Trial Outcomes & Findings for Intervention to Improve Follow-up of Abnormal Pap Test (NCT NCT00575510)
NCT ID: NCT00575510
Last Updated: 2018-08-23
Results Overview
Attendance at initial appointment to follow-up abnormal Pap test result
COMPLETED
NA
341 participants
adherence rates at initial follow-up appointment, 2 weeks to 3 months
2018-08-23
Participant Flow
Face-to-face recruitment of women 18-55 years of age occurred in 6 University of Texas Medical Branch (UTMB) Regional and Maternal Child Health Program clinics from June 1, 2006-November 30, 2010. Recruitment was interrupted for a period ranging from 2 weeks to 6 months in several clinic sites due to landfall of hurricane Ike on September 13, 2008.
6,179 women were eligible during the recruitment period. Of these, 876 declined participation, 4,671 had a normal Pap test result, 254 did not have a Pap test performed at their clinic visit, and 378 had an abnormal Pap test result and could be randomized. Of these, 90% (341/378)were randomized into the 3-arm trial.
Participant milestones
| Measure |
Intervention
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Active Control
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Standard Care Only
Clinical standard of care at time of study
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
114
|
113
|
|
Overall Study
COMPLETED
|
102
|
101
|
96
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
17
|
Reasons for withdrawal
| Measure |
Intervention
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Active Control
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Standard Care Only
Clinical standard of care at time of study
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Clinic Called Patient
|
7
|
7
|
7
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
Intervention to Improve Follow-up of Abnormal Pap Test
Baseline characteristics by cohort
| Measure |
Intervention
n=114 Participants
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Active Control
n=114 Participants
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Standard Care Only
n=113 Participants
Clinical standard of care at time of study
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 7 • n=5 Participants
|
28 years
STANDARD_DEVIATION 8 • n=7 Participants
|
29 years
STANDARD_DEVIATION 8 • n=5 Participants
|
28 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
341 Participants
n=4 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
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
114 participants
n=7 Participants
|
113 participants
n=5 Participants
|
341 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: adherence rates at initial follow-up appointment, 2 weeks to 3 monthsAttendance at initial appointment to follow-up abnormal Pap test result
Outcome measures
| Measure |
Intervention
n=102 Participants
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Intervention: Multiple component intervention based in the unified theory of behavior
|
Active Control
n=101 Participants
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active control: Partial intervention (full intervention minus cultural-specific component)
|
Standard Care Only
n=96 Participants
Clinical standard of care at time of study
|
|---|---|---|---|
|
Adherence to Initial Follow-up (Yes/no)
|
60 percentage of patients who were adherent
|
54 percentage of patients who were adherent
|
58 percentage of patients who were adherent
|
SECONDARY outcome
Timeframe: + 7-30 days post-interventionPopulation: Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.
State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
Outcome measures
| Measure |
Intervention
n=77 Participants
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Intervention: Multiple component intervention based in the unified theory of behavior
|
Active Control
n=76 Participants
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active control: Partial intervention (full intervention minus cultural-specific component)
|
Standard Care Only
n=74 Participants
Clinical standard of care at time of study
|
|---|---|---|---|
|
State Trait Anxiety Inventory (STAI)-State Scale
|
12 units on a scale
Standard Deviation 5
|
11 units on a scale
Standard Deviation 4
|
11 units on a scale
Standard Deviation 4
|
Adverse Events
Intervention
Active Control
Standard Care Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place