NCT07225894

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

October 28, 2025

Last Update Submit

February 9, 2026

Conditions

HIV

Keywords

StigmaHIVPrEP

Outcome Measures

Primary Outcomes (3)

  • Feasibility of the drama intervention as measured by the number of plays performed as intended

    Up to 1 month post-intervention

  • Feasibility of the drama intervention as measured by the number of study procedures implemented easily

    Up to 1 month post-intervention

  • Feasibility of the drama intervention as measured by the estimated number of audience members

    Up to 1 month post-intervention

Secondary Outcomes (2)

  • Potential effectiveness of the intervention's storylines on transforming audience members' PrEP-related perceptions as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS)

    Immediately post-intervention

  • PrEP (Pre-exposure Prophylaxis) stigma

    Baseline, immediately post-intervention, and up to 3 months post-intervention

Study Arms (4)

Young women intervention cohort

EXPERIMENTAL

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

Behavioral: Ethnodrama Intervention

Young women control cohort

NO INTERVENTION

Participants do not watch the drama performances.

Community cohort

EXPERIMENTAL

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.

Behavioral: Ethnodrama Intervention

Audience member group

EXPERIMENTAL

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

Behavioral: Ethnodrama Intervention

Interventions

Ethnodrama InterventionBEHAVIORAL

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 groupCommunity cohortYoung women intervention cohort

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender will be self-identified
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Impact Research and Development

Kisumu, 40100, Kenya

RECRUITING

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Amy Corneli, PhD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin C McKenna, MPH

CONTACT

9196688274kevin.mckenna@duke.edu

Amy Corneli, PhD, MPH

CONTACT

9196689238amy.corneli@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2025

First Posted

November 10, 2025

Study Start

December 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)