NCT00520117

Brief Summary

The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

August 22, 2007

Last Update Submit

September 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • psychological burden of women with abnormal pap-smear

    3 months

Study Arms (2)

negative pap-smear

positive pap-smear

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients having pap-smear at Ratchawithi Hospital

You may qualify if:

  • female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.

You may not qualify if:

  • has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
  • has other concurrent/active STD's
  • has a history of known prior vaccination with an HPV vaccine
  • has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Infectious Diseases Research Unit

Bangkok, 10400, Thailand

Location

Study Officials

  • Punnee Pitisuttithum, Professor

    Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations