Cervical CancerGC-CCPNCT06010160
Game Changers for Cervical Cancer Prevention
A study testing Game Changers for Cervical Cancer Prevention in people with Cervical Cancer, run by RAND at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Game Changers for Cervical Cancer Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 1 siteUganda
- Study dates
- 19 Aug 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- advanced stage cervical cancer (index participants only)
- screened for cervical cancer in the past (1st degree social network member participants only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Game Changers for Cervical Cancer Prevention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game Changers for Cervical Cancer PreventionBehavioural
Also called GC-CCP
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.
| Study group | Role | What they receive |
|---|---|---|
| Advocacy Training Intervention | Experimental | 6 weekly group sessions of advocacy training for cervical cancer screening Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: past 6 months
Secondary outcomes (1)
Mean score on cervical cancer prevention advocacy scale
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
Measured: past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start19 Aug 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington
- Responsible party
- Sponsor
- Investigators
- Glenn Wagner, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010160
- Sponsor's protocol ID
- 2023-N0111
- Acronym
- GC-CCP
- Status last verified
- May 2026
- First submitted
- 17 Aug 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be made available upon review of requests from outside researchers
Publications
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.
PubMed 39854403
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
- ClinicalTrials.gov ID
- NCT06010160
- Acronym / sponsor ID
- GC-CCP / 2023-N0111
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
| Arm | Type | Receives |
|---|---|---|
| Advocacy Training Intervention | Experimental | Behavioral: Game Changers for Cervical Cancer Prevention6 weekly group sessions of advocacy training for cervical cancer screening |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- advanced stage cervical cancer (index participants only)
- screened for cervical cancer in the past (1st degree social network member participants only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game Changers for Cervical Cancer PreventionAlso: GC-CCPThe 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. | Behavioural | Advocacy Training Intervention |
Primary outcome
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
1 secondary outcome
Mean score on cervical cancer prevention advocacy scale
Time frame: past 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 39854403Wagner 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.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be made available upon review of requests from outside researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Wagner, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Changers for Cervical Cancer Prevention in people with Cervical Cancer, run by RAND at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of alter participants that has received cervical cancer screening (time frame: past 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.