HIVNCT07225894
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pilot Phase
A study testing Ethnodrama Intervention in people with HIV, run by Duke University at 1 site in Kenya.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Ethnodrama Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteKenya
- Study dates
- 1 Dec 2025to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- HIV
- Being tested
- Ethnodrama Intervention
- Keywords
- Stigma, HIV, PrEP
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethnodrama InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Young women intervention cohort | Experimental | Each participant will attend all play performances in a single round (e.g., 6 plays within a week). Receives: 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. Receives: 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. Receives: Behavioral: Ethnodrama Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the drama intervention as measured by the number of plays performed as intended
Measured: Up to 1 month post-intervention
Feasibility of the drama intervention as measured by the number of study procedures implemented easily
Measured: Up to 1 month post-intervention
Feasibility of the drama intervention as measured by the estimated number of audience members
Measured: 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)
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.
Measured: 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.
Measured: Baseline, immediately post-intervention, and up to 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Dec 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Amy Corneli, PhD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225894
- Sponsor's protocol ID
- Pro00115054_1
- Other IDs
- R01TW012673
- Status last verified
- Feb 2026
- First submitted
- 28 Oct 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing an Ethnodrama Addressing PrEP Stigma Toward Young Cisgender Women in Kenya
- ClinicalTrials.gov ID
- NCT07225894
- Acronym / sponsor ID
- Pro00115054_1
- Conditions
- HIV
- Keywords
- Stigma, HIV, PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young women intervention cohort | Experimental | Behavioral: Ethnodrama InterventionEach participant will attend all play performances in a single round (e.g., 6 plays within a week). |
| Young women control cohort | No intervention | –Participants do not watch the drama performances. |
| Community cohort | Experimental | Behavioral: Ethnodrama InterventionThis 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. |
| Audience member group | Experimental | Behavioral: Ethnodrama InterventionThese are audience members who heard about the play from the public announcements and chose to attend and watch the play. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethnodrama InterventionThe 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. | Behavioural | Audience member group, Community cohort, Young women intervention cohort |
Primary outcome
Feasibility of the drama intervention as measured by the number of plays performed as intended
Time frame: Up to 1 month post-intervention
Feasibility of the drama intervention as measured by the number of study procedures implemented easily
Time frame: Up to 1 month post-intervention
Feasibility of the drama intervention as measured by the estimated number of audience members
Time frame: Up to 1 month post-intervention
2 secondary outcomes
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
PrEP (Pre-exposure Prophylaxis) stigma
Time frame: Baseline, immediately post-intervention, and up to 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Corneli, PhD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethnodrama Intervention in people with HIV, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the drama intervention as measured by the number of plays performed as intended (time frame: Up to 1 month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.