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

Designing an Ethnodrama Addressing PrEP Stigma Toward Young Cisgender Women in Kenya

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).

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: Ethnodrama Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Corneli, PhD, MPH; Phone Number: 9196689238; Email: amy.corneli@duke.edu
• Study Contact Backup: Name: Kevin C McKenna, MPH; Phone Number: 9196688274; Email: kevin.mckenna@duke.edu

Study Locations

• Kenya
  • Kisumu, Kenya, 40100
    • Recruiting
    • Impact Research and Development
    • Contact: Jacob Onyango; Email: jonyango@impact-rdo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young women intervention cohort; Each participant will attend all play performances in a single round (e.g., 6 plays within a week).	Behavioral: 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.
No Intervention: Young women control cohort; Participants do not watch the drama performances.
Experimental: 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.	Behavioral: 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.
Experimental: Audience member group; These are audience members who heard about the play from the public announcements and chose to attend and watch the play.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The 12-item scale is divided into two sub-scales: engagement and personal connection. Sample items include: "I wanted to learn what happened to the women after the story ended"; "The stories in the dramas are relevant to my everyday life"; and "The stories in the drama are realistic and believable." The total score ranges from 12 to 84, where a higher score indicates greater narrative transportation.	Immediately post-intervention
PrEP (Pre-exposure Prophylaxis) stigma	The investigators will administer the survey at three distinct time points to assess descriptive changes in stigma-related perceptions among young women. The first administration will occur prior to the implementation of any play performances to establish baseline measures (e.g., up to several weeks prior to the first play). The second administration will take place immediately after participants have attended all six plays (e.g., up to two weeks after the last play), capturing immediate post-intervention responses. The third and final administration will occur up to three months following the last performance to assess sustained impact over time.	Baseline, immediately post-intervention, and up to 3 months post-intervention

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Amy Corneli, PhD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 28, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HIV; PrEP; Stigma
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Social Stigma
• Other Study ID Numbers: Pro00115054_1; R01TW012673 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No