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

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

Mobile Technology and Incentives (Motives) for Racial and Ethnic Minorities in Los Angeles

Abstract:  HIV disproportionately affects sexual and gender minorities such as men who have sex with men (MSM) and transgender women (TGW). These individuals do not always receive the most up-to-date information on rapidly evolving guidelines in a time of new prevention technologies such as pre-exposure prophylaxis, leading to confusion in the face of recent HIV prevention developments. A lack of engagement in the traditional health care system also leads to infrequent testing for HIV. Novel ways are urgently needed to supply MSM and TGW with the most recent and accurate HIV prevention information to promote HIV health literacy and highlight the pitfalls of indirect assessments of potential infectivity rather than trimestral testing as recommended by the CDC. Mobile technologies such as text messaging present a dynamic new way to improve access to critical prevention information and care for MSM and TGW, but better ways of adapting them to the unique needs of MSM and TGW are needed, and creative ways of keeping them engaged are critical. Given the growing recognition that even if people have all necessary information and are motivated, they commonly fail to show healthy behavior, this proposal employs novel insights from behavioral economics to provide frequent feedback and incentives to keep participants engaged and support them in their intention to remain HIV negative. This proposal entails a 3-phase mobile technology based and BE supported HIV prevention intervention – called Mobile Technology and Incentives (MOTIVES) – to increase engagement with HIV prevention information and improve testing frequency. Formative Phase 1 includes 30 semi-structured interviews with MSM and TGW to finalize the planned intervention based on the insights from a preliminary study. Phase 2 will enroll 200 HIV- negative MSM and TGW in an 18-month, two-arm randomized controlled trial (RCT). Those in the intervention group will receive weekly text messages with HIV prevention information, and can win reward points for correctly answering weekly quizzes to keep them engaged and improve their retention of the HIV prevention information. Those who continue to test negative for HIV at least once every three months can enter a prize drawing to win prizes, with larger chances for those correctly answering the weekly quizzes. The control group will receive the same HIV prevention information but without the incentives. The primary outcomes include frequency of HIV testing and HIV prevention knowledge. Phase 3 includes 7 exit focus groups (with 5-8 participants per group) to evaluate areas for study improvement and estimate parameters for future scale up. The Specific Aims are to 1) develop MOTIVES and finalize the weekly text message information content and the types of incentives; 2) implement and evaluate the impact of MOTIVES; and 3) evaluate areas of improvement for MOTIVES through focus groups and estimate mission-critical design parameters with point and confidence interval estimates for a subsequent, fully-powered R01 application.

 

 

Project Number: 5R34MH109373-02

https://reporter.nih.gov/search/RSa1tMjoTkCcAib3ShEi7w/project-details/9305148

 

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: PROJECT NARRATIVE For public health it is important to improve the access of populations at high risk for HIV to the most up-to-date HIV prevention information and encourage them to test for HIV at appropriate intervals. Our study will make use of HIV testing sites as an entry point to enroll study participants and send them HIV prevention information tailored to address the specific needs of men who have sex with men and transgender women along with reminders to get tested for HIV at least once every three months by mobile phone, complemented by incentives to stay engaged in the study. The insights from this R34 grant will serve as the basis for a subsequent grant application to implement such an intervention at scale.

 

 

 

 

Project Start Date: 01-July-2016

Project End Date: 30-June-2019

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: $257,938

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

Improving Drug Adherence Among Adolescents in Uganda Using SMS Reminders

Abstract: To realize the benefits of HIV care requires high medication adherence that has been found lower than previously assumed and declining over time in sub-Saharan Africa (SSA). Youths with still developing emotional and cognitive capacities face special and unique challenges to adherence. Despite a wealth of interventions designed to increase adherence outcomes, few have focused on the period of adolescence. Developing ways to increase adherence rates among adolescents is particularly important as this group experiences the fastest growth in new HIV/AIDS cases. Such interventions are important in resource-limited settings important where second-line therapy is often too expensive or altogether unavailable. Similarly, youths are often on pre-ART co-trimoxazole prophylaxis to defer the need to take costly ART, yet most interventions do not take this reality into account. 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, yet their effectiveness among an adolescent population remains unknown. Such interventions are likely particularly effective for adolescents who have been central to the rapid growth in mobile phone ownership in developing countries. This proposal suggests to develop and test potentially cost-effective and scalable short message service (SMS)-based interventions to improve adherence to ART and pre-ART prophylaxis, as well as retention in care among HIV positive young patients aged 15-24 at two clinics in Uganda. The first aim is to hold focus groups with key stakeholders to tailor the SMS-intervention to the local needs of youths. The second aim proposed is a two-year randomized controlled trial testing one- way and two-way SMS messages (the latter offer the possibility for clients to signal health problems for follow-up by clinic staff) against a control condition of usual care to determine which method of reminding and motivating drug adherence can best achieve its goals, and whether the potentially higher adherence achieved in the two-way messages justify their increased cost. The third aim is to synthesize lessons learned and discuss them with the clinics and other key stakeholders. A cost-effectiveness analysis of one- versus two-way messages will also be performed as part of this aim.

 

 

Project Number: 5R01HD074925-05

https://reporter.nih.gov/search/T1Or88nrek2qodWnmLC_Hg/project-details/9211357

 

 

Contact PI/ Project Leader

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

 

Organization

RAND CORPORATION

 

PUBLIC HEALTH RELEVANCE: A key public health question is how to sustain drug adherence over a lifetime for individuals in HIV care, and particularly for adolescents who are in the midst of intense emotional and psychological changes. Messages delivered by mobile phones may offer a low-cost method to improve adherence in resource-limited settings and may be particularly appropriate for adolescents who have been central to the recent dramatic rise in mobile phone ownership throughout the developing world. We propose to implement a randomized controlled trial that tests one-way versus two-way text messages (where the latter allow for recipients to respond to the message to receive further support) to increase medication adherence and retention in care among young HIV-patients at two urban clinics in Kampala, Uganda.

 

 

FOA:  RFA-HD-12-206Study Section: ZHD1-DSR-W(55)R

 

 

Project Start Date:01-February-2013

Project End Date: 31-January-2019

Budget Start Date: 01-February-2017

Budget End Date: 31-January-2019

 

 

NIH Categorical Spending

Funding IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT/ FY Total Cost by IC: $405,374

A Comprehensive Community-Based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection

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

 

Project Number: 5U19HD089886-02

https://reporter.nih.gov/search/HbqgtLEtKUG1ysdAGWkuMQ/project-details/9353195

 

 

Contact PI/ Project Leader

ROTHERAM-BORUS, MARY JANE, PROFESSOR (ROTHERAM@UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

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

 

 

FOA:  RFA-HD-16-035Study Section: ZHD1-DSR-N(50)1

 

Project Start Date:30-September-2016

Project End Date: 31-May-2021

Budget Start Date: 01-June-2017

Budget End Date: 31-May-2018

 

 

NIH Categorical Spending

Funding IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT/ FY Total Cost by IC: $3,738,607

Multimodal Interventions to Improve Adherence to Oral Tenofovir/Emtricitabine as Pre-Exposure Prophylaxis in Women in Southern California

Abstract: Daily oral pre-exposure prophylaxis (PrEP) with tenofovir/emtricitabine (TDF/FTC) as part of a combination prevention package has been shown to be effective for HIV prevention in randomized control trials of MSM and heterosexual men and women at risk for HIV infection; however, some studies in African women have shown lack of efficacy that is believed to be in large part due to inadequate PrEP adherence. In addition, pharmacokinetic studies in women suggest that near-perfect adherence for TDF/FTC oral dosing may be more critical for protection against vaginal compared to rectal exposures. Taken together, these results imply that women may require substantially greater levels of adherence to oral TDF/FTC to effectively decrease HIV acquisition. Therefore, interventions to optimize adherence are particularly vital to maximizing the protective efficacy of PrEP for women. Although current FDA approval and CDC clinical guidelines for oral TDF/FTC as PrEP include at-risk women as candidates for use, limited clinical data exists on the use of PrEP in US women. Further research is needed to advance effective implementation, particularly taking into account the known challenges to achieving and maintaining high levels of adherence for women. In this demonstration project, we will evaluate adherence to, and acceptability of once-daily oral TDF/FTC as PrEP among HIV-uninfected women in Southern California who are at increased risk of HIV acquisition. Los Angeles and San Diego represent two of the top three counties in California of number of reported HIV/AIDS cases. In combination, they total over half of the number of HIV cases in the state supporting the need for ongoing prevention efforts in all at-risk populations (1). Working in tandem, the LAC PATH and CCTG partnership provides a unique opportunity to further collaborative research that has been fostered within the CHRP funding structure, capitalizing on the strengths of existing individual projects in MSM and transgender women.

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