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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491539
• Other study ID #: 526497
• Status: Completed
• Phase: N/A
• Start date: November 28, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stepped wedge cluster randomized controlled trial of the adapted FRESH intervention.

Description:

The proposed study addresses the high level of stigma against people living with HIV (PLWH), particularly gender and sexual minorities, that is embedded in the Dominican Republic's HIV treatment system through the adaptation and testing of a patient-provider intervention -- Finding Respect and Ending Stigma around HIV (FRESH). The Dominican Republic is a high priority setting with an increasing need for HIV stigma reduction studies. The Caribbean holds the second highest regional burden of HIV in the world, yet receives insufficient HIV-related stigma research funding. The Dominican Republic is 1 of 5 countries that accounts for over 95% of all Caribbean HIV infections; it also has a significant concentrated HIV epidemic, a deeply conservative society in which PLWH are stigmatized, and an exceptionally low national viral load suppression rate. To accomplish this pilot study, three Specific Aims are proposed. Aim 1 is to explore sources, characteristics, and consequences of HIV-related and intersectional stigmas experienced in healthcare settings by MSM and transgender women to inform the adaptation of FRESH. To accomplish Aim 1, we will conduct qualitative in-depth interviews with healthcare workers who provide HIV care, focus groups with MSM, and in-depth interviews with transgender women. Aim 2 is to adapt FRESH to address stigmas experienced by MSM and transgender women in the Dominican Republic. We will apply the Aim 1 findings using the ADAPT-ITT framework to systematically adapt FRESH, an intervention that has been employed to reduce stigma in healthcare settings in Africa and the United States. Through an iterative process, each revision of FRESH will be shared with both PLWH and healthcare workers to solicit and incorporate their feedback about each version of the adapted intervention. Aim 3 will pilot-test the adapted intervention to obtain estimates of its ability to reduce stigmatizing attitudes and behaviors from HWs and experiences of stigma reported by sexual and gender minorities (SGM) and non-SGM clients living with HIV (primary); while exploring if FRESH has the potential to influence clinic-level HIV cascade outcomes.. By adapting and testing the FRESH intervention for the Spanish-speaking Caribbean, FRESH could become a validated, multi-region HIV and intersectional stigma reduction intervention designed specifically for healthcare settings in high-stigma, culturally conservative, resource-constrained communities; such a scientific development would be a significant contribution to HIV stigma reduction efforts in the Caribbean and globally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria for health worker participants:

• 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

Inclusion Criteria for people living with HIV participants:

• 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

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• Hiv

Intervention

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

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-related stigma among health facility staff	18 questions measure 3 programmatically actionable drivers of stigma in health facilities (worry about transmission, attitudes towards people living with HIV, and health facility environment), and enacted stigma. The questionnaire also includes one short scale for attitudes towards PLHIV (5-item scale, a = 0.78). No reverse coding. See https://onlinelibrary.wiley.com/doi/full/10.7448/IAS.16.3.18718 for the original source of this multi-component scale.	Year 2
Primary	HIV Knowledge Index	Survey used in the Dominican Republic	Year 2
Primary	Empathy and avoidance in treating patients living with HIV/AIDS (PLWHA)	Response categories ranged from (1) "strongly agree" to (5) "strongly disagree," and the overall scale was the sum of individual items. Some items were reverse-coded so that a higher score indicated a higher level of empathy. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419277/ for original scale information.	Year 2
Secondary	HIV Continuum of Care Outcomes	Clinic level viral load suppression	Years 1-2