Game Changers for Cervical Cancer Prevention

Cervical Cancer Clinical Trial

— GC-CCP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010160
• Other study ID #: 2023-N0111
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: RAND
• Contact: Glenn Wagner, PhD
• Phone: 3103930411
• Email: gwagner[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Game 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
RAND	African Palliative Care Association, Indiana University, Bloomington, Makerere University, Rays of Hope Hospice Jinja

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	past 6 months