Game Changers for Cervical Cancer Prevention (GC-CCP)
Primary Purpose
Cervical Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Game Changers for Cervical Cancer Prevention
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria: screened for cervical cancer in the past year (index participants only) is a member of social network of enrolled index participant (social network member participants only) Exclusion Criteria: advanced stage cervical cancer (index participants only) screened for cervical cancer in the past (social network member participants only)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Wait-list control
Arm Description
7 weekly group sessions of advocacy training for cervical cancer screening
usual care (no intervention); control participants will be offered the chance to receive the intervention at the conclusion of month 12 follow-up data collection
Outcomes
Primary Outcome Measures
cervical cancer screening
screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
Secondary Outcome Measures
cervical cancer prevention advocacy
6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants
Full Information
NCT ID
NCT06010160
First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
RAND
Collaborators
Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington
1. Study Identification
Unique Protocol Identification Number
NCT06010160
Brief Title
Game Changers for Cervical Cancer Prevention
Acronym
GC-CCP
Official Title
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2024 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention (GC-CCP) for increasing cervical cancer (CC) screening advocacy among intervention recipients (index participants) towards female social network members, and uptake of CC screening among enrolled female social network members (alter participants) who have not previously been screened. The main research questions are:
Is the GC-CCP network-based peer advocacy intervention superior to usual care (no intervention) in improving uptake of CC screening among alter participants, across urban/rural and public/private clinics?
What are the mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention advocacy among index participants?
Detailed Description
This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention (GC-CCP) for increasing cervical cancer (CC) screening among previously unscreened social network members. The trial will be conducted at 4 study clinics [2 public, 2 private-not-for-profit (PNFP), one each in an urban and rural location]. At each clinic, 40 women screened for CC in the past year will be enrolled in the RCT as index participants (n=160 index) and randomized to the intervention (in two groups of 10) or wait-list control. The intervention will consist of 7 weekly group sessions that focus on CC stigma reduction, sharing of CC screening experience with others, knowledge of CC facts and myths, and skills building for engagement in CC prevention advocacy with female social network members (alters). Each index will recruit up to three alters (n~440 alters) at baseline who have not screened for CC; these index and alter participants will be followed up at months 6 and 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
Masking
Outcomes Assessor
Masking Description
The assessment interviewer will be blinded to study arm allocation of the participants at baseline only
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
7 weekly group sessions of advocacy training for cervical cancer screening
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
usual care (no intervention); control participants will be offered the chance to receive the intervention at the conclusion of month 12 follow-up data collection
Intervention Type
Behavioral
Intervention Name(s)
Game Changers for Cervical Cancer Prevention
Other Intervention Name(s)
GC-CCP
Intervention Description
The peer advocacy training sessions focus on reduction of internalized stigma, disclosure decision making, education on cervical cancer facts and myths, and building skills for cervical cancer prevention advocacy.
Primary Outcome Measure Information:
Title
cervical cancer screening
Description
screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
Time Frame
past 6 months
Secondary Outcome Measure Information:
Title
cervical cancer prevention advocacy
Description
6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants
Time Frame
past 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
screened for cervical cancer in the past year (index participants only)
is a member of social network of enrolled index participant (social network member participants only)
Exclusion Criteria:
advanced stage cervical cancer (index participants only)
screened for cervical cancer in the past (social network member participants only)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glenn Wagner, PhD
Phone
3103930411
Ext
7698
Email
gwagner@rand.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Bogart, PhD
Phone
3103930411
Email
lbogart@rand.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Wagner, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified dataset will be made available upon review of requests from outside researchers
IPD Sharing Time Frame
Following publication of primary results of the study, for 3 years
Learn more about this trial
Game Changers for Cervical Cancer Prevention
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