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CompletedNCT04331782Updated Apr 3, 2020

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

An observational study in HIV/AIDS and Depression, sponsored by Ina-Respond. Completed at 4 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-03.

Sponsored by Ina-Respond · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV/AIDS
  • Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 200 is above the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Ina-Respond is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Proportion of depressive disorders in PLWHA in hospitals.

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

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

Secondary outcomes

  1. 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: [Time Frame: 3 months] [No Safety Issue]

  2. 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: [Time Frame: 3 months] [No Safety Issue]

07

Study locations

4 sites
  • Site 600 : Adam Malik Hospital
    Medan, North Sumatra 20136, Indonesia
  • Site 650: Budi Kemuliaan Hospital
    Batam, Riau Islands, Indonesia
  • Site 630: M. Ansari Saleh Hospital
    Banjarmasin, South Kalimantan 70125, Indonesia
  • Site 640: St. Carolus Hospital
    Jakarta, 10440, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04331782
Lead sponsor
Ina-Respond
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Responsible party
Sponsor
First posted
Apr 2, 2020
Start date
Jul 22, 2019
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Apr 3, 2020

Study contacts

Dr. Muhammad Karyana, MPH
principal investigator · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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