Urban Gardening and Peer Nutritional Counseling for People With HIV and Food Insecurity (ProMeSA)

January 13, 2026 updated by: University of Massachusetts, Amherst

ProMeSA: Urban Gardening and Peer Nutritional Counseling to Improve HIV Care Outcomes Among People With Food Insecurity in the Dominican Republic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. [*Update: Because of recruitment challenges at some clinics due to USAID funding cuts and lower detectable viral load, we received NIH approval to reduce sample size to n=433 while retaining similar power]

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
433

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Dominican Republic
      • Azua, Dominican Republic
        • Hospital Taiwan 19 de marzo
      • Higüey, Dominican Republic, 23000
        • Hospital Nuestra Señora de la Altagracia
      • Monte Plata, Dominican Republic
        • CPN Las Cinco Casas
      • Peravia, Dominican Republic
        • Hospital Nuestra Señora de Regla
      • Puerto Plata, Dominican Republic, 57000
        • Hospital Ricardo Limardo
      • Punta Cana, Dominican Republic
        • SAI Veron
      • Samaná, Dominican Republic, 32000
        • Hospital Leopoldo Pou
      • San Cristóbal, Dominican Republic, 91000
        • Hospital Juan Pablo Pina
      • San Francisco de Macorís, Dominican Republic, 31000
        • Hospital San Vicente de Paul
      • San Juan de la Maguana, Dominican Republic
        • Hospital Dr. Alejandro Cabral
      • Santiago de los Caballeros, Dominican Republic, 51000
        • Centro de Salud Integral Bella Vista
      • Santiago de los Caballeros, Dominican Republic, 51000
        • Centro Especializado de Atención de Salud Juan XXIII
      • Santiago de los Caballeros, Dominican Republic, 51000
        • Hospital José María Cabral y Báez
      • Santo Domingo, Dominican Republic, 10103
        • Instituto Dominicano de Estudios Virológicos IDEV
      • Santo Domingo, Dominican Republic, 10201
        • Centro Sanitario de Santo Domingo
      • Santo Domingo, Dominican Republic, 10306
        • Hospital Dr Luis Eduardo Aybar
      • Santo Domingo, Dominican Republic, 10306
        • SAI Activo 20-30
      • Santo Domingo, Dominican Republic, 10410
        • Centro de Orientación e Investigación Integral COIN
      • Santo Domingo Este, Dominican Republic
        • AID for AIDS-Tu Salud
      • Santo Domingo Oeste, Dominican Republic
        • Hospital Dr. Vinicio Calventi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Peer Nutritional Counseling + Urban Gardening
Peer nutritional counseling and urban gardens
No Intervention: Usual Care Control
Participants 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HIV viral load
Time Frame: Change in viral load between baseline and months 6, 12, and 18
Change in viral load
Change in viral load between baseline and months 6, 12, and 18

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antiretroviral therapy adherence
Time Frame: 6, 12 and 18 months
Self-reported adherence and objective adherence verified through pharmacy refills
6, 12 and 18 months
HIV care retention
Time Frame: 6, 12, and 18 months
Self-reported missed clinic visits verified through clinic records
6, 12, and 18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Insecurity
Time Frame: 6, 12 and 18 months
Self-reported food security using the Latin American and Caribbean Food Security Scale to assess household food security over the past 90 days. Scores range from 0 to 15 for households with children (0-8 for households without children) with higher scores meaning worse outcome and are used to classify households into 4 categories: "food secure," "mild food insecurity, "moderate food insecurity" and "severe food insecurity."
6, 12 and 18 months
Internalized HIV Stigma
Time Frame: 6, 12 and 18 months
Self-reported internalized stigma will be assessed using an 8-item scale validated previously in the DR. Answers use a 4-point Likert scale (strongly disagree to strongly agree) assessing agreement with statements measuring negative self-perceptions related to HIV; higher scores indicated worse internalized stigma, range 0-32.
6, 12 and 18 months
Experienced HIV Stigma (Discrimination)
Time Frame: 6, 12 and 18 months
Self-reported experienced stigma will be assessed using 11 items on reported loss of job, denial of health and other social services, and being verbally harassed or physically abused as a result of living with HIV (with responses of "yes/no"). This scale been validated in the DR previously and examined both as continuous (range 0-11, with higher scores meaning worse outcome) and dichotomously (any experienced stigma vs. none).
6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Francisco
RAND
Universidad Autonoma de Santo Domingo
Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
CONAVIHSIDA, Republica Dominicana
Ministerio de Agricultura, Republica Dominicana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathryn P Derose, PhD, MPH, University of Massachusetts, Amherst

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH131447 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available after publication of study results, approximately 2032 for five years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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