Clinical trial NCT06412016: Urban Gardening and Peer Nutritional Counseling for People with HIV and Food Insecurity
Official title: ProMeSA: Urban Gardening and Peer Nutritional Counseling to Improve HIV Care Outcomes Among People with Food Insecurity in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Food Insecurity
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Universidad Autonoma de Santo Domingo
name: CONAVIHSIDA, Republica Dominicana
name: Ministerio de Agricultura, Republica Dominicana
name: Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
name: RAND
First posted: 2024-05-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in HIV viral load
timeFrame: Change in viral load between baseline and months 6, 12, and 18
Secondary outcomes:
measure: Antiretroviral therapy adherence
timeFrame: 6, 12 and 18 months
measure: HIV care retention
timeFrame: 6, 12, and 18 months
Other outcomes:
measure: Food Insecurity
timeFrame: 6, 12 and 18 months
measure: Internalized HIV Stigma
timeFrame: 6, 12 and 18 months
measure: Experienced HIV Stigma (Discrimination)
timeFrame: 6, 12 and 18 months
Locations:
city: Azua
country: Dominican Republic
facility: Hospital Taiwan 19 de marzo
city: Higüey
country: Dominican Republic
facility: Hospital Nuestra Señora de la Altagracia
city: Monte Plata
country: Dominican Republic
facility: CPN Las Cinco Casas
city: Peravia
country: Dominican Republic
facility: Hospital Nuestra Señora de Regla
city: Puerto Plata
country: Dominican Republic
facility: Hospital Ricardo Limardo
city: Punta Cana
country: Dominican Republic
facility: SAI Veron
city: Samaná
country: Dominican Republic
facility: Hospital Leopoldo Pou
city: San Cristóbal
country: Dominican Republic
facility: Hospital Juan Pablo Pina
city: San Francisco De Macorís
country: Dominican Republic
facility: Hospital San Vicente de Paul
city: San Juan de la Maguana
country: Dominican Republic
facility: Hospital Dr. Alejandro Cabral
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Centro de Salud Integral Bella Vista
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Centro Especializado de Atención de Salud Juan XXIII
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Hospital José María Cabral y Báez
city: Santo Domingo Este
country: Dominican Republic
facility: AID for AIDS-Tu Salud
city: Santo Domingo Oeste
country: Dominican Republic
facility: Hospital Dr. Vinicio Calventi
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dominicano de Estudios Virológicos IDEV
city: Santo Domingo
country: Dominican Republic
facility: Centro Sanitario de Santo Domingo
city: Santo Domingo
country: Dominican Republic
facility: Hospital Dr Luis Eduardo Aybar
city: Santo Domingo
country: Dominican Republic
facility: SAI Activo 20-30
city: Santo Domingo
country: Dominican Republic
facility: Centro de Orientación e Investigación Integral COIN
Study officials:
affiliation: University of Massachusetts, Amherst
name: Kathryn P Derose, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: