Improving Food Security and Nutrition to Promote ART Adherence in Latin America
17. oktober 2012 opdateret af: Homero Martinez, RAND
The purpose of this three-year study is to develop, implement, and pilot test a culturally appropriate, multi-component nutrition intervention for people living with HIV and food insecurity in Honduras, which is among the Latin America nations with the highest HIV prevalence rates. The investigators specific aims are to:
- Explore the relationships between food security, nutrition, and HIV treatment access, utilization, and adherence, and examine key mediators and moderators of these relationships.
- Develop a multi-component nutrition intervention to address food insecurity among Honduran HIV+ individuals and their families.
- Evaluate the preliminary effectiveness of the intervention on (1) food security and nutritional status; (2) HIV care retention (clinic attendance), uptake of ART when recommended, and ART adherence; and (3) clinical outcomes (CD4 count, ART side effects, and opportunistic infections).
- Examine key mediators and moderators of the intervention effects from among characteristics of the patient, household, and contextual setting.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The project will be conducted in two phases.
Phase 1 involves qualitative, formative research methods to (1) gain understanding of availability and cost of the local foods and the regular diet, (2) evaluate the level of food security among people living with HIV, including intra-household food distribution patterns, and assess the nutritional status of HIV affected individuals, and (3) examine the role that food security and nutrition play in HIV treatment access, utilization and adherence.
Phase 2 consists of developing and pilot-testing a multi-component nutrition intervention through a randomized, controlled trial conducted at 4 HIV clinics in Honduras, with two clinics randomly assigned to receive the intervention and two clinics to serve as the comparison group.
Patients at each of the 4 sites will receive nutrition counseling, following the guidelines currently proposed by the World Health Organization (WHO) as the standard of care for HIV-infected individuals.
In addition, clients at the intervention sites will receive food assistance in the form of a food-aid basket, designed ad hoc to address their macro and micronutrient needs.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Santa Monica, California, Forenede Stater, 90047
- RAND Corporation
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Registered at the clinic
- Age 18 or older
- If not on ART, CD4 < 350*
- Living in the area for the past year.
Exclusion Criteria:
- Deterioration of clinical status such that requires diet or nutrition therapy
- Cannot understand or speak Spanish
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Diet/nutrition counsel+food aid
Intervention.
Patients enrolled in the intervention group will receive a multi-component intervention that includes dietary and nutritional counseling and food assistance (food aid basket)
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Patients enrolled in the experimental arm will receive dietary and nutritional assistance plus a food aid basket, specifically tailored to meet the nutritional needs of the target population.
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Aktiv komparator: dietary/nutritional counseling
Patients enrolled in the comparison arm will receive dietary and nutrition counseling designed to help them meet their nutrition needs, based on foods which are locally available, culturally acceptable and within their budget.
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Patients enrolled in the active comparison arm will receive dietary and nutrition counseling designed to help them meet their nutrition needs, based on foods which are locally available, culturally acceptable and within their budget.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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ART uptake and adherence
Tidsramme: Monthly during 12 of follow-up
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Monthly during 12 of follow-up
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Nutritional status
Tidsramme: Monthly during 12 months of follow-up
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Nutritional status will be assess by anthropometry every month during follow-up
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Monthly during 12 months of follow-up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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HIV clinical outcomes
Tidsramme: At 6 and 12 months of follow-up
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At 6 and 12 months of follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Homero Martinez, PhD, RAND
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2010
Primær færdiggørelse (Faktiske)
1. september 2011
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
26. august 2010
Først indsendt, der opfyldte QC-kriterier
27. august 2010
Først opslået (Skøn)
30. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. oktober 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. oktober 2012
Sidst verificeret
1. oktober 2012
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GRANT00395147
- R34MH084675-02 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diet/nutrition counsel+food aid
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Rutgers, The State University of New JerseyRekrutteringMiljøeksponering | Udvalg af madForenede Stater
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Columbia UniversityNational Institute of Nursing Research (NINR)Rekruttering