Promoting Cervical Cancer Screening Through the Advocacy of Screened Women

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RAND

Status and phase

Completed
Phase 2

Conditions

Cervical Cancer Prevention

Treatments

Behavioral: WOMEN FIGHTING TO STOP CERVICAL CANCER

Study type

Interventional

Funder types

Other

Identifiers

NCT04960748
R21TW011728

Details and patient eligibility

About

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.

Full description

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.

Enrollment

143 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

143 participants in 2 patient groups

intervention
Experimental group
Description:
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
Treatment:
Behavioral: WOMEN FIGHTING TO STOP CERVICAL CANCER
wait-list control
No Intervention group
Description:
Participants will not receive the intervention until all follow-up data has been collected.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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