Clinical trial NCT06010160: Game Changers for Cervical Cancer Prevention
Official title: A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Makerere University
name: African Palliative Care Association
name: Rays of Hope Hospice Jinja
name: Indiana University, Bloomington
First posted: 2023-08-24
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of alter participants that has received cervical cancer screening
timeFrame: past 6 months
Secondary outcomes:
measure: Mean score on cervical cancer prevention advocacy scale
timeFrame: past 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University School of Public Health
Study officials:
affiliation: RAND
name: Glenn Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References: