Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT03790501

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO assessment (consisting measures of physical activity, diet intake and anthropomorphic factors) will be included after the routine patient clinic visit at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health.

Conditions

HIV/AIDS

Study ID

NCT03790501

Start date

Jan 22, 2019

Status verified date

Jun, 2021

Completion date

Apr 30, 2023

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be an active CNICS participant
2. aged ≥18 years
3. prescribed HIV antiretroviral therapy, and
4. have an undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year.

Exclusion Criteria:

1) Did not complete the HIV Symptom Index in the PRO assessment (2) No reliable access to a telephone or internet-enable telephone services needed to complete the 24-diet recalls (3) Was pregnant, breast-feeding, or planning a pregnancy at the time of PRO assessment (4) Planning to move out of the area in the next 36 months, or (5) Non-English speaking.

Study Design

Enrollment

850 participants

Anticipated

Interventions and Outcome Measures

Arms

People living with HIV (PLHIV).

We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.

Interventions

No intervention

As an observational study, no intervention will be associated with the study group.

Primary outcome measure

  • Symptom Distress [ Time Frame: Four years ]

Central Contacts and Locations

Central contacts

Vitor Oliveira, PhD

216-972-2713vitorhfo@uw.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Tammi Thomas, BS

205-934-7839tamms@uabmc.edu

Principal Investigator:

Amanda Willig, RD, PhD

Fenway Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Matteo Peretti

206-616-0201MPeretti@fenwayhealth.org

Principal Investigator:

Julia Fleming, MD

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Laurie Smith, BA

206-616-0101laursmit@uw.edu

Principal Investigator:

Heidi Crane, MD, MPH

More Information

Sponsor

University of Washington

Last update posted

Jun 8, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2021-06-08.