HIV Testing & Womens Attitudes on HIV Vaccine Trials

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Indiana University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00771537
First received: October 10, 2008
Last updated: January 25, 2011
Last verified: January 2011
  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.


Condition Intervention Phase
HIV Infections
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:
  • Acceptance of rapid HIV testing [ Time Frame: During study visit ] [ Designated as safety issue: No ]
  • Willingness to Participate in a HIV Vaccine Clinical Trial [ Time Frame: During Study Visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 2581
Study Start Date: November 2006
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
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.
Experimental: 2
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.
Experimental: 3
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.
Experimental: 4
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.
No Intervention: 5
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.
Experimental: 6
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.
Experimental: 7
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.
Experimental: 8
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.

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. 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.

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

Contacts
Contact: Jane French 317-630-6348 jaafrenc@iupui.edu

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

Publications:
Responsible Party: Gregory D. Zimet, Indiana University
ClinicalTrials.gov Identifier: NCT00771537     History of Changes
Other Study ID Numbers: 0601-09, R01NR010004
Study First Received: October 10, 2008
Last Updated: January 25, 2011
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 Infections
Acquired Immunodeficiency Syndrome
HIV Antibodies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013