Background
FDA approval of the first long-acting injectable (LAI) antiretroviral therapy (ART) formulation heralds a new era of HIV treatment. LAI ART formulations have the potential to dramatically transform HIV care delivery by providing a treatment option that is discrete, long-acting, does not require adherence to daily oral medication, and can reduce stigma. However, introducing LAI ART to new settings and delivering it to people with HIV at scale in a way that advances health equity requires significant investment to overcome logistical, financial, clinical, and psychosocial barriers. Without targeted interventions designed specifically to help clinics implement and sustain LAI ART programs among priority populations, only the most resourced clinics and the most resourced clients will have access to this important discovery, thereby exacerbating rather than ameliorating health disparities.
- Abounding Prosperity (Dallas, TX). Contact: Melissa Curry
- Baltimore City Health Department Sexual Health Clinic (Baltimore, MD). Contact: Dr. Lola Akolo
- Coastal Family Health Center (Biloxi, MS). Contact: Will Holt
- Mount Sinai Harlem Heath-Jack Martin Fund Center (New York, NY). Contact: Jesus Robles
- Positive Health Impact Center (Decatur, GA). Contact: Shin Ly
- San Antonio AIDS Foundation (San Antonio, TX). Contact: Fabriel Torres
- Sinai Infectious Disease Center (Chicago, IL). Contact: Bijou Hunt
- Sunshine Care Center, Florida Department of Health (Orlando, FL). Contact: Dr. Asim Jani
The project – Accelerating Implementation of Multilevel-strategies to Advance Long-Acting Injectables for Underserved Populations (The AIM to ALAI UP Project) – will support the implementation and delivery of LAI ART at eight demonstration sites in EHE jurisdictions across the US providing care to underserved populations and communities of color.
The ultimate goal of ALAI UP is to increase uptake and expand access to LAI ART in a way that reduces HIV-related health inequities in achieving and maintaining viral suppression among priority populations. This goal will be achieved through the formation of a multidisciplinary Coordination and Evaluation Provider (CEP) drawn from:
- Aaron Diamond AIDS Research Center (ADARC) at Columbia University Irving Medical Center (CUIMC) (Dr. Kathrine Meyers)
- Division of Infectious Diseases at CUIMC (Dr. Jason Zucker; Dr. Delivette Castor)
- The Bureau of Hepatitis, HIV, and Sexually Transmitted Infections at NYC Health Department (Moya Brown-Lopez)
- Southeast AIDS Education and Training Center at Vanderbilt University (Jenn Burdge)
- Hunter Alliance for Research and Translation at Hunter College of the City University of New York (Dr. Sarit Golub)
- Department of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine (Dr. Bryan Kutner)
With expertise in clinical, behavioral, and implementation science, along with extensive experience in capacity building and evaluation – and critical input from the ALAI UP Advisory Board which includes people with diverse lived experiences and local community members – the CEP will support demonstration sites with implementing, delivering, and ultimately sustaining provision of LAI ART through:
- The co-development of protocols and implementation resources
- The delivery of technical assistance on how to use these resources and overcome implementation barriers
- Provider capacity building to increase provider and client demand for LAI ART
- A rigorous monitoring and evaluation plan to inform continuous quality improvement
Cumulatively, ALAI UP’s activities will help reduce HIV-related health inequities among priority populations, with a primary goal of ensuring all persons with HIV have access to high-quality treatment and care that is non-stigmatizing, culturally sensitive, and aligns with evidence-based standards of care. Another goal of ALAI UP focuses on the dissemination and scale-up of activities and implementation strategies identified at demonstration sites to help facilitate the rollout of future LAI ART modalities. These activities and strategies, as well as other resources developed by our expert team, will be specified and included in a public compendium and made available on TargetHIV once finalized.
ALAI UP Protocol Toolkit
The ALAI UP Protocol Toolkit is an interactive planning tool for administrators, clinicians, and staff at clinical sites who are interested in or are in the process of developing an injectable cabotegravir/rilpivirine (iCAB/RPV) program.
Long-Acting Injectable Therapy for Persons with HIV: A QuizTime Project
This course provides an in-depth exploration of long-acting injectable antiretroviral therapies for managing HIV. Participants will gain a comprehensive understanding of the mechanisms, efficacy, and safety profiles of these therapies, including recent advancements and emerging options. The course covers patient selection criteria, administration techniques, and management of potential side effects. Emphasis is placed on clinical case studies, practical applications and patient education to enhance adherence professionals involved in HIV care. This course aims to equip participants with the knowledge and skills necessary to integrate long-acting injectables into effective HIV treatment regimens.
iCAB/RPV Medical Eligibility Considerations Checklist (DOC)
This is a guidance document for administrators, clinicians, and staff at clinical sites who want to understand some of the eligibility considerations for an injectable cabotegravir/rilpivirine (iCAB/RPV) program. As a checklist, it can be used to assess patients’ medical eligibility for iCAB/RPV, discuss eligibility criteria with patients, and document follow-up items.
- Nguyen N, Lane B, Golub SA, Chastain C, Zucker J, King K, Terry M 2nd, Burdge J, Carnevale C, Muscarella A, Castor D, Kutner B, Meyers K. Long-acting injectable ART to advance health equity: a descriptive analysis of US clinic perspectives on barriers, needed support and programme goals for implementation from applications to the ALAI UP Project. J Int AIDS Soc. 2024 Jul;27 Suppl 1(Suppl 1):e26282. doi: 10.1002/jia2.26282. PMID: 38965977; PMCID: PMC11224578.
Conference Abstracts - Oral and Poster Presentations
- Adherence 2023. Sponsor. IAPAC. Nguyen N, Golub SA, King K, Chastain C, Zucker J, Lane B, Terry II M, Burdge J, Carnevale C, Castor D, Kutner B, Simonyan A, Meyers K. US Clinic Perspectives on Barriers, Needed Support, and Program Goals for Implementation of Long-Acting Injectable ARV to Advance Health Equity. Abstract #1201. Oral Presentation. June 2023.
- US Conference on HIV/AIDS. Sponsor. NMAC. Terry II M. Addressing Past Medical Mistrust to Implement Long-Acting Injectables. Workshop Presentation. September 2023.
- Continuum 2024. Sponsor. IAPAC. Blasingame M, Burdge J, Carnevale C, Kutner B, Lane B, Golub SA, Brown-Lopez M, Muscarella A, Chastain C, Zucker J, Nguyen N, Furuya E, Castor D, Wiant S, Hijiya C, Meyers K. Early Implementation Experience and Lessons Learned from Eight Diverse Clinics Introducing Long-acting Injectables for HIV Treatment. Oral Presentation. June 2024.
- Continuum 2024. Sponsor. IAPAC. Nguyen N, Hijiya C, Meyers K, Zucker J, Wiant S, Huang S, Castor D. Early Implementation and Clinical Outcomes from Real-World Use of Injectable Cabotegravir/Rilpivirine (iCAB/RPV) at Eight US Clinics Participating in the ALAI UP Project. Oral Presentation. June 2024
- 25th International AIDS Conference. Sponsor: IAS. Nguyen N, Golub SA, Furuya E, Muscarella A, Burdge J, Carnevale C, Chastain C, Blasingame M, Brown-Lopez M, Zucker J, Castor D, Wiant S, Hijiya C, Kutner B, Lane B, Meyers K. Client Education Approaches that Enhance Equity: Benefits, Challenges, and Early Lessons from Eight Clinics across the United States Implementing Long-Acting Injectable Antiretroviral Therapy. Poster Presentation. July 2024.
- 25th International AIDS Conference. Sponsor: IAS. Nguyen N, Zucker J, Golub SA, Burdge J, Kutner B, Castor D, Blasingame M, Furuya E, Muscarella A, Carnevale C, Chastain C, Brown-Lopez M, Wiant S, Hijiya C, Lane B, Meyers K. Accelerating Implementation of Multilevel-strategies to Advance Long-Acting Injectables for Underserved Populations. Poster Presentation. July 2024.
- National Ryan White Conference on HIV Care & Treatment. Sponsor: HRSA. Nguyen N, Akolo O, Hunt B, Bastien K, Meyers K. Educational Approaches about Long-Acting Injectable Treatment for HIV that Enhance Equity: Benefits, Challenges, and Strategies. Abstract #25536. Oral Presentation. August 2024.
- National Ryan White Conference on HIV Care & Treatment. Sponsor: HRSA. Meyers K, Lane B, Nguyen N. Specifying implementation strategies to accelerate equitable implementation of long-acting injectable antiretroviral therapy. Abstract #25551. Oral Presentation. August 2024.
- National Ryan White Conference on HIV Care & Treatment. Sponsor: HRSA. Castor D, Robles J, Hunt B, Curry M, Holt WL, Meyers K. Clinical Monitoring for Real-World Delivery of Long-Acting Injectable Antiretroviral Therapy (LAI ART). Abstract #25552. Oral Presentation. August 2024.
- National Ryan White Conference on HIV Care & Treatment. Sponsor: HRSA. Meyers K, Kutner B, Castor D, Burdge J, Golub SA. Accelerating Implementation of Multilevel-strategies to Advance Long-Acting Injectables for Underserved Populations. Abstract #25548. Oral Presentation. August 2024.
- National Ryan White Conference on HIV Care & Treatment. Sponsor: HRSA. Hunt B, Ly S, Curry M. Models for Implementing LAI ART with a Lens on Equity. Abstract #25560. Oral Presentation. August 2024.
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Contact Information
Project Contacts:
HRSA Contacts:
Funding:
Recipient Organization: Columbia University Irving Medical Center
Grant number: U1SHA46532
Project Period: 9/1/2022 - 8/31/2026