Phase 3
N=2,031
HIV Testing & Womens Attitudes on HIV Vaccine Trials
HIV
Bottom Line
View on ClinicalTrials.gov: NCT00771537 ↗Enrolled (actual)
2,031
Serious AEs
—
Results posted
Jul 2013
Primary outcome: Primary: Number of Participants Who Accepted Rapid HIV Testing. — 458; 401; 410; 418 participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Message Sidedness (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Accepted Rapid HIV Testing. |
458; 401; 410; 418 | 0.05 |
| PRIMARY Willingness to Participate in a HIV Vaccine Clinical Trial |
2.46; 2.52; 2.55; 2.47 | <.60 |
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).
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
Data sourced from ClinicalTrials.gov (NCT00771537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.