Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-06-30
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enhanced Treatment as Usual (ETAU)
We anticipate the control condition will contain the following: the enhanced treatment as usual (ETAU; n=30) will consist of PWH receiving treatment at their HIV primary care clinic as usual, enhanced by supplemental food parcels and referrals for mental health care and food service organizations. Treatment as usual for mental health care is evaluation by a nurse and referral to a medical officer or to a traveling psychologist available 1 day per week. Because there is no standard of care for food insecurity, we propose that all participants will receive food parcels, but ETAU participants will not receive case management or psychosocial intervention.
No interventions assigned to this group
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
We anticipate the intervention condition (CBT-SA) will contain the following: cognitive behavioral therapy for syndemics and adherence (CBT-SA; n=30) likely will be comprised of both psychosocial and structural intervention components, based on the results of Aim 1 and refinement in Aim 2. In addition to food parcels, we expect the CBT-SA condition will also receive nutritional counseling, linkage to care, and case management. Only the CBT-SA condition will receive the psychological intervention for depression and PTSD and adherence counseling. Specific intervention components will be informed by prior aims.
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
We anticipate the intervention will contain the following: CBT for depression and trauma, Life-Steps for ART adherence, nutritional counseling, supplementary food parcels, case management, linkage to care. Specific intervention components will be informed by prior aims.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Behavioral Therapy for Syndemics and Adherence (CBT-SA)
We anticipate the intervention will contain the following: CBT for depression and trauma, Life-Steps for ART adherence, nutritional counseling, supplementary food parcels, case management, linkage to care. Specific intervention components will be informed by prior aims.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
3. Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following:
* Clinically significant depressive symptoms (CES-D ≥ 16)
* Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)
4. 18 years of age or older
Exclusion Criteria
2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
3. Current untreated or undertreated serious mental health issue that would interfere with participation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Cape Town
OTHER
University of Miami
OTHER
University of the Western Cape
OTHER
University of Stellenbosch
OTHER
University of Maryland
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Conall O'Cleirigh
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Conall O'Cleirigh, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Cape Town
Cape Town, Western Cape, South Africa
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lindsay Fester
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023P002344
Identifier Type: -
Identifier Source: org_study_id