NCT02445079

Brief Summary

Longitudinal cohort study of older-aged people living with HIV infection in southwestern Uganda and age and gender-matched HIV uninfected controls with the primary aim of measuring the epidemiology of cardiovascular and pulmonary disease in this study setting, and particularly the contribution of HIV infection to it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 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

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

4.4 years

First QC Date

May 6, 2015

Last Update Submit

March 6, 2019

Conditions

HIVCardiovascular DiseaseChronic Obstructive Pulmonary DiseaseAtherosclerosisHypertensionDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Baseline prevalence and incident change in carotid intima media thickness

    Measured by carotid ultrasonography

    Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

Secondary Outcomes (4)

  • Baseline prevalence and incident change in carotid plaque

    Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

  • Baseline prevalence and incident change in ischemic heart disease

    Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

  • Baseline prevalence and incident change in peripheral arterial disease

    Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

  • Baseline prevalence and incident change in chronic obstructive pulmonary disease

    Outcomes will be collected at baseline and every 12 months (i.e. months 12, 24, 36, 48, and 60) for study duration (planned 60 months)

Study Arms (2)

HIV infected

HIV infected sub-group

Other: This is an observational study only

HIV uninfected

HIV uninfected sub-group, age and gender matched to the HIV-infected group

Other: This is an observational study only

Interventions

This is an observational study onlyOTHER

Observational study only

HIV infectedHIV uninfected

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study recruits two sub-groups of participants: Study Group 1: -HIV infected persons aged 40 and older, in care at the Immune Suppression Syndrome HIV Clinic at Mbarara Regional Referral Hospital Study Group 2: -Community-based, HIV uninfected persons recruited from the catchment area of the Mbarara Regional Referral Hospital (greater Mbarara), and age and gender-matched to Group 1 participants

You may qualify if:

  • HIV infected
  • Age \> 40 years old at enrollment
  • Minimum 2 years of antiretroviral therapy

You may not qualify if:

  • Decline informed consent
  • Living in catchment area of Mbarara Regional Referral Hospital (greater Mbarara)
  • Age \> 40 years old
  • Age and gender matched to a participant in group 1
  • HIV infection (tested annually as part of study procedures)
  • Decline informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (1)

  • Siedner MJ, Bibangambah P, Kim JH, Lankowski A, Chang JL, Yang IT, Kwon DS, North CM, Triant VA, Longenecker C, Ghoshhajra B, Peck RN, Sentongo RN, Gilbert R, Kakuhikire B, Boum Y 2nd, Haberer JE, Martin JN, Tracy R, Hunt PW, Bangsberg DR, Tsai AC, Hemphill LC, Okello S. Treated HIV Infection and Progression of Carotid Atherosclerosis in Rural Uganda: A Prospective Observational Cohort Study. J Am Heart Assoc. 2021 Jun 15;10(12):e019994. doi: 10.1161/JAHA.120.019994. Epub 2021 Jun 5.

    PMID: 34096320DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Annual collection of serum, plasma, and stool.

MeSH Terms

Conditions

Cardiovascular DiseasesPulmonary Disease, Chronic ObstructiveAtherosclerosisHypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mark J Siedner, MD MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Medicine

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 15, 2015

Study Start

December 1, 2013

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

UG(1)