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Clinical Trials/NCT06010160
NCT06010160
Active, not recruiting
Not Applicable

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

RAND1 site in 1 country1,400 target enrollmentAugust 19, 2024
ConditionsCervical Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
RAND
Enrollment
1400
Locations
1
Primary Endpoint
Number of alter participants that has received cervical cancer screening
Status
Active, not recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 19, 2024
End Date
March 30, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
RAND
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Number of alter participants that has received cervical cancer screening

Time Frame: past 6 months

Receipt of screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants

Secondary Outcomes

  • Mean score on cervical cancer prevention advocacy scale(past 6 months)

Study Sites (1)

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