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Completed

NCT Number: NCT07225894

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Impact Research and Development

Kisumu, Kisumu County, 40100, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethnodrama Intervention

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.

Primary outcomes

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

    Time frame: Up to 1 month post-intervention

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

    Time frame: Up to 1 month post-intervention

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

    Time frame: Up to 1 month post-intervention

Secondary outcomes

  1. 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.

  2. PrEP (Pre-exposure Prophylaxis) stigma

    Time frame: Baseline, immediately post-intervention, and up to 3 months post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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