NCT01605656

Brief Summary

The goal of this study is to better understand the factors that might prevent HIV-positive women from having routine pap smear screenings. Researchers also want to learn what might make it easier or encourage women to have these screenings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration 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

First Submitted

Initial submission to the registry

May 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

May 18, 2012

Last Update Submit

March 28, 2016

Conditions

Keywords

Cancer PreventionCervixQuestionnairesFocus groupsSurveysInterviews

Outcome Measures

Primary Outcomes (1)

  • HIV Positive Women's Perceived Barriers to Cervical Cancer Screening

    Participants rank Nominal Group Technique (NGT) items (cervical cancer screening barriers and strategies to improve screening) from 1-5 (1-least important: 5-most important). Once two coders have calculated rankings, the 5 items receiving the highest number of points will be deemed the 5 barriers to cervical cancer screening. Similarly, the 5 strategy-based items receiving highest number of points will be deemed essential strategies to improving cervical cancer screening at Thomas Street Health Center (TSHC).

    1 day

Study Arms (1)

Focus Groups + Interviews + Questionnaires

HIV-positive women recruited from the population of individuals seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).

Behavioral: Cognitive InterviewBehavioral: QuestionnairesBehavioral: Focus Groups

Interventions

A research staff member will use a questionnaire to ask about many different health and social topics. The cognitive interview should take up to 45 minutes to complete.

Focus Groups + Interviews + Questionnaires
QuestionnairesBEHAVIORAL

Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete. Phase II: Completion of 2 questionnaires. The first questionnaire will ask about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete. The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.

Also known as: Surveys
Focus Groups + Interviews + Questionnaires
Focus GroupsBEHAVIORAL

Phase I: There will be up to 8 women in each of the 5 focus groups. Participants asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. Participants also asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes.

Focus Groups + Interviews + Questionnaires

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-positive women seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).

You may qualify if:

  • English speaking
  • Patient receiving HIV/AIDS care at Thomas Street Health Center
  • Female
  • years of age or older
  • Able to provide written informed consent to participate

You may not qualify if:

  • \) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Street Health Center, Harris County Hospital District

Houston, Texas, 77009, United States

Location

Related Links

MeSH Terms

Interventions

Surveys and QuestionnairesFocus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Damon Vidrine, MS, DRPH, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 25, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations