Posts classified under: Adherence

Goals for Adherence with Low-cost Incentives (GOALS)

Abstract: Treatment outcomes of HIV-positive youth in Uganda and elsewhere are threatened by low medication adherence. Despite the clear need for adherence support among youth, few interventions target this particularly vulnerable group during a time of heightened risk-taking behavior and unfinished development of cognitive control processes such as planning and goal-directed behavior. Incentives informed by behavioral economics (BE) have successfully changed a range of health behaviors by countering present bias (the tendency of overly discounting the future benefits of preventive health behaviors) including our own study that improved ART adherence. However, they have rarely been tested among youth living with HIV (YLWH) who are likely to particularly benefit from such extrinsic rewards given their observed problems with self-control. Traditional incentives that require individuals to reach a uniform, high eligible threshold by design leave out those unable to meet it, often most in need of support. In a pilot study, we tested a novel incentive design that allowed even those with low initial adherence to qualify for incentives, resulting in their improved adherence. BE theory suggests that the effort exerted to reach a goal depends on how far away it is from the participant; if the goal is within close reach, the participant shows great willingness to achieve it, but if the goal is set too high, s/he becomes demotivated and may give up. Based on this insight, we restructured our incentive design to allow participants to set their own eligibility threshold. We propose to build on our pilot results using a randomized controlled trial (RCT) to establish effectiveness. Our intervention, GOALS, proposes testing externally assigned sub-goals gradually increasing towards 90% (T1, n=140) and self-chosen, participatory interim goals (T2, n=140), against a traditional, fixed goal of 90% (T3, n=140). The control group (n=140) will receive the usual standard of care. The primary outcome is electronically measured ART adherence collected throughout the study and for 12 months after incentives are withdrawn to measure the persistence of behavior change; suppressed viral load will be the secondary outcome. The Specific Aims in year 1 (Improvement Phase) is to evaluate the relative effectiveness of the three incentivization approaches for improving adherence among YLWH. In year 2 (Maintenance Phase), we test the relative effectiveness of the three ways of incentivization for maintaining adherence. In year 3 (Persistence Phase) the goal is to investigate for 12 months the relative effectiveness of the three GOALS intervention arms at creating behavioral persistence once incentives are removed. Specific Aim 4 is to perform a cost-effectiveness analysis including a comparative analysis of those GOALS intervention arms that show a positive intervention impact for improving and/or maintaining adherence.

Project Number: 1R01HD104555-01

https://reporter.nih.gov/search/4vgAl9SY20-gSBejiQexgQ/project-details/10161248

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: There is a paucity of support for young people living with HIV (YLWH) who often fail to achieve viral suppression, with catastrophic consequences in particular in resource-constrained countries in which treatment options are limited. This study aims to improve ART adherence among YLWH by providing small incentives based on insights from behavioral economics, combined with text messages sent by mobile phone. The approach is particularly targeted at those with low adherence as it allows to adjust eligibility thresholds for incentives to participants’ initial adherence, thereby reducing health inequality and facilitating high, long-term ART adherence for a particularly vulnerable group of HIV clients.

 

 

Project Start Date: 17-May-2021

Project End Date:31-January-2026

Budget Start Date: 17-May-2021

Budget End Date:31-January-2022

 

NIH Categorical Spending

Funding IC:  EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT / FY Total Cost by IC:$724,445

Behavioral Economics to improve Antihypertensive Therapy Adherence (BETA)

Abstract: Hypertension is one of the most prevalent cardiovascular disease risk factors, with over 45% of the United States population having elevated blood pressure. Decades of research have demonstrated that controlling blood pressure can reduce the risk of serious adverse cardiovascular events including stroke, myocardial infarction, and heart failure. A key component of successfully obtaining control of hypertension is the use of medications to lower blood pressure. Unfortunately, more than 50% of Americans demonstrate medication non-adherence, a statistic that directly contributes to suboptimal blood pressure control and, therefore, excess preventable cardiovascular events. Strong data indicates that linking the taking of medications to daily routines (‘anchoring’) increases adherence, however, existing interventions built on this information have failed to create successful, long term improvements in medication adherence. This study aims to leverage behavioral economic insights to improve medication adherence to antihypertensive medications. Specifically, we propose to complement linking medication taking to a daily routine with two added components to make it easier for participants to stick to their anchoring plan: increasing information salience through frequent text messages and providing intermittent rewards for pill-taking according to the anchoring plan. This study will be implemented in a pilot randomized controlled trial (RCT) in a high-volume clinical practice to establish feasibility, acceptability, and preliminary efficacy. The specific aims include 1) a formative phase to develop the intervention and evaluate its feasibility and acceptability via focus groups with key stakeholders; 2) a RCT of 60 hypertensive patients in which a control group (n=20) is provided education on anchoring medication taking to a daily routine, and two intervention groups, one (n=20) who receives anchoring education and daily text message reminders and another (n=20) which receives anchoring education, text messages, and financial incentives for adherence in accordance with their anchoring plan; and 3) data collection in preparation for a future R01 application, including focus group discussions with key stakeholders (patients, providers [Physicians, Nurses, Advanced Care Practitioners, Pharmacists] and clinic staff) and exit focus groups with study participants regarding ways to improve the intervention. The main hypothesis is: the intervention is effective by anchoring pill-taking to an existing routine, tested by comparing the pooled (Message group + Incentive group) vs. the Control group. The secondary hypothesis is: adding incentives to the text messages is more effective for routinizing pill-taking (testing outcomes in the Incentive group vs. Message group). Outcomes from this study have the potential to greatly enhance our understanding of the barriers and facilitators of medication adherence among hypertensive patients and potentially provide evidence for a low-cost and scalable intervention to improve medication adherence in clinical practice.

Project Number: 1R21HL156132-01

https://reporter.nih.gov/search/dL93-SB4GEav4RQXqIh6Sw/project-details/10108865

 

Contact PI/ Project Leader

EBINGER, JOSEPH, FELLOW (Joseph.Ebinger@cshs.org)

 

Organization

CEDARS-SINAI MEDICAL CENTER

 

PUBLIC HEALTH RELEVANCE: Hypertension represents a major cardiovascular risk factor that can be controlled through the use of medications, yet medication non-adherence represents a common problem that leaves patients at elevated risk for adverse cardiovascular outcomes. Interventions to improve medication adherence have thus far been either unsuccessful or unsustainable. We propose an intervention that leverages insights from behavioral economics to improve medication adherence among hypertensive patients.

 

 

Project Start Date: 01-May-2021

Project End Date: 30-April-2023

Budget Start Date: 01-May-2021

Budget End Date:30-April-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL HEART, LUNG, AND BLOOD INSTITUTE/ FY Total Cost by IC: $282,197

Los Angeles CRS for the MACS/WIHS Combined Cohort Study

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

Project Number: 3U01HL146333-02S1

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

 

Contact PI/ Project Leader

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

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

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

 

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

 

Project Start Date: 15-April-2019

Project End Date: 31-March-2026

Budget Start Date: 01-July-2020

Budget End Date: 31-March-2021

 

NIH Categorical Spending

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

Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

Abstract: The proposed project is designed to evaluate the effectiveness of cefixime (400mg, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. Syphilis rates have been increasing both in the US and internationally. Incidence is higher among men-who-have-sex-with-men and more importantly in individuals with HIV infection. Currently, penicillin is used to treat syphilis in patients with and without HIV infection. Doxycycline, tetracycline and ceftriaxone are alternative treatments for non-pregnant patients who are allergic to penicillin. Existing treatment alternatives are based on clinical experience, a limited number of small clinical trials, and case series, but each poses clinical challenges. New, safe and efficacious antibiotic treatment options are needed. In this proposal, we will build upon our successful pilot study to conduct a randomized, multisite, open-label, non- inferiority clinical trial to evaluate the effectiveness of cefixime (400mg, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. We will enroll 400 participants with early syphilis infection from 9 clinical sites in the U.S. and Peru. We will follow the participants to monitor clinical progress and serological response (RPR titer) every 3 months for 9 months. Our hypothesis is that cefixime will be non-inferior to penicillin in treating syphilis, shown as a 4-fold decrease in RPR titer from enrollment to 6-months after treatment administration. These are the two specific aims of our proposal. AIM 1: Evaluate the effectiveness of cefixime in the treatment of early syphilis when compared to benzathine penicillin G. AIM 2: Determine the predictors of treatment failure among participants. The 5 year project has 4 phases. Phase I will last 9 months and will involve the development of study instruments, staff training on recruitment, enrollment, and data collection. Phase II will last 36 months and will involve recruitment and enrollment of patients. Phase III which will last 45 months, but will start simultaneously as stage II, and will include the patient follow-up period. Phase IV will last 6 months and in that time, the data will be analyzed and disseminated.

Project Number: 7R01AI155217-02

https://reporter.nih.gov/search/YayN4XwnBUe4QIvlEb1gsg/project-details/10392825

 

Contact PI/ Project Leader

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

 

Organization

UNIVERSITY OF SOUTHERN CALIFORNIA

 

PUBLIC HEALTH RELEVANCE: In the proposed study, we will examine the effectiveness of oral cefixime 400 mg twice-daily for 10 days (compared to injectable single dose benzathine penicillin G) in treating syphilis among people with and without HIV infection. The results of this clinical trial might identify cefixime as a novel alternative treatment for syphilis that is useful for people living with HIV infection, in patients with penicillin allergy or in settings of penicillin shortage. We will also describe predictors of syphilis treatment failure among people with and without HIV.

 

 

Project Start Date: 13-July-2020

Project End Date: 30-June-2025

Budget Start Date: 01-July-2021

Budget End Date: 30-June-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES/ FY Total Cost by IC: $665,080

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

An integrated incentive-based treatment to optimize HIV treatment engagement among persons who use methamphetamine

Abstract: The objective of this K23 Mentored Patient-Oriented Research Career Development Award is to assist the candidate in acquiring expertise and methodological skills to become an independent implementation science investigator focused on integrated substance use disorder and HIV care practices. The objective of the candidate’s research is two-fold: to reduce the detrimental impact of methamphetamine use while simultaneously supporting engagement in HIV care. People with HIV who use methamphetamine are susceptible to experiencing gaps at each stage of the HIV care continuum. Contingency management is an effective behavioral therapy for methamphetamine use disorder that is based on operant conditioning principles. Contingency management decreases the reinforcing effects of methamphetamine use by providing immediate, positive reinforcement following abstinence from substance use. Incentive-based interventions based on operant conditioning principles also demonstrate positive effects for improving antiretroviral therapy (ART) adherence. It remains unclear whether a contingency management program that integrates incentives for ART adherence (CM+ART, i.e., dually targeting methamphetamine use and ART adherence) is more acceptable and appropriate to people with HIV than a contingency management program targeting methamphetamine use only. The specific aims of the research plan for the five-year K23 award period are: 1) to identify resources required to implement contingency management programs in settings serving people with HIV, 2) to adapt contingency management to integrate incentives for adherence to ART (CM+ART), and 3) to evaluate whether CM+ART is acceptable and appropriate to people with HIV who use methamphetamine compared to a contingency management program targeting only reductions in methamphetamine use. Dr. Montoya’s mentored training plan, including formal didactics and other activities, aligns with the research aims and career development plans and has four key areas: 1) to deepen knowledge of evidence-based practices implemented at local and national levels to support patient engagement in HIV and substance use disorder care, 2) to apply an implementation science approach to guide adaptation of contingency management to integrate incentives for ART adherence, 3) to acquire advanced methodological skills to design and evaluate mixed-method studies and clinical trials, and 4) to engage in professional development activities geared toward development of a competitive NIDA R01 application and an independent research career. This proposal strongly aligns with NIDA Strategic Plan Objectives 3.1 (“Develop and test novel treatments based on the science of addiction”) and 3.4 (“Develop and test strategies for effectively and sustainably implementing evidence-based treatments”); the NIH Office of AIDS Research priority to address HIV- associated comorbidities such as substance use disorders; and the “Ending the HIV Epidemic: A Plan for America” initiative. The comprehensive training activities and research plan will effectively position the candidate for an independent research career focused on the integration of HIV and substance use disorder care.

Project Number: 1K23DA051324-01A1

https://reporter.nih.gov/search/go5OXMt_20GPUJMlOviWPw/project-details/10161337

 

Contact PI/ Project Leader

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

 

Organization

UNIVERSITY OF CALIFORNIA, SAN DIEGO

 

PUBLIC HEALTH RELEVANCE: Substantial resources have been invested to combat the HIV epidemic; however, methamphetamine use is a persistent and growing concern in the U.S. that contributes to worse patient outcomes and HIV transmission. An integrated treatment that addresses methamphetamine use and adherence to HIV treatment may help advance efforts to end the HIV epidemic. Building from a large body of evidence showing the effectiveness of a behavioral treatment (called contingency management) for treating methamphetamine use disorder, we plan to identify resources required to implement contingency management programs in settings serving people with HIV, as well as to adapt and evaluate a contingency management program that dually targets reductions in methamphetamine use and increased adherence to HIV treatment.

 

 

Project Start Date: 01-May-2021

Project End Date: 30-April-2026

Budget Start Date: 01-May-2021

Budget End Date: 30-April-2022

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE ON DRUG ABUSE/ FY Total Cost by IC:$205,740

Incentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)

Abstract: Recently the number of people initiating antiretroviral (ART) treatment (“treatment initiators”) has increased but too many fail to achieve viral suppression. Healthy routines are key to achieving long-term behavioral change and healthy outcomes, but few people manage to form them on their own. Existing interventions typically suggest that people anchor the targeted behavior to an existing routine, but fail to support participants during the time it takes to turn the behavior into a routine, with the result that typically fewer than half end up carrying the targeted behavior out automatically. Behavioral economics (BE) points to two important biases preventing many people from translating their good intentions into successful routines; it also suggests two readily implementable approaches to counter these same biases: the bias of lack of salience of chronic treatment adherence (i.e. over time, the more pressing needs of daily life dominate good intentions) can be countered by low-cost reminder messages sent via mobile phone during the time it takes to turn pill-taking into a routine behavior. Present bias (i.e. giving in to short-term temptations, which can lead to skipping pill doses) explains why many people have trouble sticking to their good intentions. Using small, intermittent incentives until the behavior becomes a routine is a novel approach that has the potential to be a game changer for establishing the (currently elusive) goal of long-term high ART adherence. The proposed R34 study will be implemented in a Ugandan HIV clinic in a 12-month randomized controlled trial (RCT) among treatment initiators to establish feasibility, acceptability, and preliminary efficacy of the intervention. Following formative work in Phase 1, all study participants will be told about the importance of routine pill-taking and receive a leaflet with strategies for anchoring pill-taking to an existing routine. Participants in the first intervention group (n=50) will then receive daily text messages for 3 months to reinforce that information (Message group). Participants in the second intervention group (n=50) will receive the same messages, but will also have a chance of winning small rewards conditional on high and timely medication adherence (Incentive group). Participants in the Control group will receive the usual standard of care. Persistence of adherence (primary outcome) and timely pill- taking (secondary outcome) will be measured using MEMS caps for 9 months after the 3-months intervention, and retention in care as well as viral loads (secondary outcomes) will be assessed at month 12. Specific Aim 1 will be to evaluate the feasibility and acceptability of INMIND and develop the intervention using the ADAPT- ITT framework. Based on these insights, Specific Aims 2a and 2b will test the preliminary effectiveness of the intervention, including the relative effectiveness of two different implementation approaches (i.e. text messages alone vs. together with small BE-based incentives). Specific Aim 3 will collect data allowing adaptation of intervention parameters for a subsequent R01 application to test the intervention at scale.

Project Number: 1R34MH122331-01A1

https://reporter.nih.gov/search/MU2vuIDeYkKInZGRQ5l_CQ/project-details/10082687

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: For public health it is important to support the growing number of ART treatment-initiating clients who often fail to achieve viral suppression, with catastrophic consequences in particular in resource-constrained countries in which treatment options are limited. This study aims to increase ART adherence among treatment initiators by anchoring pill-taking to an existing routine behavior with the help of small incentives based on principles from behavioral economics in combination with text messages sent by mobile phone. The approach is particularly targeted at those with low motivation and cognitive problems, thereby reducing health inequality and facilitating high, long-term ART adherence for a particularly vulnerable group of HIV clients.

 

 

Project Start Date: 01-September-2020

Project End Date: 31-August-2023

Budget Start Date: 01-September-2020

Budget End Date:31-August-2021

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC:$275,080

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

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

Project Number: 5R01MH110350-05

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

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

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

 

 

Project Start Date: 13-September-2017

Project End Date: 30-June-2022

Budget Start Date: 01-July-2021

Budget End Date: 30-June-2022

 

NIH Categorical Spending

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

Evaluating the PrEP cascade in HIV-negative pregnant and breastfeeding women in South Africa (PrEP-PP)

Abstract: HIV-negative pregnant and breastfeeding women in South Africa are at extremely high risk of HIV acquisition despite increased access to and initiation of antiretroviral therapy (ART) in South Africa. We urgently need effective interventions to reduce HIV incidence in pregnant and breastfeeding women. Currently PrEP is one of the only female controlled methods that is effective for preventing HIV acquisition. PrEP-PP is a study of pre-exposure prophylaxis (PrEP) among HIV-1 seronegative Pregnant and Postpartum women in two South African urban primary health care facilities. Effective use of PrEP could contribute to eliminating maternal HIV acquisition, and hence eliminating mother to child HIV transmission (MTCT). However, PrEP efficacy requires adherence during periods of sexual activity and adherence requires PrEP access, awareness and counseling. Currently, a major obstacle in the field is the lack of knowledge of women’s initiation, retention and adherence to PrEP during pregnancy and breastfeeding periods in Africa. Now is the time to evaluate how best to provide PrEP to vulnerable pregnant and breastfeeding women as WHO recently developed guidelines for providing PrEP in pregnancy and breastfeeding women but there are limited data on acceptability, initiation and adherence in pregnant and breastfeeding women in Africa where the burden of HIV is greatest. Our study will focus on the following specific aims: 1. Determine the distribution of women across the PrEP cascade (initiation, retention, and adherence) and outcomes (HIV acquisition, transmission, and adverse events) in a cohort of pregnant and breastfeeding women in Cape Town, South Africa 2. Evaluate patient and provider-level factors associated with the PrEP cascade (initiation, retention and adherence) using quantitative and qualitative approaches 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal) Our PrEP-PP study is urgent and essential to understand the PrEP cascade in pregnant and breastfeeding women in South Africa and to identify factors associated with PrEP initiation and adherence to develop interventions to ensure that everyone in this at-risk population can benefit from PrEP. The results from the PrEP-PP study will provide a model for the South African Government, and other Governments in the region, to scale up PrEP delivery among pregnant and breastfeeding women at risk of HIV acquisition and perinatal transmission and contribute to the elimination of perinatal HIV transmission.

Project Number: 1R01MH116771-01A1

https://reporter.nih.gov/search/dkK25PIoW0KfsaDd4N5FHw/project-details/9623865

 

Contact PI/ Project Leader

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

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: HIV-negative pregnant and breastfeeding women in South Africa (SA) are populations at very high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) is one of the only female controlled methods that can prevent HIV acquisition. Our study, PrEP-PP, will evaluate the PrEP cascade ( PrEP initiation, retention, adherence) and patient and provider-level factors associated with the PrEP cascade to inform future PrEP programs.

 

 

Project Start Date: 15-September-2018

Project End Date: 30-June-2023

Budget Start Date: 15-September-2018

Budget End Date: 30-June-2019

 

NIH Categorical Spending

Funding IC:  NATIONAL INSTITUTE OF MENTAL HEALTH / FY Total Cost by IC: $579,553

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

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