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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02646605
Other study ID # 12-2158
Secondary ID
Status Completed
Phase N/A
First received January 4, 2016
Last updated January 4, 2016
Start date May 2013
Est. completion date September 2013

Study information

Verified date January 2016
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardMalawi: National Health Sciences Research Committee
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
depression screening
Patient Health Questionnaire

Locations

Country Name City State
Malawi Lighthouse Clinic Lilongwe

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Fogarty AIDS international training research program

Country where clinical trial is conducted

Malawi, 

References & Publications (5)

Guilbert JJ. The world health report 2002 - reducing risks, promoting healthy life. Educ Health (Abingdon). 2003 Jul;16(2):230. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi the survey will be administered one time enrollment No
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