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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04491539
Enrollment
36
Registered
2020-07-29
Start date
2020-11-28
Completion date
2023-06-30
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Keywords

Stigma, Intervention, HIV, Dominican Republic, Spanish

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.

Detailed 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 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.

Interventions

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.

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
Florida State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

No masking.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HIV-related StigmaYear 2For 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).
HIV Knowledge IndexYear 2Results 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.
Empathy and Avoidance in Treating Patients Living With HIV/AIDSYear 2For 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).

Secondary

MeasureTime frameDescription
Multiple Discrimination Scale - OrientationYear 2For 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Providers
Healthcare providers from both clinics that received the FRESH intervention.
20
Clients
People with HIV clients from both clinics that received the FRESH intervention.
16
Total36

Baseline characteristics

CharacteristicProvidersClientsTotal
Age, Customized40.40 years
STANDARD_DEVIATION 10.33
32.47 years
STANDARD_DEVIATION 6.78
36.88 years
STANDARD_DEVIATION 5.61
Race/Ethnicity, Customized
Black
4 participants6 participants10 participants
Race/Ethnicity, Customized
Multiracial
14 participants8 participants22 participants
Race/Ethnicity, Customized
Other or Not Reported
0 participants2 participants3 participants
Race/Ethnicity, Customized
White
2 participants0 participants2 participants
Region of Enrollment
Dominican Republic
20 participants16 participants36 participants
Sex/Gender, Customized
Female
16 participants0 participants16 participants
Sex/Gender, Customized
Male
4 participants13 participants17 participants
Sex/Gender, Customized
Not Reported or Other
0 participants3 participants3 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 16
other
Total, other adverse events
0 / 200 / 16
serious
Total, serious adverse events
0 / 200 / 16

Outcome results

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).

Time frame: Year 2

Population: 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).

ArmMeasureGroupValue (MEAN)Dispersion
ProvidersEmpathy and Avoidance in Treating Patients Living With HIV/AIDSPre-Intervention37.10 units on a scaleStandard Deviation 4.64
ProvidersEmpathy and Avoidance in Treating Patients Living With HIV/AIDSPost-Intervention38.00 units on a scaleStandard Deviation 5.7
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.

Time frame: Year 2

Population: 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).

ArmMeasureGroupValue (MEAN)Dispersion
ProvidersHIV Knowledge IndexPre-Intervention7.00 units on a scaleStandard Deviation 0.58
ProvidersHIV Knowledge IndexPost-Intervention6.63 units on a scaleStandard Deviation 0.76
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).

Time frame: Year 2

Population: 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).

ArmMeasureGroupValue (MEAN)Dispersion
ProvidersHIV-related StigmaPre-Intervention8.74 units on a scaleStandard Deviation 3.12
ProvidersHIV-related StigmaPost-Intervention7.16 units on a scaleStandard Deviation 2.4
ClientsHIV-related StigmaPre-Intervention10.25 units on a scaleStandard Deviation 3.91
ClientsHIV-related StigmaPost-Intervention8.42 units on a scaleStandard Deviation 4.03
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).

Time frame: Year 2

Population: 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).

ArmMeasureGroupValue (MEAN)Dispersion
ClientsMultiple Discrimination Scale - OrientationPre-Intervention0.83 units on a scaleStandard Deviation 2.29
ClientsMultiple Discrimination Scale - OrientationPost-Intervention1.45 units on a scaleStandard Deviation 2.42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026