Urban Gardening and Peer Nutritional Counseling for People With HIV and Food Insecurity
ProMeSA
ProMeSA: Urban Gardening and Peer Nutritional Counseling to Improve HIV Care Outcomes Among People With Food Insecurity in the Dominican Republic
1 other identifier
interventional
433
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Jun 2024
Typical duration for not_applicable hiv
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedStudy Start
First participant enrolled
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
January 14, 2026
January 1, 2026
2.7 years
May 8, 2024
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HIV viral load
Change in viral load
Change in viral load between baseline and months 6, 12, and 18
Secondary Outcomes (2)
Antiretroviral therapy adherence
6, 12 and 18 months
HIV care retention
6, 12, and 18 months
Other Outcomes (3)
Food Insecurity
6, 12 and 18 months
Internalized HIV Stigma
6, 12 and 18 months
Experienced HIV Stigma (Discrimination)
6, 12 and 18 months
Study Arms (2)
Peer Nutritional Counseling + Urban Gardening
EXPERIMENTALParticipants 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.
Usual Care Control
NO INTERVENTIONParticipants in the control clinics will receive their usual care from the clinic. After 18-month follow-up, they will be offered the opportunity to receive the intervention.
Interventions
Peer nutritional counseling and urban gardens
Eligibility Criteria
You may qualify if:
- registered at one of the 20 HIV clinics in the study;
- age 18 or older;
- having initiated ART at least 6 months ago;
- 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);
- moderate or severe household food insecurity
- 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)
- planned residency in the local area for the duration of the study
You may not qualify if:
- Does not meet above criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Amherstlead
- University of California, San Franciscocollaborator
- RANDcollaborator
- Universidad Autonoma de Santo Domingocollaborator
- CONAVIHSIDA, Republica Dominicanacollaborator
- Ministerio de Agricultura, Republica Dominicanacollaborator
- Ministerio de Salud Publica y Asistencia Social, Republica Dominicanacollaborator
Study Sites (20)
Hospital Taiwan 19 de marzo
Azua, Dominican Republic
Hospital Nuestra Señora de la Altagracia
Higüey, 23000, Dominican Republic
CPN Las Cinco Casas
Monte Plata, Dominican Republic
Hospital Nuestra Señora de Regla
Peravia, Dominican Republic
Hospital Ricardo Limardo
Puerto Plata, 57000, Dominican Republic
SAI Veron
Punta Cana, Dominican Republic
Hospital Leopoldo Pou
Samaná, 32000, Dominican Republic
Hospital Juan Pablo Pina
San Cristóbal, 91000, Dominican Republic
Hospital San Vicente de Paul
San Francisco de Macorís, 31000, Dominican Republic
Hospital Dr. Alejandro Cabral
San Juan de la Maguana, Dominican Republic
Centro de Salud Integral Bella Vista
Santiago de los Caballeros, 51000, Dominican Republic
Centro Especializado de Atención de Salud Juan XXIII
Santiago de los Caballeros, 51000, Dominican Republic
Hospital José María Cabral y Báez
Santiago de los Caballeros, 51000, Dominican Republic
Instituto Dominicano de Estudios Virológicos IDEV
Santo Domingo, 10103, Dominican Republic
Centro Sanitario de Santo Domingo
Santo Domingo, 10201, Dominican Republic
Hospital Dr Luis Eduardo Aybar
Santo Domingo, 10306, Dominican Republic
SAI Activo 20-30
Santo Domingo, 10306, Dominican Republic
Centro de Orientación e Investigación Integral COIN
Santo Domingo, 10410, Dominican Republic
AID for AIDS-Tu Salud
Santo Domingo Este, Dominican Republic
Hospital Dr. Vinicio Calventi
Santo Domingo Oeste, Dominican Republic
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn P Derose, PhD, MPH
University of Massachusetts, Amherst
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Analytic database will not have any indication of intervention or control group assignment
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 14, 2024
Study Start
June 14, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Data will become available after publication of study results, approximately 2032 for five years
- Access Criteria
- Users must submit brief proposals regarding intended use of the data; the study team will determine the scientific soundness of the proposal, as well as whether adequate data protections in place, as part of the decision for the researcher to be able to access the public use dataset.
The final dataset will include self-reported, biometric, chart abstraction, pharmacy refill, and clinical outcome variables. Following publication of the main paper(s) for this study and the grant end-date, the investigators will make the data publicly available in the form of an electronic database for researchers who successfully complete a registration process. Data will be de-identified and will not contain any direct identifiers or indirect identifiers. The investigators will provide documentation in the form of a codebook in which each variable name and response options are defined. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.