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

September 19, 2022 updated by: Kathryn Derose, RAND

Improving ART Adherence Through Urban Gardening and Peer 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
    • La Vega
      • Concepcion de La Vega, La Vega, Dominican Republic
        • Hospital Regional Dr. Luis Manuel Morillo King
    • Valverde
      • Mao, Valverde, Dominican Republic
        • Hospital Regional Luis L. Bogaert

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional counseling + urban gardening
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.
Behavioral: Nutritional counseling + urban gardening
Peer nutritional counseling and urban gardens
No Intervention: Usual care control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in viral load
Time Frame: Change in viral load between baseline and months 6 and 12
Change in viral load
Change in viral load between baseline and months 6 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiretroviral therapy adherence
Time Frame: Months 6 and 12
Self-reported adherence and verified through pharmacy records
Months 6 and 12
HIV care retention
Time Frame: Months 6 and 12
Self-reported missed clinic visits verified through clinic records
Months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

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

Investigators

  • Principal Investigator: Kathryn P Derose, PhD, MPH, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R34MH110325 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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