Game Changers for Cervical Cancer Prevention

Study Overview
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Brief Summary
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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: 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? 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
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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 7 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 (alters). Each index will recruit up to three alters (n 440 alters) at baseline who have not screened for CC; these index and alter participants will be followed up at months 6 and 12.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Game Changers for Cervical Cancer Prevention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: screened for cervical cancer in the past year (index participants only) is a member of social network of enrolled index participant (social network member participants only) Exclusion Criteria: advanced stage cervical cancer (index participants only) screened for cervical cancer in the past (social network member participants only)

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advocacy Training Intervention<br>7 weekly group sessions of advocacy training for cervical cancer screening | Behavioral: Game Changers for Cervical Cancer Prevention<br>* 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.<br>* Other names: GC-CCP;|
| No Intervention: Usual care control<br>usual care (no intervention); control participants will be offered the chance to receive the intervention at the conclusion of month 12 follow-up data collection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |