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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06365450
Other study ID # IRB00315481
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2022
Est. completion date April 5, 2024

Study information

Verified date April 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference.


Description:

The aims of this study are to: 1. develop educational materials on breast and cervical cancer screening; 2. administer the intervention using a PowerPoint presentation; 3. evaluate changes in breast and cervical cancer literacy levels after the intervention; and 4. assess participants'; satisfaction with the program


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 5, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - able to read and write in English - self-identify as HIV positive - - Black/African American. Exclusion Criteria: - Acutely ill

Study Design


Intervention

Other:
Educational Intervention
Participants will receive hybrid educational intervention on breast and cervical cancer

Locations

Country Name City State
United States Johns Hopkins University School of Nursing Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Older Women Embracing Life, The John G. Bartlett Specialty Practice

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool. The dimensions of health literacy adapted from the AHL-C tool are:
Numeracy (2 items)
Familiarity (9 items)
Comprehension (1 item)
Navigation (7 items).
To determine health literacy scores of participants, each item will be scored on a scale of 0 to 1. A higher score would mean a better outcome. Items will be summed for each of the four sub-scales as well as the entire scale (AHL-C) and then determine the mean and standard deviation.
Assessment will be completed immediately post intervention (after two sessions on breast and cervical cancer)
Immediately Post intervention
Secondary Number of participants recruited from each community partner Participants recruited from each community partner Immediately Post intervention
Secondary Number of participants who preferred virtual or in person sessions Participant session attendance preference Immediately Post intervention
Secondary Number of participants who were lost of follow up Participants lost to follow up Immediately post intervention
Secondary Number of participants who needed help redeeming their gift codes Participants needing help redeeming gift cards Immediately post intervention
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