View Clinical Trial (Medical Research Study)
HIV Testing & Womens Attitudes on HIV Vaccine Trials
| City: |
|
Indianapolis |
| State: |
|
Indiana |
| Zip Code: |
|
46202 |
| Conditions: |
|
HIV Infections |
| Purpose: |
|
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.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
Inclusion Criteria:
- Female
- 18 years of age or older
- Able to understand English or Spanish
- Able to give informed consent
Exclusion Criteria:
- Not female
- Under 18 years of age
- Not able to understand English and Spanish
- Unable to give informed consent
|
| NCT ID: |
|
NCT00771537 |
| Primary Contact: |
|
Principal Investigator
Gregory D Zimet, PhD
Indiana University
Jane French
Phone: 317-630-6348
Email: jaafrenc@iupui.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Indianapolis, Indiana 46202
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|