Urban Gardening and Peer Nutritional Counseling for People with HIV and Food Insecurity

Not Applicable

Recruiting

• Conditions: HIV; Food Insecurity
• Interventions: Behavioral: Peer Nutritional Counseling + Urban Gardening

• Registration Number: NCT06412016
• Lead Sponsor: University of Massachusetts, Amherst

Brief Summary

The investigators are conducting a fully powered cluster randomized controlled trial (RCT) of a culturally appropriate, multicomponent intervention combining peer nutritional counseling with urban gardening among people with human immunodeficiency virus (HIV) in the Dominican Republic (DR) to assess efficacy, analyze mediators of effects, and evaluate detailed process data to inform scale-up. The study will examine the impact of the intervention on participants' HIV clinical outcomes (HIV viral load, antiretroviral therapy adherence, and HIV care retention) as well as intermediate outcomes such as food security and HIV-related stigma.

Detailed Description

HIV and food insecurity pose severe and interrelated problems in Latin America and the Caribbean, including in the Dominican Republic (DR), where HIV ranks as one of the top 5 causes of death and our prior studies have found that nearly 70% of people with HIV (PWH) have moderate or severe food insecurity. Despite the established, detrimental role of food insecurity on poor HIV treatment outcomes, evidence on sustainable interventions that address the cycle of food insecurity and poor HIV health is scarce. To address this gap, the investigators developed and piloted Proyecto para Mejorar la Seguridad Alimentaria (ProMeSA or Project to Improve Food Security in English), an integrated urban gardens and peer nutritional counseling intervention, and found it feasible, acceptable, and with preliminary efficacy at 6 and 12 months of improving food security and HIV virologic suppression. The purpose of this 5-year study is to conduct a fully powered cluster randomized controlled trial (RCT) of ProMeSA to assess intervention efficacy evaluated over a longer period (18 months) as well as mediators and barriers and facilitators to intervention uptake, implementation, and sustainability. The specific aims are: (1) Determine the efficacy of an integrated urban gardens and peer nutritional counseling intervention on the primary outcome of HIV viral suppression \[undetectable HIV viral load (VL)\] and secondary outcomes of antiretroviral therapy (ART) adherence and HIV care retention care among people with food insecurity across diverse regions in the DR; (2) Examine the intervention effects on intermediate outcomes posited to mediate the impact of ProMeSA on ART adherence, care retention, and viral suppression; (3) Evaluate process-related factors associated with intervention uptake and implementation (facilitators, barriers, fidelity, and replication costs) to inform future scale-up. The trial will include 20 HIV clinics randomized to intervention or usual care control (n=25 per clinic; 500 total study participants). VL and other key outcomes will be assessed at baseline, and 6-, 12- and 18-months. Following the investigators' intervention causal framework and pilot findings, they hypothesize that ProMeSA will improve food security and diet quality and reduce stigma and competing needs, which in turn will improve HIV clinical outcomes. The predominant causal paths identified will inform tailoring ProMeSA to enhance impact in future dissemination and implementation. In addition, the investigators will collect extensive quantitative and qualitative data on intervention implementation and participant experiences with the intervention across diverse settings and participants to inform scale-up. The study involves a partnership among researchers from the University of Massachusetts Amherst, University of California, San Francisco, RAND, and the Universidad Autonóma de Santo Domingo as well as the Dominican Ministries of Agriculture and Public Health, the Dominican National HIV/AIDS Council, and the United Nations World Food Program. To the investigators' knowledge, this will be the first full-scale trial to integrate nutritional counseling with food-generating activities among PWH with food insecurity, in support of national and international goals to achieve viral suppression and reduce the disease- and economic burden of HIV.

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Study First Posted: 2024-05-14
• Study Start: 2024-06-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-03-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. registered at one of the 20 HIV clinics in the study;
2. age 18 or older;
3. having initiated ART at least 6 months ago;
4. detectable viral load in the previous 12 months based on medical records and/or evidence of adherence problems (missed clinic visits, delays in picking up antiretrovirals);
5. moderate or severe household food insecurity
6. physically able to plant and maintain an urban garden; stable housing and space for a garden (subjectively assessed by participants after hearing a description of what is involved)
7. planned residency in the local area for the duration of the study

Exclusion Criteria

Does not meet above criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Nutritional Counseling + Urban Gardening	Peer Nutritional Counseling + Urban Gardening	Participants in the intervention clinics will receive: 1) nutritional counseling from peer counselors in their clinic (4 sessions administered); 2) training from the Ministry of Agriculture on how to plant and maintain a garden in their home (2 group training workshops and monthly individual follow-up); 3) low-cost tanks for water storage to participants whose communities only have water on certain days; 4) access to community gardens; and 5) two cooking and nutrition workshops.

Primary Outcome Measures

Name	Time	Method
Change in HIV viral load	Change in viral load between baseline and months 6, 12, and 18	Change in viral load

Secondary Outcome Measures

Name	Time	Method
Antiretroviral therapy adherence	6, 12 and 18 months	Self-reported adherence and objective adherence verified through pharmacy refills
HIV care retention	6, 12, and 18 months	Self-reported missed clinic visits verified through clinic records

Trial Locations

Locations (20)

Hospital Ricardo Limardo; 🇩🇴 Puerto Plata, Dominican Republic

Hospital Nuestra Señora de la Altagracia; 🇩🇴 Higüey, Dominican Republic

CPN Las Cinco Casas; 🇩🇴 Monte Plata, Dominican Republic

AID for AIDS-Tu Salud; 🇩🇴 Santo Domingo Este, Dominican Republic

Hospital Taiwan 19 de marzo; 🇩🇴 Azua, Dominican Republic

Hospital Nuestra Señora de Regla; 🇩🇴 Peravia, Dominican Republic

Hospital San Vicente de Paul; 🇩🇴 San Francisco De Macorís, Dominican Republic

Centro Especializado de Atención de Salud Juan XXIII; 🇩🇴 Santiago De Los Caballeros, Dominican Republic

Instituto Dominicano de Estudios Virológicos IDEV; 🇩🇴 Santo Domingo, Dominican Republic

Hospital Dr Luis Eduardo Aybar; 🇩🇴 Santo Domingo, Dominican Republic

SAI Activo 20-30; 🇩🇴 Santo Domingo, Dominican Republic

Hospital Juan Pablo Pina; 🇩🇴 San Cristóbal, Dominican Republic

Hospital José María Cabral y Báez; 🇩🇴 Santiago De Los Caballeros, Dominican Republic

SAI Veron; 🇩🇴 Punta Cana, Dominican Republic

Hospital Leopoldo Pou; 🇩🇴 Samaná, Dominican Republic

Hospital Dr. Alejandro Cabral; 🇩🇴 San Juan de la Maguana, Dominican Republic

Centro de Salud Integral Bella Vista; 🇩🇴 Santiago De Los Caballeros, Dominican Republic

Hospital Dr. Vinicio Calventi; 🇩🇴 Santo Domingo Oeste, Dominican Republic

Centro Sanitario de Santo Domingo; 🇩🇴 Santo Domingo, Dominican Republic

Centro de Orientación e Investigación Integral COIN; 🇩🇴 Santo Domingo, Dominican Republic