HIV Testing & Womens Attitudes on HIV Vaccine Trials
2 other identifiers
interventional
2,031
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv
Started Nov 2006
Typical duration for phase_3 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
July 9, 2013
CompletedJuly 9, 2013
June 1, 2013
4.2 years
October 10, 2008
April 7, 2013
June 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Accepted Rapid HIV Testing.
Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.
During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
Willingness to Participate in a HIV Vaccine Clinical Trial
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).
Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
Study Arms (16)
Arm 1. Control PLUS Control
NO INTERVENTIONArm 2. Control PLUS 1-Sided
EXPERIMENTALNo message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 3. Control PLUS 2-Sided Trivial
EXPERIMENTALNo message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
Arm 4. Control PLUS 2-Sided Major
EXPERIMENTALNo message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
Arm 5. 1-Sided PLUS Control
EXPERIMENTAL1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Arm 6. 1-Sided PLUS 1-Sided
EXPERIMENTAL1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 7. 1-Sided PLUS 2-Sided Trivial
EXPERIMENTAL1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Aim 8. 1-Sided PLUS 2-Sided Major
EXPERIMENTAL1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 9. 2-Sided Trivial PLUS Control
EXPERIMENTAL2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Arm 10. 2-Sided Trivial PLUS 1-Sided
EXPERIMENTAL2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 11. 2-Sided Trivial PLUS 2-Sided Trivial
EXPERIMENTAL2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 12. 2-Sided Trivial PLUS 2-Sided Major
EXPERIMENTAL2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 13. 2-Sided Major PLUS Control
EXPERIMENTAL2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Arm 14. 2-Sided Major PLUS 1-Sided
EXPERIMENTAL2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 15. 2-Sided Major PLUS 2-Sided Trivial
EXPERIMENTAL2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
Arm 16. 2-Sided Major PLUS 2-Sided Major
EXPERIMENTAL2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female
- years of age or older
- Able to understand English or Spanish
- Able to give informed consent
You may not qualify if:
- Not female
- Under 18 years of age
- Not able to understand English and Spanish
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institutes of Health (NIH)collaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Indiana University Medical Group Clinics
Indianapolis, Indiana, 46202, United States
Related Publications (2)
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.
PMID: 18191770RESULTKasting 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.
PMID: 25374047DERIVED
Results Point of Contact
- Title
- Gregory D Zimet
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Zimet, PhD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
November 1, 2006
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
July 9, 2013
Results First Posted
July 9, 2013
Record last verified: 2013-06