Educational intervention for HPV and cervical cancer prevention
A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV
This study is testing a new educational program to help women in Kenya understand HPV and cervical cancer better, aiming to reduce stigma and encourage more people to get screened.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 946 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Kisumu) |
| Trial ID | NCT05736588 on ClinicalTrials.gov |
What this trial studies
This research aims to create an educational intervention that addresses stigma related to HPV and cervical cancer through simplified scripts and peer-led videos. The intervention will be integrated into the 'Elimisha' HPV service delivery model, which focuses on cervical cancer prevention. Approximately 804 women will be enrolled from government-supported health facilities in Kenya, targeting those eligible for cervical cancer screening. Community Health Volunteers will also be trained to support the implementation of this stigma-responsive model.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 to 65 living with HIV and women aged 30 to 65 who are eligible for cervical cancer screening.
Not a fit: Patients who do not understand the study purpose or are unwilling to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve awareness and reduce stigma around HPV and cervical cancer, leading to increased screening and prevention efforts.
How similar studies have performed: Other studies have shown success with stigma-responsive interventions in health education, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Women attending government-supported health facilities (Aim 2) For Aim 2, activity 4, investigators will enroll approximately 804 randomly selected women, (67 per facility in each of 12 facilities). * Inclusion criteria: \*Has attended a study facility during the study period \*Is eligible for cervical cancer screening per the Kenya Ministry of Health guidelines include: Women living with HIV (WLWH) will be between the age of 25 and 65. All other women will be between the age of 30 and 65 \* All women should have an intact uterus and cervix * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent CHVs working at government-supported health facilities (Aim 2) Investigators will enroll approximately 36 Community Health Volunteers (CHVs) across 12 sites. CHVs will be identified by CHV supervisors and will be recruited into the study for training and participation in the stigma-responsive service delivery model at the time of randomization. Since study outcomes may appear to reflect their job performance, we will explain this as part of the informed consent and emphasize the voluntary nature of participation in the study. For both optimization of study activities and to avoid any coercion, CHVs will be able to decline participation without impact on their position in the facility. * Inclusion criteria: * Age 18 or older * Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to sign an informed consent HIV-peer navigators (Aim 2) Approximately 60 (10 per intervention health facility) HIV-peer navigator or a woman attending these facilities, including a woman living with HIV (WLWH). * Inclusion criteria: * Age 18 or older * Must have complete HPV screening and treatment in the past * Must be interested in getting trained as a peer navigator * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to sign an informed consent Aim 3 Participants Participants will be purposively recruited from each study arm to achieve a sample with heterogeneous demographic and clinical characteristics (e.g., age, HIV and HPV status). Women attending government-supported health facilities (Aim 3) Investigators will enroll approximately 24 women with the option to recruit more if new themes are emerging in the IDIs. * Inclusion criteria: * Will have completed an HPV screening test at one of the intervention or control facilities * Agree to be audio recorded * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to provide informed consent Community Health Volunteers (CHVs) and Peer Navigators (Aims 3) Investigators will enroll approximately 10 CHVs and peer navigators with the option to recruit more if new themes are emerging in the IDIs. * Inclusion criteria: * Participated as a CHV or peer navigator at one of the facilities participating in the study * Agree to be audio recorded * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to sign an informed consent Facility managers (Aim 3) Investigators will enroll approximately 12 facility managers. * Inclusion criteria: * Age 18 or older * A manager at one of the facilities participating in the study * Agree to be audio recorded * Exclusion criteria: * Does not understand the study purpose and details * Is not willing to sign an informed consent
Where this trial is running
Kisumu
- Kenya Medical Research Institute — Kisumu, Kenya (Recruiting)
Study contacts
- Study coordinator: Megan Huchko, MD, MPH
- Email: megan.huchko@duke.edu
- Phone: 919 613 5062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.