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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21TW011761-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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 randomized controlled trial of the adapted FRESH intervention.
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 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 trans- women. Aim 2 is to adapt FRESH to address stigmas experienced these individuals 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthcare Workers or Providers | Experimental | Healthcare Workers or Providers receiving the FRESH intervention. Arm to test the intervention's effect on this specific population. |
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| Clients | Experimental | People with HIV Clients receiving the FRESH intervention. Arm to test the intervention's effect on this specific population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Discrimination Scale - Orientation | For clients, the results are reported for experiences of discrimination related to sexual orientation, 10 questions. Response options are Yes and No. Higher scores indicate higher levels of stigma. The score can range from 0 (min) to 10 (max). | Year 2 |
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Inclusion Criteria for health worker participants:
Inclusion Criteria for people living with HIV participants:
Exclusion Criteria:
• Does not meet inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41199402 | Derived | 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. | |
| 40988523 | 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. |
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All data gathered during the proposed study will be available to all participating investigators and institutions. This includes the University of Alabama at Birmingham (UAB), Universidad Iberoamericana (UNIBE), and the Caribbean Vulnerable Communities Coalition (CVC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Providers or Healthcare Workers | Half the providers received the Finding Respect and Ending Stigma around HIV (FRESH) intervention first, and then 6-months later, the other half of providers received the intervention. The goal of this pilot study was not to compare outcomes by site or intervention receipt order, rather it was to assess the impact of the intervention on each group, in the case providers; thus, we conducted pre- and post-intervention evaluations by participant type. |
| FG001 | People With HIV (PWH) Clients | Half the PWH clients received the Finding Respect and Ending Stigma around HIV (FRESH) intervention first, and then 6-months later, the other half of PWH clients received the intervention. The goal of this pilot study was not to compare outcomes by site or intervention receipt order, rather it was to assess the impact of the intervention on each group, in the case PWH clients; thus, we conducted pre- and post-intervention evaluations by participant type. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Providers | Healthcare providers from both clinics that received the FRESH intervention. |
| BG001 | Clients | People with HIV clients from both clinics that received the FRESH intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Pre -and post- survey measures were then compared to assess the change after the FRESH workshop intervention using paired t-tests if the normality was confirmed. The significance level was identified as p<0.05. All analyses were performed with SAS (Version 9.4, Cray, North Carolina, USA). | Posted | Mean | Standard Deviation | units on a scale | Year 2 |
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Participants were actively monitored over the duration of the 2.5 day intervention but could report adverse events up to 6 months after receipt of the intervention.
No deviation from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Providers or Healthcare Workers | Providers received the adapted Finding Respect and Ending Stigma around HIV (FRESH) intervention. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henna Budhwani | Florida State University | (850) 644-3296 | hbudhwani@fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2022 | Apr 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Pre- and post- intervention participation assessment; arms represent participant types, either healthcare worker or person with HIV (PWH) client.
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No masking.
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|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Providers |
Change in scores among providers pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery. |
| OG001 | Clients | Change in scores among people with HIV (PWH) clients pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery. |
|
|
| Primary | 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. | Pre -and post- survey measures were then compared to assess the change after the FRESH workshop intervention using paired t-tests if the normality was confirmed. The significance level was identified as p<0.05. All analyses were performed with SAS (Version 9.4, Cray, North Carolina, USA). | Posted | Mean | Standard Deviation | units on a scale | Year 2 |
|
|
|
| Primary | 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). | Pre -and post- survey measures were then compared to assess the change after the FRESH workshop intervention using paired t-tests if the normality was confirmed. The significance level was identified as p<0.05. All analyses were performed with SAS (Version 9.4, Cray, North Carolina, USA). | Posted | Mean | Standard Deviation | units on a scale | Year 2 |
|
|
|
| Secondary | Multiple Discrimination Scale - Orientation | For clients, the results are reported for experiences of discrimination related to sexual orientation, 10 questions. Response options are Yes and No. Higher scores indicate higher levels of stigma. The score can range from 0 (min) to 10 (max). | Pre -and post- survey measures were then compared to assess the change after the FRESH workshop intervention using paired t-tests if the normality was confirmed. The significance level was identified as p<0.05. All analyses were performed with SAS (Version 9.4, Cray, North Carolina, USA). | Posted | Mean | Standard Deviation | units on a scale | Year 2 |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | People With HIV (PWH) Clients | Clients received the adapted Finding Respect and Ending Stigma around HIV (FRESH) intervention. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |