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

RanD

Status: Completed

Conditions: HIV

Treatments: Behavioral: Nutritional counseling + urban gardening

Study type: Interventional

Funder types: Other

Identifiers

NCT03568682

R34MH110325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Nutritional counseling + urban gardening

Experimental group

Description:

Participants in the intervention clinic will receive: 1) nutritional counseling from peer counselors in their clinic (approximately 4-5 sessions administered monthly); 2) training from the Ministry of Agriculture on how to plant and maintain a garden in their home (training workshop and monthly follow-up); and 3) a cooking and nutrition workshop facilitated by project nutritionists once garden produce are available.

Treatment:

Behavioral: Nutritional counseling + urban gardening

Usual care control

No Intervention group

Description:

Participants in the control clinic will receive their usual care from the clinic. After 12 month follow-up, they will be offered the opportunity to receive the intervention.