Active Research Studies
UniquelyU
Study name: Understanding Viral Suppression for Newly Diagnosed HIV+ Men to Inform Implantation of TasP and U=U
Study name: Understanding Viral Suppression for Newly Diagnosed HIV+ Men to Inform Implantation of TasP and U=U
Introduction: In a world where sexual minority men are disproportionately affected by the HIV epidemic, linking this group to care becomes pivotal in reducing long-term health impacts and HIV transmission rates. Clinical trials have demonstrated that consistent use of HIV medications leads to suppressed viral loads, reducing the risk of transmission to partners. This underscores the significance of treatment as prevention, known as U=U (Undetectable = Untransmittable). The UniquelyU study aims to unravel the factors that influence the U=U movement along the HIV continuum of care.
Why this Study Matters: The findings of the UniquelyU study hold crucial importance. By understanding the experiences related to mental health, physical health, and medical care, the study aims to drive change and promote wider acceptance of U=U.
Our Approach: For two years, participants answer online surveys, provide regular dried blood spot (DBS) samples and once-yearly self-swabs for sexually transmitted infections (STIs) and digestive health/inflammation completed at home, and provide details about their medical care. All study components are completed at the participant’s home.
Get Involved: Participation in UniquelyU is for participants who have previously participated in a LITE cohort study. If you think you may be eligible, and want to get involved, please reach out to uniquelyu@whitman-walker.org.
SHARE
Study Name: SHARE
Study Name: SHARE
Introduction: SHARE is part of the longest-running HIV research study in the U.S. – the MACS/WIHS Combined Cohort Study (MWCCS) – and is a collaborative effort between Johns Hopkins University and Whitman-Walker Institute. This study was first funded by the National Institute of Allergy and Infectious Diseases (NIAID) in 1983 to investigate the natural history of HIV/AIDS and continues to receive funding from multiple institutes within the National Institutes of Health (NIH).
Why this Study Matters: The study seeks to understand how HIV effects health and well-being and its impact on aging. This study has contributed to scientific advances in HIV prevention, diagnosis, treatment, and care and is built on forming long-term partnerships with participants, communities, and researchers across the country. This study aims to support positive health outcomes for people living with HIV.
Our Approach: This study involves at least one in-person two-to-three-hour study visit every year. This visit includes an interview, physical exam, blood draw, biospecimen collection, and several medical tests to study health conditions. It also may involve mental health and quality of life assessments. SHARE is not a treatment study and does not involve taking experimental medicines.
Get Involved: Join the effort and earn $20 for completing a 60-minute screening visit.
Call the SHARE Line: 202-745-6137 or Email SHARE: share@whitman-walker.org.
UPLIFT
Study Name: Multilevel strategies to understand and modify the role of structural and environmental context on HIV inequities for sexual and gender minorities of color
Study Name: Multilevel strategies to understand and modify the role of structural and environmental context on HIV inequities for sexual and gender minorities of color
Introduction: The UPLIFT Cohort under the direction of Dr. Jonathon Rendina and Dr. Tamara Taggart of the Departments of Epidemiology and Prevention and Community Health, George Washington University (GWU), in collaboration with Whitman-Walker Institute, aims to understand how state and local factors influence HIV-related inequities for people of color with male partners with a diverse range of sexual and gender identities.
Why this Study Matters: We’re hoping to learn about how laws and policies at the local and state levels influence the health and well-being of people with a broad range of racial, ethnic, sexual, and gender identities. With this information, we’re aiming to develop recommendations for policymakers on how to improve the health and wellbeing of diverse LGBTQ+ communities.
Our Approach: There are three different components to the UPLIFT study: yearly online surveys, yearly at-home HIV testing, and a one-time series of short online surveys after enrollment. Participants can earn up to $450 over three years.
INCLUDEStudy Name: Implementation and Navigation of Cancer Liquid biopsy to Understand Diverse Patient Experiences
Introduction: INCLUDE is a study being conducted by researchers at Whitman-Walker Institute, in collaboration with the Cancer Support Community (CSC), to test a new multi-cancer early detection product called Galleri®.
Galleri® is a simple blood test that detects and measures potentially cancerous cells circulating within the bloodstream. With this new technology, Galleri® provides a new solution for detecting many common cancers that do not have a targeted screening available.
Why this Study Matters: Around 70% of cancer deaths are caused by cancers with no targeted screening available. Multi-cancer early detection enables you to proactively test for many cancers, increasing the chances of finding cancer early. In fact, which cancers are diagnosed early before they have had the chance to spread, the overall 5-year survival rate is 4x higher than when diagnosed in later stages. The purpose of this study is to learn more about an individual’s experiences with the Galleri® test and may also help the study investigators in further evaluating the barriers and facilitators to receiving multi-cancer early detection blood tests to improve access for all communities.
Our Approach: During the study visit, you will be asked to complete a brief survey. In addition, a trained phlebotomist will collect the blood draw sample for Galleri® – the multi-cancer early detection test. Following completion of the survey and blood draw, you will receive a $25 gift card. Participants may be eligible for another $20 gift card for completing a post-study completion survey.
Galleri® test results may come via email or phone call. If your results signal that a cancer was detected, study staff will call you along with members of the CSC team to discuss next steps. Without impacting your participation in the study, you will be offered the opportunity to participate in CSC’s supportive navigation services to provide you with assistance for any follow-up care or other services.
Get Involved: If you’re interested in participating in the INCLUDE study, complete this online screening survey to see if you’re eligible.
SHINE
Study Name: Capacity-Building for LGBTQ+ Sexual and Reproductive Health Outcomes Research
Study Name: Capacity-Building for LGBTQ+ Sexual and Reproductive Health Outcomes Research
Introduction: High-quality and responsive sexual and reproductive health (SRH) care is vital for supporting the overall health of LGBTQ-identifying individuals assigned female at birth (AFAB). Research demonstrates that cisgender sexual minority women and transmasculine and gender-diverse individuals are underserved populations who face barriers in accessing person-centered and structurally competent SRH care. This initiative partners with the community regarding the care they want and need and patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER) critical to supporting care decisions.
Why this Study Matters: This project will develop and implement a peer-based community engagement workshop series to build the capacity of community to lead future patient centered outcomes research (PCOR). The team will also identify key elements of healthcare delivery models to achieve community-identified priority sexual and reproductive health outcomes to be evaluated through PCOR after the project is completed.
Our Approach: The project will occur in a two-stage process of community leaders developing a workshop series for broader participation, with ongoing activities to engage the communities across Washington, DC. The project team will work with investigators and other clinical stakeholders to ensure long-term research partnerships.
Get Involved: If you are interested in participating in a SHINE workshop, please reach out to project-shine@whitman-walker.org.
PrEP Mobile Health Strategies
Study Name: Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Study Name: Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention
Introduction: The purpose of this study is to compare two mobile health technologies (text messaging or a mobile app) that are designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medication by HIV-negative people to help prevent HIV infection.
Why this Study Matters: PrEP is the use of a daily anti-HIV pill by HIV-negative people to help prevent HIV infection. PrEP has been shown to be safe and effective and has been approved by the US Food and Drug Administration. However, taking PrEP on a daily basis can be difficult. Therefore, it is important to find new ways to support daily PrEP pill-taking. Studies show that some people are stopping PrEP because they do not think they are at risk for HIV, have difficulty taking a daily pill, experience side effects, change insurance plans, and/or have difficulty attending medical appointments.
Mobile technologies (such as text messaging or “smartphone” applications or “apps”) are a new tool available to help make it easier for people to stay on PrEP. The purpose of this study is to test two mobile technologies to see if they help people take and stay on PrEP.
Our Approach: Study participants will be randomly assigned to use 1 of the 2 mobile technologies (either a mobile app or a text-messaging program) in the study that are designed to help people take PrEP as prescribed by their provider. The study will last for 12 months, including 3 visits, some of which can be done remotely.
CHRADE
Study Name: Community-Driven HIV Research Agenda for DC CFAR Expansion
Study Name: Community-Driven HIV Research Agenda for DC CFAR Expansion
Introduction: We are developing and conducting a community Needs Assessment in DC’s Wards 7 and 8 to identify areas of highest urgency for HIV research as a means of centering community needs and members within HIV treatment and prevention research. We will translate the findings from the Needs Assessment into a Research Agenda to support the design and implementation of research conducted within the new Max Robinson Center.
Why this Study Matters: Residents in the neighborhoods of Southeast DC have been chronically underserved and need an HIV research initiative catered to the research needs of Wards 7 and 8
Our Approach: Using a community-based participatory research approach, we are convening community members who serve residents in Wards 7 and 8 as well as Whitman-Walker Health staff to develop a Needs Assessment survey. We will distribute this survey to 400 community members and 25 service providers residing in Wards 7 and 8. Results from the survey will be used to develop a research agenda and will be reported to community members via a listening session.
Get Involved: To participate in this research, you must reside in Wards 7 or 8 and belong to at least one of the following groups: transgender people of color, cisgender heterosexual Black women, people who use drugs, and adolescents and young adults (13-24). For more information, please call 202-207-2467 or email Rodrigo Aguayo-Romero at raguayo-romero@whitman-walker.org.
PURPOSE-2
Study Name: A Phase 3, Double-Blind, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection
Study Name: A Phase 3, Double-Blind, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age who Have Sex with Male Partners and are at Risk for HIV Infection
Introduction: PURPOSE 2 is a clinical study to evaluate if Lenacapavir (LEN), an investigational medicine, given every 6 months can help to reduce the chance of getting HIV through sex (PrEP, or Pre-exposure Prophylaxis).
Why this Study Matters: Even though a variety of prevention options exist, HIV remains a serious health concern for many people around the world. In the United States, socioeconomic inequity, racism, stigma, homophobia, transphobia, and other factors have led to higher rates of HIV in some communities. PURPOSE 2 will test whether an investigational PrEP (pre-exposure prophylaxis) medicine, lenacapavir, helps reduce the chance of getting HIV through sex.
Our Approach: There are two parts in this study, Incidence Phase (Single Visit) and Randomized Phase. Part 1/Incidence Phase includes a single visit with a questionnaire. Also, a blood sample will be taken for an HIV test. Part 2/Randomized Phase, is 1- 2½ years and includes getting injections under the skin every 6 months and taking a table every day.
CREATE
Study Name: Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living with HIV Who Are Not Retained in Care
Study Name: Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living with HIV Who Are Not Retained in Care
Introduction: This research study aims to understand patient care outcomes related to HIV treatment with long-acting injectable rilpivirine and cabotegravir, why clients choose to take the medication, and why people choose not to receive the medication.
Why this Study Matters: We are trying to see how people like taking long-acting injectable rilpivirine and cabotegravir. The medication is approved by the United States Food and Drug Administration (FDA) and is considered standard of care if you are eligible to be prescribed it. However, there is little known about how patients experience this medication as a part of routine HIV care since its FDA approval was granted within the past few years.
Our Approach: The study is a total duration of 18 months. All participants will have their medical records reviewed to obtain relevant clinical data and receive two 30-minute, self-administered quantitative surveys; a subset of 30 participants will receive one 60-minute qualitative interview. In addition, all persons will have their medical records reviewed to assess injectable HIV therapy, related appointments, and related laboratories. Individuals can earn up to $100 for their participation.
Get Involved: Talk to your Whitman-Walker provider to see if you’re a good fit for this study.
EYEWITNESS
Study Name: A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
Study Name: A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
Introduction: The purpose of this research study is to determine the effectiveness and safety of switching from Biktarvy (a single fixed-dose combination tablet containing 3 medications) to a different treatment for HIV called Dovato. Dovato is also a single tablet of study drug, but it contains 2 study drugs called dolutegravir (DTG) and lamivudine (3TC).
Why this Study Matters: Several studies have already looked at the effectiveness and safety of switching to Dovato in people living with HIV who are virally suppressed on other antiretroviral therapies, including Biktarvy. Because Dovato contains only 2 study drugs instead of 3, we hope that it will cause fewer side effects and have a lower risk of interactions with other medications. This is important, as with effective treatment for HIV, people living with HIV live longer and may need to take medications for other conditions linked to ageing along with their antiretroviral treatment.
Our Approach: All participants in this study will switch from their current Biktarvy medication to Dovato and will continue to receive Dovato for the duration of the study (96 weeks). As part of the study, some participants will be given the option to wear an activity monitoring watch and self-report behaviors through a mobile app.
EBONI
Study Name: A study evaluating implementation strategies for the delivery of APRETUDE for Black cis-and transgender women in United States EHE territories.
Study Name: A study evaluating implementation strategies for the delivery of APRETUDE for Black cis-and transgender women in United States EHE territories.
Introduction: The EBONI study is for Black women who are interested in preventing HIV by using Cabotegravir, a long-acting injectable PrEP. The study aims to figure out best practices for using Cabotegravir in clinics and identify ways in which to support women receiving Cabotegravir.
Why this Study Matters: To disrupt the impact of HIV among Black women, it is important to understand their experiences, views, perceptions and reasons for PrEP care. This includes interactions with providers around PrEP, how easy or hard it is to receive Cabotegravir, how Cabotegravir works for different women, and if certain tools and information about Cabotegravir can help women understand, start, and maintain PrEP.
Our Approach: This study includes answering computer-based health surveys and possibly participating in virtual interviews. Compensation is provided for time on both surveys and interviews.
Get Involved: If you are 18 years or older, identify as Black or African American, and identify as a cisgender or transgender woman, you may be eligible to participate. For more information, visit www.ebonistudyinfo.com.
PROMISE-US
Study Name: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States
Study Name: A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States
Introduction: The purpose of the PROMISE-US study is to evaluate the long-term efficacy, safety, and tolerability of antiretroviral treatment regimens in people living with HIV who have limited treatment options, primarily due to drug resistance.
Why this Study Matters: This research study has been created to better understand HIV, resistance, and treatment options available. This will help healthcare providers understand long term efficacy and safety of HIV medications for patients who have changed medications in the past. The more we all know, the easier it will be to make the best treatment choices to help people living with HIV become and remain undetectable.
Our Approach: PROMISE-US is a database research study that collects relevant information from participant medical records that is normally captured as part of routine treatment and healthcare. This study does NOT involve any new treatments or procedures outside of the normal care received from healthcare providers.
MK8591A-052
Study Name: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Study Name: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Introduction: This study is testing an investigational medicine in people living with HIV-1. Researchers will assess the safety and tolerability of switching from BIC/FTC/TAF to the investigational medicine and how well the investigational medicine works compared to BIC/FTC/TAF. They will also test how the body’s immune system responds to this switch.
Why this Study Matters: This study is an important step in testing what happens when people with HIV-1 switch from BIKTARVY® (BIC/FTC/TAF) to the investigational medicine.
Our Approach: People in this study will be placed into 1 of 2 groups: Group 1 will get the investigational medicine and a placebo, and Group 2 will get BIC/FTC/TAF and a placebo. All participants in this two-year study have their health closely monitored by an experienced study team. Some of the tests that take place during the study include physical exams, blood and urine tests, vital signs, questionnaires, electrocardiograms, and DEXA (bone density) scans.
STRIDE-07
Study Name: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV
Study Name: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV
Introduction: This clinical study will allow researchers to learn about an investigational vaccine to see if it may help protect against pneumococcal disease in adults.
Why this Study Matters: The results of this clinical study may help researchers learn about the safety of this investigational pneumococcal vaccine, and how well the vaccine may help protect against pneumococcal disease.
Our Approach: During the study, participants receive a dose of an investigational vaccine followed by a placebo or a dose of PCV15 (15-valent pneumococcal conjugate vaccine) followed by PPSV23 (pneumococcal polysaccharide vaccine, 23-valent), have their blood drawn, and keep an electronic diary at home of their temperature and any side effects. Certain people are also asked to return for Part B of the study, which lasts for approximately 1 month and includes additional visits.
ACTG
Following the creation of the NIH federally funded AIDS Clinical Trial Group (ACTG) in 1987, Whitman-Walker became the first federally qualified health center (FQHC) to be selected as a clinical research site as part of the grant. Today, we have many open studies related to HIV treatment, prevention, and comorbidities, as well as hepatitis and other infectious diseases.
Learn More: To learn more about our active ACTG studies, including those open for enrollment, please visit: https://actgnetwork.org/clinical-site/whitman-walker-health-crs/.
Historic Studies
Strengths & Stressors
Study Name: Reducing Black Men’s Drug Use and Co-Occurring Negative Mental and Physical Health Outcomes – Intersectionality, Social Structural Stressors, and Protective Factors
Introduction: This study aims to better understand the intricate relationship between social-structural stressors, discrimination, coping mechanisms, and their impact on drug use, mental health, and physical well-being within the DC Black men’s community.
Why this Study Matters: Did you know that drug use is linked to six of the top ten leading causes of death among Black men aged 18 to 54? In Strengths & Stressors, we’re committed to understanding the underlying factors contributing to this alarming statistic.
Our Approach: Our research approach is rooted in intersectionality, social-structural stress, and resilience frameworks. As part of the study, participants completed surveys and provided biological samples at two time points, three months apart.
Multipurpose Prevention Study
Study Name: Formative research to understand preferred user characteristics of dolutegravir/levonorgestrel injectable multipurpose prevention technology product
Introduction: The purpose of this research is to gain a better understanding of people’s experiences with contraception and HIV prevention and what they might want in a new product that combines contraception and HIV prevention.
Why this Study Matters: Participant’s contributions will be used to inform the development of a combination contraception and HIV prevention product that aligns with preferences of potential users.
Our Approach: Participants will be asked to answer a series of questions about their experiences and preferences regarding contraception and HIV prevention during an interview with study staff.
Day2Day
Study Name: Day2Day
Introduction: The primary goal of the day2day study is to shed light on how sexual minority and HIV-related stressors shape health outcomes in HIV-positive gay and bisexual men. By investigating daily experiences – encompassing thoughts, emotions, social interactions, sexual behavior, substance use, medication adherence, and overall well-being – the study aims to develop robust and lasting interventions for enhanced health.
Why this Study Matters: Gay and bisexual men in the U.S. are disproportionately affected by HIV infection rates. The day2day study acknowledges the significance of chronic sexual minority stressors, which influence mental, behavioral, and physical health outcomes for these men. Furthermore, the study recognizes the impact of HIV-related stressors on mental health and health behaviors in HIV-positive individuals.
Our Approach: Participation in the study included five in-office visits approximately 90 days apart. These visits encompassed blood draws, urine samples, rectal swabs, saliva collection, neurocognitive tasks, and comprehensive interviews with a Research Specialist to examine the past 30 days of participant’s lives.
Trans Women HIV Prevention Study
Study Name: Systemic and mucosal immune dysregulation and HIV risk in transgender women who have sex with men
Introduction: Led by Dr. Mimi Ghosh, of George Washington University, this study aimed to better understand the immune system (the part of the body that fights infection) in people assigned male at birth (AMAB) who have sex with men.
Why this Study Matters: The results of the study will help us learn more about the effects of GAHT, specifically estrogen usage, on the immune system in the blood and in the rectum. It may help us understand how to prevent infections such as HIV.
Our Approach: This study included a questionnaire, HIV screening test, and collection of a blood sample and three swabs for STI testing and additional analysis. Some participants were invited back for a second, 3-month follow-up visit.
Trans Men HPV Prevention Study
Study Name: Genital Health of Trans-males on Testosterone
Introduction: Led by Dr. Mimi Ghosh, of George Washington University, this study aimed to understand the risk for developing Human Papilloma Virus (HPV) associated cervical and anal cancers in people assigned female at birth (AFAB) who are now taking the hormone testosterone. This includes a variety of gender identities including but not limited to transmen, transmasculine, and non-binary people.
Why this Study Matters: The results of the study will help us learn more about the effects of GAHT, specifically testosterone usage, on the immune system in the blood and in the rectum. It may help us understand how to prevent infections such as HPV.
Our Approach: Study procedures included a one-time visit lasting between 1-2 hours. During the visit, participants were asked to complete a survey, provide a blood sample, and collect vaginal, rectal, and oral swabs.
LITE
Study Name: Leading Innovation for Transgender Women’s Health and Empowerment
Introduction: The LITE study was the first cohort study of transgender women and transfeminine people in the United States, which enrolled 1,100 transgender women in eastern and southern United States.
Why this Study Matters: Health and HIV research often includes transgender women with other populations, such as with men who have sex with men (MSM), resulting in research that is not gender affirming or responsive to transgender women’s experiences and needs. This leaves many gaps in our knowledge about health and HIV issues that are specific and unique to transgender women.
Our Approach: Throughout the study, the study team check-in with transgender women participants approximately every few months for 2 years, with incentives given at each check-in. The study focused on sexual health and HIV in order to learn about engagement in HIV prevention and treatment; however, we also collected data on a wide range of health and social topics.
LITE Plus
Study Name: LITE Plus
Introduction: The purpose of this research study was to understand how chronic stress affects the physical health of transgender women living with HIV. In addition, the study team would like to learn how gender affirming hormone therapy affects the health of transgender women. This will be done through biological methods (like blood samples), and non-biological methods (like surveys).
Why this Study Matters: This study will help researchers and health care providers learn more about the role that stress and stigma play in the health of Black and Latina transgender women.
Our Approach: LITE Plus is a 2-year study with study visits every 6 months. Study visits include surveys, clinical measures (height, weight, and waist circumference), a blood draw, and (for eligible participants) an analysis of stress hormones found in your saliva (spit), which participants will collect at home over 2 days.
PILLAR
Study Name: A Phase 4, randomized, open-label, two-arm study evaluating implementation strategies for the delivery of Cabotegravir in low and high-volume pre-exposure prophylaxis (PrEP) sites in the U.S. for HIV uninfected MSM and transgender men ≥ 18
Introduction: The PILLAR study is for MSM and transgender men who are interested in preventing HIV by using PrEP.
Why this Study Matters: In this study, we want to help providers figure out best practices for using Cabotegravir in their clinic and identify ways in which to support patients receiving Cabotegravir. Cabotegravir is the first long-acting injectable form of PrEP.
Our Approach: Participants are asked to answer 3 surveys, or participate in 3 interviews, over the 12 months of the study. Surveys and interviews ask how participants are feeling and most importantly, their experience with Cabotegravir.
REPRIEVE
Study Name: Randomized Trial to Prevent Vascular Events in HIV
Introduction: REPRIEVE is the largest randomized trial to date in HIV and results from REPRIEVE are helping clinical researchers and clinical care providers to develop heart disease prevention and treatment guidelines, specifically for people with HIV.
Why this Study Matters: The primary results of the REPRIEVE Trial are now available online and show that pitavastatin calcium lowers the incidence rate of heart disease events by 35% in people with HIV. In February 2024, the Department of Health and Human Services Guidelines Panel for the Use of Antiretroviral Agents in Adults and Adolescents with HIV released recommendations for the use of statin therapy in people with HIV.
Our Approach: REPRIEVE is the first large-scale randomized clinical research trial to test a strategy for heart disease prevention among people living with HIV. Specifically, REPRIEVE tested whether a daily dose of a statin (pitavastatin calcium) reduces the risk of heart disease among people with HIV. The study enrolled over 7,500 people with HIV at over 100 clinical sites across 12 countries. The trial was conducted through the AIDS Clinical Trials Network and many other sites approved by the NIH Division of AIDS. REPRIEVE enrolled the last participant in 2019, the last participant’s study visit occurred in 2023.
