NCT03568682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2018

Typical duration for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

June 4, 2018

Last Update Submit

September 19, 2022

Conditions

HIV

Keywords

food insecuritynutritiontreatment adherence

Outcome Measures

Primary Outcomes (1)

  • Change in viral load

    Change in viral load

    Change in viral load between baseline and months 6 and 12

Secondary Outcomes (2)

  • Antiretroviral therapy adherence

    Months 6 and 12

  • HIV care retention

    Months 6 and 12

Study Arms (2)

Nutritional counseling + urban gardening

EXPERIMENTAL

Participants in the intervention clinic will receive: 1) nutritional counseling from peer counselors in their clinic (approximately 4-5 sessions administered monthly); 2) training from the Ministry of Agriculture on how to plant and maintain a garden in their home (training workshop and monthly follow-up); and 3) a cooking and nutrition workshop facilitated by project nutritionists once garden produce are available.

Behavioral: Nutritional counseling + urban gardening

Usual care control

NO INTERVENTION

Participants in the control clinic will receive their usual care from the clinic. After 12 month follow-up, they will be offered the opportunity to receive the intervention.

Interventions

Nutritional counseling + urban gardeningBEHAVIORAL

Peer nutritional counseling and urban gardens

Nutritional counseling + urban gardening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Does not meet above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Regional Dr. Luis Manuel Morillo King

Concepción de la Vega, La Vega, Dominican Republic

Location

Hospital Regional Luis L. Bogaert

Mao, Valverde Province, Dominican Republic

Location

Related Publications (1)

  • 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.

    PMID: 36066760DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Kathryn P Derose, PhD, MPH

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Policy Researcher

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 26, 2018

Study Start

May 22, 2018

Primary Completion

March 31, 2021

Study Completion

September 30, 2021

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DO(2)