ACTG Announces Behavioral Health and Implementation Study to Optimize Long-Acting HIV Treatment among People who have Struggled to Maintain HIV Suppression 

CHAPEL HILL, N.C., July 17, 2026 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of A5432, a study assessing factors that may affect how long-acting antiretroviral therapy (ART) is used and researched among people living with HIV who previously have been unable to maintain viral suppression on a daily oral ART regimen. A5432 is an exploratory study that utilizes several qualitative methods to better understand the experiences of participants and staff who were part of the LATITUDE study (also known as A5359), in order to design future studies and support broader uptake of long-acting ART among this population.

LATITUDE was a landmark ACTG trial finding that long-acting ART suppressed HIV replication better than a daily regimen among people living with HIV who were not virally suppressed on daily ART (a group that represents approximately one-third of people on ART). In the study, participants received adherence support, including conditional economic incentives, to achieve viral suppression while taking daily oral ART. Researchers then randomized participants who achieved viral suppression to either receive long-acting injectable ART (cabotegravir and rilpivirine) every four weeks or continue taking daily oral ART. In February 2024, an independent Data and Safety Monitoring Board recommended halting randomization and inviting all eligible study participants to take long-acting ART based on interim efficacy data.

“LATITUDE was a groundbreaking study that has changed how we approach treatment for the many people who have had challenges maintaining virologic suppression on daily oral therapy,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “A5432 is an exciting opportunity to gain important insights that will enable us to better leverage these findings to support long-acting treatment for this community of people living with HIV more broadly.”

A5432 will use qualitative methods, including in-depth interviews, with approximately 30 LATITUDE participants who remain in the study or have completed the study procedures, as well as focus group discussions with up to 48 LATITUDE study staff members. A5432 will analyze experiences both with long-acting ART and with LATITUDE itself, with an emphasis on what made long-acting ART easier or harder to use, barriers to its use, LATITUDE study accessibility, and conditional economic incentives. It will also explore the process of transitioning from the study to receiving long-acting ART through traditional medical channels, including differences in care and challenges to remaining on treatment.

“As guidelines rapidly evolve to expand access to long-acting HIV treatment to populations that have struggled to maintain viral suppression, it is critical that we understand and mitigate any potential implementation challenges for both future ACTG trials and intervention scale-up efforts,” said Study Chair Elizabeth Montgomery, Ph.D., RTI International. “Using an implementation science lens and qualitative methods, A5432 will reveal unique perspectives from LATITUDE’s participants and study staff about how to successfully deliver and use long-acting treatment among individuals who have historically been unable to maintain viral suppression on daily ART. We hope to learn how real-world implementation efforts can be improved based on staff and participant insights about the conduct of LATITUDE, both at the clinical and individual level.”

A5432 was developed as an initiative of ACTG’s Behavioral Science Subcommittee, which works closely with all of ACTG’s transformative science groups (TSG) and collaborative science groups in protocol development. Investigators from ACTG’s Implementation Science Subcommittee, a new committee dedicated to identifying opportunities for implementation science innovation and driving the development of novel implementation science studies, also contributed to the study design, along with representatives of the National Institute of Mental Health (NIMH) Division of AIDS Research (Michael Stirratt, Ph.D.) and the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (Pablo Belaunzaran, M.D., M.Sc., A5432 Medical Officer). The protocol was developed by ACTG’s Antiretroviral Strategies TSG.

A5432 is led by Dr. Montgomery (Chair) and Iván C. Balán, Ph.D., Florida State University College of Medicine, and Aadia Rana, M.D., University of Alabama at Birmingham (Vice Chairs). ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) NIMH and NIAID (which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634.

About ACTG
ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research and implementation science studies to improve the management of HIV and its comorbidities; develop a cure for HIV; and discover treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.

Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH.

Media Contact:
Jenna Conley, ACTG
jenna@conleycommunications.net

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