Cervical Cancer PreventionPhase 2NCT04960748
Promoting Cervical Cancer Screening Through the Advocacy of Screened Women
A Phase 2 study testing WOMEN FIGHTING TO STOP CERVICAL CANCER in people with Cervical Cancer Prevention, run by RAND at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Prevention
- What is being tested?
- WOMEN FIGHTING TO STOP CERVICAL CANCER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUganda
- Study dates
- 30 Aug 2021to 25 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot of a Network-driven, Advocacy Intervention to Promote Cervical Cancer Screening in Uganda
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.
Read the detailed 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.
- Conditions
- Cervical Cancer Prevention
- Being tested
- WOMEN FIGHTING TO STOP CERVICAL CANCER
- Keywords
- cervical cancer screening, prevention advocacy, group intervention, Uganda, social networks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOMEN FIGHTING TO STOP CERVICAL CANCERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of social network members who report cervical cancer screening
cervical cancer screening among women in social network
Measured: past 6 months
Secondary outcomes (1)
Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy
discussing cervical cancer and encouraging CC screening with women in social network
Measured: past 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start30 Aug 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial of parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Rays of Hope Hospice Jinja, African Palliative Care Association
- Responsible party
- Sponsor
- Investigators
- Rhoda Wanyenze, MD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960748
- Sponsor's protocol ID
- R21TW011728
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37702912Ghai 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.
PubMed 37656308Wanyenze 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.
PubMed 36476609
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a Network-driven, Advocacy Intervention to Promote Cervical Cancer Screening in Uganda
- ClinicalTrials.gov ID
- NCT04960748
- Acronym / sponsor ID
- R21TW011728
- Conditions
- Cervical Cancer Prevention
- Keywords
- cervical cancer screening, prevention advocacy, group intervention, Uganda, social networks
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Makerere University, Rays of Hope Hospice Jinja, African Palliative Care Association
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial of parallel groups
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: WOMEN FIGHTING TO STOP CERVICAL CANCER7-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 |
| wait-list control | No intervention | –Participants will not receive the intervention until all follow-up data has been collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- unstable medical status (e.g., advance disease stage that calls into question her ability to complete the 6-month study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WOMEN FIGHTING TO STOP CERVICAL CANCERThe 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. | Behavioural | intervention |
Primary outcome
Proportion of social network members who report cervical cancer screening
Time frame: past 6 months
cervical cancer screening among women in social network
1 secondary outcome
Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy
Time frame: past 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 37702912Wagner 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.
- Derived from this study: PubMed 37656308Ghai 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.
- Derived from this study: PubMed 36476609Wanyenze 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhoda Wanyenze, MD principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WOMEN FIGHTING TO STOP CERVICAL CANCER in people with Cervical Cancer Prevention, run by RAND at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of social network members who report cervical cancer screening (time frame: past 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960748, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.