Elimisha HPV (Human Papillomavirus)

HIV Clinical Trial

Official title:

A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736588
• Other study ID #: Pro00111929
• Secondary ID: 1R01TW012415
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: July 19, 2025

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Megan Huchko, MD, MPH
• Phone: 919 613 5062
• Email: megan.huchko[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study aims to develop a stigma-responsive educational intervention which includes simplified scripts that provide clear messages about HPV and video aimed at addressing fears and misperceptions from a peer perspective. These educational components will be incorporated into 'Elimisha' HPV a multi-level stigma-responsive cervical cancer prevention service delivery model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 946
• Est. completion date: July 19, 2025
• Est. primary completion date: July 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HIV
• HPV
• Stigma
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Elimisha HPV
Elimisha HPV is a multi-level stigma-responsive cervical cancer prevention service delivery model that incorporates stigma-responsive education, peer navigation and a patient-centered delivery strategy, addressing drivers while mitigating harms from stigma.

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Factors related to the success of the delivery model	Factors at the patient, community health volunteer and peer navigator level; factors at the health facility level; and factors at the County Health Management Team level.	Approximately 12 months
Primary	Overall HPV testing rates	Number of women screened for HPV/Number of women eligible for HPV-based cervical cancer screening during study period	Approximately 12 months
Secondary	HPV testing rates among women living with HIV (WLWH) enrolled in HIV care	Number of WLWH enrolled in HIV care screened for HPV/Number of WLWH living in the study area	Approximately 12 months
Secondary	Follow-up rates for HPV treatment	Number of women testing HPV+ seeking treatment within 3 months/Number of women testing HPV+	Approximately 12 months
Secondary	Follow-up rates for HPV treatment among WLWH	Number of WLWH testing HPV+ seeking HPV treatment within 3 months/Number of WLWH testing HPV+	Approximately 12 months
Secondary	Proportion of WLWH enrolled in HIV care attending at least one visit within study period		Approximately 12 months
Secondary	Overall level of stigma related to cervical cancer, HPV and HIV	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within each health domain.	Approximately 12 months
Secondary	Level of stigma related to cervical cancer	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within cervical cancer domain	Approximately 12 months
Secondary	Level of stigma related to HPV	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale 0 (strongly disagree) to 3 (strongly agree) within HPV domain.	Approximately 12 months
Secondary	Level of stigma related to HIV	HPV and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 0 (strongly disagree) to 3 (strongly agree) within HIV domain.	Approximately 12 months