An interventional study of Syndemic-Adapted Medly Uganda (SAMU) in Mental Health, sponsored by Yale University. Not yet recruiting at 3 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
Healthcare Workers/Caregivers Criteria:
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 screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.
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.
Number of participants diagnosed
Number of participants screened and diagnosed with anxiety and/or depression.
Time frame: up to 18 months
Number of participants linked to care
Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension.
Time frame: 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.
Time frame: Baseline and 6, 12, 18 months
Mean systolic blood pressure
Mean systolic blood pressure in mmHg
Time frame: Baseline and 6, 12 months
Mean diastolic blood pressure
Mean diastolic blood pressure in mmHg
Time frame: 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
Time frame: Baseline and 6, 12 months
Self-reported medication adherence
Assessed as mean days adherent in the last 7 days
Time frame: Baseline and 6, 12 months
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University