HivNCT04491539

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

A study testing Finding Respect and Ending Stigma around HIV (FRESH) in people with Hiv, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Hiv
What is being tested?: Finding Respect and Ending Stigma around HIV (FRESH)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 28 Nov 2020to 30 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

Does not meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida State University
Tallahassee, Florida, 32306

Other trials in United States

About this study

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.

Read the 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.

Conditions: Hiv
Being tested: Finding Respect and Ending Stigma around HIV (FRESH)
Keywords: Stigma, Intervention, HIV, Dominican Republic, Spanish
Medical subject headings: Acquired Immunodeficiency Syndrome, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Finding Respect and Ending Stigma around HIV (FRESH)Behavioural
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.

Study groups in NCT04491539
Study group	Role	What they receive
Healthcare Workers or Providers	Experimental	Healthcare Workers or Providers receiving the FRESH intervention. Arm to test the intervention's effect on this specific population. Receives: 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. Receives: Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: Year 2

Secondary outcomes (1)

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).
Measured: Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 202030 Jun 2023

First posted29 Jul 2020
Study start28 Nov 2020
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Model description: Pre- and post- intervention participation assessment; arms represent participant types, either healthcare worker or person with HIV (PWH) client.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04491539
Sponsor's protocol ID: 526497
Other IDs: 5R21TW011761-02
Status last verified: May 2025
First submitted: 24 Jul 2020
Last updated: 16 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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).

Publications

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.
PubMed 41199402
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.
PubMed 40988523

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
ClinicalTrials.gov ID: NCT04491539
Acronym / sponsor ID: 526497
Conditions: Hiv
Keywords: Stigma, Intervention, HIV, Dominican Republic, Spanish
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Collaborators: Fogarty International Center of the National Institute of Health
Study start: 28 Nov 2020 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 29 Jul 2020 (actual)
Results: Posted 16 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Pre- and post- intervention participation assessment; arms represent participant types, either healthcare worker or person with HIV (PWH) client.

Arm	Type	Receives
Healthcare Workers or Providers	Experimental	Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)Healthcare Workers or Providers receiving the FRESH intervention. Arm to test the intervention's effect on this specific population.
Clients	Experimental	Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)People with HIV Clients receiving the FRESH intervention. Arm to test the intervention's effect on this specific population.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (1 listed)

Does not meet inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Clients, Healthcare Workers or Providers

Primary outcome

HIV-related Stigma
Time frame: Year 2
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).
HIV Knowledge Index
Time frame: Year 2
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.
Empathy and Avoidance in Treating Patients Living With HIV/AIDS
Time frame: Year 2
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).

1 secondary outcome

Multiple Discrimination Scale - Orientation
Time frame: Year 2

Results and safety

Results posted to the registry on 16 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Providers or Healthcare Workers	20	20
People With HIV (PWH) Clients	16	16

Primary outcome: HIV-related Stigma

Time frame: Year 2. Mean (Standard Deviation). Unit: units on a scale

Measure	Providers n = 20	Clients n = 16
Pre-Intervention	8.74 (3.12)	10.25 (3.91)
Post-Intervention	7.16 (2.40)	8.42 (4.03)

Population analysed: 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).

Primary outcome: HIV Knowledge Index

Time frame: Year 2. Mean (Standard Deviation). Unit: units on a scale

Measure	Providers or Healthcare Workers n = 20	People With HIV (PWH) Clients n = 0
Pre-Intervention	7.00 (0.58)	–
Post-Intervention	6.63 (0.76)	–

Primary outcome: Empathy and Avoidance in Treating Patients Living With HIV/AIDS

Time frame: Year 2. Mean (Standard Deviation). Unit: units on a scale

Measure	Providers or Healthcare Workers n = 20	People With HIV (PWH) Clients n = 0
Pre-Intervention	37.10 (4.64)	–
Post-Intervention	38.00 (5.70)	–

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Providers or Healthcare Workers	0 of 20 (0%)	0 of 20 (0%)	0 of 20
People With HIV (PWH) Clients	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41199402Budhwani 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.
Derived from this study: PubMed 40988523Yigit 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.
Individual participant dataSharing planned: No. 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).

Related trials for Hiv

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Finding Respect and Ending Stigma around HIV (FRESH) in people with Hiv, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-related Stigma (time frame: Year 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04491539, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.