NCT06365450

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

April 10, 2024

Last Update Submit

April 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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: 1. Numeracy (2 items) 2. Familiarity (9 items) 3. Comprehension (1 item) 4. 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 Outcomes (4)

  • Number of participants recruited from each community partner

    Immediately Post intervention

  • Number of participants who preferred virtual or in person sessions

    Immediately Post intervention

  • Number of participants who were lost of follow up

    Immediately post intervention

  • Number of participants who needed help redeeming their gift codes

    Immediately post intervention

Study Arms (1)

Educational Single-group

EXPERIMENTAL

1 educational session on cervical cancer and one educational session on breast cancer

Other: Educational Intervention

Interventions

Participants will receive hybrid educational intervention on breast and cervical cancer

Educational Single-group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • able to read and write in English
  • self-identify as HIV positive -
  • Black/African American.

You may not qualify if:

  • Acutely ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsBreast NeoplasmsHealth Behavior

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Hae-Ra Han, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 15, 2024

Study Start

September 22, 2022

Primary Completion

February 28, 2024

Study Completion

April 5, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations