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HIV/AIDSPROSPER-HIVNCT03790501

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

An observational study of HIV/AIDS, run by University of Washington at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS
How many people
850 participants
Where
4 sitesUnited States
Study dates
22 Jan 2019to 30 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Vitor Oliveira, PhD contact

216-972-2713

vitorhfo@uw.edu

United States4 sites, 4 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Tammi Thomas, BS, 205-934-7839, tamms@uabmc.edu

    Amanda Willig, RD, PhD

    Recruiting

  • Fenway Institute

    Boston, Massachusetts, 02215

    Matteo Peretti, 206-616-0201, MPeretti@fenwayhealth.org

    Julia Fleming, MD

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Recruiting

  • University of Washington

    Seattle, Washington, 98104

    Laurie Smith, BA, 206-616-0101, laursmit@uw.edu

    Heidi Crane, MD, MPH

    Recruiting

Other trials in United States

About this study

Official title: Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV

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.

Read the detailed description

PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who will complete an enhanced patient-reported outcome (PRO) assessment to measure physical activity and diet intake, once a year for three years. All participants will also complete the standard CNICS PRO and clinical assessment procedures. We propose to integrate the following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment of patient reported outcomes at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary objectives are to:

  1. Identify and characterize longitudinal, objectively measured, physical activity and dietary patterns among PLHIV
  2. Examine the relationship between objectively-measured physical activity and self-reported physical activity on the Lipid Research Clinics Physical Activity Questionnaire.
  3. Determine which aspects of physical activity patterns and diet quality are associated with decreased symptom burden and intensity in PLHIV, and if this relationship is moderated by age and sex.
  4. Explore the potential mediating effect of anthropomorphic and physical fitness variables on the relationships between physical activity, dietary patterns, and symptom burden and intensity in PLHIV.

We hypothesize that people living with HIV who 1) have more intense, frequent and longer physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced symptom burden and intensity and that this relationship will also vary by age and sex.

Conditions
HIV/AIDS
Being tested
No intervention
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

Study groups in NCT03790501
Study groupRoleWhat they receive
People living with HIV (PLHIV).We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2018
  2. Study start22 Jan 2019
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790501
Sponsor's protocol ID
STUDY00013048
Other IDs
R01NR018391
Acronym
PROSPER-HIV
Status last verified
Jun 2021
First submitted
28 Dec 2018
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared consistent with the CNICS Data Sharing Policy found here: https://www.uab.edu/cnics/images/CNICSdatasharing\_policy\_v081515.pdf

Publications

  • Webel A, Ruderman S, Horvat Davey C, Oliveira VHF, Crane HM, Buford TW, Gripshover BM, Burkholder GA, Fleming JG, Delaney JA, Saag MS, Willig AL. Higher steps per day and better diet quality associated with lower symptom burden in adults with HIV: results from the PROSPER-HIV study. Res Connect. 2026 Jun 29;1(3):vmag109. doi: 10.1093/rescon/vmag109. eCollection 2026 Jul.

    PubMed 42500135

  • 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.

    PubMed 41026762

  • 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.

    PubMed 38100820

  • 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.

    PubMed 37382891

  • 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.

    PubMed 31789686

Questions about this trial

What is this clinical trial studying?

An observational study of HIV/AIDS, run by University of Washington at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vitor Oliveira, PhD (216-972-2713, vitorhfo@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Distress (time frame: Four years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790501, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.

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