Trial Outcomes & Findings for HIV Testing & Womens Attitudes on HIV Vaccine Trials (NCT NCT00771537)

Last Updated: 2013-07-09

Results Overview

Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2031 participants

Primary outcome timeframe

During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.

Results posted on

2013-07-09

Participant Flow

Message intervention details are in the Brief Summary

Participant milestones

Participant milestones
Measure	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.	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.	HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	135	124	151	114	127	118	128	132	115	119	133	137	128	124	124	122
Overall Study COMPLETED	135	124	151	114	127	118	128	132	115	119	133	137	128	124	124	122
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Testing & Womens Attitudes on HIV Vaccine Trials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV TEST MSG Control/ VACCINE TRIAL MSG Control n=135 Participants No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided n=124 Participants No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial n=151 Participants No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major n=114 Participants No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control n=127 Participants 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided n=118 Participants 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial n=128 Participants 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major n=132 Participants 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control n=115 Participants 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided n=119 Participants 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia n=133 Participants 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major n=137 Participants 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control n=128 Participants 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided n=124 Participants 2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial n=124 Participants 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.	HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major n=122 Participants 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.	Total n=2031 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	2 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	10 Participants n=136 Participants
Age, Categorical Between 18 and 65 years	126 Participants n=5 Participants	115 Participants n=7 Participants	137 Participants n=5 Participants	104 Participants n=4 Participants	119 Participants n=21 Participants	111 Participants n=10 Participants	121 Participants n=115 Participants	124 Participants n=6 Participants	111 Participants n=6 Participants	112 Participants n=64 Participants	126 Participants n=17 Participants	128 Participants n=21 Participants	118 Participants n=22 Participants	120 Participants n=8 Participants	118 Participants n=16 Participants	119 Participants n=135 Participants	1909 Participants n=136 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	7 Participants n=64 Participants	6 Participants n=17 Participants	7 Participants n=21 Participants	10 Participants n=22 Participants	4 Participants n=8 Participants	6 Participants n=16 Participants	3 Participants n=135 Participants	112 Participants n=136 Participants
Age Continuous	42 years STANDARD_DEVIATION 14 • n=5 Participants	44 years STANDARD_DEVIATION 14 • n=7 Participants	47 years STANDARD_DEVIATION 13 • n=5 Participants	45 years STANDARD_DEVIATION 15 • n=4 Participants	44 years STANDARD_DEVIATION 13 • n=21 Participants	44 years STANDARD_DEVIATION 12 • n=10 Participants	44 years STANDARD_DEVIATION 14 • n=115 Participants	45 years STANDARD_DEVIATION 14 • n=6 Participants	42 years STANDARD_DEVIATION 13 • n=6 Participants	44 years STANDARD_DEVIATION 13 • n=64 Participants	44 years STANDARD_DEVIATION 13 • n=17 Participants	43 years STANDARD_DEVIATION 13 • n=21 Participants	46 years STANDARD_DEVIATION 13 • n=22 Participants	44 years STANDARD_DEVIATION 13 • n=8 Participants	44 years STANDARD_DEVIATION 12 • n=16 Participants	42 years STANDARD_DEVIATION 13 • n=135 Participants	44 years STANDARD_DEVIATION 13 • n=136 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	124 Participants n=7 Participants	151 Participants n=5 Participants	114 Participants n=4 Participants	127 Participants n=21 Participants	118 Participants n=10 Participants	128 Participants n=115 Participants	132 Participants n=6 Participants	115 Participants n=6 Participants	119 Participants n=64 Participants	133 Participants n=17 Participants	137 Participants n=21 Participants	128 Participants n=22 Participants	124 Participants n=8 Participants	124 Participants n=16 Participants	122 Participants n=135 Participants	2031 Participants n=136 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants
Region of Enrollment United States	135 participants n=5 Participants	124 participants n=7 Participants	151 participants n=5 Participants	114 participants n=4 Participants	127 participants n=21 Participants	118 participants n=10 Participants	128 participants n=115 Participants	132 participants n=6 Participants	115 participants n=6 Participants	119 participants n=64 Participants	133 participants n=17 Participants	137 participants n=21 Participants	128 participants n=22 Participants	124 participants n=8 Participants	124 participants n=16 Participants	122 participants n=135 Participants	2031 participants n=136 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=524 Participants No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	1-Sided n=505 Participants 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	2-Sided Trivial n=504 Participants 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.	2-Sided Major n=498 Participants 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
Number of Participants Who Accepted Rapid HIV Testing.	458 participants	401 participants	410 participants	418 participants

PRIMARY outcome

Timeframe: 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.

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).