Clinical trial NCT04491539: Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
Official title: Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: Stigma
Intervention
HIV
Dominican Republic
Spanish
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-07-29
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pre- and post- intervention participation assessment; arms represent participant types, either healthcare worker or person with HIV (PWH) client.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: HIV-related Stigma
timeFrame: Year 2
measure: HIV Knowledge Index
timeFrame: Year 2
measure: Empathy and Avoidance in Treating Patients Living With HIV/AIDS
timeFrame: Year 2
Secondary outcomes:
measure: Multiple Discrimination Scale - Orientation
timeFrame: Year 2
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References: