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

Integration of Mental Health in HIV Clinic to Increase the Success of Antiretroviral Treatment: Screening for Depression Disorders in People With HIV 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.

Study Overview

• Status: Completed
• Conditions: Depression; HIV/AIDS

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10440
    • Site 640: St. Carolus Hospital
  • North Sumatra
    • Medan, North Sumatra, Indonesia, 20136
      • Site 600 : Adam Malik Hospital
  • Riau Islands
    • Batam, Riau Islands, Indonesia
      • Site 650: Budi Kemuliaan Hospital
  • South Kalimantan
    • Banjarmasin, South Kalimantan, Indonesia, 70125
      • Site 630: M. Ansari Saleh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 from HIV outpatient clinics in research hospital in Indonesia.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]
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]

Collaborators and Investigators

• Sponsor: Ina-Respond
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: INA104.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No