HivNCT04809636
Evaluating the Impact of Incentives on Clinical Trial Participation
An observational study of Hiv and Aging, run by University of California, Riverside at 1 site in United States.
Trial summary
The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Aging, Incentives
- What is being tested?
- This is not an interventional study
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit patient partners, biomedical HIV researchers and IRB members/bioethicists involved in HIV research and patient partners with HIV co-morbidities (depression, heart disease, arthritis). For the patient populations, we will target men (including MSM) and women aging with HIV, cis and transgender women, and youth (age 18+) of color, but participation will be open to everyone over 18 years of age living with HIV who speaks English and live in the United States.
Who may be able to join
- people living with HIV
- biomedical HIV researchers
- IRB members/bioethicists involved in HIV research
Who cannot join
- people under 18 years of age
- people living outside of the United States
- people who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UC Riverside
Riverside, California, 92521
Christine Davis, 951-827-5733, christine.davis@medsch.ucr.edu
Brandon Brown, PhD
About this study
Official title: Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation
The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test using vignettes for incentive decision making. We hypothesize that potential study participants make trade-offs regarding the characteristics of a research study when deciding whether to volunteer. This amendment is to document IRB reliance between UCR and USF.
- Conditions
- Hiv, Aging, Incentives
- Being tested
- This is not an interventional study
- Keywords
- hiv, aging, incentives
- 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.
This is not an interventional studyOther
While this is not an intervention, there will be separate participants for the survey study and for the other components of the study (focus groups, interviews, conjoint analysis, piloting the vignettes
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize how people living with HIV assess incentives
we will conduct a 20 question quantitative survey of a nationally representative sample of people living with HIV asking about specific study payment information and scenarios
Measured: 3 months
characterize key stakeholders' views on and assessment of incentives
focus groups, and key informant interviews will be used to characterize key stakeholders' (people aging with HIV, IRB members, researchers) views on and assessment of incentives, with qualitative analysis of text done using RaDAR. We will use Conjoint Analysis (CJA) to estimate the relative importance (also called "weight") that participants place on each study characteristic when choosing between different hypothetical studies.
Measured: 3 months
pilot testing vignettes for incentive decision making
We will develop HIV related vignettes (hypothetical scenarios) utilizing the data from outcomes 1 and 2. Specifically, once we have 6 to 8 study characteristics from Aim 2, and the final number of choices (2 - 3) per characteristic, we will use a factorial design to create 25 vignettes (hypothetical scenarios). Individuals from each group (i.e., study participants, researchers, and IRB members) will select the most appropriate incentive from a list of possibilities based on various scenarios. These vignettes will be based on studies identified in the literature and a review of consent forms and created in conjunction with the external advisory board (including pre-testing and revision prior to finalization).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809636
- Sponsor's protocol ID
- 59270
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galea JT, Greene KY, Nguyen B, Polonijo AN, Dube K, Taylor J, Christensen C, Zhang Z, Brown B. Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33608. doi: 10.2196/33608.
PubMed 34817381
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Incentives on HIV Related Clinical Trial Participation
- ClinicalTrials.gov ID
- NCT04809636
- Acronym / sponsor ID
- 59270
- Conditions
- Hiv, Aging, Incentives
- Keywords
- hiv, aging, incentives
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Collaborators
- University of South Florida
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the impact of incentives on clinical trial participation. 1) characterize key stakeholders' views on and assessment of incentives, 2) reach consensus among stakeholders on the factors to be considered when choosing incentives and their relative importance, 3) pilot test using vignettes for incentive decision making. We hypothesize that potential study participants make trade-offs regarding the characteristics of a research study when deciding whether to volunteer. This amendment is to document IRB reliance between UCR and USF.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit patient partners, biomedical HIV researchers and IRB members/bioethicists involved in HIV research and patient partners with HIV co-morbidities (depression, heart disease, arthritis). For the patient populations, we will target men (including MSM) and women aging with HIV, cis and transgender women, and youth (age 18+) of color, but participation will be open to everyone over 18 years of age living with HIV who speaks English and live in the United States.
Key inclusion criteria (3 listed)
- people living with HIV
- biomedical HIV researchers
- IRB members/bioethicists involved in HIV research
Key exclusion criteria (3 listed)
- people under 18 years of age
- people living outside of the United States
- people who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is not an interventional studyWhile this is not an intervention, there will be separate participants for the survey study and for the other components of the study (focus groups, interviews, conjoint analysis, piloting the vignettes | Other | – |
Primary outcome
characterize how people living with HIV assess incentives
Time frame: 3 months
we will conduct a 20 question quantitative survey of a nationally representative sample of people living with HIV asking about specific study payment information and scenarios
characterize key stakeholders' views on and assessment of incentives
Time frame: 3 months
focus groups, and key informant interviews will be used to characterize key stakeholders' (people aging with HIV, IRB members, researchers) views on and assessment of incentives, with qualitative analysis of text done using RaDAR. We will use Conjoint Analysis (CJA) to estimate the relative importance (also called "weight") that participants place on each study characteristic when choosing between different hypothetical studies.
pilot testing vignettes for incentive decision making
Time frame: 3 months
We will develop HIV related vignettes (hypothetical scenarios) utilizing the data from outcomes 1 and 2. Specifically, once we have 6 to 8 study characteristics from Aim 2, and the final number of choices (2 - 3) per characteristic, we will use a factorial design to create 25 vignettes (hypothetical scenarios). Individuals from each group (i.e., study participants, researchers, and IRB members) will select the most appropriate incentive from a list of possibilities based on various scenarios. These vignettes will be based on studies identified in the literature and a review of consent forms and created in conjunction with the external advisory board (including pre-testing and revision prior to finalization).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Derived from this study: PubMed 34817381Galea JT, Greene KY, Nguyen B, Polonijo AN, Dube K, Taylor J, Christensen C, Zhang Z, Brown B. Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study. JMIR Res Protoc. 2021 Nov 23;10(11):e33608. doi: 10.2196/33608.
- Individual participant dataSharing planned: No
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Aging, run by University of California, Riverside at 1 site 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 3 inclusion and 3 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize how people living with HIV assess incentives (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04809636, which also lists 1 linked publication.
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 22 Mar 2021.