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Game Changers for Cervical Cancer Prevention

A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06010160
Acronym
GC-CCP
Enrollment
936
Registered
2023-08-24
Start date
2024-08-19
Completion date
2026-04-30
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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. 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. 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.

Interventions

BEHAVIORALGame Changers for Cervical Cancer Prevention

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.

Sponsors

RAND
Lead SponsorOTHER
Makerere University
CollaboratorOTHER
African Palliative Care Association
CollaboratorUNKNOWN
Rays of Hope Hospice Jinja
CollaboratorUNKNOWN
Indiana University, Bloomington
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessment interviewer will be blinded to study arm allocation of the participants at baseline only

Intervention model description

Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of alter participants that has received cervical cancer screeningpast 6 monthsReceipt of screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants

Secondary

MeasureTime frameDescription
Mean score on cervical cancer prevention advocacy scalepast 6 months6-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

Countries

Uganda

Contacts

PRINCIPAL_INVESTIGATORGlenn Wagner, PhD

RAND

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026