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.
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.
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.
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
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+).
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
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.
Abstract: The Evaluation and Technical Assistance Center (ETAC) will be comprised of a collaborative team of experts from the Department of Family Medicine and the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS) at the University of California, Los Angeles (UCLA), and an expert from the University of California, San Francisco (UCSF). The ETAC is guided by three goals:
- To provide technical assistance to equip demonstration sites with the skills and capacity to design, implement, evaluate and sustain social media-based interventions to improve engagement and retention of HIV-positive youth and young adults in HIV medical care.
- To conduct a national, multi-site evaluation of social media-based interventions for HIV positive youth and young adults across demonstration sites. We will employ mixed methods to understand intervention effectiveness. Overall potential evaluation questions include:
- To what extent is implementation of each demonstration project’s social media-based intervention associated with improvements in identification, engagement, treatment, adherence and retention in HIV care among youth and young adults living with HIV?
- To what extent is implementation of each demonstration project’s social media intervention associated with improved utilization and adherence to appropriate HIV care and services?
- To what extent does each demonstration project’s social media intervention improve behavioral and biomedical health outcomes among youth and young adults living with HIV?
- To what extent is each demonstration project able to engage and retain HIV-positive youth and young adults in the use of their social media-based intervention?
- What is the acceptability and usability of each demonstration project’s social media delivered interventions among HIV-positive youth and young adults?
- What site, provider, and client characteristics are associated with engagement in HIV care, utilization of HIV clinical and support services, and/or behavioral and biomedical health outcomes?
- What individual, interpersonal, cost, and community/societal factors are associated with engagement in HIV care, utilization of HIV clinical and social support services, and/or behavioral and biomedical health outcomes?
- To coordinate dissemination of findings. The ETAC will support demonstration sites in
disseminating results to ensure that findings are widely distributed to diverse audiences. Based on the collaborative team’s research experience in using social media technologies, extensive experience providing technical assistance and training, and our ongoing experience implementing existing ETACs for other HRSA Special Projects of National Significance (SPNS), we are uniquely qualified to serve as the ETAC for this initiative
Abstract: People living with HIV/AIDS (PLHA) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others. Our research suggests that as PLHA receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients. With effective advocacy training, mobilizing PLHA to be change agents within their social networks has the potential to be a “game changer” for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV. Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test “Game Changers”– an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks. In Phase 1, we will conduct separate focus groups of PLHA and members of their social networks (family and friends) to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy can be most effective in motivating behavior change, and how to best structure the intervention and its content. In Phase 2 we will use findings from Phase 1, and draw from network-based intervention models to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy. In Phase 3 we will pilot the group intervention in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control. Assessments will be administered to all participants at baseline and months 4, 8 and 12, after which the control group will receive the intervention. Surveys and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma. Game Changers is innovative as it encompasses aspects of all major HIV prevention paradigms, targets advocacy to all network members rather than within and by specific risk groups, and uses social network data not only to evaluate effects but also strategically target advocacy. Findings will inform a larger R01 trial.
Project Number: 5R36MH111460-02
The 2.3 million persons living with HIV (PLH) in India are being offered access to anti-retroviral therapies (ARV) by the government. ARVs offer the possibility of improving the individual’s health and to reduce transmission by decreasing viral load. Yet, non-adherence remains high, typically around 50% (WHO, 2008). Mobile phones have been used in the US and globally to increase ARV adherence among PLH. As a low cost, easily diffused intervention strategy in a country such as India in which the mobile phone penetration rate is expected to reach 74% by 2013 and 101% by 2014 (Informa World, 2010), designing a mobile phone intervention to increase ARV adherence is a potentially highly efficacious intervention. In this proposal, we aim to adapt an existing mobile phone system for ARV adherence for PLH in India. However, because HIV is a chronic infectious disease, PLH are also challenged with maintaining mental health and reducing transmission risks (Swendeman et al., 2009a). Furthermore, reviews and meta-analyses have concluded that ARV adherence interventions are more effective when a comprehensive approach is adopted (Malta, 2008; Rueda, 2006; Simoni, 2006). In particular, mental health symptoms and transmission acts that co-occur with and undermine ARV adherence (Kalichman, 2008, Malta, 2008) are likely to be behaviors that may also be influenced by mobile phone delivered intervention.
This R21 aims to adapt and develop two versions of a mobile phone program to enhance medical adherence: 1) one aimed solely at increasing medication and appointment adherence; and 2) one aimed at increasing adherence, plus reducing mental health symptoms and transmission acts.
Three world-renowned HIV prevention and technology organizations will collaborate: 1) UCLA CHIPTS, with expertise in behavioral intervention development, adaptation, and randomized trials for PLH and other high risk populations; 2) Durbar, with expertise in multi-level prevention and support services for high risk populations in India; and 3) Dimagi Inc., a technology company with expertise in mobile phone solutions for global health challenges. Dimagi has developed “ARemind” to assess and remind ARV and appointment adherence with feedback from PLH and providers in the U.S. and tested in a pilot study and subsequent SBIR funded study. The software assesses and reminds PLH through text messaging (i.e. Simple Messaging Service [SMS]) or Interactive Voice Response (IVR) methods. This program can also be leveraged to address the co-morbid challenges of preventing transmission and improving mental health and quality of life for PLH. In this study, ARemind will be adapted and developed for PLH in Kolkata, India to address the co-morbid challenges of ARV adherence, transmission risk reduction, and poor mental health faced by PLH. ARemind will be adapted and developed for PLH recruited from two sites in Kolkata, India; 1) a community based care and treatment center operated by Durbar serving primarily female sex workers living with HIV (i.e., the Mamata Care & Treatment Center [MCTC]), and 2) PLH recruited from the primary ARV center in Kolkata operated by the Government of India.
In Phase 1 over Year 1, focus groups with PLH (n=10 from each site) and design meetings with the UCLA and Durbar research team and Dimagi programmers will identify acceptable and feasible enhancements to iteratively adapt and pilot test ARemind for PLH in India. In addition, the team will further develop the program into “ARemind Plus” to also address the co-occurring challenges of mental health and transmission risks for PLH. Dimagi will program adaptations, which will be iteratively pilot tested by research teams in Kolkata overseen by Durbar and trained by UCLA, with small groups of PLH (n=10 from each site).
In Phase 2, over Year 2, we will preliminarily evaluate the efficacy of the enhanced system with 400 PLH (n=200 from each site), with PLH randomized within site to ARemind Plus (n=100 each site) compared to ARemind for medication adherence only as standard care control (n=100 each site). PLH will be recruited with informed consent and complete a baseline and 3 follow-up interviews at 2-month intervals over 8 months to assess the impacts of ARemind compared to baseline adherence rates, and the impacts of ARemind Plus compared to ARemind for adherence only. ARemind for medical adherence will be the standard care control because ARemind and other electronic adherence reminders (e.g., beepers, pagers, timers) have already been established as improving ARV adherence. PLH will be provided with low cost mobile phones that cost about the same as one months supply of ARV medication in India (<$25), which could be a cost- effective strategy for eventual scale up. Both the choice of the standard care and mobile phone provision are warranted by values of distributive justice and ethical conduct of research. Finally, from months 22-24, we will collect post-intervention feedback from PLH and providers, conduct data analyses, and prepare ARemind for dissemination and subsequent field trials and adaptations in India.
Specific Aims:
Our aims are to:
1. Adapt the ARemind program for PLH in Kolkata, India;
2. Further develop ARemind to address factors the co-occurring factors of ARV non-adherence, poor mental health, and transmission risks;
3. Examine the acceptability, engagement, and adherence by PLH to the ARemind programs; and
4. Examine the efficacy of ARemind Plus compared to ARemind for medical adherence only to improve adherence and mental health, and reduce transmission risks, in a pilot randomized controlled trial.
Mobile Phone Adherence and Prevention Support for People Living with HIV in India - Research Plan