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Completed

NCT Number: NCT04960748

Promoting Cervical Cancer Screening Through the Advocacy of Screened Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Buyinja HCIV

Namayingo, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WOMEN FIGHTING TO STOP CERVICAL CANCER

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.

Primary outcomes

  1. Proportion of social network members who report cervical cancer screening

    Time frame: past 6 months

    cervical cancer screening among women in social network

Secondary outcomes

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

    Time frame: past 6 months

    discussing cervical cancer and encouraging CC screening with women in social network

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • African Palliative Care Association
  • Makerere University
  • Rays of Hope Hospice Jinja

Registry information

Official study title

Pilot of a Network-driven, Advocacy Intervention to Promote Cervical Cancer Screening in Uganda

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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