Trial Phase: Syndemic Adapted Medly Uganda (SAMU)

Yale University

Status: Begins enrollment this month

Conditions: Mental Health

Treatments: Device: Syndemic-Adapted Medly Uganda (SAMU)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07525271

1R21MH134565-01 (U.S. NIH Grant/Contract)

2000042286

4R33MH134565-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

SAMU intervention

Experimental group

Description:

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.

Treatment:

Device: Syndemic-Adapted Medly Uganda (SAMU)

Control

No Intervention group

Description:

Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility.