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

October 28, 2025 updated by: Duke University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Aim 1/Year 1, the investigators will develop the ethnodrama intervention; no data collection activities are included. In Aim 2/Year 2, the investigators will pre-test the ethnodrama intervention with invited groups of young women and members of young women's socio ecology (i.e., male partners, female peers, healthcare providers, informal community leaders, and family members).

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya, 40100
        • Impact Research and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • Young cisgender women who have taken or are taking PrEP
  • Male partners of young women
  • Female peers of young women
  • Healthcare providers
  • Informal community leaders
  • Family members of young women

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ethnodrama Audience Members
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
Measure Description
Time Frame
Number of participants who find the storylines and interactive components acceptable
Time Frame: Immediately post-intervention
The investigators will gather feedback on the acceptability of the storylines (e.g., perceptions of whether the storylines seem real and identifiable) and interactive components (e.g., facilitated discussion).
Immediately 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)
Time Frame: Immediately post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Actual)

September 3, 2025

Study Completion (Actual)

September 3, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115054
  • 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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