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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• registered at one of the 20 HIV clinics in the study;

• age 18 or older;

• having initiated ART at least 6 months ago;

• 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);

• moderate or severe household food insecurity

• 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)

• planned residency in the local area for the duration of the study

Locations
Other Locations
Dominican Republic
Hospital Taiwan 19 de marzo
RECRUITING
Azua
Hospital Nuestra Señora de la Altagracia
RECRUITING
Higüey
CPN Las Cinco Casas
RECRUITING
Monte Plata
Hospital Nuestra Señora de Regla
RECRUITING
Peravia
Hospital Ricardo Limardo
RECRUITING
Puerto Plata
SAI Veron
RECRUITING
Punta Cana
Hospital Leopoldo Pou
RECRUITING
Samaná
Hospital Juan Pablo Pina
RECRUITING
San Cristóbal
Hospital San Vicente de Paul
RECRUITING
San Francisco De Macorís
Hospital Dr. Alejandro Cabral
RECRUITING
San Juan De La Maguana
Centro de Salud Integral Bella Vista
RECRUITING
Santiago De Los Caballeros
Centro Especializado de Atención de Salud Juan XXIII
RECRUITING
Santiago De Los Caballeros
Hospital José María Cabral y Báez
RECRUITING
Santiago De Los Caballeros
Centro de Orientación e Investigación Integral COIN
RECRUITING
Santo Domingo
Centro Sanitario de Santo Domingo
RECRUITING
Santo Domingo
Hospital Dr Luis Eduardo Aybar
RECRUITING
Santo Domingo
Instituto Dominicano de Estudios Virológicos IDEV
RECRUITING
Santo Domingo
SAI Activo 20-30
RECRUITING
Santo Domingo
AID for AIDS-Tu Salud
RECRUITING
Santo Domingo Este
Hospital Dr. Vinicio Calventi
RECRUITING
Santo Domingo Oeste
Contact Information
Primary
Kathryn P Derose, PhD, MPH
kpderose@umass.edu
4135454202
Backup
Kartika Palar, PhD, MA
Kartika.Palar@ucsf.edu
4152067159
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 500
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: CONAVIHSIDA, Republica Dominicana, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana, Universidad Autonoma de Santo Domingo, Ministerio de Agricultura, Republica Dominicana, University of California, San Francisco, RAND
Leads: University of Massachusetts, Amherst

This content was sourced from clinicaltrials.gov

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