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Completed

NCT Number: NCT03568682

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Dr. Luis Manuel Morillo King, Concepción de la Vega, La Vega, Dominican Republic

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional counseling + urban gardening

Behavioral

Peer nutritional counseling and urban gardens

Primary outcomes

  1. Change in viral load

    Time frame: Change in viral load between baseline and months 6 and 12

    Change in viral load

Secondary outcomes

  1. Antiretroviral therapy adherence

    Time frame: Months 6 and 12

    Self-reported adherence and verified through pharmacy records

  2. HIV care retention

    Time frame: Months 6 and 12

    Self-reported missed clinic visits verified through clinic records

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Ministerio de Salud Publica, Dominican Republic
  • Universidad Autonoma de Santo Domingo

Registry information

Official study title

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

Acronym: ProMeSA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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