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Integration of Mental Health in HIV Clinic to Increase the Success of ARV Treatment in PLWHA in Hospitals

Sponsor
Ina-Respond (Other)
Overall Status
Completed
CT.gov ID
NCT04331782
Collaborator
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia (Other)
200
Enrollment
4
Locations
3.3
Actual Duration (Months)
50
Patients Per Site
15.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Integration of mental health in HIV clinics is needed in order to accelerate fast track 90-90-90 for controlling HIV. Symptoms of depression are sometimes difficult to recognize. In people living with HIV (PLWHA), depression that fails to be recognized and uncontrolled increases the risk of unsuccessful antiretroviral treatment and mortality.

The main purpose of this study is to estimate the proportion of depressive disorders in people living with HIV. The study included adult HIV patients aged ≥18 years, both men and women, who had received ARV treatment for at least six months, with no history of being diagnosed with depression.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study was a cross-sectional, non-intervention and multicenter in adults with HIV-AIDS (PLWHA) who were treated at a hospital who had received ARV treatment for at least six months, without a history of being diagnosed with depression.

    Patients from HIV outpatient clinics in each research hospital were briefed on the study and offered to participate. Furthermore, based on the assessment of inclusion and exclusion criteria, PLWHA who meet the requirements were recruited and data were collected.

    Sociodemographic data, HIV risk factors, risk behaviors, clinical characteristics such as duration of HIV, family history of mental illness, AIDS-related illnesses, other serious non-AIDS-related illnesses, treatment (antiretroviral (ARV) and non-ARV) and history ARV treatment response (HIV and CD4 viral load) were collected from each participant. In addition, a rapid screening for depressive disorders was carried out using the Patient Health Questionnaire-9 (PHQ-9) which was translated and validated in Indonesian. The PHQ-9 questionnaire was filled in by the patient with the assistance of health personnel. The total PHQ-9 questionnaire score were added up and the severity of depression associated with the score was reported to the patient's physician for further management.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Integration of Mental Health in HIV Clinic to Increase the Success of Antiretroviral Treatment: Screening for Depression Disorders in People With HIV in Hospitals
    Actual Study Start Date :
    Jul 22, 2019
    Actual Primary Completion Date :
    Oct 31, 2019
    Actual Study Completion Date :
    Oct 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of depressive disorders in PLWHA in hospitals. [[Time Frame: 3 months] [No Safety Issue]]

      Number in percentage for Proportion of depressive disorders in PLWHA in hospitals.

    Secondary Outcome Measures

    1. Distribution of the severity of depressive disorders in PLWHA [[Time Frame: 3 months] [No Safety Issue]]

      Distribution of the severity of depressive disorders in PLWHA catagorized into minimal, mild, moderate, moderate-severe and severe

    2. The correlation of depression with various factors. [[Time Frame: 3 months] [No Safety Issue]]

      The correlation of depression with various factors: the Risk behavior in the past 30 days, socio-demographic, clinical characteristic and ARV response history.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Adults aged ≥18 years.

    2. HIV positive based on diagnosis standards of care in research hospitals.

    3. Have received ARV treatment for at least six months.

    4. Without a history of being diagnosed with a depressive disorder beforehand.

    5. Has been given an explanation before the research and give approval after the explanation.

    Exclusion Criteria:

    1. Being pregnant / nursing.

    2. Currently undergoing a period of detention.

    3. Being seriously ill (according to the doctor's justification at the hospital).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 600 : Adam Malik Hospital Medan North Sumatra Indonesia 20136
    2 Site 650: Budi Kemuliaan Hospital Batam Riau Islands Indonesia
    3 Site 630: M. Ansari Saleh Hospital Banjarmasin South Kalimantan Indonesia 70125
    4 Site 640: St. Carolus Hospital Jakarta Indonesia 10440

    Sponsors and Collaborators

    • Ina-Respond
    • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    Investigators

    • Principal Investigator: Dr. Muhammad Karyana, MPH, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ina-Respond
    ClinicalTrials.gov Identifier:
    NCT04331782
    Other Study ID Numbers:
    • INA104.02
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Apr 3, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Apr 3, 2020