Preventative Misconception Intervention

March 2, 2017 updated by: University of North Carolina, Chapel Hill

Evaluation of an Intervention to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 20723
        • University of Maryland Medical School
    • New York
      • New York, New York, United States, 10128
        • Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Supplemental Information
Participants will be administered a standard HIV vaccine trial consent form but no additional information.
Experimental: Supplemental information with 1-sided message
Participants 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).
Behavioral: 1-sided messages
Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).
Experimental: Supplemental information with 2-sided messages
Participants 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).
Behavioral: 2-sided messages
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge about phase 3 HIV vaccine clinical trials, specifically, understanding of random assignment and the unproven efficacy of the vaccine.
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 7 months
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.
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Gregory Zimet, Ph.D., Adolescent Trials Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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