NCT05692531

Brief Summary

Using a quasi-experimental evaluation approach, the purpose of this study is to assess feasibility, acceptability, and preliminary efficacy of a novel community-level intervention component, which is a filmed dramatization or set of "scenarios" to be "screened" in a virtual event. Attendees will be polled and engaged in an evaluation of the scenarios, before during and after the screening. This NCT registration is for the final aim of the study as described in the detailed description (AIMS) below. (Please note Aims 1-2 are complete.)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

December 22, 2022

Last Update Submit

January 19, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • internalized/anticipated HIV stigma

    single-item, adapted, self-reported internalized/anticipated HIV stigma; we will use an item from Sayles et al (2008) valid and reliable measure of internalized/anticipated stigma (for example "I am living with HIV and feel ashamed when I tell people that I have HIV/I am not living with HIV but would feel ashamed if I had to tell people that I have HIV"). This item is adapted from Sayles, J. N., Hays, R. D., Sarkisian, C. A., Mahajan, A. P., Spritzer, K. L., \& Cunningham, W. E. (2008). Development and psychometric assessment of a multidimensional measure of internalized HIV stigma in a sample of HIV-positive adults. AIDS and Behavior, 12(5), 748-758.

    immediately post-intervention

  • internalized homophobia

    single-item, self-reported internalized HIV stigma; we will use items from a valid and reliable measure of internalized homophobia (Smolenski et al 2010; for example "I would change myself to be heterosexual, if I could") From: Smolenski, D. J., Diamond, P. M., Ross, M. W., \& Rosser, B. S. (2010). Revision, criterion validity, and multigroup assessment of the Reactions to Homosexuality Scale. Journal of Personality Assessment,92, 568-576

    immediately post-intervention

  • internalized/anticipated PrEP stigma

    single-item, self-reported PrEP stigma; we will use an item from a measure of PrEP stigma (Frye et al 2020) (for example "People who who use PrEP are having too much sex or sex with the wrong kinds of people") From: Chittamuru, D., Frye, V., Koblin, B. A., Brawner, B., Tieu, H. V., Davis, A., \& Teitelman, A. M. (2020). PrEP stigma, HIV stigma, and intention to use PrEP among women in New York City and Philadelphia. Stigma and health, 5(2), 240.

    immediately post-intervention

  • HIV testing stigma

    single-item, self-reported HIV testing stigma; we will use an item adapted from a measure of HIV testing stigma (for example "if people know I get HIV tests frequently, they will think I am promiscuous or am having sex with men") From: Andrinopoulos, K., Hembling, J., Guardado, M. E., de Maria Hernández, F., Nieto, A. I., \& Melendez, G. (2015). Evidence of the negative effect of sexual minority stigma on HIV testing among MSM and transgender women in San Salvador, El Salvador. AIDS and Behavior, 19(1), 60-71.

    immediately post-intervention

Study Arms (1)

A Story Within A Story

EXPERIMENTAL

This is a single event that will be evaluated using quasi-experimental design methods.

Behavioral: A Story Within A Story

Interventions

The intervention is the screening via Zoom of "A Story Within A Story," two dramatized scenarios. The first depicts a reinforcing feedback loop connecting internalized, anticipated and enacted HIV stigma and serosorting within the Black SGL/MSM community. Set during the COVID-19 pandemic, it depicts a Zoom call among three generations of Black SGL/MSM, a chosen family. In this scene, the oldest member of the family, not knowing that the youngest has just tested positive for HIV, describes how they would never partner with someone who was living with HIV because of what they saw at the beginning of the HIV epidemic. The middle-aged member attempts to mitigate the damage done by this, while the youngest member describes what kind of support he needs. The second scenario depicts a Telehealth visit between a young Black gay man and his sexual health provider; his older lover joins the call at one point and the focus is on sexual communication and PrEP use.

Also known as: CHHARGE novel component
A Story Within A Story

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all attendees of the event

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Victoria Frye, DrPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is an evaluation of a virtual event. The investigators will conduct a social media metrics analysis (of the social media-based run-up to the event as well as the actual event) via responses to polls embedded within the social media-based run-up, and sentiment assessment and analysis during the event itself. The investigators will conduct "flash polls" during the event using sentiments that reflect key stigmatization process-related aspects of the scenarios being depicted, for example asking attendees to rate the actors on specific qualities on a scale of 1 to 10 (for example, "respect" "admire" "dislike" "annoyed" "tactful" "sensitive" "shady" etc.); the investigators will repeat this after the scenarios are screened and integrate the immediate results into the discussion of the filmed scenarios. The investigators will conduct flash polls on confidence confronting stigmatizing language toward someone who is considering taking PrEP.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Professor

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 20, 2023

Study Start

March 1, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01