NCT06501885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2025

Completed
Last Updated

July 29, 2026

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

July 9, 2024

Last Update Submit

July 28, 2026

Conditions

HIV

Keywords

StigmaHIVPrEP

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

    Immediately post-intervention

Study Arms (1)

Ethnodrama Audience Members

EXPERIMENTAL
Behavioral: Ethnodrama Intervention

Interventions

Ethnodrama InterventionBEHAVIORAL

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.

Ethnodrama Audience Members

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender will be self-identified
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Impact Research and Development

Kisumu, Kisumu County, 40100, Kenya

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Amy Corneli, PhD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 15, 2024

Study Start

November 11, 2024

Primary Completion

September 3, 2025

Study Completion

September 3, 2025

Last Updated

July 29, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)