NCT04331782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

March 31, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

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: 3 months] [No Safety Issue]

Secondary Outcomes (2)

  • Distribution of the severity of depressive disorders in PLWHA

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

  • The correlation of depression with various factors.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Site 600 : Adam Malik Hospital

Medan, North Sumatra, 20136, Indonesia

Location

Site 650: Budi Kemuliaan Hospital

Batam, Riau Islands, Indonesia

Location

Site 630: M. Ansari Saleh Hospital

Banjarmasin, South Kalimantan, 70125, Indonesia

Location

Site 640: St. Carolus Hospital

Jakarta, 10440, Indonesia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepression

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Dr. Muhammad Karyana, MPH

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

July 22, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations