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

NCT ID: NCT03568682

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2021-09-30

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nutritional counseling + urban gardening

Intervention Type: BEHAVIORAL

Peer nutritional counseling and urban gardens

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional counseling + urban gardening

Peer nutritional counseling and urban gardens

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Santo Domingo

UNKNOWN

Sponsor Role: collaborator

Ministerio de Salud Publica, Dominican Republic

UNKNOWN

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Derose

Senior Policy Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn P Derose, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

Hospital Regional Dr. Luis Manuel Morillo King

Concepción de la Vega, La Vega, Dominican Republic

Hospital Regional Luis L. Bogaert

Mao, Valverde Province, Dominican Republic

Countries

Dominican Republic

References

Derose KP, Then-Paulino A, Han B, Armenta G, Palar K, Jimenez-Paulino G, Sheira LA, Acevedo R, Fulcar MA, Lugo Bernard C, Veloz Camacho I, Donastorg Y, Wagner GJ. Preliminary Effects of an Urban Gardens and Peer Nutritional Counseling Intervention on HIV Treatment Adherence and Detectable Viral Load Among People with HIV and Food Insecurity: Evidence from a Pilot Cluster Randomized Controlled Trial in the Dominican Republic. AIDS Behav. 2023 Mar;27(3):864-874. doi: 10.1007/s10461-022-03821-3. Epub 2022 Sep 6.

Reference Type: DERIVED

PMID: 36066760 (View on PubMed)

Other Identifiers

R34MH110325

Identifier Type: NIH

Identifier Source: org_study_id

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