Preventative Misconception Intervention
Evaluation of an Intervention to Reduce Preventive Misconception in HIV Vaccine Clinical Trials
1 other identifier
interventional
120
1 country
4
Brief Summary
This study will carry out a preliminary "proof of concept" to evaluate two types of supplemental information that would serve as an adjunct to the traditional informed consent in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to the condition where the traditional informed consent form is used alone. Using four intervention sites, participants will be administered a standard HIV vaccine trial consent form. They will then be randomized into three conditions: 1) No supplemental information; 2) Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine); and 3) Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument). An interviewer-administered questionnaire (IAQ) Part 1 will be administered before the traditional HIV vaccine trial informed consent is reviewed with the participant. An IAQ Part 2 will be administered directly after the HIV vaccine trial informed consent in the control condition or after reading through the supplemental material. Debriefing interviews will be conducted with selected participants to review their understanding of the study procedures and their reactions to the supplemental materials and/or questionnaires. The proposed research is a "proof of concept" study and is therefore not designed to test hypotheses. Consequently, formal hypothesis and related power calculations to detect certain effect sizes are not required. Instead, the goal will be to enroll an appropriate number of subjects for purpose of determining the feasibility of developing a larger study of supplemental information to be used as an adjunct to the informed consent statement in HIV vaccine clinical trials and providing related descriptive statistics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Jan 2010
Shorter than P25 for not_applicable hiv
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMarch 3, 2017
March 1, 2016
8 months
January 13, 2010
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge about phase 3 HIV vaccine clinical trials, specifically, understanding of random assignment and the unproven efficacy of the vaccine.
7 months
Secondary Outcomes (2)
To carry out preliminary evaluations of potential moderators of the intervention: health literacy, numeracy, impulsivity, STI history, risk behaviors, socio-demographics (e.g., age), and health beliefs.
7 months
Debriefing interviews with a subset of 36 participants in order to obtain feedback regarding research methodology, procedure, wording and content of the messages.
7 months
Study Arms (3)
No Supplemental Information
NO INTERVENTIONParticipants will be administered a standard HIV vaccine trial consent form but no additional information.
Supplemental information with 1-sided message
EXPERIMENTALParticipants will be administered a standard HIV vaccine trial consent form and supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).
Supplemental information with 2-sided messages
EXPERIMENTALParticipants will be administered a standard HIV vaccine trial consent form and supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument).
Interventions
Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).
Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds with the information content and seeks to neutralize those beliefs through counter-argument).
Eligibility Criteria
You may qualify if:
- Not known to be HIV positive by self report; NOTE: HIV test is not a criterion for entry. Participants will be referred for HIV testing, if interested;
- A history of at least one unprotected sexual encounter involving either vaginal or anal penetration (receptive or insertive) with a male partner during the 6 months prior to enrollment;
- Between the ages of 16-19 (inclusive) at the time of informed consent/assent;
- Ability to understand both written and spoken English;
- Willing to consider enrollment into an HIV vaccine trial; and
- Gives informed consent/assent for study participation.
You may not qualify if:
- \- Anything that would impair the participant's ability to meet the study requirements (i.e. readily apparent psychiatric symptoms (hallucinations, thought disorder), visibly distraught (suicidal, homicidal, exhibiting violent behavior), intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*;
- \*NOTE: Participants cannot be visibly under the influence at the time of consent/enrollment, or during interviews.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California at San Francisco
San Francisco, California, 94143, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Maryland Medical School
Baltimore, Maryland, 20723, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gregory Zimet, Ph.D.
Adolescent Trials Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 3, 2017
Record last verified: 2016-03