Clinical trial NCT05371327: Community Solutions to Adolescent Research Consent - Minor Consent for Biomedical HIV Research
Official title: Use of Public Deliberation in Diverse Communities to Improve Consent Processes for Clinical Research
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Informed Consent
HIV Infections
Keywords: Public Deliberation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-05-12
Enrollment: 136
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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).


Eligibility criteria: Inclusion Criteria - Deliberants must:

* 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
  * 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of parental permission in consent for HIV biomedical prevention research.
timeFrame: Duration of public deliberation (2-4 weeks)
measure: Acceptability of minor self-consent for HIV biomedical prevention research.
timeFrame: Duration of public deliberation (2-4 weeks)
measure: Acceptability of ombudsman for consent for HIV biomedical prevention research.
timeFrame: Duration of public deliberation (2-4 weeks)
Secondary outcomes:
measure: Quality of public deliberation
timeFrame: Duration of public deliberation (2-4 weeks)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine and School of Nursing
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Amy Knopf, PhD RN MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: De 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.