Informed ConsentC-STARTNCT05371327
Community Solutions to Adolescent Research Consent - Minor Consent for Biomedical HIV Research
An observational study of Informed Consent and HIV Infections, run by Indiana University at 1 site in United States.
Trial summary
Public deliberation is a novel method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Informed Consent, HIV Infections
- What is being tested?
- Public deliberation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 13 Aug 2025
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Deliberants will include both adolescents/young adults and adults. They need to live, work, or engage with communities with youth at risk for HIV. Communities can be geographic communities, LGBTQ communities, Black or Latinx communities, etc.
Who may be able to join
- Complete the screening survey;
- Be at least 14 years of age;
- Speak and understand English; and,
- Be able to commit to attend all virtual deliberation sessions in their entirety.
- Be one of the following:
- 14-21years old
Show all 10Show fewer
- Have an adolescent who lives with you
- Closely involved with an adolescent on a regular basis (e.g. grandparent, adult sibling)
- Work for an organization or program that is invested in the wellbeing of adolescents in your community (e.g. social worker, high school teacher, nonprofit work)
- Part of an organization or program that is invested in the wellbeing of adolescents in your community (e.g. mentor, volunteer, church youth group)
Who cannot join
- Those who are obviously inebriated or high at the time of screening, the deliberation event, or the pre-/post-event interviews;
- Those who reside in a home with another eligible participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine and School of Nursing
Indianapolis, Indiana, 46220
About this study
Official title: Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research
Public deliberation is a novel method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate. Public deliberation involves: in-depth education on the topic of interest, presentation of conflicting perspectives from expert witnesses and key stakeholders, facilitated public discussion of core issues, and development of resolutions that are acceptable to participants. Public deliberation requires significant commitment from deliberants who are actively engaged over the course of several sessions. Public deliberation can be successful when more traditional methods of stakeholder engagement fail, as it allows for in-depth discussion and demonstrated awareness of the moral difference in deciding for oneself and others.
Minor consent to biomedical HIV prevention research highlights difficulties with consent, particularly for minors, and how key ethical principles may come into conflict. Typically, institutions and investigators rely upon parental permission to protect minors from research-related harm and coercion. However, the parent permission model may be harmful in stigmatizing health research such as HIV. The consent process creates potential for disclosure of the minor's sensitive behaviors and/or identities to their parents who were otherwise unaware of them. This risk is heightened for sexual and gender minority adolescents, who may face physical and social harm when their sexual or gender identities are disclosed. This risk of harm, and the ethical conflict it creates has contributed to delays in clinical trials and clinical use of HIV prevention methods in minors.
This project will test public deliberation as a method for improving consent processes for engaging individuals from marginalized communities in clinical research on sensitive or stigmatizing health problems. The investigators use minor consent for biomedical HIV prevention research as an exemplar case. The primary hypothesis is that public deliberation will produce a resolution to ethical conflicts in minor consent that is better or different from the results of more traditional study approaches (e.g. surveys, in depth interviews).
- Conditions
- Informed Consent, HIV Infections
- Being tested
- Public deliberation
- Keywords
- Public Deliberation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public deliberationBehavioural
Public deliberation is a method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate.
| Study group | Role | What they receive |
|---|---|---|
| Public Deliberants | Minors and adults recruited through a community outreach process. Receives: Behavioral: Public deliberation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of parental permission in consent for HIV biomedical prevention research.
One of three items adapted from a previous study (see citation), and are scored separately on a 1-5 scale with 5 being the most acceptable:
Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen asks their parent/guardian to come to the research clinic with them. The parent/guardian is given information about the study, and has the opportunity to ask any questions they want to ask. After the parent's questions are answered, they are asked whether or not they give permission for their teen to join the study.
In this approach to consent, the parent/guardian has the final say about whether the teen can join the study. How acceptable is this approach to research consent?
- Completely unacceptable
- Somewhat unacceptable
- Neither unacceptable nor acceptable
- Somewhat acceptable
- Completely acceptable
Measured: Duration of public deliberation (2-4 weeks)
Acceptability of minor self-consent for HIV biomedical prevention research.
One of three items adapted from a previous study (see citation), and scored separately on a 1-5 scale with 5 being the most acceptable:
Imagine again that a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. Once their questions are answered, the teen is ready to consent to the study. They are allowed to sign the consent form and join the study without speaking to anyone else about the decision.
In this approach to consent, the teen is allowed to make the decision about joining the research study on their own. How acceptable is this approach to research consent?
- Completely unacceptable
- Somewhat unacceptable
- Neither unacceptable nor acceptable
- Somewhat acceptable
- Completely acceptable
Measured: Duration of public deliberation (2-4 weeks)
Acceptability of ombudsman for consent for HIV biomedical prevention research.
Third item, scored 1-5, with 5 most acceptable. Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. The teen is required to have an adult's permission to sign up for the study. They can choose to ask either their parent or a neutral adult, called an "ombudsman." The ombudsman is not in charge of the study; the ombudsman's job is to ensure the teen understands the research study, and to help them think about the risks and benefits of joining the study. The teen would need either their parents' permission OR the ombudsman's permission to join the study.
In this approach to consent, the teen must have an adult's permission to join the study; the teen would be able to choose whether to seek permission from their parent or the ombudsman. How acceptable is this approach to research consent? (Same 5 responses as above)
Measured: Duration of public deliberation (2-4 weeks)
Secondary outcomes (1)
Quality of public deliberation
This qualitative assessment of transcripts of the public deliberation assesses 4 dimensions of quality (adapted from DeVries, PMID 20378225). This is a group-level measure (rather than individual level). (1) Equal participation is a count of the number and length of comments from participants in transcripts. (2) Respect for opinions of others is a qualitative assessment that includes recognition of value of comments or support. We will assess number of instances and examples. (3) Adoption of a societal perspective is a qualitative assessment of whether opinions or recommendations are from an individual perspective or societal perspective. (4) Reasoned justification of ideas is a qualitative assessment of whether reasons are given when opinions or statements. We will create a scoring rubric for these 4 dimensions specific to the topic of the deliberation, with examples. This is a qualitative description of how the dimension has been met, rather than a numeric score.
Measured: Duration of public deliberation (2-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start8 Apr 2021
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Amelia Knopf, Indiana University
- Investigators
- Amy Knopf, PhD RN MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371327
- Sponsor's protocol ID
- ME-2018C3-14766
- Acronym
- C-START
- Status last verified
- Nov 2025
- First submitted
- 29 Mar 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified full data package will be available from principal investigators, including protocol, participant-level quantitative data, public deliberation transcripts, analysis plan, documentation of IRB approval and supporting information listed below.
Publications
Knopf A, Ott MA, Draucker CB, Fortenberry JD, Reirden DH, Arrington-Sanders R, Schneider J, Straub D, Baker R, Bakoyannis G, Zimet GD. Innovative Approaches to Obtain Minors' Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives. JMIR Res Protoc. 2020 Mar 30;9(3):e16509. doi: 10.2196/16509.
PubMed 32224493De Vries R, Stanczyk A, Wall IF, Uhlmann R, Damschroder LJ, Kim SY. Assessing the quality of democratic deliberation: a case study of public deliberation on the ethics of surrogate consent for research. Soc Sci Med. 2010 Jun;70(12):1896-1903. doi: 10.1016/j.socscimed.2010.02.031. Epub 2010 Mar 16.
PubMed 20378225
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research
- ClinicalTrials.gov ID
- NCT05371327
- Acronym / sponsor ID
- C-START / ME-2018C3-14766
- Conditions
- Informed Consent, HIV Infections
- Keywords
- Public Deliberation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 12 May 2022 (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.
Public deliberation is a novel method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate. Public deliberation involves: in-depth education on the topic of interest, presentation of conflicting perspectives from expert witnesses and key stakeholders, facilitated public discussion of core issues, and development of resolutions that are acceptable to participants. Public deliberation requires significant commitment from deliberants who are actively engaged over the course of several sessions. Public deliberation can be successful when more traditional methods of stakeholder engagement fail, as it allows for in-depth discussion and demonstrated awareness of the moral difference in deciding for oneself and others.
Minor consent to biomedical HIV prevention research highlights difficulties with consent, particularly for minors, and how key ethical principles may come into conflict. Typically, institutions and investigators rely upon parental permission to protect minors from research-related harm and coercion. However, the parent permission model may be harmful in stigmatizing health research such as HIV. The consent process creates potential for disclosure of the minor's sensitive behaviors and/or identities to their parents who were otherwise unaware of them. This risk is heightened for sexual and gender minority adolescents, who may face physical and social harm when their sexual or gender identities are disclosed. This risk of harm, and the ethical conflict it creates has contributed to delays in clinical trials and clinical use of HIV prevention methods in minors.
This project will test public deliberation as a method for improving consent processes for engaging individuals from marginalized communities in clinical research on sensitive or stigmatizing health problems. The investigators use minor consent for biomedical HIV prevention research as an exemplar case. The primary hypothesis is that public deliberation will produce a resolution to ethical conflicts in minor consent that is better or different from the results of more traditional study approaches (e.g. surveys, in depth interviews).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Public Deliberants | – | Behavioral: Public deliberationMinors and adults recruited through a community outreach process. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Deliberants will include both adolescents/young adults and adults. They need to live, work, or engage with communities with youth at risk for HIV. Communities can be geographic communities, LGBTQ communities, Black or Latinx communities, etc.
Key inclusion criteria (10 listed)
- Complete the screening survey;
- Be at least 14 years of age;
- Speak and understand English; and,
- Be able to commit to attend all virtual deliberation sessions in their entirety.
- Be one of the following:
Key exclusion criteria (2 listed)
- Those who are obviously inebriated or high at the time of screening, the deliberation event, or the pre-/post-event interviews;
- Those who reside in a home with another eligible participant
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 |
|---|---|---|
| Public deliberationPublic deliberation is a method for engaging the public in collective decision-making. Its goal is to facilitate debate and discussion that: 1) fosters the formation of reasonable and informed opinions, 2) permits participants to revise their perspectives and positions in light of new information and dialogue with others, and 3) encourages participants to consider not only their own preferences but also the greater goal of a policy or resolution that is justifiable for all persons affected by the issue under debate. | Behavioural | Public Deliberants |
Primary outcome
Acceptability of parental permission in consent for HIV biomedical prevention research.
Time frame: Duration of public deliberation (2-4 weeks)
One of three items adapted from a previous study (see citation), and are scored separately on a 1-5 scale with 5 being the most acceptable: Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen asks their parent/guardian to come to the research clinic with them. The parent/guardian is given information about the study, and has the opportunity to ask any questions they want to ask. After the parent's questions are answered, they are asked whether or not they give permission for their teen to join the study. In this approach to consent, the parent/guardian has the final say about whether the teen can join the study. How acceptable is this approach to research consent? 1. Completely unacceptable 2. Somewhat unacceptable 3. Neither unacceptable nor acceptable 4. Somewhat acceptable 5. Completely acceptable
Acceptability of minor self-consent for HIV biomedical prevention research.
Time frame: Duration of public deliberation (2-4 weeks)
One of three items adapted from a previous study (see citation), and scored separately on a 1-5 scale with 5 being the most acceptable: Imagine again that a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. Once their questions are answered, the teen is ready to consent to the study. They are allowed to sign the consent form and join the study without speaking to anyone else about the decision. In this approach to consent, the teen is allowed to make the decision about joining the research study on their own. How acceptable is this approach to research consent? 1. Completely unacceptable 2. Somewhat unacceptable 3. Neither unacceptable nor acceptable 4. Somewhat acceptable 5. Completely acceptable
Acceptability of ombudsman for consent for HIV biomedical prevention research.
Time frame: Duration of public deliberation (2-4 weeks)
Third item, scored 1-5, with 5 most acceptable. Imagine a teen wants to join a biomedical HIV prevention study like the one you just read about. The teen comes to the research clinic on their own. They read the consent form, and have an opportunity to ask questions. The teen is required to have an adult's permission to sign up for the study. They can choose to ask either their parent or a neutral adult, called an "ombudsman." The ombudsman is not in charge of the study; the ombudsman's job is to ensure the teen understands the research study, and to help them think about the risks and benefits of joining the study. The teen would need either their parents' permission OR the ombudsman's permission to join the study. In this approach to consent, the teen must have an adult's permission to join the study; the teen would be able to choose whether to seek permission from their parent or the ombudsman. How acceptable is this approach to research consent? (Same 5 responses as above)
1 secondary outcome
Quality of public deliberation
Time frame: Duration of public deliberation (2-4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 32224493Knopf A, Ott MA, Draucker CB, Fortenberry JD, Reirden DH, Arrington-Sanders R, Schneider J, Straub D, Baker R, Bakoyannis G, Zimet GD. Innovative Approaches to Obtain Minors' Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives. JMIR Res Protoc. 2020 Mar 30;9(3):e16509. doi: 10.2196/16509.
- Background: PubMed 20378225De Vries R, Stanczyk A, Wall IF, Uhlmann R, Damschroder LJ, Kim SY. Assessing the quality of democratic deliberation: a case study of public deliberation on the ethics of surrogate consent for research. Soc Sci Med. 2010 Jun;70(12):1896-1903. doi: 10.1016/j.socscimed.2010.02.031. Epub 2010 Mar 16.
- Individual participant dataSharing planned: Yes. A de-identified full data package will be available from principal investigators, including protocol, participant-level quantitative data, public deliberation transcripts, analysis plan, documentation of IRB approval and supporting information listed below.
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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.
Amy Knopf, PhD RN MPH principal investigator
Indiana University
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 Informed Consent and HIV Infections, run by Indiana University 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 10 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of parental permission in consent for HIV biomedical prevention research. (time frame: Duration of public deliberation (2-4 weeks)). 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 NCT05371327, which also lists 2 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 21 Nov 2025.