Trial Phase: Syndemic Adapted Medly Uganda

Official title

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

Overview

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

• Device Syndemic-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.

Primary outcome measures

• Number of participants diagnosed [Time frame: up to 18 months]

Secondary outcome measures (6)

• Number of participants linked to care [Time frame: up to 18 months]
• Mean score Alcohol Use Disorders Identification Test- C (AUDIT-C) [Time frame: Baseline and 6, 12, 18 months]
• Mean systolic blood pressure [Time frame: Baseline and 6, 12 months]
• Mean diastolic blood pressure [Time frame: Baseline and 6, 12 months]
• Number of participants with HIV viral load suppression [Time frame: Baseline and 6, 12 months]
• Self-reported medication adherence [Time frame: Baseline and 6, 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Uganda · 3 centers

• Kawaala Hospital — Kampala
• Naguru Hospital — Kampala
• Nsambya Hospital — Kampala

Identifiers

NCT: NCT07525271 · 2000042286 · 5R21MH134565-02 · 4R33MH134565-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗