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Trial Title:
Game Changers for Cervical Cancer Prevention
NCT ID:
NCT06010160
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Individual randomization to one of two parallel groups, the intervention or usual care
(no intervention) control group
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:
Intervention type:
Behavioral
Intervention name:
Game Changers for Cervical Cancer Prevention
Description:
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.
Arm group label:
Advocacy Training Intervention
Other name:
GC-CCP
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Makerere University School of Public Health
Address:
City:
Kampala
Country:
Uganda
Status:
Recruiting
Contact:
Last name:
Violet Gwokyalya
Start date:
August 19, 2024
Completion date:
November 30, 2025
Lead sponsor:
Agency:
RAND
Agency class:
Other
Collaborator:
Agency:
Makerere University
Agency class:
Other
Collaborator:
Agency:
African Palliative Care Association
Agency class:
Other
Collaborator:
Agency:
Rays of Hope Hospice Jinja
Agency class:
Other
Collaborator:
Agency:
Indiana University, Bloomington
Agency class:
Other
Source:
RAND
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010160
