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

Study acronym: ProMeSA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 500 to confirmed 433
    • Study description expanded, about 32 words
    • Site details revised at 20 of 20 sites
    v6
  2. Primary completion date: Nov 30, 2026 to Mar 1, 2027
    • Study completion date: May 31, 2027 to Jun 30, 2027
    v5
  3. Site details revised at 11 of 20 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 20
    • Start date changed from estimate of May 20, 2024 to Jun 14, 2024
    v3
  5. Eligibility criteria revised
    • Study description expanded, about 17 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06412016
Lead Sponsor University of Massachusetts, Amherst
Collaborators: University of California, San Francisco, Universidad Autonoma de Santo Domingo, CONAVIHSIDA, Republica Dominicana, Ministerio de Agricultura, Republica Dominicana, Ministerio de Salud Publica y Asistencia Social, Republica Dominicana, RAND
Conditions
(from sponsor)		 HIV, Food Insecurity
Enrollment 433 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov