Promoting Cervical Cancer Screening Through the Advocacy of Screened Women

NCT ID: NCT04960748

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cervical cancer (CC) is the most common cancer and accounts for \~25% of all cancer related deaths among women in Uganda, which has one of the highest incidence rates in the world. Adding to the burden is the general lack of knowledge about, and social stigma towards CC and its screening in Uganda, where lifetime CC screening is estimated to be as low as 5%. There is a dire need to increase CC screening in Uganda to ensure timely and lifesaving treatment, as well as the need to enhance the capacity to conduct behavioral and health services research related to CC and other stigmatizing conditions among local researchers and service providers. Accordingly, the proposed intervention pilot study seeks to (1) empower women who have been screened for CC, to advocate for CC screening and early treatment among women in their social networks, and (2) engage and train local public health researchers and programmers. The proposed intervention draws on theories of social diffusion, cognitive consistency, and social influence, and the investigator's 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. This study will pilot the 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. The primary aims of the study are to assess the feasibility, acceptability and preliminary efficacy of the group intervention to promote CC screening and treatment; identify characteristics associated with successful advocacy; and increase local capacity for conducting public health research on CC control and use of social network-based intervention and measurement methods.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial of parallel groups
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

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

Group Type EXPERIMENTAL

WOMEN FIGHTING TO STOP CERVICAL CANCER

Intervention Type BEHAVIORAL

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.

wait-list control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WOMEN FIGHTING TO STOP CERVICAL CANCER

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Makerere University

OTHER

Sponsor Role collaborator

Rays of Hope Hospice Jinja

UNKNOWN

Sponsor Role collaborator

African Palliative Care Association

UNKNOWN

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rhoda Wanyenze, MD

Role: PRINCIPAL_INVESTIGATOR

Makerere University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Buyinja HCIV

Namayingo, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37702912 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37656308 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36476609 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21TW011728

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.