Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03568682 |
| Other study ID # |
R34MH110325 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2018 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
RAND |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This pilot study proposes to develop, implement, and evaluate the feasibility, acceptability
and preliminary effectiveness of a culturally appropriate, multi-component intervention
combining peer nutrition counseling with sustainable urban gardening among people with HIV in
the Dominican Republic. The overall hypothesis is that this combined intervention will
improve adherence to antiretroviral therapy (ART) and virologic suppression among food
insecure HIV+ individuals with suboptimal adherence.
Description:
The purpose of this pilot clinical trial is to evaluate the feasibility, acceptability, and
preliminary effectiveness of a culturally appropriate, multi-component intervention that
targets food insecurity and nutritional health with the ultimate goal of improving
antiretroviral therapy adherence and virologic suppression for people with HIV in the
Dominican Republic. Through an initial phase, we conducted formative research on dietary
patterns and locally available foods and, together with our preliminary research on
nutritional counseling and urban gardening, developed a multi-component nutrition
intervention to address food insecurity among people with HIV that integrates
culturally-appropriate, peer-led nutritional education with a sustainable urban garden
component. During the clinical trial phase, we will enroll 120 HIV+ adults with food
insecurity and suboptimal adherence in 2 HIV clinics (60 participants in the intervention
clinic and 60 participants in the control clinic) and will evaluate the feasibility,
acceptability and preliminary effectiveness of urban gardening plus peer nutritional
counseling on improving virologic suppression and ART adherence in both the short (month 6)
and longer terms (month 12). We will also explore preliminary intervention effects on
potential mediators (food security, nutritional status, internalized HIV stigma, and social
support). As one of the first studies to develop a sustainable food production approach with
peer nutrition counseling among people with HIV, key products will include: 1) an easy-to-use
peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on
the feasibility, acceptability, and effects of our intervention on primary outcomes and
potential mediators; and 3) if results are promising, an R01 application to conduct a
fully-powered cluster randomized controlled trial that examines effects across a larger
number of clinics in the Dominican Republic.
