FDA approval of the first long-acting injectable (LAI) antiretroviral (ARV) medication formulation heralds a new era of HIV treatment. LAI ARV 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 a daily oral medication, and can reduce stigma. However, introducing LAI ARV to new settings and delivering it to people with HIV (PWH) at scale in a way that ensures equal opportunity for access requires significant investment to overcome logistical, financial, clinical, and psychosocial barriers. Without targeted interventions designed specifically to help clinics implement and sustain LAI ARV programs among populations disproportionately affected by HIV, only the most resourced clinics and the most resourced patients will have access to this important discovery, thereby exacerbating rather than ameliorating health disparities.

The proposed project – “Accelerating Implementation of Multilevel-strategies to Advance Long-Acting Injectables for Underserved Populations” (The ALAI UP Project) – will support the implementation and delivery of LAI ARV 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).

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:

1. Co-developing protocols and implementation resources to ensure effective and equitable program design, implementation, and sustainment.

2. Providing technical assistance to help sites utilize resources and address implementation challenges.

3. Building provider capacity to drive both provider and patient demand for LAI ART.

4. Establishing a rigorous monitoring and evaluation plan to support continuous quality improvement and ensure equitable implementation.

5. Encouraging community engagement through CLS, story sharing, and other feedback mechanisms to shape program design and delivery.

6. Facilitating cross-site learning and collaboration through annual in-person Convenings and Communities of Practice meetings.

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)

1. Public Health Detailing

2. Resource Incubator

3. Community Listening Sessions

4. Development of Protocol

5. Process Monitoring

6. Technical Assistance

7. Convening

8. Clinical Monitoring & Feedback

9. Motivational Interviewing

10. Communities of Practice

11. Site Visits

Cumulatively, ALAI UP’s activities will help reduce differences in HIV-related outcomes among populations disproportionately affected by HIV, with a primary goal of ensuring all persons with HIV have access to high-quality treatment and care that is respectful and person-centered, 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 once finalized.