Game Changers for Cervical Cancer Prevention (GC-CCP)
May 22, 2026 updated by: RAND
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 6 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 (1st degree alters).
Each index will recruit up to three alters (n~440 1st degree alters) at baseline who have not screened for CC; these index and alter participants will be followed up at months 6 and 12.
At month 6, half of the 1st degree alters will be asked to recruit up to female social network members (2nd degree alters) whom they have engaged in CC screening advocacy with; these 2nd degree alters will receive a single phone-based brief interview; at month 12, the other half of the 1st degree alters will be asked to recruit up to two 2nd degree alters for the same purpose.
Study Type
Interventional
Enrollment (Actual)
936
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kampala, Uganda
- Makerere University School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- screened for cervical cancer in the past year (index participants only)
- has shared cervical cancer screening experience with at least one adult female social network member whom is believed to not have been screening for cervical cancer; or she reports that there is at least one female social network member who has not screened and she would feel comfortable disclosing her personal screening experience to her (index participants only)
- is a member of social network of enrolled participant (social network member participants only)
Exclusion Criteria:
- advanced stage cervical cancer (index participants only)
- screened for cervical cancer in the past (1st degree social network member participants only)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual care control
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
|
|
|
Experimental: Advocacy Training Intervention
6 weekly group sessions of advocacy training for cervical cancer screening
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of alter participants that has received cervical cancer screening
Time Frame: past 6 months
|
Receipt of screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
|
past 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean score on cervical cancer prevention advocacy scale
Time Frame: past 6 months
|
6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants; higher scores reflect greater advocacy
|
past 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenn Wagner, PhD, RAND
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2024
Primary Completion (Actual)
April 30, 2026
Study Completion (Actual)
April 30, 2026
Study Registration Dates
First Submitted
August 17, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Uterine Cervical Neoplasms
Other Study ID Numbers
- 2023-N0111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.