Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic

NCT04491539 | Completed Results DMC

• 2 other identifiers: 5264975R21TW011761-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This research has the potential to make important contributions toward HIV and intersectional stigma reduction across the Spanish-speaking Caribbean. It will do so by adapting and testing a patient-provider, clinic-based intersectional stigma-reduction intervention -- Finding Respect and Ending Stigma around HIV (FRESH) -- for the Dominican Republic. Preliminary results from this R21 study (e.g. workshop satisfaction, stigma outcomes, HIV continuum of care outcomes, etc.) will inform the development of an investigator-initiated R01 proposal to conduct a full scale randomized controlled trial of the adapted FRESH intervention.

Conditions

Hiv

Keywords

Stigma; Intervention; HIV; Dominican Republic; Spanish

Outcome Measures

Primary Outcomes (3)

• HIV-related Stigma

  For providers, the results are reported for the Opinions about People with HIV sub-scale from the HIV-related stigma among health facility staff scale, 6 questions. Response options are Strongly Agree, Agree, Disagree, and Strongly Disagree. This scale does not include reverse coding. Higher scores indicate higher levels of stigma. The score can range from 5 (min) to 20 (max). For clients, the results are reported for the Experiencing HIV-related Stigma in Healthcare Settings scale, 5 questions. Response options are Never, Rarely, Sometimes, Usually, and Always. This scale does not include reverse coding. Higher scores indicate higher levels of stigma. The score can range from 0 (min) to 20 (max).

  Year 2

• HIV Knowledge Index

  Results are reported for the HIV Knowledge Index from providers only. This is not a validated scale but was being tested in the context of this study. It included 13 homegrown questions. Range was 0 (min) to 13 (max), with higher scores indicating greater knowledge.

  Year 2

• Empathy and Avoidance in Treating Patients Living With HIV/AIDS

  For providers, the results are reported for empathy and avoidance in treating patients living with HIV/AIDS, 11 questions. Response options are Strongly Agree, Agree, Neutral, Disagree, and Strongly Disagree. This scale includes reverse coding. Higher scores indicate higher levels of stigma. The score can range from 11 (min) to 55 (max).

  Year 2

Secondary Outcomes (1)

• Multiple Discrimination Scale - Orientation

  Year 2

Study Arms (2)

Healthcare Workers or Providers

EXPERIMENTAL

Healthcare Workers or Providers receiving the FRESH intervention. Arm to test the intervention's effect on this specific population.

Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)

Clients

EXPERIMENTAL

People with HIV Clients receiving the FRESH intervention. Arm to test the intervention's effect on this specific population.

Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)

Interventions

Finding Respect and Ending Stigma around HIV (FRESH) BEHAVIORAL

The Finding Respect and Ending Stigma around HIV (FRESH) intervention is theoretically informed by Social Cognitive Theory (SCT) and Interpersonal Contact theory (ICT) and was specifically designed for delivery in high-stigma settings, such as Dominican Republic. FRESH was originally developed in Africa to address HIV-related stigma, and later was adapted to address intersectional stigmas experienced by sexual and gender minorities (SGM) living with HIV in the United States Deep South. To our knowledge, FRESH will be the first intervention to address intersectional stigmas experienced by men who have sex with men, transgender women, and people living with HIV in clinical settings in the Spanish-speaking Caribbean.

Clients; Healthcare Workers or Providers

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimally 18 years and 0 months of age
• Works at one of the three study sites
• Interacts with people living with HIV
• Spanish speaking
• Can read Spanish text
• Able and willing to provide informed consent
• Minimally 16 years and 0 months of age
• Is HIV-positive
• Spanish speaking
• Receives treatment at one of the three study sites
• Identifies as an SGM
• Able and willing to provide informed consent

Sponsors & Collaborators

• Florida State University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (2)

• Budhwani H, Yigit I, Paulino-Ramirez R, Waters J, Bond CL, Varas-Diaz N, Naar S, Nyblade L, Turan JM. Finding Respect and Ending Stigma around HIV (FRESH) intervention in the Dominican Republic: results from a pilot study. BMC Glob Public Health. 2025 Nov 7;3(1):99. doi: 10.1186/s44263-025-00219-w.

  PMID: 41199402 DERIVED

• Yigit I, Paulino-Ramirez R, Waters J, Turan JM, Budhwani H. Disclosure concerns moderate the association between internalized stigma and antiretroviral medication adherence among people with HIV in the Dominican Republic. AIDS Care. 2025 Nov;37(11):1950-1958. doi: 10.1080/09540121.2025.2562253. Epub 2025 Sep 24.

  PMID: 40988523 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Limitations and Caveats

Data was collected from two clinics and the sample size was small. A selection bias could have affected results wherein providers who were amenable to change may have been more likely to participate and clients with higher levels of self-efficacy may have been more likely to attend the workshop.

Results Point of Contact

• Title: Henna Budhwani
• Organization: Florida State University

hbudhwani@fsu.edu

(850) 644-3296

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre- and post- intervention participation assessment; arms represent participant types, either healthcare worker or person with HIV (PWH) client.

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: November 28, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)