PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pilot Phase

NCT ID: NCT07225894

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators will pilot test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using Pre-exposure Prophylaxis (PrEP).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In Aim 3, the investigators will pilot test the ethnodrama intervention (i.e., six plays on reducing PrEP stigma toward young women) that were pre-tested in Aim 2. The pilot evaluation will focus on evaluating logistical feasibility and describing participants' perceptions of the intervention's influence on PrEP-related stigma toward young women.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Stigma HIV PrEP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Young women intervention cohort

Each participant will attend all play performances in a single round (e.g., 6 plays within a week).

Group Type EXPERIMENTAL

Ethnodrama Intervention

Intervention Type BEHAVIORAL

The intervention is six drama performances that are designed to transform community member beliefs about and foster support of young women's PrEP use, reduce PrEP-related enacted stigma toward young women, and reduce PrEP-related anticipated and internalized stigma among young women.

Young women control cohort

Participants do not watch the drama performances.

Group Type NO_INTERVENTION

No interventions assigned to this group

Community cohort

This cohort consists of community members who will be identified from the audience during the first play in a round. They will be asked to watch all plays in a round.

Group Type EXPERIMENTAL

Ethnodrama Intervention

Intervention Type BEHAVIORAL

The intervention is six drama performances that are designed to transform community member beliefs about and foster support of young women's PrEP use, reduce PrEP-related enacted stigma toward young women, and reduce PrEP-related anticipated and internalized stigma among young women.

Audience member group

These are audience members who heard about the play from the public announcements and chose to attend and watch the play.

Group Type EXPERIMENTAL

Ethnodrama Intervention

Intervention Type BEHAVIORAL

The intervention is six drama performances that are designed to transform community member beliefs about and foster support of young women's PrEP use, reduce PrEP-related enacted stigma toward young women, and reduce PrEP-related anticipated and internalized stigma among young women.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ethnodrama Intervention

The intervention is six drama performances that are designed to transform community member beliefs about and foster support of young women's PrEP use, reduce PrEP-related enacted stigma toward young women, and reduce PrEP-related anticipated and internalized stigma among young women.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Young women who are currently using or have previously used PrEP
* Community members (adult women and men) who will be identified from the audience during the first play in a round
* Adult audience members (female and male) who heard about the play from the public announcements and chose to attend and watch the play

Exclusion:

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy Corneli, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Impact Research and Development

Kisumu, , Kenya

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Kenya

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kevin C McKenna, MPH

Role: CONTACT

Phone: 9196688274

Email: [email protected]

Amy Corneli, PhD, MPH

Role: CONTACT

Phone: 9196689238

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jacob Onyango

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01TW012673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00115054_1

Identifier Type: -

Identifier Source: org_study_id