NCT05736588Completed
Elimisha HPV (Human Papillomavirus)
A Stigma Responsive Service Delivery Model for HPV-based Screening Among Women Living With HIV
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 963 (actual)
- First submitted
- 8 Feb 2023
- Start date
- 25 Sept 2023
- Primary completion date
- 26 Nov 2024
- Lead sponsor
- Duke University
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05736588
What you commit to
- Study type: Interventional
- Participants enrolled: 963
- From 25 Sept 2023 to the primary completion date, 26 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Other
- Does not understand the study purpose and details
- Is not willing to provide informed consent
- CHVs working through government-supported health facilities (Aim 2) We will work with CHV supervisors to approach CHVs for study participation and possible enrollment into the study for training and participation in the stigma-responsive service delivery model. Since study outcomes may appear to reflect CHV 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.
- Does not understand the study purpose and details
- 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.
- 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.
- Does not understand the study purpose and details
- Is not willing to sign an informed consent
Who the study is looking for
- A Community Health Volunteer (CHV) has registered the woman in the mSaada App (electronic HPV-based cervical cancer screening tracking tool) 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
- Age 18 or older
- Must be a Community Health Volunteer (CHV) at government-supported facilities in Kisumu County
- Will have completed an HPV screening test at one of the intervention or control facilities
- Agree to be audio recorded
- Participated as a CHV or peer navigator at one of the facilities participating in the study
- Agree to be audio recorded
- Age 18 or older
- A manager at one of the facilities participating in the study
- Agree to be audio recorded
Criteria the registry did not label
- Aim 2 Participants Women registered within the 12 community units participating in the study (Aim 2)
- For Aim 2, activity 4, we will enroll approximately 804 randomly selected women, (67 per community unit in each of 12 facilities)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Kisumu | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.