Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV

NCT03790501 | Unknown DMC

• 2 other identifiers: STUDY00013048R01NR018391
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Symptom Distress

  Symptom distress will be measured with the-20 item HIV Symptom Index. As recommended, our primary endpoints include 1) total symptom count (sum all symptoms that are reported as having the symptom and it bothers the participant at least a little); and 2) a total count of symptoms that bother the participant a lot (high symptom distress).

  Four years

Study Arms (1)

People living with HIV (PLHIV).

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

Other: No intervention

Interventions

No intervention OTHER

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

People living with HIV (PLHIV).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit and enroll 850 people living with HIV (PLHIV) who participate in the Centers for AIDS Research Network of Integrated Clinical Systems cohort to participate in this longitudinal observational study.

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Washington: lead
• University of Alabama at Birmingham: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Fenway Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Related Publications (4)

• Horvat Davey C, Willig AL, Ruderman SA, Dos Santos AP, Oliveira V, Gripshover BM, Long DM, Cleveland JD, Crane HM, Fleming J, Buford TW, Burkholder G, Saag MS, Webel AR. Exploring the Relationship Between Insomnia and Biological Factors, Substance Use, and Physical Activity in People With HIV in the United States: Insights From the PROSPER Study. J Assoc Nurses AIDS Care. 2026 Jan-Feb 01;37(1):52-62. doi: 10.1097/JNC.0000000000000589. Epub 2025 Oct 1.

  PMID: 41026762 DERIVED

• Oliveira VHF, Willig AL, Horvat Davey C, Buford TW, Menezes P, Cachay E, Crane HM, Burkholder GA, Gripshover BM, Fleming JG, Cleveland JD, Webel AR. Brief Report: Relationship Between Adiposity and Biomarkers of Aging and Frailty Among Adults Aging With HIV. J Acquir Immune Defic Syndr. 2024 Apr 1;95(4):377-382. doi: 10.1097/QAI.0000000000003362.

  PMID: 38100820 DERIVED

• Webel AR, Davey CH, Oliveira V, Cleveland D, Crane HM, Gripshover BM, Long DM, Fleming JG, Buford TW, Willig AL. Physical activity is associated with adiposity in older adults with HIV in the modern HIV era. AIDS. 2023 Oct 1;37(12):1819-1826. doi: 10.1097/QAD.0000000000003635. Epub 2023 Jun 27.

  PMID: 37382891 DERIVED

• Webel AR, Long D, Rodriguez B, Davey CH, Buford TW, Crane HM, Mayer K, Saag MS, Willig AL. The PROSPER-HIV Study: A Research Protocol to Examine Relationships Among Physical Activity, Diet Intake, and Symptoms in Adults Living With HIV. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):346-352. doi: 10.1097/JNC.0000000000000145. No abstract available.

  PMID: 31789686 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Allison Webel, BSN, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor Oliveira, PhD

CONTACT

216-972-2713; vitorhfo@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: December 31, 2018
• Study Start: January 22, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (4)