Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-05 @ 12:58 AM
Study NCT ID:
NCT06010160
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Game Changers for Cervical Cancer Prevention
Sponsor:
RAND
Organization:
Study Overview
Official Title:
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GC-CCP
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?
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: