Monday, May 12, 2025
5/12/2025
Alternative Administration of Long-Acting Injectables to Optimize Uptake and Retention (ALAI) - ABSTRACT/PROJECT SUMMARY There is high interest in long-acting injectables (LAIs) among people with (PWH), with many convenience as a key determinant of uptake and persistence. However, patients and clinicians have described important barriers to effective implementation. Co-packaged long-acting cabotegravir and rilpivirine (CAB/RPV) for HIV treatment requires monthly or bimonthly injection visits. While LAIs eliminate the need for daily pill-taking and have the potential to help close critical gaps in HIV care, patients have expressed concerns that frequent clinic visits can exacerbate stigma, increase the risk of unwanted disclosure, and lead to frequent disruptions in their daily lives. The need to travel to a clinic for injection visits multiple times throughout the year can also be financially and logistically prohibitive for many patients and can widen existing healthcare disparities. Similarly, clinicians worry that additional visits outside of routine care may lead to missed appointments, decreased engagement in care, and put further strain on limited clinic resources. Administration of LAIs by a trained layperson (such as family, friend, or partner of the patient) can help mitigate some of these patient- and clinician-identified barriers. This model of care has been used successfully in other contexts, but up to now it has not been evaluated for HIV treatment. The proposed R21 Developmental Research Grant is designed to establish preliminary feasibility and acceptability data that will inform our overarching goal of optimizing the delivery of LAIs for HIV treatment through the use of future innovative delivery methods, such as training layperson injectors for home administration. Alternative LAI delivery methods have the potential to increase the PWH and layperson injector’s confidence, competence, empowerment, convenience, privacy, and self-management skills, and ultimately facilitate LAI uptake and persistence. Grounded in Adult Learning Theory or Andragogy, the proposed study will develop a scalable, theory-informed, patient-centered training protocol that will teach patients and laypersons to correctly and safely administer LAIs. We will recruit study participants from three clinical sites with demographically diverse patient populations. In Aim 1, we will qualitatively evaluate the injection training barriers, facilitators, needs, and preferences of PWH, candidate layperson injectors, and clinicians to develop a structured and comprehensive LAI training protocol. In Aim 2, we will pilot test the LAI training protocol to evaluate feasibility, acceptability, and patient’s and layperson injector’s perceptions around the training protocol. Pilot data will provide essential information and identify modifications prior to full-scale testing. Next steps will include testing the efficacy of training protocol in improving care and health-related quality of life in a future randomized clinical trial.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).