Trial Phase: Syndemic Adapted Medly Uganda
SAMU
An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)
3 other identifiers
interventional
1,500
1 country
3
Brief Summary
The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 13, 2026
April 1, 2026
1.3 years
April 6, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants diagnosed
Number of participants screened and diagnosed with anxiety and/or depression.
up to 18 months
Secondary Outcomes (6)
Number of participants linked to care
up to 18 months
Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)
Baseline and 6, 12, 18 months
Mean systolic blood pressure
Baseline and 6, 12 months
Mean diastolic blood pressure
Baseline and 6, 12 months
Number of participants with HIV viral load suppression
Baseline and 6, 12 months
- +1 more secondary outcomes
Study Arms (2)
SAMU intervention
EXPERIMENTALParticipants will receive the SAMU digital mental health screening intervention and SMS reminders to complete a SAMU session over the duration of trial consistent with their level of need.
Control
NO INTERVENTIONParticipants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.
Interventions
Participants will receive an SMS reminding them to enter a SAMU screening session at a regular basis, based on their initial screening scores. Subsequent screeners will trigger a tailored message based on the participants' inputs.
Eligibility Criteria
You may qualify if:
- Patient at a participating HIV clinic site
- Currently living in Uganda with no intention of moving abroad in next 2 years
- Access to a mobile phone
- Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.
You may not qualify if:
- No access to a mobile phone
- Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW
- Healthcare Workers/Caregivers Criteria:
- Age \>=18 years
- Healthcare worker at participating site or caregiver for study participant at site
- Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (3)
Kawaala Hospital
Kampala, Uganda
Naguru Hospital
Kampala, Uganda
Nsambya Hospital
Kampala, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Schwartz, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2026
First Posted
April 13, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be shared beyond the study team once approved by the PIs and a data sharing team, members to be determined. The project website will include all necessary information concerning data sharing, including direct links to the data repository.
- Access Criteria
- Data will be accessible to any researcher or non-researcher who submits a data access request form as described above. Once data are cleared for sharing by the data sharing team, they will be moved to a federally sanctioned repository. All repository rules for requesting data sets will need to be followed by requesting individuals.
Partial, individualized data sets will be made available based on specific requests. All data to be shared will be fully deidentified, will undergo rigorous cleaning and quality control prior to sharing, will be accompanied by a data dictionary to prevent misunderstanding or misuse, and will be encoded using common standards. Audio recordings will not be shared, however final transcripts will be shared. The project website will include all necessary information concerning data sharing, including direct links to the data repository.