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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Device: Syndemic-Adapted Medly Uganda (SAMU)

Detailed Description

All staff will be trained in mental health screening prior to the trial launch, and all clinics will be equipped with health education materials to raise awareness of mental health, self-care and available resources in the clinic and community

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Schwartz, MD; Phone Number: 203-530-7261; Email: jeremy.schwartz@yale.edu
• Study Contact Backup: Name: Sarah Christie, PhD, MPH; Phone Number: 475-439-4660; Email: sarah.christie@yale.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Nsambya Hospital
  • Kampala, Uganda
    • Kawaala Hospital
  • Kampala, Uganda
    • Naguru Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAMU intervention; Participants 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.	Device: Syndemic-Adapted Medly Uganda (SAMU); 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.
No Intervention: Control; Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants diagnosed	Number of participants screened and diagnosed with anxiety and/or depression.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants linked to care	Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension.	up to 18 months
Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)	3-item alcohol screening tool (abbreviated version of the 10-question AUDIT) that identifies hazardous drinking or active alcohol use disorders. It is scored 0-12. Higher scores indicate a higher likelihood of harmful alcohol consumption.	Baseline and 6, 12, 18 months
Mean systolic blood pressure	Mean systolic blood pressure in mmHg	Baseline and 6, 12 months
Mean diastolic blood pressure	Mean diastolic blood pressure in mmHg	Baseline and 6, 12 months
Number of participants with HIV viral load suppression	HIV viral load suppression defined as having <200 copies/mL of HIV RNA in the blood	Baseline and 6, 12 months
Self-reported medication adherence	Assessed as mean days adherent in the last 7 days	Baseline and 6, 12 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jeremy Schwartz, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Depression; HIV; Anxiety; hypertension; Alcohol Use Disorder
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Behavior; Personal Satisfaction; Hypertension; Anxiety Disorders; Alcoholism; Depression; Psychological Well-Being
• Other Study ID Numbers: 2000042286; 1R21MH134565-01 (U.S. NIH Grant/Contract); 4R33MH134565-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No