Preventative Misconception Intervention

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01049139
First received: January 13, 2010
Last updated: September 5, 2011
Last verified: August 2011

January 13, 2010
September 5, 2011
January 2010
September 2010   (final data collection date for primary outcome measure)
Knowledge about phase 3 HIV vaccine clinical trials, specifically, understanding of random assignment and the unproven efficacy of the vaccine. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01049139 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preventative Misconception Intervention
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • HIV Infections
  • Behavioral: 1-sided messages
    Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).
  • 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).
  • 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).
    Intervention: Behavioral: 1-sided messages
  • 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).
    Intervention: Behavioral: 2-sided messages
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2010
September 2010   (final data collection date for primary outcome measure)

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.

Both
16 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01049139
ATN 076
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
Study Chair: Gregory Zimet, Ph.D. Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP