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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331782
• Other study ID #: INA104.02
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2020
• Source: Ina-Respond
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV/AIDS

Locations

Country	Name	City	State
Indonesia	Site 630: M. Ansari Saleh Hospital	Banjarmasin	South Kalimantan
Indonesia	Site 650: Budi Kemuliaan Hospital	Batam	Riau Islands
Indonesia	Site 640: St. Carolus Hospital	Jakarta
Indonesia	Site 600 : Adam Malik Hospital	Medan	North Sumatra

Sponsors (2)

Lead Sponsor	Collaborator
Ina-Respond	National Institute of Health Research and Development (NIHRD), Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of depressive disorders in PLWHA in hospitals.	Number in percentage for Proportion of depressive disorders in PLWHA in hospitals.	[Time Frame: 3 months] [No Safety Issue]
Secondary	Distribution of the severity of depressive disorders in PLWHA	Distribution of the severity of depressive disorders in PLWHA catagorized into minimal, mild, moderate, moderate-severe and severe	[Time Frame: 3 months] [No Safety Issue]
Secondary	The correlation of depression with various factors.	The correlation of depression with various factors: the Risk behavior in the past 30 days, socio-demographic, clinical characteristic and ARV response history.	[Time Frame: 3 months] [No Safety Issue]