NCT02646605

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 4, 2016

Last Update Submit

January 4, 2016

Conditions

HIVAIDS

Keywords

DepressionAIDSHIV

Outcome Measures

Primary Outcomes (1)

  • Prevalence of depression amongst HIV positive patients attending ART clinic at Lighthouse Lilongwe, Malawi

    the survey will be administered one time

    enrollment

Study Arms (2)

patients initiating ART

HIV positive men and women initiating ART

Other: depression screening

patients on established ART

HIV positive men and women on established ART

Other: depression screening

Interventions

depression screeningOTHER

Patient Health Questionnaire

patients initiating ARTpatients on established ART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women accessing HIV care at Lighthouse clinic, Lilongwe, Malawi will be invited to participate.

You may qualify if:

  • 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

You may not qualify if:

  • Too sick to comprehend consent or requiring admission
  • Known mentally ill patient on psychiatric drugs
  • Less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lighthouse Clinic

Lilongwe, P/Bag A-104, Malawi

Location

Related Publications (5)

  • Malawi Demographic Profile 2012

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 14741909BACKGROUND

  • 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.

    PMID: 15159365BACKGROUND

  • 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.

    BACKGROUND

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

  • Mina Hosseinipour, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)