Promoting Cervical Cancer Screening Through the Advocacy of Screened Women
Primary Purpose
Cervical Cancer Prevention
Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
WOMEN FIGHTING TO STOP CERVICAL CANCER
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer Prevention focused on measuring cervical cancer screening, prevention advocacy, group intervention, Uganda, social networks
Eligibility Criteria
Inclusion Criteria:
- age 18 years or older
- has been previously screened for cervical cancer
- has told at least one woman in her social network about her cervical cancer screening experience
Exclusion Criteria:
- unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)
Sites / Locations
- Buyinja HCIV
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
wait-list control
Arm Description
7-sesson group intervention that uses dyadic instruction, role playing and group sharing and discussion to reduce internalized stigma, improve disclosure decision making and healthy living, and teach advocacy skills
Participants will not receive the intervention until all follow-up data has been collected.
Outcomes
Primary Outcome Measures
Proportion of social network members who report cervical cancer screening
cervical cancer screening among women in social network
Secondary Outcome Measures
Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy
discussing cervical cancer and encouraging CC screening with women in social network
Full Information
NCT ID
NCT04960748
First Posted
June 25, 2021
Last Updated
April 25, 2022
Sponsor
RAND
Collaborators
Makerere University, Rays of Hope Hospice Jinja, African Palliative Care Association
1. Study Identification
Unique Protocol Identification Number
NCT04960748
Brief Title
Promoting Cervical Cancer Screening Through the Advocacy of Screened Women
Official Title
Pilot of a Network-driven, Advocacy Intervention to Promote Cervical Cancer Screening in Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Makerere University, Rays of Hope Hospice Jinja, African Palliative Care Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study pilots a 7-session group intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members.
Detailed Description
Cervical cancer (CC) is the most common cancer and accounts for ~25% of all cancer related deaths among women in Uganda, which has one of the highest incidence rates in the world. Adding to the burden is the general lack of knowledge about, and social stigma towards CC and its screening in Uganda, where lifetime CC screening is estimated to be as low as 5%. There is a dire need to increase CC screening in Uganda to ensure timely and lifesaving treatment, as well as the need to enhance the capacity to conduct behavioral and health services research related to CC and other stigmatizing conditions among local researchers and service providers. Accordingly, the proposed intervention pilot study seeks to (1) empower women who have been screened for CC, to advocate for CC screening and early treatment among women in their social networks, and (2) engage and train local public health researchers and programmers. The proposed intervention draws on theories of social diffusion, cognitive consistency, and social influence, and the investigator's recently developed and tested group intervention that mobilized people living with HIV in Uganda to successfully act as change agents for HIV prevention within their social networks. The intervention actively targets internalized stigma, disclosure decision making, healthy living, and advocacy communication skills. This study will pilot the intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members. The primary aims of the study are to assess the feasibility, acceptability and preliminary efficacy of the group intervention to promote CC screening and treatment; identify characteristics associated with successful advocacy; and increase local capacity for conducting public health research on CC control and use of social network-based intervention and measurement methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Prevention
Keywords
cervical cancer screening, prevention advocacy, group intervention, Uganda, social networks
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial of parallel groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
7-sesson group intervention that uses dyadic instruction, role playing and group sharing and discussion to reduce internalized stigma, improve disclosure decision making and healthy living, and teach advocacy skills
Arm Title
wait-list control
Arm Type
No Intervention
Arm Description
Participants will not receive the intervention until all follow-up data has been collected.
Intervention Type
Behavioral
Intervention Name(s)
WOMEN FIGHTING TO STOP CERVICAL CANCER
Intervention Description
The group intervention draws on theories of social diffusion, cognitive consistency, and social influence, and our own recently developed and tested group intervention that mobilized people living with HIV in Uganda to successfully act as change agents for HIV prevention within their social networks. The intervention actively targets internalized stigma, disclosure decision making, healthy living, and advocacy communication skills. The ultimate goal of the program is to encourage female social network members to get screened for cervical cancer.
Primary Outcome Measure Information:
Title
Proportion of social network members who report cervical cancer screening
Description
cervical cancer screening among women in social network
Time Frame
past 6 months
Secondary Outcome Measure Information:
Title
Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy
Description
discussing cervical cancer and encouraging CC screening with women in social network
Time Frame
past 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
persons with female sex organs
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18 years or older
has been previously screened for cervical cancer
has told at least one woman in her social network about her cervical cancer screening experience
Exclusion Criteria:
unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rhoda Wanyenze, MD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buyinja HCIV
City
Namayingo
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Promoting Cervical Cancer Screening Through the Advocacy of Screened Women
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