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Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV (CHECC-uP)

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health-Literacy Focused Education Session
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Intervention includes: Trained community health workers will deliver 1) 1.5-2 hour health literacy training offered in a group format at an approved community site that is most convenient to the majority of participants ; and 2) monthly phone follow-up and navigation assistance for 6 months. We will offer a Human Papilloma Virus (HPV) mobile app for participant's adolescent/young adult child (11-26 yrs), as an option rather than part of the standardized protocol. The app will be introduced at the end of the health literacy group training session for the intervention group; those who choose to download the app will be given a link with study specific password. They will be encouraged to go through the key HPV related contents with their children at home at a time that is most convenient for them.

Outcomes

Primary Outcome Measures

Completion of Pap test (medical records)
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 Outcome Measures

Change scores for health literacy
Health Literacy scores will be measured using Assessment of Health Literacy-Cancer, a cervical cancer specific instrument with 52 items. Scores on the scale range from 0-52 with a score > 26 signifying a high health literacy score and scores <26 signifying low health literacy score. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
Change scores for cervical cancer knowledge
Cervical cancer knowledge will be measured with the Cervical Cancer Knowledge Test, a 22- item which measures knowledge of cervical cancer using a binary (true/false) scale. Higher scores indicate higher cervical cancer knowledge. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
Change scores for self-efficacy
Self-efficacy will be measured with the Self Efficacy Scale, a 4- item instrument which measures how confident a woman is in carrying out tasks in relation to Pap testing. Higher scores indicate higher self-efficacy. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05

Full Information

First Posted
January 25, 2017
Last Updated
June 16, 2020
Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03033888
Brief Title
Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Acronym
CHECC-uP
Official Title
Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Other
Arm Description
Intervention includes: Trained community health workers will deliver 1) 1.5-2 hour health literacy training offered in a group format at an approved community site that is most convenient to the majority of participants ; and 2) monthly phone follow-up and navigation assistance for 6 months. We will offer a Human Papilloma Virus (HPV) mobile app for participant's adolescent/young adult child (11-26 yrs), as an option rather than part of the standardized protocol. The app will be introduced at the end of the health literacy group training session for the intervention group; those who choose to download the app will be given a link with study specific password. They will be encouraged to go through the key HPV related contents with their children at home at a time that is most convenient for them.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health-Literacy Focused Education Session
Primary Outcome Measure Information:
Title
Completion of Pap test (medical records)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change scores for health literacy
Description
Health Literacy scores will be measured using Assessment of Health Literacy-Cancer, a cervical cancer specific instrument with 52 items. Scores on the scale range from 0-52 with a score > 26 signifying a high health literacy score and scores <26 signifying low health literacy score. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
Time Frame
Baseline and 6 months
Title
Change scores for cervical cancer knowledge
Description
Cervical cancer knowledge will be measured with the Cervical Cancer Knowledge Test, a 22- item which measures knowledge of cervical cancer using a binary (true/false) scale. Higher scores indicate higher cervical cancer knowledge. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
Time Frame
Baseline and 6 months
Title
Change scores for self-efficacy
Description
Self-efficacy will be measured with the Self Efficacy Scale, a 4- item instrument which measures how confident a woman is in carrying out tasks in relation to Pap testing. Higher scores indicate higher self-efficacy. The rationale for using change scores is to account for differences in baseline performance for study participants, and to focus on improvement in scores after intervention. Differences in change scores between groups will be tested using a one-sided, two-group test of means with p=0.05
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae-Ra Han, PhD
Organizational Affiliation
Johns Hopkins University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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