HIVNCT02646605
Depression Amongst HIV Positive Patients in Lilongwe
An observational study of HIV and AIDS, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
Quantitative, validated tools of depression screening will be used to collect data to determine the prevalence of depression and its association with antiretroviral (ARV) adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- depression screening
- How many people
- 206 participants
- Where
- 1 siteMalawi
- Study dates
- May 2013to Sep 2013
- 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: Men and women accessing HIV care at Lighthouse clinic, Lilongwe, Malawi will be invited to participate.
Who may be able to join
- 18 years and above
- HIV positive men and women accessing care at LH
- Both ART naïve and on ART
- Registered with LH
- Receiving primary care and/ or ART from LH
Who cannot join
- Too sick to comprehend consent or requiring admission
- Known mentally ill patient on psychiatric drugs
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Depression Amongst HIV Positive Patients Attending ART Clinic at Lighthouse Clinic, Lilongwe
Quantitative, validated tools of depression screening will be used to collect data to determine the prevalence of depression and its association with antiretroviral (ARV) adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.
Read the detailed description
Preliminary data on prevalence and associations will be collected from 200 HIV positive adult men and women attending ART clinic at the Lighthouse in Lilongwe, Malawi. Quantitative, validated tools of depression screening will be used. A short structured demographic questionnaire will be used to collect demographic data. For depression, a Patient Health Questionnaire (PHQ) will be used while alcohol use will be assessed by Alcohol Use Disorders Identification Test (AUDIT) screening tool. The data collected will provide baseline data planning, program development and evaluation, and to promote comprehensive care provision for the people living with AIDS attending ART clinics in Malawi.
- Being tested
- depression screening
- Keywords
- Depression, AIDS, HIV
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depression screeningOther
Patient Health Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patients initiating ART | HIV positive men and women initiating ART Receives: Other: depression screening | |
| patients on established ART | HIV positive men and women on established ART Receives: Other: depression screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi
the survey will be administered one time
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty AIDS international training research program
- Responsible party
- Principal investigator, Mina Hosseinipour, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Mina Hosseinipour, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646605
- Sponsor's protocol ID
- 12-2158
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Malawi Demographic Profile 2012
Mwale M.C. et al (2006) The Prevalence Of Psychological Distress And Associated Factors Among People Living With Aids Attending Antiretroviral Therapy Clinics In Mzuzu, Malawi: A Cross Sectional Descriptive study. Accessed on 09 June 2012 from www.medcol.mw/mph/.../Charles%20M%20%20Mwale.pdf
Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
PubMed 14741909Rochon PA, Mashari A, Cohen A, Misra A, Laxer D, Streiner DL, Dergal JM, Clark JP, Gold J, Binns MA. Relation between randomized controlled trials published in leading general medical journals and the global burden of disease. CMAJ. 2004 May 25;170(11):1673-7. doi: 10.1503/cmaj.1031006.
PubMed 15159365World Health Organisation. (2005). Promoting Mental Health: concepts, emerging evidence, practice: report of the world health organisation, Dept of Mental Health and Substance Abuse in collaboration with the Victorian Health Promotion Foundation & the University of Melbourne. Geneva: World Health Organisation.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Depression Amongst HIV Positive Patients Attending ART Clinic at Lighthouse Clinic, Lilongwe
- ClinicalTrials.gov ID
- NCT02646605
- Acronym / sponsor ID
- 12-2158
- Keywords
- Depression, AIDS, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Fogarty AIDS international training research program
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Quantitative, validated tools of depression screening will be used to collect data to determine the prevalence of depression and its association with antiretroviral (ARV) adherence amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi.
Detailed description
Preliminary data on prevalence and associations will be collected from 200 HIV positive adult men and women attending ART clinic at the Lighthouse in Lilongwe, Malawi. Quantitative, validated tools of depression screening will be used. A short structured demographic questionnaire will be used to collect demographic data. For depression, a Patient Health Questionnaire (PHQ) will be used while alcohol use will be assessed by Alcohol Use Disorders Identification Test (AUDIT) screening tool. The data collected will provide baseline data planning, program development and evaluation, and to promote comprehensive care provision for the people living with AIDS attending ART clinics in Malawi.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients initiating ART | – | Other: depression screeningHIV positive men and women initiating ART |
| patients on established ART | – | Other: depression screeningHIV positive men and women on established ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women accessing HIV care at Lighthouse clinic, Lilongwe, Malawi will be invited to participate.
Key inclusion criteria (5 listed)
- 18 years and above
- HIV positive men and women accessing care at LH
- Both ART naïve and on ART
- Registered with LH
- Receiving primary care and/ or ART from LH
Key exclusion criteria (3 listed)
- Too sick to comprehend consent or requiring admission
- Known mentally ill patient on psychiatric drugs
- Less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depression screeningPatient Health Questionnaire | Other | patients initiating ART, patients on established ART |
Primary outcome
Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi
Time frame: enrollment
the survey will be administered one time
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 5 Jan 2016.
- BackgroundMalawi Demographic Profile 2012
- BackgroundMwale M.C. et al (2006) The Prevalence Of Psychological Distress And Associated Factors Among People Living With Aids Attending Antiretroviral Therapy Clinics In Mzuzu, Malawi: A Cross Sectional Descriptive study. Accessed on 09 June 2012 from www.medcol.mw/mph/.../Charles%20M%20%20Mwale.pdf
- Background: PubMed 14741909Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. doi: 10.1080/1357628031000116808. No abstract available.
- Background: PubMed 15159365Rochon PA, Mashari A, Cohen A, Misra A, Laxer D, Streiner DL, Dergal JM, Clark JP, Gold J, Binns MA. Relation between randomized controlled trials published in leading general medical journals and the global burden of disease. CMAJ. 2004 May 25;170(11):1673-7. doi: 10.1503/cmaj.1031006.
- BackgroundWorld Health Organisation. (2005). Promoting Mental Health: concepts, emerging evidence, practice: report of the world health organisation, Dept of Mental Health and Substance Abuse in collaboration with the Victorian Health Promotion Foundation & the University of Melbourne. Geneva: World Health Organisation.
- 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.
Mina Hosseinipour, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and AIDS, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. 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?
Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646605, which also lists 5 linked publications.
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 5 Jan 2016.