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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH134565-01 | U.S. NIH Grant/Contract | View source | |
| 4R33MH134565-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | Participants will receive screening, diagnosis and linkage to care that is consistent with the standard of care provided by the facility. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants diagnosed | Number of participants screened and diagnosed with anxiety and/or depression. | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants linked to care | Number of participants linked to care for mental health, alcohol use disorder, HIV and/or hypertension. | up to 18 months |
| Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C) |
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Inclusion Criteria:
Exclusion Criteria:
Healthcare Workers/Caregivers Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Schwartz, MD | Contact | 203-530-7261 | jeremy.schwartz@yale.edu | |
| Sarah Christie, PhD, MPH | Contact | 475-439-4660 | sarah.christie@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Schwartz, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kawaala Hospital | Kampala | Uganda | ||||
| Naguru Hospital |
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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Data will be shared beyond the study team once approved by the PIs and a data sharing team, members to be determined. The project website will include all necessary information concerning data sharing, including direct links to the data repository.
Data will be accessible to any researcher or non-researcher who submits a data access request form as described above. Once data are cleared for sharing by the data sharing team, they will be moved to a federally sanctioned repository. All repository rules for requesting data sets will need to be followed by requesting individuals.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000437 | Alcoholism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
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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.)
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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.
| Baseline and 6, 12, 18 months |
| Mean systolic blood pressure | Mean systolic blood pressure in mmHg | Baseline and 6, 12 months |
| Mean diastolic blood pressure | Mean diastolic blood pressure in mmHg | 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 | Baseline and 6, 12 months |
| Self-reported medication adherence | Assessed as mean days adherent in the last 7 days | Baseline and 6, 12 months |
| Kampala |
| Uganda |
| Nsambya Hospital | Kampala | Uganda |
| D019973 |
| Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |