Mental Health
Conditions
Keywords
Depression, Anxiety, HIV, Alcohol Use Disorder, hypertension
Brief 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. 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
Interventions
DEVICESyndemic-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.
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants diagnosed | up to 18 months | Number of participants screened and diagnosed with anxiety and/or depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants linked to care | up to 18 months | Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension. |
| Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C) | 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. |
| Mean systolic blood pressure | Baseline and 6, 12 months | Mean systolic blood pressure in mmHg |
| Mean diastolic blood pressure | Baseline and 6, 12 months | Mean diastolic blood pressure in mmHg |
| Number of participants with HIV viral load suppression | Baseline and 6, 12 months | HIV viral load suppression defined as having \<200 copies/mL of HIV RNA in the blood |
| Self-reported medication adherence | Baseline and 6, 12 months | Assessed as mean days adherent in the last 7 days |
Countries
Uganda
Contacts
CONTACTJeremy Schwartz, MD
CONTACTSarah Christie, PhD, MPH
PRINCIPAL_INVESTIGATORJeremy Schwartz, MD
Yale University
Outcome results
None listed