Health Trials

Trial Phase: Syndemic Adapted Medly Uganda

ConditionMental Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: SAMU interventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants diagnosed

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

Time frame
up to 18 months

Secondary outcomes

1

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
2

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
3

Mean systolic blood pressure

Mean systolic blood pressure in mmHg

Time frame
Baseline and 6, 12 months
4

Mean diastolic blood pressure

Mean diastolic blood pressure in mmHg

Time frame
Baseline and 6, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: