NCT06010160

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:

  1. 1.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?
  2. 2.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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
936

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

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

First Submitted

Initial submission to the registry

August 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

August 17, 2023

Last Update Submit

May 22, 2026

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of alter participants that has received cervical cancer screening

    Receipt of screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants

    past 6 months

Secondary Outcomes (1)

  • Mean score on cervical cancer prevention advocacy scale

    past 6 months

Study Arms (2)

Advocacy Training Intervention

EXPERIMENTAL

6 weekly group sessions of advocacy training for cervical cancer screening

Behavioral: Game Changers for Cervical Cancer Prevention

Usual care control

NO INTERVENTION

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

Interventions

Game Changers for Cervical Cancer PreventionBEHAVIORAL

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.

Also known as: GC-CCP
Advocacy Training Intervention

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • advanced stage cervical cancer (index participants only)
  • screened for cervical cancer in the past (1st degree social network member participants only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University School of Public Health

Kampala, Uganda

Location

Related Publications (1)

  • Wagner GJ, Bogart LM, Matovu JKB, Gwokyalya V, Beyeza-Kashesya J, Ober A, Green HD, Nakami S, Juncker M, Namisango E, Luyirika E, McBain RK, Bouskill K, Wanyenze RK. Study protocol for a hybrid implementation-effectiveness trial of Game Changers for Cervical Cancer Prevention in Uganda. PLoS One. 2025 Jan 24;20(1):e0317491. doi: 10.1371/journal.pone.0317491. eCollection 2025.

    PMID: 39854403DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Glenn Wagner, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessment interviewer will be blinded to study arm allocation of the participants at baseline only
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 24, 2023

Study Start

August 19, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

A de-identified dataset will be made available upon review of requests from outside researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Following publication of primary results of the study, for 3 years

Locations

UG(1)