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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Behavioral: Health-Literacy Focused Education Session

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Other: Intervention Group; 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.	Behavioral: Health-Literacy Focused Education Session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 6 months
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	Baseline and 6 months
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	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Hae-Ra Han, PhD, Johns Hopkins University School of Nursing

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: IRB00060938; P30AI094189 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO