Urban gardening and nutritional counseling for people with HIV and food insecurity
ProMeSA: Urban Gardening and Peer Nutritional Counseling to Improve HIV Care Outcomes Among People with Food Insecurity in the Dominican Republic
This study is testing whether combining urban gardening with nutritional counseling can help people living with HIV in the Dominican Republic who struggle with food insecurity improve their health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Amherst Academic / other |
| Locations | 20 sites (Azua and 19 other locations) |
| Trial ID | NCT06412016 on ClinicalTrials.gov |
What this trial studies
This intervention combines peer nutritional counseling with urban gardening to support individuals living with HIV in the Dominican Republic who are facing food insecurity. The study employs a cluster randomized controlled trial design to assess the efficacy of this culturally appropriate approach over 18 months. It aims to improve HIV clinical outcomes, such as viral load suppression and adherence to antiretroviral therapy, while also addressing food security and stigma related to HIV. The research will analyze mediators of effects and gather detailed process data to inform future scaling of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are registered at participating HIV clinics, have been on antiretroviral therapy for at least six months, and experience moderate to severe food insecurity.
Not a fit: Patients who do not meet the eligibility criteria, such as those without detectable viral loads or those not experiencing food insecurity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for people living with HIV by enhancing their food security and treatment adherence.
How similar studies have performed: Previous pilot studies have shown preliminary efficacy of similar interventions, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Azua and 19 other locations
- Hospital Taiwan 19 de marzo — Azua, Dominican Republic (Recruiting)
- Hospital Nuestra Señora de la Altagracia — Higüey, Dominican Republic (Recruiting)
- CPN Las Cinco Casas — Monte Plata, Dominican Republic (Recruiting)
- Hospital Nuestra Señora de Regla — Peravia, Dominican Republic (Recruiting)
- Hospital Ricardo Limardo — Puerto Plata, Dominican Republic (Recruiting)
- SAI Veron — Punta Cana, Dominican Republic (Recruiting)
- Hospital Leopoldo Pou — Samaná, Dominican Republic (Recruiting)
- Hospital Juan Pablo Pina — San Cristóbal, Dominican Republic (Recruiting)
- Hospital San Vicente de Paul — San Francisco De Macorís, Dominican Republic (Recruiting)
- Hospital Dr. Alejandro Cabral — San Juan de la Maguana, Dominican Republic (Recruiting)
- Centro de Salud Integral Bella Vista — Santiago De Los Caballeros, Dominican Republic (Recruiting)
- Centro Especializado de Atención de Salud Juan XXIII — Santiago De Los Caballeros, Dominican Republic (Recruiting)
- Hospital José María Cabral y Báez — Santiago De Los Caballeros, Dominican Republic (Recruiting)
- AID for AIDS-Tu Salud — Santo Domingo Este, Dominican Republic (Recruiting)
- Hospital Dr. Vinicio Calventi — Santo Domingo Oeste, Dominican Republic (Recruiting)
- Instituto Dominicano de Estudios Virológicos IDEV — Santo Domingo, Dominican Republic (Recruiting)
- Centro Sanitario de Santo Domingo — Santo Domingo, Dominican Republic (Recruiting)
- Hospital Dr Luis Eduardo Aybar — Santo Domingo, Dominican Republic (Recruiting)
- SAI Activo 20-30 — Santo Domingo, Dominican Republic (Recruiting)
- Centro de Orientación e Investigación Integral COIN — Santo Domingo, Dominican Republic (Recruiting)
Study contacts
- Principal investigator: Kathryn P Derose, PhD, MPH — University of Massachusetts, Amherst
- Study coordinator: Kathryn P Derose, PhD, MPH
- Email: kpderose@umass.edu
- Phone: 4135454202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.