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

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04491539
Collaborator
(none)
3
1
3
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Study Details

Study Description

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 stepped wedge cluster randomized controlled trial of the adapted FRESH intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Finding Respect and Ending Stigma around HIV (FRESH)
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Pilot stepped wedged cluster randomized controlled trial.Pilot stepped wedged cluster randomized controlled trial.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
Actual Study Start Date :
Nov 28, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Adaptation

Site will inform the adaptation of the FRESH intervention.

Experimental: First Receipt

Site will received the adapted FRESH intervention first.

Behavioral: 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.

Experimental: Second Receipt

Site will received the adapted FRESH intervention second.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Stigma and Discrimination in Health Care Facilities [Year 2]

    This will be assessed via participant observation in clinical settings; there is no standardized scale.

  2. HIV Knowledge Scale (HIV-KQ-19) [Year 2]

    Includes 18 T/F questions to be collected from providers and patients

  3. Berger HIV Stigma Sclae [Year 2]

    40-item instrument with sub-scales on empathy, enacted stigma, and disclosure concerns

Secondary Outcome Measures

  1. HIV Continuum of Care Outcomes [Years 1-2]

    Aggregated cascade data by clinic from the Ministry of Health. This includes rates of viral suppression, those on antiretroviral therapies, and number of newly diagnosed patients licing with HIV per clinic.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham (UAB) Birmingham Alabama United States 35294

Sponsors and Collaborators

  • Florida State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henna Budhwani, Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT04491539
Other Study ID Numbers:
  • 526497
First Posted:
Jul 29, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Henna Budhwani, Professor, Florida State University

Study Results

No Results Posted as of Aug 22, 2022