Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Indiana University National Institutes of Health (NIH) National Institute of Nursing Research (NINR) |
---|---|
Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00771537 |
The purpose of this study is to test the effects of different persuasive informational messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited. Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger oppostion to testing, then refutes the opposition. Women will be offered HIV testing, then re-randomized to a similar set of 4 messages related to HIV vaccine trials.
Condition | Intervention | Phase |
---|---|---|
HIV |
Behavioral: Message Sidedness |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | HIV Testing & Womens Attitudes on HIV Vaccine Trials |
Estimated Enrollment: | 2581 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention
No message intervention control condition regarding HIV testing.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
2: Experimental
1-sided message emphasizing advantages of HIV testing
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
3: Experimental
2-sided trivial message about HIV testing.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
4: Experimental
2-sided substantive message about HIV testing.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
5: No Intervention
No message control condition regarding willingness to participate in a HIV vaccine clinical trial.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
6: Experimental
1-sided message regarding willingness to participate in a HIV vaccine clinical trial
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
7: Experimental
2-sided trivial message regarding willingness to participate in a HIV vaccine clinical trial.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
8: Experimental
2-sided substantive message regarding willingness to participate in a HIV vaccine clinical trial.
|
Behavioral: Message Sidedness
Informational messages that vary on the basis of message sidedness. Arm 1 is a no message control condition regarding HIV testing. Arm 2 is an experimental condition with a 1-sided message about HIV testing. Arm 3 is an experimental condition with a trivial 2-sided message about HIV testing. Arm 4 is an experimental condition with a substantive 2-sided message about HIV testing. Arm 5 is a no message control condition regarding HIV vaccine clinical trial participation. Arm 6 is an experimental condition with a 1-sided message about HIV vaccine clinical trial participation. Arm 7 is an experimental condition with a trivial 2-sided message about HIV vaccine clinical trial participation. Arm 8 is an experimental condition with a substantive 2-sided message about HIV vaccine clinical trial participation.
|
This 5-year proposal responds to PAS-03-168, "Enrolling Women and Minorities in HIV/AIDS Research Trials." This study seeks to evaluate persuasive message interventions to increase HIV testing rates and improve acceptability of participation in a phase 3 HIV vaccine clinical trial among African-American, Latina, and White women. We plan to evaluate 1-sided messages, which mention only the benefits of an action, versus 2-sided messages, which mention negative aspects of the action, followed by positive counterarguments. The Health Belief Model, Inoculation and Attribution Theories will guide the research. Participants will be women attending urban community health clinics in Indianapolis, IN. Specific Aim 1 is to identify obstacles to HIV testing and to participation in a HIV vaccine clinical trial. This aim will be accomplished in years 1 and 2 through individual semi-structured interviews. We will analyze data via thematic content analysis and will use interview findings to assist in the development of measures and interventions employed in the intervention phase (years 3-5). Specific Aim 2 is to evaluate the effects of 2-sided versus 1-sided persuasive messages on rates of acceptance of rapid HIV testing. Demographic, behavioral, and attitudinal measures will be administered via audio computer-assisted self-interview (A-CASI). Participants will be randomized to the intervention groups via A-CASI as well. The outcome will be acceptance/rejection of free rapid HIV testing. Specific Aim 3 is to evaluate the effects of 2-sided versus 1-sided messages on willingness to participate in phase 3 clinical trials for a preventive HIV vaccine. Participants will complete this 2nd A-CASI survey and will again be randomized to intervention groups. The outcome will be a scale measuring acceptability of clinical trial participation. The order of presentation of the 2 A-CASI surveys and interventions will be counter-balanced such that half of the participants are randomly selected to receive the HIV testing component first and half are randomly selected to receive the HIV vaccine trial component first. We will analyze data via multiple linear and logistic regression modeling and with structural equation modeling. This study is relevant to public health in that the results may help us to understand how to improve enrollment of women and minorities into preventive HIV vaccine clinical trials and how to encourage women and minorities to get tested for HIV.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jane French | 317-630-6348 | jaafrenc@iupui.edu |
United States, Indiana | |
Indiana University Medical Group Clinics | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Gregory D. Zimet, PhD |
Principal Investigator: | Gregory D Zimet, PhD | Indiana University |
Responsible Party: | Indiana University ( Gregory D. Zimet ) |
Study ID Numbers: | R01NR010004, R01NR010004 |
Study First Received: | October 10, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00771537 |
Health Authority: | United States: Federal Government |
HIV Testing Persuasion Health Communication Clinical Trials Participation |
Attitudes toward Health Diagnostic Tests Behavioral Research Intervention Studies |
Antibodies HIV Antibodies HIV Infections Acquired Immunodeficiency Syndrome Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |