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HIV Testing & Womens Attitudes on HIV Vaccine Trials

HIV Testing & Womens Attitudes on HIV Vaccine Trials

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00771537
Enrollment
2031
Registered
2008-10-13
Start date
2006-11-30
Completion date
2011-01-31
Last updated
2013-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Nursing Research (NINR)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
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 TrialApproximately 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

ArmCount
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
Total2,031

Baseline characteristics

CharacteristicHIV TEST MSG Control/ VACCINE TRIAL MSG 1-SidedHIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided TrivialHIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided MajorHIV TEST MSG 1-Sided/ VACCINE TRIAL MSG ControlHIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-SidedHIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided TrivialHIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided MajorHIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG ControlHIV TEST MSG Control/ VACCINE TRIAL MSG ControlHIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-SidedHIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided TriviaHIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided MajorHIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG ControlHIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-SidedHIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided TrivialHIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided MajorTotal
Age, Categorical
<=18 years
1 Participants0 Participants0 Participants1 Participants1 Participants1 Participants2 Participants1 Participants0 Participants0 Participants1 Participants2 Participants0 Participants0 Participants0 Participants0 Participants10 Participants
Age, Categorical
>=65 years
8 Participants14 Participants10 Participants7 Participants6 Participants6 Participants6 Participants3 Participants9 Participants7 Participants6 Participants7 Participants10 Participants4 Participants6 Participants3 Participants112 Participants
Age, Categorical
Between 18 and 65 years
115 Participants137 Participants104 Participants119 Participants111 Participants121 Participants124 Participants111 Participants126 Participants112 Participants126 Participants128 Participants118 Participants120 Participants118 Participants119 Participants1909 Participants
Age Continuous44 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 participants151 participants114 participants127 participants118 participants128 participants132 participants115 participants135 participants119 participants133 participants137 participants128 participants124 participants124 participants122 participants2031 participants
Sex: Female, Male
Female
124 Participants151 Participants114 Participants127 Participants118 Participants128 Participants132 Participants115 Participants135 Participants119 Participants133 Participants137 Participants128 Participants124 Participants124 Participants122 Participants2031 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
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 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)
ControlNumber of Participants Who Accepted Rapid HIV Testing.458 participants
1-SidedNumber of Participants Who Accepted Rapid HIV Testing.401 participants
2-Sided TrivialNumber of Participants Who Accepted Rapid HIV Testing.410 participants
2-Sided MajorNumber of Participants Who Accepted Rapid HIV Testing.418 participants
p-value: 0.0595% CI: [0.5, 0.96]Regression, Logistic
p-value: 0.195% CI: [0.54, 1.04]Regression, Logistic
p-value: 0.6395% CI: [0.65, 1.3]Regression, Logistic
Primary

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.

ArmMeasureValue (MEAN)Dispersion
ControlWillingness to Participate in a HIV Vaccine Clinical Trial2.46 units on a scaleStandard Deviation 1.15
1-SidedWillingness to Participate in a HIV Vaccine Clinical Trial2.52 units on a scaleStandard Deviation 1.18
2-Sided TrivialWillingness to Participate in a HIV Vaccine Clinical Trial2.55 units on a scaleStandard Deviation 1.18
2-Sided MajorWillingness to Participate in a HIV Vaccine Clinical Trial2.47 units on a scaleStandard Deviation 1.12
Comparison: One-way Analysis of Variancep-value: <0.695% CI: [2.42, 2.56]ANOVA
Comparison: One-Way Analysis of Variancep-value: <0.2595% CI: [2.44, 2.58]ANOVA
Comparison: One-Way Analysis of Variancep-value: <0.9195% CI: [2.4, 2.54]ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026