Preventative Misconception Intervention
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| ClinicalTrials.gov Identifier: NCT01049139 |
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Recruitment Status :
Completed
First Posted : January 14, 2010
Last Update Posted : March 3, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV HIV Infections | Behavioral: 1-sided messages Behavioral: 2-sided messages | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Evaluation of an Intervention to Reduce Preventive Misconception in HIV Vaccine Clinical Trials |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | September 2010 |
| Actual Study Completion Date : | September 2010 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: No Supplemental Information
Participants will be administered a standard HIV vaccine trial consent form but no additional information.
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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).
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Behavioral: 1-sided messages
Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine). |
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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).
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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). |
- Knowledge about phase 3 HIV vaccine clinical trials, specifically, understanding of random assignment and the unproven efficacy of the vaccine. [ Time Frame: 7 months ]
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049139
| United States, California | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Louisiana | |
| Tulane University Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland Medical School | |
| Baltimore, Maryland, United States, 20723 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10128 | |
| Study Chair: | Gregory Zimet, Ph.D. | Adolescent Trials Network |
Additional Information:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01049139 History of Changes |
| Other Study ID Numbers: |
ATN 076 |
| First Posted: | January 14, 2010 Key Record Dates |
| Last Update Posted: | March 3, 2017 |
| Last Verified: | March 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
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vaccination HIV prevention YMSM youth HIV Preventative Vaccine |
Additional relevant MeSH terms:
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Vaccines HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Immunologic Factors Physiological Effects of Drugs |