Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06010160
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-08-17
Brief Title:
Game Changers for Cervical Cancer Prevention
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
Status:
RECRUITING
Status Verified Date:
2024-09
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 urbanrural and publicprivate 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 urbanrural and publicprivate 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 n160 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 n440 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:
None
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?:
None