- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646605
Depression Amongst HIV Positive Patients in Lilongwe
January 4, 2016 updated by: Mina Hosseinipour, MD, MPH, University of North Carolina, Chapel Hill
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
206
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lilongwe, Malawi, P/Bag A-104
- Lighthouse clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Men and women accessing HIV care at Lighthouse clinic, Lilongwe, Malawi will be invited to participate.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Too sick to comprehend consent or requiring admission
- Known mentally ill patient on psychiatric drugs
- Less than 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients initiating ART
HIV positive men and women initiating ART
|
Patient Health Questionnaire
|
patients on established ART
HIV positive men and women on established ART
|
Patient Health Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi
Time Frame: enrollment
|
the survey will be administered one time
|
enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mina Hosseinipour, MD, MPH, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
- Rochon 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.
- World 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
January 4, 2016
First Submitted That Met QC Criteria
January 4, 2016
First Posted (Estimate)
January 5, 2016
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-2158 (Other Identifier: University of Chicago Comprehensive Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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