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Completed

NCT Number: NCT04491539

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

Secondary outcomes

  1. Multiple Discrimination Scale - Orientation

    Time frame: Year 2

    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).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2020
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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