Clinical trial NCT00771537: HIV Testing & Womens Attitudes on HIV Vaccine Trials
Official title: HIV Testing & Womens Attitudes on HIV Vaccine Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: HIV Testing
Persuasion
Health Communication
Clinical Trials Participation
Attitudes toward Health
Diagnostic Tests
Behavioral Research
Intervention Studies
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2008-10-13
Enrollment: 2031
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 opposition 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. There will therefore be 16 groups in total (4 X 4).

Detailed description: 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. This Aim will be evaluated via binary logistic regression. 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. This Aim will be evaluated via one-way Analysis of Variance. 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Accepted Rapid HIV Testing.
timeFrame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
measure: Willingness to Participate in a HIV Vaccine Clinical Trial
timeFrame: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Group Clinics
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burrage JW, Zimet GD, Cox DS, Cox AD, Mays RM, Fife RS, Fife KH. The Centers for Disease Control and Prevention revised recommendations for HIV testing: reactions of women attending community health clinics. J Assoc Nurses AIDS Care. 2008 Jan-Feb;19(1):66-74. doi: 10.1016/j.jana.2007.11.003.
citation: Kasting ML, Cox AD, Cox D, Fife KH, Katz BP, Zimet GD. The effects of HIV testing advocacy messages on test acceptance: a randomized clinical trial. BMC Med. 2014 Nov 6;12:204. doi: 10.1186/s12916-014-0204-4.