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

University of Massachusetts, Amherst

Status: Active, not recruiting

Conditions: HIV; Food Insecurity

Treatments: Behavioral: Peer Nutritional Counseling + Urban Gardening

Study type: Interventional

Funder types: Other

Identifiers

NCT06412016

R01MH131447

Details and patient eligibility

About

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.

Full 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]

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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433 participants in 2 patient groups

Peer Nutritional Counseling + Urban Gardening

Experimental group

Description:

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.

Treatment:

Behavioral: Peer Nutritional Counseling + Urban Gardening

Usual Care Control

No Intervention group

Description:

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.