanced by high prevalence networks. Proposed investigators lead the science on studying associations between non-injection drug use, risk behaviors and infectious disease among MSM, and contribute a broad portfolio of inter-disciplinary work from immunology and basic science to epidemiology, prevention and treatment. The work proposed leverages existing cohorts including the Multicenter AIDS Cohort (MACS) and existing repositories and builds on preliminary work to guide assembly of a cohort for the study of basic and behavioral factors in younger MMSM who actively use substances and engage transmission risks. Establishing a cohort of young active substance users, particularly stimulant users, who have poor histories of antiretroviral treatment (ART) adherence as marked by measurable and clinically relevant Plasma Viral Load (PVL) will enable important tests of biological influences of substances on immune function in MMSM. This cohort is central to prevention and treatment efforts and will provide well-characterized, extensive repository samples for leveraged use with other cohorts, networks’ and individual’s studies. The MMSM will be: (i) HIV-positive with viral load >5000 copies/ml or (ii) HIV-negative at high risk for HIV infection (unprotected anal intercourse in the past 6 months). This unique cohort will facilitate studies on interactions between substance use and HIV progression and/or transmission, which are of critical public health significance. This cohort of MMSM will characterize: (i) effects substance use on behavioral and network level risk in exposed and infected MMSM on acquisition of HIV and other sexually transmitted infections (STIs: gonorrhea, Chlamydia, syphilis, Hepatitis C (HCV)); and (ii) the extent to which substance use in MMSM facilitates behaviors that transmit HIV compared to non-drug using MMSM. The application also proposes to develop and maintain a bio repository that is HIPAA-compliant, technologically-current and DAIDS Network interfaced that includes a scientific advisory committee. This cohort will comprise 620 MMSM with repeated data visits (from 1,080 MMSM). At least half of these MMSM will be active substance users and younger than age 30.

 

 

Project Number: 5U01DA036267-05

https://reporter.nih.gov/search/tyATmmCktE-kfQBMC4JEpA/project-details/9267958

 

 

Contact PI/ Project Leader

SHOPTAW, STEVEN J, PROFESSOR (SSHOPTAW@MEDNET.UCLA.EDU)

GORBACH, PAMINA MAE, PROFESSOR (PGORBACH@UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: The public health significance of the work described is very high in that the project seeks to establish a cohort of minority men who have sex with men who are active substance users who are either HIV-positive and have measurable viral load (indicating intermittent antiretroviral medication adherence) or who are HIV-negative and engage high risk sexual transmission behaviors for sexually transmitted infections, including HIV, gonorrhea, Chlamydia, syphilis and Hepatitis C. It is the composition of this cohort that confers outstanding impact. Establishing the cohort and the corresponding UCLA Bio repository for storing samples from these cohort members will provide a matchless platform to investigate basic, biological and behavioral effects of active substance use, especially stimulant use (i.e., cocaine, crack, methamphetamine, amphetamine and Ecstasy) in minority MSM who are sexually active (i.e., younger than existing cohort members) and who are inconsistent with antiretroviral medications. Findings from the proposed set of specific aims and from future research that will be made possible by establishment of the cohort and the UCLA Biorepository will enable important tests of biological influences of substances, especially stimulants, on immune function and HIV infection in very high risk MMSM, both HIV positive and HIV negative. This novel cohort will optimize our chances to clarify fundamental questions that have challenged NIDA/NIAID in curtailing infections in these populations.

 

 

FOA: PAR-12-222/ Study Section: ZDA1-NXR-B(15)S

 

Project Start Date: 30-September-2013

Project End Date: 31-May-2018

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: $1,488,949

Resiliency Education to Reduce Depression Disparities

Abstract: Depression is the leading cause of adult disability and common among lesbian, gay, bisexual (LGB) adults. Primary care depression quality improvement (QI) programs can improve outcomes for minorities more significantly than for nonminorities, but they are seldom available in safety-net systems. We build on findings from Community Partners in Care (CPIC) and Building Resiliency and Increasing Community Hope (B-RICH). CPIC compared depression QI approaches across healthcare and social /community services in communities of color. CPIC included healthcare and “community-trusted” programs (e.g., homeless, faithbased) to work as a network to address depression, compared to individual-program technical assistance. In CPIC, both conditions improved mental wellness, mental health quality of life, and depression over 12 months. B-RICH, a randomized study, evaluated lay delivery of a seven-session, CBTinformed resiliency education class versus case management on patients’ depressive symptoms over three months, in unpublished but completed analyses. The proposed demonstration supplements the resiliency class with a mobile/interactive voice response case management tool to reinforce class content and depression care reminders (BRICH+).

 

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/1YPJTvEdrkOYuksN9Y1zJA/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 ON MENTAL HEALTH / FY Total Cost by IC: $290,065

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

MMT CARE for HIV Prevention: A Randomized Controlled Trial

Abstract: This project uses a combination prevention approach to respond to the urgent need for improved quality of services at methadone maintenance therapy clinics, provider-client interactions, and client outcomes.

We conduct the 5-year randomized controlled trial that targets methadone maintenance treatment (MMT) programs in China. Applying the principles of combination prevention, the intervention (MMT CARE) integrates psychosocial and behavioral components into a pharmacological framework for methadone maintenance. A total of 68 MMT clinics are randomly selected from five provinces. From each clinic, 6 service providers and 36 clients are recruited, totaling 408 providers and 2,448 clients in the study. The 68 clinics are randomized to 1) an MMT CARE intervention group or 2) a control group (34 clinics each). Service providers who complete the training conduct three individual motivational enhancement sessions with clients. Efficacy of the intervention is evaluated at baseline and at 6, 12, 18, and 24-month follow-ups.

Project Number: 4r01da033160-05

HIV Testing, Linkage, and Retention in Care: Contextual Factors and Disparities

Abstract: The purpose of this study is to determine if associations exist between the contexts in which people obtain healthcare (i.e., healthcare context) or live (i.e., residential context) and each of five outcomes (HIV testing, receipt of test results, linkage to HIV/AIDS care, retention in HIV care and HIV viral load). The epidemiology of HIV/AIDS among racial/ethnic minorities (specifically, Blacks and Latinos) and older adults (i.e., 50 and older) suggests they may encounter barriers that contribute to disparities in early detection of HIV and in their prognoses. Hence, we will also examine disparities in the outcomes by race/ethnicity and older age (age >50). Drawing on the sociobehavioral sciences, the study will inform clinical practice in ways that promote equity in care across diverse groups, neighborhood conditions and stages of adulthood. The study’s primary Specific Aims are to: (1) Examine relations between healthcare context, residential context and HIV testing during primary care visits using logistic regression multilevel models with random effects based on primary care patients’ electronic medical records; and, (2) Examine relations between healthcare context, residential context and receipt of HIV test results and linkage to HIV/AIDS care, respectively, among managed care enrollees newly diagnosed as HIV-positive using multilevel logistic regression and Cox proportional hazards models with random effects. The secondary Specific Aim is to determine if racial/ethnic- or age-related (i.e., aged <50 vs. >50 years) disparities exist in these relationships. Building on our work on HIV testing and care, and guided by a model integrating the Public Health Critical Race Praxis and Behavioral Model of Healthcare Utilization, the four-year study based on the electronic medical records (EMRs) of adults enrolled in the largest managed care organization in the region. We will pool data over five years (2007-2011) to examine HIV testing among all patients presenting for primary care, and to examine receipt of HIV test results, linkage to and retention in HIV/AIDS care as well as HIV viral load among all patients newly diagnosed as HIV-positive. The study will comprise four multilevel analyses of patients’ residential contexts (e.g., neighborhood HIV prevalence) and healthcare contexts (e.g., characteristics of the patient population) relative to HIV testing during primary care visits (Aim 1), receipt of HIV test results and linkage to HIV/AIDS care among those diagnosed as HIV-positive (Aim 2), retention in HIV/AIDS care and HIV RNA viral load up to one-year post diagnosis. We will use personal and geospatial codes in the EMRs to link to: (1) files containing detailed information on each provider (e.g., demographics, specialty); (2) public data from the Centers for Disease Control and Prevention on HIV prevalence and HIV test sites in each zip code; (3) 2010 Census socioeconomic data (e.g., concentrated poverty) for each zip code; and, (4) global positioning system software to calculate the distance from a patient’s home to their provider. This interdisciplinary, inter- institutional collaboration leverages the expertise of a diverse team of new and seasoned investigators.

 

Project Number: 5R01NR014789-04

https://reporter.nih.gov/search/IbMfJxDXuUq2-aD5SULsNw/project-details/9215532

 

 

Contact PI/ Project Leader

FORD, CHANDRA L , POSTDOCTORAL SCHOLAR (clford@ucla.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: The goal of the proposed research is to learn why adults, especially racial/ethnic minorities and older adults, who have insurance may nevertheless not receive HIV testing or HIV/AIDS care at the recommended levels. The study compares MCO enrollees based on their medical records, assigned providers and neighborhood social conditions to see if certain patients have a harder time getting testing or care because of the type of provider they see or because of where they live.

 

 

 

Project Start Date: 10-April-2014

Project End Date: 28-February-2019

Budget Start Date: 01-March-2017

Budget End Date: 28-February-2019

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF NURSING RESEARCH  / FY Total Cost by IC: $371,958

An mHealth Platform for Health Care Workers to Link South Africans to HIV Care

Abstract:  The South African National Development Plan recognizes the value of health care delivery models such as home based counselling and testing (HBCT) by aiming to train between 700,000 and 1.3 million community health workers (CHW) to implement community-based health care by 2030. The CHW role include working with households to facilitate access and linkage to primary health care facilities, provide outreach and community organization support, health education and coaching on health system navigation. Key barriers to sustainability and scale-up of community health worker programs include: i) a lack of integration between CHW and the health system; ii) poor tracking of how many people receive health services in their home; and iii) once referrals are successful, inadequate communication about the referral to and from the referral site. The South African health information system is currently ill equipped to handle these challenges and needs to be strengthened. We propose a 2-year study to develop and test a mHealth platform aimed at addressing these challenges for persons living with HIV (PLH). We focus on HIV due to the high prevalence rates in South Africa and impact that mobile technologies can make on HIV care. A mHealth platform will be developed that can be used by CHW to enroll household members and track their movement into and between health facilities. It will provide a standard interface by which current and future systems can query the stored data, thereby increasing interoperability and long term sustainability. The platform will unobtrusively support communication between clinic-based health providers and CHW supervisors. In summary, we aim to:1) Assess the perceived barriers and benefits to implementing an mHealth platform to link PLH to care through key informant interviews and foucs groups with health officials, clinic staff, CHW, and PLH; 2) Develop an mHealth platform that is inexpensive, scalable, open to integration, and can monitor patients from HBCT into facility based health care; and 3) Pilot test the mHealth platform and compare linkage to care between PLH from two communities that deploy our mHealth platform (mHealth communities) and PLH from two control communities where HBCT is currently being conducted without our mHealth platform. In the mHealth communities, we will also evaluate process measures to identify bottle necks between HBCT and visitation to an mHealth clinic.

Project Number: 5R21MH16351-02

Transprep: Social Network-Based PreP Adherence for Transgender Women in Peru

Abstract: The effectiveness of Pre-Exposure Prophylaxis (PrEP) for reducing HIV transmission is strongly dependent on adherence, which is influenced by individual, social, and structural factors. We propose a social network-based intervention to promote PrEP adherence among transgender women (TW) in Lima, Peru: 1) Formative research. To optimize content for a PrEP adherence intervention, we will conduct semi- structured interviews and focus groups. Results will be used to refine the PrEP adherence intervention. 2) To conduct an open evaluation of a social network-based PrEP adherence intervention for TW in Peru. The intervention model will be piloted with a small group of 5-10 TW. Data will be used to finalize the study design and assessment tools for a pilot randomized controlled trial (RCT). 3) To conduct a pilot RCT of a social network-based PrEP adherence intervention for TW in Peru. We plan to randomize 8 social network-based clusters of TW that to either a network-based PrEP adherence intervention or standardized PrEP adherence counseling. The primary outcome will be PrEP adherence. The intervention will use a combination of individual counseling, group workshops, social media-based network interactions, and practical support tools to promote PrEP adherence among TW. Individual Counseling: Participants will complete two biweekly counseling sessions addressing PrEP use and HIV prevention. The goals of individual counseling are to introduce PrEP as an HIV prevention tool and address basic issues of PrEP adherence as part of a comprehensive HIV prevention strategy. Group Workshops. Group workshops will establish a common understanding of PrEP as a central component of comprehensive HIV prevention, address the importance of PrEP adherence, develop practical strategies to support adherence, and generate and maintain norms of HIV prevention and PrEP adherence within the peer group. Biweekly maintenance meetings will address ongoing issues related to PrEP use and adherence. Social Network Interactions. The social network component of the intervention will include structured social media platforms to educate, motivate, and promote discussions of PrEP adherence within the participant network, unstructured participant-generated interactions to articulate and reinforce newly developed social norms within the network, and practical tools to support daily adherence. PrEP Use. Participants will be provided with daily Truvada for the 6-month study period. Assessment Procedures, Timing and Measures. There will be three major assessment points: baseline, short-term outcome (3 month), and long-term outcome (6 month). The primary outcome of the intervention will be a comparison of PrEP adherence in the intervention and control groups. Findings will be used to support an NIH-funded R01 proposal using social networks of TW and social media technologies to generate, implement, and reinforce new social norms of PrEP adherence, sexual risk behavior, and HIV prevention.

 

Project Number: 5R34MH104072-03

https://reporter.nih.gov/search/clOmBeNL3EiQvAvH8MjhLQ/project-details/9119194

 

 

Contact PI/ Project Leader

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

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Pre-exposure prophylaxis (PrEP) is an important new tool for HIV prevention, but is highly dependent on patient adherence. Our study the uses social networks of transgender women in Peru as a framework to promote PrEP adherence in socially marginalized communities at high risk for HIV infection.

 

FOA: PAR-11-278/ Study Section:ZMH1-ERB-M(02)

 

Project Start Date: 01-August-2014

Project End Date: 31-July-2018

Budget Start Date: 01-August-2016

Budget End Date: 31-July-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $141,615

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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