Elimisha HPV (Human Papillomavirus)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual care
|
|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Overall HPV testing rates [Approximately 18 months]
Number of women screened/number of women attending clinic visits at least once during study period
- HPV testing rates among women living with HIV (WLWH) enrolled in care [Approximately 18 months]
Number of WLWH enrolled in HIV care screening/number of WLWH attending clinic visits at least once during study period
- Follow-up rates for HPV treatment [Approximately 18 months]
Number of women testing HPV+ seeking treatment/number of women testing HPV+
- Follow-up rates for treatment among WLWH [Approximately 18 months]
Number of WLWH testing HPV+ seeking treatment/number of WLWH testing HPV+
- Proportion of WLWH enrolled in care attending at least one visit [Approximately 18 months]
- Overall level of stigma related to cervical cancer, HPV and HIV [Approximately 18 months]
HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
- Level of stigma related to cervical cancer [Approximately 18 months]
HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
- Level of stigma related to HPV [Approximately 18 months]
HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
- Level of stigma related to HIV [Approximately 18 months]
HPV-and Cervical Cancer Associated Stigma Scale will be used which is scored on a scale of 1-3 within each health domain, with 3 representing higher levels of stigma.
Other Outcome Measures
- Factors related to the success of the delivery model [Approximately 18 months]
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.
Eligibility Criteria
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
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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.
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Inclusion criteria:
-
Age 18 or older
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Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County
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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).
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Inclusion criteria:
-
Age 18 or older
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Must have complete HPV screening and treatment in the past
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Must be interested in getting trained as a peer navigator
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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.
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Inclusion criteria:
-
Will have completed an HPV screening test at one of the intervention or control facilities
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Agree to be audio recorded
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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.
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Inclusion criteria:
-
Participated as a CHV or peer navigator at one of the facilities participating in the study
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Agree to be audio recorded
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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.
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Inclusion criteria:
-
Age 18 or older
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A manager at one of the facilities participating in the study
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Agree to be audio recorded
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Exclusion criteria:
-
Does not understand the study purpose and details
-
Is not willing to sign an informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
- Fogarty International Center of the National Institute of Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00111929
- 1R01TW012415