Trial Phase: Syndemic Adapted Medly Uganda

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.

Первичные конечные точки

• Number of participants diagnosed [Срок оценки: up to 18 months]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Uganda · 3 центра

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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