Posts classified under: Transgender

A.S.K.-PrEP Program (Assistance Services Knowledge-PrEP)

Abstract: The A.S.K.-PrEP (Assistance Services Knowledge-PrEP) program works with extremely high-risk HIV-negative trans women and men who have sex with men to link participants into PrEP medical services. A.S.K.-PrEP consists of individualized, client-centered PrEP navigation sessions to assess PrEP readiness, assess barriers to PrEP initiation and/or adherence, assess readiness for adherence, and to plan for PrEP persistence. Additionally, through the five-session A.S.K.-PrEP intervention, the PrEP navigator works with each participant to remove structural barriers to PrEP initiation/adherence (mental health, substance use [including injection drug use], intimate partner violence, STDs, housing, hormones, sex work), insurance enrollment/patient assistance), link participants into needed ancillary services, all with the ultimate goal of linkage to PrEP and persistent daily PrEP adherence. Discussions of PrEP readiness and individual and structural barriers to PrEP linkage and adherence occur throughout the five sessions. Throughout the duration of the project, participants can opt-in/opt-out of receiving culturally competent, theory-based PrEP adherence support text messages. Each text message has a theoretical conceptual foundation based on Social Support Theory (to provide informational, emotional or instrumental PrEP support), Health Belief Model (to identify or reduce HIV risks) or Social Cognitive Theory (to increase self-regulation skills and self-efficacy for PrEP persistence). A.S.K.-PrEP partners with three local clinics to provide culturally appropriate PrEP medical services.

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.

HPTN 085: The AMP Study

The AMP Study (also known as HVTN 704/HPTN 085) tests an experimental antibody against HIV. AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies that fight HIV to see if they will protect people from becoming HIV infected.

The AMP study tests an antibody called VRC01, a manufactured antibody against HIV. This is a new idea for HIV prevention that is related to what has been done in HIV vaccine research. In traditional HIV vaccine studies, people get a vaccine and researchers wait to see if their bodies will make antibodies against HIV in response to the vaccine. In this study, we will skip that step, and give people the antibodies directly.

VRC01 will be given using intravenous infusions. This is more commonly known as getting an IV, or getting a drip. The IV is given to the study participant every eight weeks for 30-60 minutes. To get an IV, a sterile needle is used to place a small plastic tube into a vein in the participant’s arm. A bag of fluid is hung from a pole and connected to a pump, which controls how quickly the contents of the bag flow through the tube into the participant’s arm.

There will be 3 different groups in this study. One third of study participants will get a higher dose of the antibody in their IV. One third will get a lower dose of the antibody in their IV. One third will get an infusion of sterile salt water without any antibody in it. This is called a placebo. Participants will be enrolled in the study for about two years.

HPTN-083

Abstract: Cabotegravir LA (CAB LA) is a long-acting injectable integrase inhibitor, also known as GSK 1265744 LA or 744 LA. This is a Phase 2b/3 study designed to establish the efficacy of CAB LA for pre-exposure prophylaxis (PrEP) in HIV-uninfected men who have sex with men (MSM) and in transgender women (TGW). Small single-dose and multiple-dose studies and Phase 2a safety/tolerability studies have been performed for CAB LA. This PrEP efficacy study is the next developmental investigation of CAB LA in healthy, HIV-uninfected MSM and TGW. CAB LA is the first antiretroviral (ARV) drug being studied as an intervention for HIV prevention prior to regulatory approval of the drug for HIV treatment. A parallel development program for use of cabotegravir (oral and injectable) for treatment of HIV-infected individuals is currently in Phase 2b studies with a salutary safety and efficacy profile to date.

To enroll in HPTN-083, click here for more information.

Project Number: 5um1ai068619-11

Engaging Seronegative Youth to Optimize HIV Prevention Continuum

Abstract: Young people at highest risk for HIV in the U.S. will be gay, bisexual transgender youth (GBTY) and homeless youth (HY) in communities with high HIV incidence and overwhelmingly Black and Latino. Focusing on Los Angeles and New Orleans, seronegative youth at highest risk for HIV will be screened in homeless shelters and gay-identified community-based organizations (CBO). A cohort of 1500 seronegative youth will be recruited that is 82% male (79% GBTY), 66% Black, 16% Latino, and 18% white, non-Hispanic. About 27% will be 12-17 and 73% between 18-24 years old. All youth will be followed longitudinally over 24 months at four month intervals and tested for HIV, STI, serious substance abuse, health care utilization, and comorbid conditions – a Prototypical Retention/Prevention (R/P) Strategy. Over 24 months, acutely HIV infected youth will be triaged to Study 1. This Prototypical R/P Strategy operationalizes the CDC’s recommendations for the engagement of GBTY in repeat HIV testing, linkage to care, and options for combination prevention (PrEP, PEP – with behavioral interventions). Building on this team’s extensive experience with behavioral and mobile/social media interventions, a randomized controlled trial (RCT) will be conducted with four intervention conditions: 1) an Automated Messaging and Monitoring Intervention (AMMI), which will use texts to diffuse prevention messages daily and to monitor risk behaviors weekly (n=900); 2) a Peer Support intervention on a social media platform (i.e., Facebook) in which young people will post messages and stories about their experiences preventing HIV, plus the AMMI (n=200); 3) an eNavigator intervention in which a B.A.-level staff supports youth, primarily through texting and social media, but also in-person meetings, to provide support in crisis situations, refer to treatment, and assist in gaining access to health care and other services, plus Peer Support and AMMI (n=200); and, 4) a combined intervention of eNavigator, Peer Support, and AMMI (n=200). A single outcome will be composed of six key behaviors (access to medical care, accessing and adherence to PrEP or PEP, treatment of all STI, and 100% condom use). In addition to evaluating the added benefit of increasing levels of intervention, the brief 7- item weekly text-messaging monitoring surveys will provide approximately 100,000 weekly reports of indicators of primary and secondary outcomes that can inform our understandings about the relationships between risk and comorbid states. This study will have policy implications for the allocation of resources to HIV testing resources in local communities, the uptake and scalability of text and social media interventions, and the models for diffusing evidence-based interventions (EBI) globally (without requiring replication with fidelity to a manual).

Project Number: 5U19HD089886-02

Risk and Protective Factors for Adherence to Pre-exposure Prophylaxis (PreP) in Transwomen of Color

Abstract: Transgender women (TW) are currently the SGM population at highest risk for HIV infection in the United States, especially those who are racial/ethnic minorities. TW also report the highest levels of discrimination, victimization, traumatic life events, and other stressful experiences and are of the highest risk groups for substance abuse and mental health problems. HIV researchers have suggested resiliency may be a largely untapped resource in behavioral interventions and that it may be associated with reductions in mental health problems, substance abuse, and HIV related risk among marginalized populations. Daily pre-exposure prophylaxis (PrEP) is extremely effective in preventing HIV infection among those who are HIV-negative. While this is an exciting development for HIV prevention among minority TW, HIV prevention efforts must now shift focus to research on optimizing PrEP adherence among this high-risk population facing multiple recurring stressful life events and numerous structural barriers. In the proposed study, we will leverage an ongoing study of (N =300) racially and ethnically diverse TW enrolled in the Southern California based PrEP demonstration project, in order to conduct mixed-methods research, first using structural equation modeling (SEM) to assessing the risk and resiliency factors most associated with PrEP adherence among TW. Then using the SEM findings to inform follow-on, in-depth qualitative interviews with a sub-sample of high- to low-adherence minority TW to further explore those risk and resiliency factors and experiences most salient to PrEP adherence among high-risk minority TW. This study will provide the preliminary data to support the submission of an intervention development grant (NIDA R34) to develop a resilience-based intervention focused on improving PrEP adherence for TW.

 

 

Project Number: 5R21DA044073-02

https://reporter.nih.gov/search/eHlIDivHPECE2F8MLmltRg/project-details/9457401

 

Contact PI/ Project Leader

STORHOLM, ERIK D, ASSISTANT PROFESSOR (estorholm@sdsu.edu)

 

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Project Narrative The proposed 2-year mixed-methods study will have important scientific, clinical, and public health implications. a) Scientific: this study will advance our basic understanding of the risks and protectivefactors for PrEPadherence among transgender women (TW). b) Clinical: this study will provide the preliminary data to identify predictors of PrEPadherence and support development of a resilience-based intervention focused on improving PrEPadherence for TW. c) Public Health: findings from the proposed pilot study have major implications for future HIV intervention efforts to maximize PrEPadherence among those at highest risk for HIV, racial/ethnic minority TW.

 

 

 

 

Project Start Date: 01-May-2017

Project End Date: 30-April-2021

Budget Start Date: 01-May-2017

Budget End Date: 30-April-2021

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE / FY Total Cost by IC: $262,330

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

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-16-035/ Study 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

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