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

HIV Clinical Trial

— ProMeSA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412016
• Other study ID #: R01MH131447
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Amherst
• Contact: Kathryn P Derose, PhD, MPH
• Phone: 4135454202
• Email: kpderose[@]umass.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 31, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• HIV

Intervention

Behavioral:
• Peer Nutritional Counseling + Urban Gardening
Peer nutritional counseling and urban gardens

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst	CONAVIHSIDA, Republica Dominicana, Ministerio de Agricultura, Republica Dominicana, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana, RAND, Universidad Autonoma de Santo Domingo, University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food Insecurity	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
Other	Internalized HIV Stigma	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
Other	Experienced HIV Stigma (Discrimination)	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
Primary	Change in HIV viral load	Change in viral load	Change in viral load between baseline and months 6, 12, and 18
Secondary	Antiretroviral therapy adherence	Self-reported adherence and objective adherence verified through pharmacy refills	6, 12 and 18 months
Secondary	HIV care retention	Self-reported missed clinic visits verified through clinic records	6, 12, and 18 months