HIV Testing & Womens Attitudes on HIV Vaccine Trials

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier:
NCT00771537
First received: October 10, 2008
Last updated: June 28, 2013
Last verified: June 2013
  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 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).


Condition Intervention Phase
HIV
Behavioral: Message Sidedness
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: HIV Testing & Womens Attitudes on HIV Vaccine Trials

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Number of Participants Who Accepted Rapid HIV Testing. [ Time Frame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed. ] [ Designated as safety issue: No ]
    Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.

  • Willingness to Participate in a HIV Vaccine Clinical Trial [ Time Frame: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire. ] [ Designated as safety issue: No ]
    Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).


Enrollment: 2031
Study Start Date: November 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1. Control PLUS Control
Experimental: Arm 2. Control PLUS 1-Sided
No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 3. Control PLUS 2-Sided Trivial
No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 4. Control PLUS 2-Sided Major
No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 5. 1-Sided PLUS Control
1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 6. 1-Sided PLUS 1-Sided
1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 7. 1-Sided PLUS 2-Sided Trivial
1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Aim 8. 1-Sided PLUS 2-Sided Major
1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 9. 2-Sided Trivial PLUS Control
2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 10. 2-Sided Trivial PLUS 1-Sided
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 12. 2-Sided Trivial PLUS 2-Sided Major
2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 13. 2-Sided Major PLUS Control
2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 14. 2-Sided Major PLUS 1-Sided
2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 15. 2-Sided Major PLUS 2-Sided Trivial
2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Experimental: Arm 16. 2-Sided Major PLUS 2-Sided Major
2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Behavioral: Message Sidedness
There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771537

Locations
United States, Indiana
Indiana University Medical Group Clinics
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Gregory D Zimet, PhD Indiana University
  More Information

Publications:
Responsible Party: Gregory Zimet, Professor, Indiana University
ClinicalTrials.gov Identifier: NCT00771537     History of Changes
Other Study ID Numbers: 0601-09, R01NR010004
Study First Received: October 10, 2008
Results First Received: April 7, 2013
Last Updated: June 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Indiana University:
HIV Testing
Persuasion
Health Communication
Clinical Trials Participation
Attitudes toward Health
Diagnostic Tests
Behavioral Research
Intervention Studies

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 28, 2014