Clinical trial NCT04960748: Promoting Cervical Cancer Screening Through the Advocacy of Screened Women
Official title: Pilot of a Network-driven, Advocacy Intervention to Promote Cervical Cancer Screening in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer Prevention
Keywords: cervical cancer screening
prevention advocacy
group intervention
Uganda
social networks
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Rays of Hope Hospice Jinja
name: African Palliative Care Association
First posted: 2021-07-14
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial of parallel groups
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of social network members who report cervical cancer screening
timeFrame: past 6 months
Secondary outcomes:
measure: Proportion of index participants who self-report engagement in cervical cancer (CC) prevention advocacy
timeFrame: past 6 months
Other outcomes:
Locations:
city: Namayingo
country: Uganda
facility: Buyinja HCIV
Study officials:
affiliation: Makerere University
name: Rhoda Wanyenze, MD
role: PRINCIPAL_INVESTIGATOR
References: