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Clinical Trials/NCT03033888
NCT03033888
Completed
Not Applicable

Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV

Johns Hopkins University1 site in 1 country123 target enrollmentApril 2016
ConditionsCervical Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Johns Hopkins University
Enrollment
123
Locations
1
Primary Endpoint
Completion of Pap test (medical records)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The long-term goal is to build a sustainable, community-based outreach program to promote cervical cancer screening among women living with HIV (WLH), thereby reducing related morbidity and mortality. The strategy for achieving this goal is to develop an intervention incorporating health literacy approaches and principles of community-based participatory research. Health literacy is a relatively new concept that has been applied mainly toward identifying high-risk individuals rather than toward changing health behaviors and outcomes. The proposed intervention is the first to integrate health literacy into educating WLH to promote cervical cancer screening. Community Health Workers (CHW) support has also rarely been incorporated into cancer screening interventions targeting WLH, making the proposed intervention a uniquely comprehensive approach. Building on recent successful testing by the investigators of a health literacy-focused intervention to promote cervical cancer screening in recent immigrant women, the investigators will test whether health literacy-focused interventions delivered by trained CHWs will be effective in promoting health literacy and increasing Pap test rates in a new population, WLH. The investigators hypothesize that, compared to WLH in the control group, WLH who receive the health literacy-focused CHW intervention will demonstrate: (1) higher rates of Pap test, (2) greater levels of health literacy, (3) higher levels of cervical cancer knowledge, and (4) higher self-efficacy.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • HIV infection Able to read and write English 12+ months since Pap test Willing to provide written consent to allow the team to audit medical records for Pap test use

Exclusion Criteria

  • Had undergone a hysterectomy Pregnant

Outcomes

Primary Outcomes

Completion of Pap test (medical records)

Time Frame: 6 months

Participants medical records will be audited to verify completion of a Pap test within 6 months of completing baseline survey. The measure of completion of Pap testing by 6 months after baseline visit will be tested using a one-sided, two-group test of proportions set at an alpha of 0.05. Known covariates of Pap test screening (e.g., age, education, insurance, and provider recommendation) will be controlled in the analyses.

Secondary Outcomes

  • Change scores for cervical cancer knowledge(Baseline and 6 months)
  • Change scores for self-efficacy(Baseline and 6 months)
  • Change scores for health literacy(Baseline and 6 months)

Study Sites (1)

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