Mental HealthSAMUNCT07525271
Trial Phase: Syndemic Adapted Medly Uganda
A study testing Syndemic-Adapted Medly Uganda (SAMU) in people with Mental Health, run by Yale University at 3 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Syndemic-Adapted Medly Uganda (SAMU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 3 sitesUganda
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda3 sites
Kawaala Hospital
Kampala
Naguru Hospital
Kampala
Nsambya Hospital
Kampala
About this study
Official title: 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.
Read the 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
- Conditions
- Mental Health
- Being tested
- Syndemic-Adapted Medly Uganda (SAMU)
- Keywords
- Depression, Anxiety, HIV, Alcohol Use Disorder, hypertension
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Alcoholism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndemic-Adapted Medly Uganda (SAMU)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| SAMU intervention | Experimental | 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. Receives: Device: Syndemic-Adapted Medly Uganda (SAMU) |
| Control | No intervention | Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed
Number of participants screened and diagnosed with anxiety and/or depression.
Measured: up to 18 months
Secondary outcomes (6)
Number of participants linked to care
Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension.
Measured: 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.
Measured: Baseline and 6, 12, 18 months
Mean systolic blood pressure
Mean systolic blood pressure in mmHg
Measured: Baseline and 6, 12 months
Mean diastolic blood pressure
Mean diastolic blood pressure in mmHg
Measured: 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
Measured: Baseline and 6, 12 months
Self-reported medication adherence
Assessed as mean days adherent in the last 7 days
Measured: Baseline and 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult participants from 3 clinic sites from the Kampala district that are living with HIV and/ hypertension that are currently receiving care at the participating clinic sites. . (A subset of these participants with hypertension will be enrolled into a longitudinal cohort.)
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jeremy Schwartz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525271
- Sponsor's protocol ID
- 2000042286
- Other IDs
- 5R21MH134565-02, 4R33MH134565-03
- Acronym
- SAMU
- Status last verified
- Aug 2026
- First submitted
- 6 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)
- ClinicalTrials.gov ID
- NCT07525271
- Acronym / sponsor ID
- SAMU / 2000042286
- Conditions
- Mental Health
- Keywords
- Depression, Anxiety, HIV, Alcohol Use Disorder, hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adult participants from 3 clinic sites from the Kampala district that are living with HIV and/ hypertension that are currently receiving care at the participating clinic sites. . (A subset of these participants with hypertension will be enrolled into a longitudinal cohort.)
| Arm | Type | Receives |
|---|---|---|
| SAMU intervention | Experimental | Device: Syndemic-Adapted Medly Uganda (SAMU)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. |
| Control | No intervention | –Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- No access to a mobile phone
- Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SAMU intervention |
Primary outcome
Number of participants diagnosed
Time frame: up to 18 months
Number of participants screened and diagnosed with anxiety and/or depression.
6 secondary outcomes
Number of participants linked to care
Time frame: up to 18 months
Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)
Time frame: Baseline and 6, 12, 18 months
Mean systolic blood pressure
Time frame: Baseline and 6, 12 months
Mean diastolic blood pressure
Time frame: Baseline and 6, 12 months
Number of participants with HIV viral load suppression
Time frame: Baseline and 6, 12 months
Self-reported medication adherence
Time frame: Baseline and 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Schwartz, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syndemic-Adapted Medly Uganda (SAMU) in people with Mental Health, run by Yale University at 3 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Schwartz, MD (203-530-7261, jeremy.schwartz@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants diagnosed (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.