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New program tackles stigma to get more women with HIV screened for cervical cancer

NCT ID NCT05736588

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

982 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Kenya Medical Research Institute

    Kisumu, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.