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Improving Antiretroviral Therapy Adherence Through Urban Gardening and Nutritional Counseling in the Dominican Republic

Improving ART Adherence Through Urban Gardening and Peer Nutritional Counseling in the Dominican Republic

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03568682
Acronym
ProMeSA
Enrollment
115
Registered
2018-06-26
Start date
2018-05-22
Completion date
2021-09-30
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

food insecurity, nutrition, treatment adherence

Brief 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.

Detailed 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.

Interventions

BEHAVIORALNutritional counseling + urban gardening

Peer nutritional counseling and urban gardens

Sponsors

Universidad Autonoma de Santo Domingo
CollaboratorUNKNOWN
Ministerio de Salud Publica, Dominican Republic
CollaboratorUNKNOWN
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HIV+ and on ART * Has moderate or severe household food insecurity * Has detectable viral load (\>50 copies) and/or suboptimal adherence to ART

Exclusion criteria

* Does not meet above criteria

Design outcomes

Primary

MeasureTime frameDescription
Change in viral loadChange in viral load between baseline and months 6 and 12Change in viral load

Secondary

MeasureTime frameDescription
Antiretroviral therapy adherenceMonths 6 and 12Self-reported adherence and verified through pharmacy records
HIV care retentionMonths 6 and 12Self-reported missed clinic visits verified through clinic records

Countries

Dominican Republic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026