Preventative Misconception Intervention

Not Applicable

Completed

• Conditions: HIV; HIV Infections
• Interventions: Behavioral: 2-sided messages; Behavioral: 1-sided messages

• Registration Number: NCT01049139
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplemental information with 2-sided messages	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).
Supplemental information with 1-sided message	1-sided messages	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).

Primary Outcome Measures

Name	Time	Method
Knowledge about phase 3 HIV vaccine clinical trials, specifically, understanding of random assignment and the unproven efficacy of the vaccine.	7 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

University of Maryland Medical School; 🇺🇸 Baltimore, Maryland, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Tulane University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States