New program tackles stigma to get more women with HIV screened for cervical cancer
NCT ID NCT05736588
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a program called Elimisha HPV, designed to reduce stigma and increase cervical cancer screening among women living with HIV in Kenya. The program included simple educational scripts, a video addressing fears, and peer support. Nearly 1,000 women participated, and researchers measured how many got screened for HPV and followed up for treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Elimisha HPV (behavioral intervention: education, peer navigation, patient-centered delivery)
- What this could lead to
- If successful, this model could increase cervical cancer screening rates among women living with HIV, reducing cancer risk in a high-stigma population.
- What could go wrong
- This is a completed behavioral study, not a drug trial. Results may not apply outside Kenya or to other populations. Stigma reduction is complex and hard to scale.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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982 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) Inclusion criteria: * 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 Exclusion criteria: * 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. 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kenya Medical Research Institute
Kisumu, Kenya
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Other studies related to the condition(s) this trial covers.
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