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

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

Project Number: 1K01DA051329-01A1

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

 

Contact PI/ Project Leader

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

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

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

 

 

Project Start Date: 01-April-2021

Project End Date: 31-March-2026

Budget Start Date: 01-April-2021

Budget End Date:31-March-2022

 

NIH Categorical Spending

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

Healthy Divas: Improving engagement in HIV care for high-risk women

Abstract: Trans women are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. Trans women living with HIV (hereafter:  TWH) are less likely than other populations to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART adherence, lower self-efficacy for integrating ART into daily routines, and report fewer positive interactions with health care providers than non-transgender adults. As a result, TWH have an almost three-fold higher viral load than non-transgender adults; TWH are less likely to be virally suppressed than any other behavioral risk group. There are both individual and public health consequences to poor engagement in care among TWH stemming from high transmission risk factors, including substance abuse, high numbers of sex partners, engagement in sex work, and high rates of mental illness. Healthy Divas is a randomized controlled trial, grounded in Models of Gender Affirmation and Health Care Empowerment, that compares the Healthy Divas intervention to a treatment as usual (TAU) control condition. The Healthy Divas intervention is a combination of 6 individual sessions, completed within 3 months, with a peer counselor and a peer-led group workshop with other TWH, a HIV primary care provider, and a transgender health care provider. TWH (N=286) who are confirmed HIV-positive and show evidence of suboptimal engagement in care, defined as meeting one or more of the following three indicators: a) not on ART, b) on ART but reporting non-adherence, c) reporting no HIV care appointments in the prior 6 months, are enrolled at either the San Francisco site or the Los Angeles site (n=143/site). The primary outcome is virologic control. The specific aims are: 1) To evaluate rates of virologic control for TWH in response to the Healthy Divas intervention; 2) To evaluate the efficacy of the intervention on HIV treatment engagement among TWH; and, 3) To explore the effect of the intervention on hypothesized mechanisms of action. The randomized two-group design uses repeated assessments at baseline and at 3-, 6-, 9-, and 12-month post-randomization follow-up.

Project Number: 5R01MH106373-03

https://reporter.nih.gov/search/0yGsD9H-3UaHRoJMIRctgg/project-details/9312318

 

Contact PI/ Project Leader

SEVELIUS, JEANNE M. (jae.sevelius@ucsf.edu)

 

Organization

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

 

PUBLIC HEALTH RELEVANCE: The proposed trial is grounded in a novel transgender-specific framework and is the culmination of years of work in a community at heightened risk for HIV treatment failure and transmission of HIV to others. If effective, the proposed intervention approach has the potential to optimize health outcomes in a population highly burdened by HIV while preventing further transmission.

 

 

Project Start Date: 08-September-2015

Project End Date:30-June-2020

Budget Start Date: 01-July-2017

Budget End Date: 30-June-2018

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $788,397

Text Me, Girl! – Text Messaging to Improve Linkage, Retention and Health Outcomes among HIV-positive Young Transgender Women

Abstract: Young trans women experience a number of psychosocial challenges including discrimination, prejudice, stigmatization, and social/economic marginalization, which stand as obstacles to linkage and retention in HIV care and ART medication adherence. Due to these challenges, and their often transient nature, a text-messaging HIV intervention that is easily accessible, culturally competent, private and portable is a particularly salient method for engaging and retaining young trans women in HIV care. This project utilizes a text-messaging intervention to improve engagement, retention, and health outcomes along the HIV Care Continuum, with the desired outcome of viroligical suppression, among HIV-positive young trans women, aged 18-34, who are not linked to care, or not retained in care, or not prescribed ART, or nonadherent to ART, or not virologically suppressed. Over the course of the 90-day intervention, participants receive 270 theory-based text messages that are targeted, tailored, and personalized specifically for HIV-positive young trans women; participants receive three messages per day in real-time within a 10-hour graduated and automated delivery system. The text-message content is pre-written along the HIV Care Continuum (i.e., HIV positivity/physical and emotional health, linkage/retention in care, ART adherence/viral load suppression) and is based on three proven theories of behavior change (i.e., Social Support Theory, Social Cognitive Theory, and Health Belief Model). Following screening for eligibility, informed consent, and baseline assessment, participants are randomized into one of two conditions: Group A: Immediate Text Message Intervention Delivery (ID, n=60); or, Group B: Delayed Text Message Intervention (DD, n=60) whereby participants are delivered the text-messaging intervention after a delayed 90-day period. Participants in both groups receive the exact same 90-day text-messaging intervention. Following the 90-day theory-based, trans-specific text-messaging intervention, participants may opt in/opt out of continued weekly post-intervention messages for ongoing retention and engagement support derived from the HRSA-funded UCARE4LIFE library. The randomized two-group repeated measures design assesses participants at 3-, 6-, 12-, and 18-months post-randomization to determine observed intervention effects and longitudinal intervention effects.

The Alexis Project

Abstract: Trans women of color experience a number of psychosocial challenges including discrimination, prejudice, stigmatization, and social/economic marginalization, which stand as obstacles to HIV care and other needed services. The Alexis Project* employs a multi-tiered, comprehensive approach, which includes network, individual and structural components to identify, recruit, test, link, treat and retain trans women of color into quality HIV care. The Alexis Project incorporates three proven models, Social Network Recruitment (network), Peer Health Navigation (individual) and Contingency Management (structural), into one multi-leveled project to optimize HIV health outcomes for trans women of color. Through Social Network Recruitment, local trans women recruit trans women of color from their social, sexual and drug-using networks into the project for either testing (HIV unknown status) or (for those who are aware of their HIV infection but not in care) to the combined Peer Health Navigation and Contingency Management intervention. Over the five-year study, 139 trans women of color will enroll in the combined Peer Health Navigation and Contingency Management intervention.  The project goals are: 1) to identify trans women of color who are unaware of their HIV-positive status and identify trans women of color who are already aware of their HIV infection but have never been engaged in care or have refused a referral to care or have dropped out of care; 2) to directly link HIV-infected trans women of color to a Peer Health Navigator; 3) to link HIV-infected trans women of color to quality HIV care; 4) to work with HIV-infected trans women of color to address the barriers in their life that limits or impedes their access to HIV care; and, 5) to retain HIV-infected trans gender women of color in HIV care to reach and sustain HIV milestones. Peer Health Navigators work with participants to identify HIV care services and other needed services, develop a specific client-centered treatment plans, remove barriers to those services and access those services. Contingency Management provides increasing valuable incentives for attending HIV medical visits and reaching and sustaining HIV milestones.

Hours: Weekdays, 10:30 a.m. to 7:00 p.m.

Contact: 323-793-4645 or 323-512-7014

Funding Source: This project is funded by the Health Resources and Services Administration (HRSA) and sponsored by Friends Research Institute, Inc.

https://www.friendscommunitycenter.org/alexis-project

*The Alexis Project is named after Alexis Rivera who died on March 28, 2012, at the age of 34, from complications related to HIV. Alexis was a proud Latina trans woman; a community activist, a peer advocate and a gatekeeper.

Mining Real-Time Social Media Big Data to Monitor HIV: Development and Ethical Issues

Abstract:  Social “big data” holds information with wide-ranging implications for addressing issues along the HIV care continuum. Social big data refers to information from social media and online platforms on which individuals and communities create, share, and discuss content. One in four people worldwide, or over a billion people, are publically documenting their activities, intentions, moods, opinions, and social interactions on these sites. They are doing so with increasing volume and velocity, including 400 million “tweets” per day on Twitter and 4.75 billion content items shared per day on Facebook. With an increasing number of these platforms supporting access to publicly-available user data, social big data analysis is a promising new approach for attaining organic observations of behavior that can be used to monitor and predict real-world public health problems, such as HIV incidence. New tools such as social data are therefore needed to supplement existing HIV data collection methods. In preliminary research, our team developed the first approach that identifies psychological and behavioral characteristics from social big data (>550 million tweets) found to be associated with HIV diagnoses. Since groups at the highest risk for HIV (e.g., minority populations) are the fastest growing Twitter users, and because social media users have been found to publicly share personal information, we identified and collected tweets suggesting HIV risk behaviors (e.g., drug use, high-risk sexual behaviors, etc.) and modeled them alongside CDC statistics on HIV diagnoses. We found a significant positive relationship between HIV- related tweets and county-level HIV cases, controlling for socioeconomic status measures and other variables. The problem is that this approach is not currently scalable for use by HIV researchers and public health organizations. Although public health agencies are interested in mining social data to address HIV, current tools are not accessible to most health scientists, as the tools require advanced computer science expertise. For example, analyzing 500 million tweets a day requires expertise in big data engineering, advanced machine learning, natural language processing, and artificial intelligence. Developing a single platform for mining social data that has been designed and tested by and for HIV researchers could provide a significant impact on HIV prevention, testing, and treatment. We seek to create a single automated platform that collects social media data; identifies, codes, and labels tweets that suggest HIV-related behaviors; and ultimately predicts regional HIV incidence. Because of the potential ethical issues associated with mining people’s data, we also seek to interview staff at local and regional HIV organization and participants affected by HIV to gain their perspectives on the ethical issues associated with this approach. The software developed from this application will be shared with HIV researchers and health care workers to provide additional tools that can be used to combat the spread of HIV.

Project Number: 1R56AI125105-01A1

https://reporter.nih.gov/search/jRCGXVrkakWONMVPH59sPA/project-details/9317061

 

 

Contact PI/ Project Leader

YOUNG, SEAN, ASSOCIATE PROFESSOR (syoung5@hs.uci.edu)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Project Narrative Surveillance and monitoring of HIV and related risk behaviors is a top priority. This project is of particularly high impact because it seeks to develop software to allow researchers to analyze real-time conversations from social media big data to monitor HIV diagnoses. It also will provide data on the ethical issues associated with the increasing number of these “social data mining” approaches. The software developed from this application will be shared with HIV researchers and health care workers to provide additional tools that can be used to combat the spread of HIV.

 

 

 

 

Project Start Date: 01-September-2016

Project End Date: 31-August-2019

Budget Start Date: 01-September-2016

Budget End Date: 31-August-2019

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES / FY Total Cost by IC: $671,438

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-12-222Study 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

Theory-Based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM

Abstract: Methamphetamine use among men who have sex with men (MSM) is deeply integrated into socio-sexual networks including physical risk venues such as circuit parties, sex clubs, and bathhouses and digital spaces such as cell phone applications, websites, and digital chat rooms to “hook up” for sex. Thus, methamphetamine use is highly associated with HIV infection due specifically to concomitant high-risk sexual behaviors that occur while using the drug. Text-messaging is a novel, feasible, and sustainable approach for targeting high-risk, out-of-treatment MSM; particularly, MSM who fail to attend face-to-face or site-based interventions. A real-time text-messaging intervention capitalizes on a communication channel to which this population will attend at the exact time they are most likely to make high-risk sexual decisions. This application is in response to PA-10-012 for technologically enhanced Stage II research. Consistent with the specific research interest of the PA, this application builds on findings from an open-label Stage I study that developed and piloted a HIV prevention intervention to reduce methamphetamine use and high-risk sexual behaviors among out-of-treatment, methamphetamine-using MSM. During the pilot study, text messages – based on established behavioral change theories and specifically tailored to urban, out-of-treatment, methamphetamine-using MSM – were developed and tested. The proposed Stage II trial will assess the impact of an 8-week, gay-specific, theory-based text-messaging intervention designed to decrease methamphetamine use and HIV sexual risk behavior and, for the HIV-infected participants, simultaneously increase HIV antiretroviral treatment/adherence in out-of-treatment, methamphetamine-using MSM (N = 285). Participants will receive text messages that are personally tailored to fit their risk profile; the theory-based text messages serve as the mechanisms of behavior change. Participants will be randomized into one of three conditions: Group 1: culturally relevant theory-based text messages interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or, Group 3: assessment-only (AO) control with no theoretically based text messages. Participants will receive brief weekly text-message assessments on their methamphetamine use and HIV sexual behaviors in the previous seven days. The specific aims of this research are: 1) To determine differential immediate and sustained effects of transmitting theory-based text messages by PHE (TXT-PHE) versus by automation (TXT- Auto), compared to an assessment-only (AO) control condition among out-of-treatment, methamphetamine- using MSM for reductions of methamphetamine use and HIV sexual risk behaviors; and, 2) To determine the cost-effectiveness of TXT-PHE vs. TXT-Auto compared to AO for reducing methamphetamine use and HIV sexual risk behaviors. The randomized three-group design uses repeated assessments at baseline, at the end of the intervention, and at 3-, 6-, and 9-month post-randomization follow-up.

 

 

Project Number: 4R01DA035092-04

https://reporter.nih.gov/search/Qh9D4Tpmqk6QOQbxOJSWcw/project-details/9012056

 

 

Contact PI/ Project Leader

REBACK, CATHY J , (reback@friendsresearch.org)

 

Organization

FRIENDS RESEARCH INSTITUTE, INC.

 

PUBLIC HEALTH RELEVANCE: Methamphetamine use among MSM is highly associated with HIV infection due specifically to the concomitant high-risk sexual behaviors that occur while using the drug. The “real-time” theoretically based text-messaging HIV prevention intervention will reach out-of-treatment, methamphetamine-using MSM while they are in the contexts of greatest risk and interrupt both drug use and HIV sexual risk behaviors. The proposed research will determine differential immediate and sustained effects and cost effectiveness of the text-messaging intervention to reduce methamphetamine use and concomitant HIV sexual risk behaviors and, for the HIV- infected participants, increase HIV antiretroviral treatment/adherence.

 

 

 

Project Start Date: 01-Feburary-2013

Project End Date: 31-Janurary-2019

Budget Start Date: 01-Feburary-2016

Budget End Date: 31-Janurary-2019

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE / FY Total Cost by IC: $464,688

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

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