The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Launched by BRIGHAM AND WOMEN'S HOSPITAL · Aug 13, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The SUSTAIN 2 Study is a clinical trial designed to find out if a new approach called the DSD model can help people living with HIV stick to their treatment plans. The study aims to answer important questions about whether this intervention can improve how well participants follow their HIV treatment, help them stay in regular care at clinics, and reduce gaps in their treatment.
To participate, individuals must be at least 18 years old, living with HIV, and currently on a specific type of medication called dolutegravir. They should also have missed appointments or have a higher viral load in the past year. Participants will be involved for 24 months, either joining an adherence club where they can get medication for six months at a time and receive support from peers, or continuing with standard care at the clinic. Throughout the study, they will have regular blood tests to check their viral load and may share their experiences through interviews. This study is not yet recruiting, so interested individuals should stay tuned for updates.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults (≥18 years or age)
- • Living with HIV
- • On a dolutegravir-based first-line ART regimen
- • Evidence of a care gap (\>28 days late for appointment) or having a raised viral load (\>50 copies/ml) in the preceding year, either from SUSTAIN study data or from clinic records.
- • Able to provide full informed consent.
- • Willingness to comply with study procedures, including providing regular update of contact details or locator information.
- • A purposively selected subset of 30 enrolled participants will be invited for a semi-structured, in-depth interview at (or within 2 months after) the month 24 visit (for experience and perceptions; aim 2); and 20 different participants will be invited to participate in in-depth interviews to determine acceptability and feasibility (aim 3) within the same time frame.
- Exclusion Criteria:
- • Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
- • Sustained retention in care (no gaps of \>28days) and viral suppression in the preceding year.
- • Plans to leave Cape Town permanently within the next 24 months.
About Brigham And Women's Hospital
Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Ingrid T Katz, MD, MHS
Principal Investigator
Brigham and Women's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported