Clinical trial NCT03568682: Improving Antiretroviral Therapy Adherence Through Urban Gardening and Nutritional Counseling in the Dominican Republic
Official title: Improving ART Adherence Through Urban Gardening and Peer Nutritional Counseling in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: food insecurity
nutrition
treatment adherence
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Santo Domingo
name: Ministerio de Salud Publica, Dominican Republic
First posted: 2018-06-26
Enrollment: 115
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: This pilot study proposes to develop, implement, and evaluate the feasibility, acceptability and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer nutrition counseling with sustainable urban gardening among people with HIV in the Dominican Republic. The overall hypothesis is that this combined intervention will improve adherence to antiretroviral therapy (ART) and virologic suppression among food insecure HIV+ individuals with suboptimal adherence.

Detailed description: The purpose of this pilot clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of a culturally appropriate, multi-component intervention that targets food insecurity and nutritional health with the ultimate goal of improving antiretroviral therapy adherence and virologic suppression for people with HIV in the Dominican Republic. Through an initial phase, we conducted formative research on dietary patterns and locally available foods and, together with our preliminary research on nutritional counseling and urban gardening, developed a multi-component nutrition intervention to address food insecurity among people with HIV that integrates culturally-appropriate, peer-led nutritional education with a sustainable urban garden component. During the clinical trial phase, we will enroll 120 HIV+ adults with food insecurity and suboptimal adherence in 2 HIV clinics (60 participants in the intervention clinic and 60 participants in the control clinic) and will evaluate the feasibility, acceptability and preliminary effectiveness of urban gardening plus peer nutritional counseling on improving virologic suppression and ART adherence in both the short (month 6) and longer terms (month 12). We will also explore preliminary intervention effects on potential mediators (food security, nutritional status, internalized HIV stigma, and social support). As one of the first studies to develop a sustainable food production approach with peer nutrition counseling among people with HIV, key products will include: 1) an easy-to-use peer nutritional counseling curriculum and urban gardens training materials; 2) pilot data on the feasibility, acceptability, and effects of our intervention on primary outcomes and potential mediators; and 3) if results are promising, an R01 application to conduct a fully-powered cluster randomized controlled trial that examines effects across a larger number of clinics in the Dominican Republic.

Eligibility criteria: Inclusion Criteria:

* HIV+ and on ART
* Has moderate or severe household food insecurity
* Has detectable viral load (\>50 copies) and/or suboptimal adherence to ART

Exclusion Criteria:

* Does not meet above criteria

Primary outcomes:
measure: Change in viral load
timeFrame: Change in viral load between baseline and months 6 and 12
Secondary outcomes:
measure: Antiretroviral therapy adherence
timeFrame: Months 6 and 12
measure: HIV care retention
timeFrame: Months 6 and 12
Other outcomes:
Locations:
city: Concepcion de La Vega
country: Dominican Republic
facility: Hospital Regional Dr. Luis Manuel Morillo King
state: La Vega
city: Mao
country: Dominican Republic
facility: Hospital Regional Luis L. Bogaert
state: Valverde
Study officials:
affiliation: RAND
name: Kathryn P Derose, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derose KP, Then-Paulino A, Han B, Armenta G, Palar K, Jimenez-Paulino G, Sheira LA, Acevedo R, Fulcar MA, Lugo Bernard C, Veloz Camacho I, Donastorg Y, Wagner GJ. Preliminary Effects of an Urban Gardens and Peer Nutritional Counseling Intervention on HIV Treatment Adherence and Detectable Viral Load Among People with HIV and Food Insecurity: Evidence from a Pilot Cluster Randomized Controlled Trial in the Dominican Republic. AIDS Behav. 2023 Mar;27(3):864-874. doi: 10.1007/s10461-022-03821-3. Epub 2022 Sep 6.