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NCT Number: NCT07525271

Trial Phase: Syndemic Adapted Medly Uganda

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.

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Key information

Conditions

Mental Health Alcohol-Related Disorders Alcoholism Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Chemically-Induced Disorders Depression Hypertension Mental Disorders Personal Satisfaction Psychological Well-Being Substance-Related Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kawaala Hospital, Kampala, Uganda

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants diagnosed

    Time frame: up to 18 months

    Number of participants screened and diagnosed with anxiety and/or depression.

Secondary outcomes

  1. Number of participants linked to care

    Time frame: up to 18 months

    Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension.

  2. Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C)

    Time frame: Baseline and 6, 12, 18 months

    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.

  3. Mean systolic blood pressure

    Time frame: Baseline and 6, 12 months

    Mean systolic blood pressure in mmHg

  4. Mean diastolic blood pressure

    Time frame: Baseline and 6, 12 months

    Mean diastolic blood pressure in mmHg

  5. Number of participants with HIV viral load suppression

    Time frame: Baseline and 6, 12 months

    HIV viral load suppression defined as having <200 copies/mL of HIV RNA in the blood

  6. Self-reported medication adherence

    Time frame: Baseline and 6, 12 months

    Assessed as mean days adherent in the last 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Jeremy Schwartz, MD

CONTACT

[email protected]

203-530-7261

Sarah Christie, PhD, MPH

CONTACT

[email protected]

475-439-4660

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)

Acronym: SAMU

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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