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.
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.
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
Abstract: To evaluate the safety, tolerability, pharmacokinetics and acceptability of the injectable agent, GSK1265744 long-acting injectable (744LA), in healthy, HIV-uninfected men and women. It is a multi-site, double-blind, two-arm, randomized, placebo-controlled trial of the safety, tolerability, and acceptability of 744LA. HPTN-077 will study HIV-uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65. of approximately 176 men and women, randomized 3:1, with 132 in the active drug arm, and 44 in the placebo arm. It is anticipated that approximately 60% of the enrolled participants will be women. Participants will be randomized to receive daily oral GSK1265744 (30 mg tablets) or daily oral placebo for 4 weeks, followed by a one-week washout, to assess safety and tolerability before they receive injections. After safety and tolerability assessments from the oral phase have been completed (if no concerns are identified), participants will enter the injection phase of the study and will receive two intra-muscular (IM) gluteal injections of 744LA (800 mg, administered as two 400 mg injections) or placebo (matching vehicle control) at three study visits performed at 12-week intervals.
Project Number: 5UM1AI068619-11
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: The NIH Working Group on Diversity in the Biomedical Research Workforce recently released a set of recommendations to improve the diversity of the research workforce, including establishing a “system of mentorship “networks” for underrepresented minority students that will provide career guidance throughout their career development.” To that end, this R25 application responds to PAR-10-173 (NIDA Research Education Program for Clinical Researchers and Clinicians) and seeks five years of funding for the UCLA HIV/AIDS, Substance Abuse, and Trauma Training Program (hereafter, “Program”). The Program mission is to provide training and mentorship to early career clinician researchers or post-doctoral scholars who are ethnically and culturally diverse and whose focus is reducing substance abuse and HIV transmission in underserved populations at high risk for traumatic stress and health disparities. The goal is for Scholars to establish career independence, including NIH funding for their research. This program represents an evolution of our multidisciplinary, multiethnic team’s NIMH ARRA-funded HIV/AIDS Translational Training Program, which successfully provided two years of training and mentorship to five postdoctoral scholars, several of whom have received or are seeking NIDA funding. Our pilot program highlighted the need to make substance abuse and traumatic stress more central to the Program’s conceptual orientation because this link has not been the focus of training grants that target underserved populations at risk for HIV and health disparities. Our Program will provide a two-year course of training and mentorship to a total of 20 (five per year for 4 years) early career clinical researchers and post-doctoral scholars who hold funded fellowships or other academic positions but need specific training in HIV/AIDS, substance abuse, traumatic stress and health disparities. Underserved populations, particularly those racial/ethnic minority populations, are disproportionately affected by substance abuse and HIV/AIDS and typically experience a high degree of traumatic stress. To learn about the confluence of these phenomena, Scholars will attend two week-long Institutes per year for two years and will receive continual, personalized career mentoring, training, and research supervision. Each cohort of Scholars will be followed for the duration of the training grant and each cohort will present their research in Year 2, form a network of collaborative mentoring, and come together in Year 5 to share their experiences and progress in achieving Program goals. Scholars will be mentored by a core faculty mentor as well as a “home” mentor, i.e., someone regularly accessible to the Scholar who has the relevant expertise and commitment to mentoring the Scholar for the duration of the Program. Each Scholar will be expected to use pilot funding from the Program to conduct research (e.g., qualitative study, secondary analyses, etc.) that will serve as preliminary studies in their NIDA application during their two year tenure.
Project Number: 5R25DA035692-025
Abstract: Implementation science examines the efficiency of intervention implementation and to translate the existing efficacious intervention models to real world services. It could potentially enhance the effectiveness and sustainability of the behavioral intervention projects. I received my PhD in epidemiology from the University of California, Los Angeles (UCLA) in 2009. Through my involvement in several large-scale HIV behavioral intervention projects and my doctoral dissertation study, I realized the importance of implementation science in intervention delivery and determined long-term career goal to become an implementation science researcher to bridge the gap between existing knowledge and service delivery. To fill in the gap between my current skill set and the career goal, I will receive training in areas related to implementation science, including health policy, intervention adaptation, and healthcare management. The health policy training will familiarize me with the process of policy development and its influence on the intervention adaptation and implementation; the intervention adaptation courses will inform me with the general concept and framework to design the study ensuring all aspects of intervention implementation are addressed; and the health management training will provide me with analytical tools to model leadership decision making and to evaluate the implementation flow in healthcare settings. The mentor team members, Drs. Li Li, Mary-Jane Rotheram-Borus, Thomas J. Coates and Zunyou Wu, are all internationally reorganized experts in behavioral intervention implementation and adaptation. My institute, the UCLA Semel Center for Community Health (CCH) and the Center for HIV Identification, Prevention, and Treatment Services (CHIPTS), UCLA, provide me with support from a multidisciplinary team of top researchers. Collaborating with the National Center for AIDS/STD Control and Prevention (NCAIDS), China CDC, I will conduct a mentored research using an intervention trial with significant yet heterogeneous outcome to investigate multilevel factors influencing the intervention implementation and outcome, and to find the optimal approach to incorporate the intervention model into the current healthcare settings. The study will be conducted in three phases. Phase 1 will be review of related policies and in-depth interviews with healthcare administrators and hospital directors, with the aim to explore the policy barriers and facilitators in adaptation of the intervention model. Phase 2 will be conjoint analysis with hospital directors to model the decision-making in intervention adaptation and routinization in the healthcare facilities. Phase 3 will be bottleneck analysis to locate structure bottlenecks in compliance with the intervention component. The finding will provide implications for future intervention delivery in healthcare settings. Application of some analytical tools in other fields, including conjoint analysis and bottleneck analysis, will potentially contribute to the development of implementation science methodology. Based on the data achieved from the study, I will prepare for a R01 application in implementation science in Year 4 of the K award period.
Project Number: 5K01MH1021447-05
Abstract: This 5-year project aims to enhance the role of commune health workers (CHWs) in HIV and drug use prevention and treatment. We demonstrate the process of development, implementation, and evaluation of an integrated intervention for CHWs, IDUs, and their family members (FMs) in Vietnam. In Phase 1, intervention topics, format, delivery procedures, and supporting materials are developed through a series of focus group discussions. In Phase 2, implementation pilot and process evaluation are conducted to collect feedback from participating CHWs, IDUs, and their FMs by in-depth interviews in two commune health centers. In Phase 3, we conduct an intervention trial (CHW CARE intervention) in 60 commune health centers (5 CHWs, 15 IDUs and 10 FMs from each commune center), totaling 300 CHWs; 900 IDUs and 600 FMs. Randomization occurs at the commune level (30 communes assigned to the intervention group; 30 communes assigned to the control group). At each commune assigned to the intervention, the intervention is delivered to CHWs first, and the participating CHWs are required to conduct individual and group sessions with IDUs and FMs in their communes. The efficacy of the intervention is assessed at baseline, 3, 6, 9, and 12-month follow-ups by comparing outcome measures of CHWs, IDUs and FMs in the intervention group to those in the control group. Relationships between the intervention outcomes of CHWs, IDUs, and FMs are explored.
Project number: 4R01DA03360-05
Abstract: This project uses a combination prevention approach to respond to the urgent need for improved quality of services at methadone maintenance therapy clinics, provider-client interactions, and client outcomes.
We conduct the 5-year randomized controlled trial that targets methadone maintenance treatment (MMT) programs in China. Applying the principles of combination prevention, the intervention (MMT CARE) integrates psychosocial and behavioral components into a pharmacological framework for methadone maintenance. A total of 68 MMT clinics are randomly selected from five provinces. From each clinic, 6 service providers and 36 clients are recruited, totaling 408 providers and 2,448 clients in the study. The 68 clinics are randomized to 1) an MMT CARE intervention group or 2) a control group (34 clinics each). Service providers who complete the training conduct three individual motivational enhancement sessions with clients. Efficacy of the intervention is evaluated at baseline and at 6, 12, 18, and 24-month follow-ups.
Project Number: 4r01da033160-05
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.