Skip to main content
OpenTrials
Completed

NCT Number: NCT04331782

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Depression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 600 : Adam Malik Hospital, Medan, North Sumatra, Indonesia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years.
  • HIV positive based on diagnosis standards of care in research hospitals.
  • Have received ARV treatment for at least six months.
  • Without a history of being diagnosed with a depressive disorder beforehand.
  • Has been given an explanation before the research and give approval after the explanation.

Exclusion criteria

  • Being pregnant / nursing.
  • Currently undergoing a period of detention.
  • Being seriously ill (according to the doctor's justification at the hospital).

Treatment and study plan

Primary outcomes

  1. Proportion of depressive disorders in PLWHA in hospitals.

    Time frame: [Time Frame: 3 months] [No Safety Issue]

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

Secondary outcomes

  1. Distribution of the severity of depressive disorders in PLWHA

    Time frame: [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: [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.

Sponsors and collaborators

Lead sponsor

Ina-Respond

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.