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临床试验/NCT06010160
NCT06010160已完成不适用

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

RAND1 个研究点 分布在 1 个国家目标入组 936 人开始时间: 2024年8月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
936
试验地点
1
主要终点
Number of alter participants that has received cervical cancer screening

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The assessment interviewer will be blinded to study arm allocation of the participants at baseline only

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • advanced stage cervical cancer (index participants only)
  • screened for cervical cancer in the past (1st degree social network member participants only)

研究组 & 干预措施

Usual care control

No Intervention

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

Advocacy Training Intervention

Experimental

6 weekly group sessions of advocacy training for cervical cancer screening

干预措施: Game Changers for Cervical Cancer Prevention (Behavioral)

结局指标

主要结局

Number of alter participants that has received cervical cancer screening

时间窗: past 6 months

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

次要结局

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

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (1)

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