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

• ClinicalTrials.gov Identifier: NCT03568682
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2018
• Last Update Posted: October 6, 2020
• Sponsor: RAND
• Collaborators: Universidad Autonoma de Santo Domingo; Ministerio de Salud Publica, Dominican Republic
• Information provided by (Responsible Party): Kathryn Derose, RAND

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: Nutritional counseling + urban gardening	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Improving ART Adherence Through Urban Gardening and Peer Nutritional Counseling in the Dominican Republic
• Actual Study Start Date: May 22, 2018
• Estimated Primary Completion Date: January 31, 2021
• Estimated Study Completion Date: January 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in viral load [ Time Frame: Change in viral load between baseline and month 12 ]
   Change in viral load

Secondary Outcome Measures :

1. Antiretroviral therapy adherence [ Time Frame: Month 12 ]
   Self-reported adherence and verified through pharmacy records
2. Change in CD4 cell count [ Time Frame: Change in CD4 cell count between baseline and month 12 ]
   Change in CD4 cell count

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Dominican Republic

Hospital Regional Dr. Luis Manuel Morillo King

Concepcion de La Vega, La Vega, Dominican Republic

Hospital Regional Luis L. Bogaert

Mao, Valverde, Dominican Republic

Sponsors and Collaborators

RAND

Universidad Autonoma de Santo Domingo

Ministerio de Salud Publica, Dominican Republic

Investigators

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

More Information

• Responsible Party: Kathryn Derose, Senior Policy Researcher, RAND
• ClinicalTrials.gov Identifier: NCT03568682
• Other Study ID Numbers: R34MH110325 ( U.S. NIH Grant/Contract )
• First Posted: June 26, 2018
• Last Update Posted: October 6, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathryn Derose, RAND:

food insecurity; nutrition; treatment adherence