HIV/AIDSNCT04331782
Integration of Mental Health in HIV Clinic to Increase the Success of ARV Treatment in PLWHA in Hospitals
An observational study of HIV/AIDS and Depression, run by Ina-Respond at 4 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Depression
- How many people
- 200 participants
- Where
- 4 sitesIndonesia
- Study dates
- 22 Jul 2019to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Being pregnant / nursing.
- Currently undergoing a period of detention.
- Being seriously ill (according to the doctor's justification at the hospital).
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Site 630: M. Ansari Saleh Hospital
Banjarmasin, South Kalimantan, 70125
Site 650: Budi Kemuliaan Hospital
Batam, Riau Islands
Site 640: St. Carolus Hospital
Jakarta, 10440
Site 600 : Adam Malik Hospital
Medan, North Sumatra, 20136
About this study
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
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.
- Conditions
- HIV/AIDS, Depression
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of depressive disorders in PLWHA in hospitals.
Number in percentage for Proportion of depressive disorders in PLWHA in hospitals.
Measured: [Time Frame: 3 months] [No Safety Issue]
Secondary outcomes (2)
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
Measured: [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.
Measured: [Time Frame: 3 months] [No Safety Issue]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start22 Jul 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Sponsor
- Investigators
- Dr. Muhammad Karyana, MPH, Principal investigator, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331782
- Sponsor's protocol ID
- INA104.02
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04331782
- Acronym / sponsor ID
- INA104.02
- Conditions
- HIV/AIDS, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Being pregnant / nursing.
- Currently undergoing a period of detention.
- Being seriously ill (according to the doctor's justification at the hospital).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Distribution of the severity of depressive disorders in PLWHA
Time frame: [Time Frame: 3 months] [No Safety Issue]
The correlation of depression with various factors.
Time frame: [Time Frame: 3 months] [No Safety Issue]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Muhammad Karyana, MPH principal investigator
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Depression, run by Ina-Respond at 4 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of depressive disorders in PLWHA in hospitals. (time frame: [Time Frame: 3 months] [No Safety Issue]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.