HIV
Conditions
Keywords
HIV Testing, Persuasion, Health Communication, Clinical Trials Participation, Attitudes toward Health, Diagnostic Tests, Behavioral Research, Intervention Studies
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Accepted Rapid HIV Testing. | During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed. | 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 | Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire. | 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). |
Countries
United States
Participant flow
Pre-assignment details
Message intervention details are in the Brief Summary
Participants by arm
| Arm | Count |
|---|---|
| HIV TEST MSG Control/ VACCINE TRIAL MSG Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. | 135 |
| HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. | 124 |
| HIV TEST MSG Control/ VACCINE TRIAL MSG 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. | 151 |
| HIV TEST MSG Control/ VACCINE TRIAL MSG 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. | 114 |
| HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. | 127 |
| HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation. | 118 |
| HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 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. | 128 |
| HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 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. | 132 |
| HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. | 115 |
| HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 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. | 119 |
| HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation. | 133 |
| HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 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. | 137 |
| HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation. | 128 |
| HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 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. | 124 |
| HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 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. | 124 |
| HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 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. | 122 |
| Total | 2,031 |
Baseline characteristics
| Characteristic | HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided | HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial | HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major | HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control | HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided | HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial | HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major | HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control | HIV TEST MSG Control/ VACCINE TRIAL MSG Control | HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided | HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia | HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major | HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control | HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided | HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial | HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Age, Categorical >=65 years | 8 Participants | 14 Participants | 10 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 9 Participants | 7 Participants | 6 Participants | 7 Participants | 10 Participants | 4 Participants | 6 Participants | 3 Participants | 112 Participants |
| Age, Categorical Between 18 and 65 years | 115 Participants | 137 Participants | 104 Participants | 119 Participants | 111 Participants | 121 Participants | 124 Participants | 111 Participants | 126 Participants | 112 Participants | 126 Participants | 128 Participants | 118 Participants | 120 Participants | 118 Participants | 119 Participants | 1909 Participants |
| Age Continuous | 44 years STANDARD_DEVIATION 14 | 47 years STANDARD_DEVIATION 13 | 45 years STANDARD_DEVIATION 15 | 44 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 12 | 44 years STANDARD_DEVIATION 14 | 45 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 14 | 44 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 | 43 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 12 | 42 years STANDARD_DEVIATION 13 | 44 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 124 participants | 151 participants | 114 participants | 127 participants | 118 participants | 128 participants | 132 participants | 115 participants | 135 participants | 119 participants | 133 participants | 137 participants | 128 participants | 124 participants | 124 participants | 122 participants | 2031 participants |
| Sex: Female, Male Female | 124 Participants | 151 Participants | 114 Participants | 127 Participants | 118 Participants | 128 Participants | 132 Participants | 115 Participants | 135 Participants | 119 Participants | 133 Participants | 137 Participants | 128 Participants | 124 Participants | 124 Participants | 122 Participants | 2031 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Participants Who Accepted Rapid HIV Testing. | 458 participants |
| 1-Sided | Number of Participants Who Accepted Rapid HIV Testing. | 401 participants |
| 2-Sided Trivial | Number of Participants Who Accepted Rapid HIV Testing. | 410 participants |
| 2-Sided Major | Number of Participants Who Accepted Rapid HIV Testing. | 418 participants |
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).
Time frame: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.
Population: Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Willingness to Participate in a HIV Vaccine Clinical Trial | 2.46 units on a scale | Standard Deviation 1.15 |
| 1-Sided | Willingness to Participate in a HIV Vaccine Clinical Trial | 2.52 units on a scale | Standard Deviation 1.18 |
| 2-Sided Trivial | Willingness to Participate in a HIV Vaccine Clinical Trial | 2.55 units on a scale | Standard Deviation 1.18 |
| 2-Sided Major | Willingness to Participate in a HIV Vaccine Clinical Trial | 2.47 units on a scale | Standard Deviation 1.12 |