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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pilot stepped wedged cluster randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Adaptation<br>Site will inform the adaptation of the FRESH intervention. | |
| Experimental: First Receipt<br>Site will received the adapted FRESH intervention first. | Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)<br>* 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.<br>|
| Experimental: Second Receipt<br>Site will received the adapted FRESH intervention second. | Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, α = 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 | 
| HIV Knowledge Index | Survey used in the Dominican Republic | Year 2 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Continuum of Care Outcomes | Clinic level viral load suppression | Years 1-2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, Intervention, HIV, Dominican Republic, Spanish