Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412016
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-08
Brief Title:
Urban Gardening and Peer Nutritional Counseling for People With HIV and Food Insecurity
Sponsor:
University of Massachusetts Amherst
Organization:
University of Massachusetts Amherst
Study Overview
Official Title:
ProMeSA Urban Gardening and Peer Nutritional Counseling to Improve HIV Care Outcomes Among People With Food Insecurity in the Dominican Republic
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProMeSA
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 n25 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 HIVAIDS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None