HIVNCT06501885
PrEP (Pre-exposure Prophylaxis) Stigma and Women Ethnodrama Pre-Test Phase
A study testing Ethnodrama Intervention in people with HIV, run by Duke University at 1 site in Kenya.
Trial summary
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. 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
- 63 participants
- Where
- 1 siteKenya
- Study dates
- 11 Nov 2024to 3 Sep 2025
- 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
- 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
Who cannot join
- None
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 develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.
Read the 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).
- 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 |
|---|---|---|
| Ethnodrama Audience Members | Experimental | Not described Receives: Behavioral: Ethnodrama Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention storylines and interactive components
The investigators will gather feedback on the acceptability of the storylines (e.g., perceptions of whether the storylines seem relatable) and interactive components, as measured by several single-item questions scored from 1 (strongly agree) to 6 (strongly disagree), with lower scores reflecting greater acceptability.
Measured: Immediately post-intervention
Secondary outcomes (1)
Potential effectiveness of the intervention's storylines on "transporting" participants, as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS).
The Storytelling/Narrative Theory (Lee et al., 2016) suggests that when audiences become deeply absorbed in a story (i.e., when the story is relatable and audiences identify with the characters), they are more likely to reflect on and reconsider their existing beliefs, attitudes, and behaviors. The NTS includes 12 items scored from 1 (strongly agree) to 6 (strongly disagree), with lower scores reflecting greater transportation into the story. Example questions include: "While you were watching the play, you could easily see the stories in it taking place in real life." and "You could picture yourself or someone you know in the stories described in the play."
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start11 Nov 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT06501885
- Sponsor's protocol ID
- Pro00115054
- Other IDs
- R01TW012673
- Status last verified
- Oct 2025
- First submitted
- 9 Jul 2024
- Last updated
- 29 Jul 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 29 Jul 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
- NCT06501885
- Acronym / sponsor ID
- Pro00115054
- Conditions
- HIV
- Keywords
- Stigma, HIV, PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 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
- 11 Nov 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 15 Jul 2024 (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 develop and pre-test an ethnodrama intervention designed to transform community member beliefs about and foster support of young cisgender women (YCW) using PrEP.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethnodrama Audience Members | Experimental | Behavioral: Ethnodrama Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 | Ethnodrama Audience Members |
Primary outcome
Acceptability of the intervention storylines and interactive components
Time frame: Immediately post-intervention
The investigators will gather feedback on the acceptability of the storylines (e.g., perceptions of whether the storylines seem relatable) and interactive components, as measured by several single-item questions scored from 1 (strongly agree) to 6 (strongly disagree), with lower scores reflecting greater acceptability.
1 secondary outcome
Potential effectiveness of the intervention's storylines on "transporting" participants, as measured by a brief interviewer-administered survey using the Narrative Transportation Scale (NTS).
Time frame: Immediately 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 29 Jul 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 7 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 29 Jul 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?
Acceptability of the intervention storylines and interactive components (time frame: Immediately post-intervention). 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 29 Jul 2026.