NCT04960748

Brief Summary

This study pilots a 7-session group intervention among 40 screened women, 20 of whom will be randomly assigned to take part in the intervention, and 20 to the wait-list control. Assessments will be administered at baseline and month 6 to index participants as well as up to three unscreened female social network members of each index participant (up to 120 total). The primary outcome is CC screening among participating social network members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

June 25, 2021

Last Update Submit

April 25, 2022

Conditions

Cervical Cancer Prevention

Keywords

cervical cancer screeningprevention advocacygroup interventionUgandasocial networks

Outcome Measures

Primary Outcomes (1)

  • Proportion of social network members who report cervical cancer screening

    cervical cancer screening among women in social network

    past 6 months

Secondary Outcomes (1)

  • Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy

    past 6 months

Study Arms (2)

intervention

EXPERIMENTAL

7-sesson group intervention that uses dyadic instruction, role playing and group sharing and discussion to reduce internalized stigma, improve disclosure decision making and healthy living, and teach advocacy skills

Behavioral: WOMEN FIGHTING TO STOP CERVICAL CANCER

wait-list control

NO INTERVENTION

Participants will not receive the intervention until all follow-up data has been collected.

Interventions

WOMEN FIGHTING TO STOP CERVICAL CANCERBEHAVIORAL

The group intervention draws on theories of social diffusion, cognitive consistency, and social influence, and our own recently developed and tested group intervention that mobilized people living with HIV in Uganda to successfully act as change agents for HIV prevention within their social networks. The intervention actively targets internalized stigma, disclosure decision making, healthy living, and advocacy communication skills. The ultimate goal of the program is to encourage female social network members to get screened for cervical cancer.

intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspersons with female sex organs
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • has been previously screened for cervical cancer
  • has told at least one woman in her social network about her cervical cancer screening experience

You may not qualify if:

  • unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buyinja HCIV

Namayingo, Uganda

Location

Related Publications (3)

  • Wagner GJ, Matovu JKB, Juncker M, Namisango E, Bouskill K, Nakami S, Beyeza-Kashesya J, Luyirika E, Bogart LM, Green HD, Wanyenze RK. Effects of a peer advocacy intervention on cervical cancer screening among social network members: results of a randomized controlled trial in Uganda. J Behav Med. 2023 Dec;46(6):930-939. doi: 10.1007/s10865-023-00418-6. Epub 2023 Sep 13.

    PMID: 37702912DERIVED

  • Ghai I, Wagner GJ, Matovu JKB, Juncker M, Namisango E, Bouskill K, Nakami S, Beyeza-Kashesya J, Luyirika E, Wanyenze RK. Increased Knowledge Mediates the Effect of Game Changers for Cervical Cancer Prevention on Diffusion of Cervical Cancer Screening Advocacy Among Social Network Members in a Pilot Trial. Int J Behav Med. 2024 Oct;31(5):753-763. doi: 10.1007/s12529-023-10217-7. Epub 2023 Sep 1.

    PMID: 37656308DERIVED

  • Wanyenze RK, Matovu JKB, Bouskill K, Juncker M, Namisango E, Nakami S, Beyeza-Kashesya J, Luyirika E, Wagner GJ. Social network-based group intervention to promote uptake of cervical cancer screening in Uganda: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Dec 7;8(1):247. doi: 10.1186/s40814-022-01211-z.

    PMID: 36476609DERIVED

Study Officials

  • Rhoda Wanyenze, MD

    Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial of parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 14, 2021

Study Start

August 30, 2021

Primary Completion

April 25, 2022

Study Completion

April 25, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

UG(1)