Trial Outcomes & Findings for Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic (NCT NCT04491539)
NCT ID: NCT04491539
Last Updated: 2025-05-16
Results Overview
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).
COMPLETED
NA
36 participants
Year 2
2025-05-16
Participant Flow
Participant milestones
| Measure |
Providers or Healthcare Workers
Half the providers received the Finding Respect and Ending Stigma around HIV (FRESH) intervention first, and then 6-months later, the other half of providers received the intervention. The goal of this pilot study was not to compare outcomes by site or intervention receipt order, rather it was to assess the impact of the intervention on each group, in the case providers; thus, we conducted pre- and post-intervention evaluations by participant type.
|
People With HIV (PWH) Clients
Half the PWH clients received the Finding Respect and Ending Stigma around HIV (FRESH) intervention first, and then 6-months later, the other half of PWH clients received the intervention. The goal of this pilot study was not to compare outcomes by site or intervention receipt order, rather it was to assess the impact of the intervention on each group, in the case PWH clients; thus, we conducted pre- and post-intervention evaluations by participant type.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adapting the Finding Respect and Ending Stigma Around HIV (FRESH) Intervention for the Dominican Republic
Baseline characteristics by cohort
| Measure |
Providers
n=20 Participants
Healthcare providers from both clinics that received the FRESH intervention.
|
Clients
n=16 Participants
People with HIV clients from both clinics that received the FRESH intervention.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
40.40 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
32.47 years
STANDARD_DEVIATION 6.78 • n=7 Participants
|
36.88 years
STANDARD_DEVIATION 5.61 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
4 participants
n=5 Participants
|
13 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
16 participants
n=5 Participants
|
0 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Reported or Other
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or Not Reported
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Year 2Population: 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).
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).
Outcome measures
| Measure |
Providers
n=20 Participants
Change in scores among providers pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
Clients
n=16 Participants
Change in scores among people with HIV (PWH) clients pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
|---|---|---|
|
HIV-related Stigma
Pre-Intervention
|
8.74 units on a scale
Standard Deviation 3.12
|
10.25 units on a scale
Standard Deviation 3.91
|
|
HIV-related Stigma
Post-Intervention
|
7.16 units on a scale
Standard Deviation 2.40
|
8.42 units on a scale
Standard Deviation 4.03
|
PRIMARY outcome
Timeframe: Year 2Population: 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).
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.
Outcome measures
| Measure |
Providers
n=20 Participants
Change in scores among providers pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
Clients
Change in scores among people with HIV (PWH) clients pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
|---|---|---|
|
HIV Knowledge Index
Pre-Intervention
|
7.00 units on a scale
Standard Deviation 0.58
|
—
|
|
HIV Knowledge Index
Post-Intervention
|
6.63 units on a scale
Standard Deviation 0.76
|
—
|
PRIMARY outcome
Timeframe: Year 2Population: 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).
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).
Outcome measures
| Measure |
Providers
n=20 Participants
Change in scores among providers pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
Clients
Change in scores among people with HIV (PWH) clients pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
|---|---|---|
|
Empathy and Avoidance in Treating Patients Living With HIV/AIDS
Pre-Intervention
|
37.10 units on a scale
Standard Deviation 4.64
|
—
|
|
Empathy and Avoidance in Treating Patients Living With HIV/AIDS
Post-Intervention
|
38.00 units on a scale
Standard Deviation 5.70
|
—
|
SECONDARY outcome
Timeframe: Year 2Population: 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).
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).
Outcome measures
| Measure |
Providers
Change in scores among providers pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
Clients
n=16 Participants
Change in scores among people with HIV (PWH) clients pre- and post- attending the intervention, regardless of if they received the intervention in the first or second cycle of delivery.
|
|---|---|---|
|
Multiple Discrimination Scale - Orientation
Pre-Intervention
|
—
|
0.83 units on a scale
Standard Deviation 2.29
|
|
Multiple Discrimination Scale - Orientation
Post-Intervention
|
—
|
1.45 units on a scale
Standard Deviation 2.42
|
Adverse Events
Providers or Healthcare Workers
People With HIV (PWH) Clients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place