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

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ClinicalTrials.gov Identifier: NCT03033888
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Health-Literacy Focused Education Session Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-Based Cervical Cancer Prevention and Education Among Women Living With HIV
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
No Intervention: Control Group



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change scores for health literacy [ Time Frame: Baseline and 6 months ]
    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

  2. Change scores for cervical cancer knowledge [ Time Frame: Baseline and 6 months ]
    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

  3. Change scores for self-efficacy [ Time Frame: Baseline and 6 months ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033888


Contacts
Contact: Hae-Ra Han, PhD 410-614-2669 hhan3@jhu.edu

Locations
United States, Maryland
Johns Hopkins University School of Nursing Recruiting
Baltimore, Maryland, United States, 21205
Contact: Hae-Ra Han, PhD    410-614-2669    hhan3@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Hae-Ra Han, PhD Johns Hopkins University School of Nursing

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03033888     History of Changes
Other Study ID Numbers: IRB00060938
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female