- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00582101
Family-Based HIV Prevention for Latinos
5 juni 2012 uppdaterad av: Celia Lescano, Ph.D., Rhode Island Hospital
The proposed project will develop and test an HIV prevention intervention for Latino families. This study will:
- Conduct a pilot "run-through" of an adapted family-based intervention with three cohorts (about 24 families) to determine the feasibility, acceptability, and appropriateness for the target population.
- Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews.
- Recruit and randomize 100 families into the Latino family-based HIV prevention intervention or a general health promotion condition.
- Estimate the effect size of the Latino family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes and parental monitoring/supervision over 6 months.
Based on a thorough review of the literature, the following is anticipated:
- The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received.
- The family-based HIV prevention intervention will result in safer adolescent sexual behavior, greater change with regard to primary outcome measures of behavior (recent sexual activity, the number of unprotected sex acts, proportion of condom use, and intentions to use condoms), safer HIV-related attitudes, improved parent-child communication skills, and greater parental monitoring than the Latino families in the general health promotion condition.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Latinos are disproportionately represented among those diagnosed with HIV and Latino adolescents are at risk for engaging in sexual behaviors that can lead to HIV.
However, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have not been published to date.
This K Award will conduct an initial study of a family-based intervention specifically for Latino families.
With the support of a NIMH Minority Supplement Award, Dr. Lescano has adapted a family-based intervention from a multi-site trial for non-minority youth.
Using a qualitative approach, Dr. Lescano has added to the intervention family context issues relevant to Latinos such as acculturation, religiosity, gender role and sexual socialization, parent-child communication, and monitoring practices.
The initial phase of the K Award will be a run-through of the adapted family-based intervention with three cohorts (8 families per group) to further assess participant reaction and appropriateness.
The intervention will then be revised based on feedback using structured exit interviews.
Next, 100 Latino families with an adolescent between the ages of 13 and 18 will be randomized into either the family based HIV prevention intervention or a general health promotion (GHP) condition that focuses on healthy behaviors such as diet and exercise.
Groups consist of 6 to 8 parent and youth dyads in a one-day, 7-hour workshop.
Both interventions employ activities for youth and parents separately (e.g., focus on adolescent vulnerability) and parents and adolescents together.
The project will estimate the effect size of the Latino Family-based HIV prevention intervention from assessment of changes in the adolescents' HIV-related sexual behavior and attitudes, gender and sexual socialization, parent-child communication, and parental monitoring.
Measures will be completed at baseline and at 3 and 6 months post-intervention.
The work done in this K Award will provide pilot data that will lead to submission of an R01 to determine the efficacy of the intervention, compared to a adolescent-only, skills-based HIV prevention group and a general health promotion group, in a larger sample of Latinos.
An efficacious intervention is urgently needed for Latino communities.
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
13 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Adolescent must be English-speaking and can converse in Spanish with parent
- Parent must be Spanish-speaking
- Adolescent and parent must be living together for at least 3 months prior to workshop
- Both parent and adolescent self-identify as being of Hispanic/Latino origin
Exclusion Criteria:
- Adolescent HIV positive
- Adolescent pregnant or intending to get pregnant
- Active psychosis
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Family-based HIV
|
7-hour one-day workshop with adolescents and parents in separate and joint sessions
Andra namn:
|
Aktiv komparator: Family-based HP
|
7 hour one-day workshop on general health promotion topics
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Number (#) of unprotected sex acts
Tidsram: baseline, 3, and 6 months
|
baseline, 3, and 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
parent-child communication
Tidsram: baseline, 3, and 6 months
|
baseline, 3, and 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Celia M Lescano, PhD, Rhode Island Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2007
Primärt slutförande (Faktisk)
1 september 2010
Avslutad studie (Faktisk)
1 september 2010
Studieregistreringsdatum
Först inskickad
19 december 2007
Först inskickad som uppfyllde QC-kriterierna
27 december 2007
Första postat (Uppskatta)
28 december 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1K01MH078783-01 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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Kliniska prövningar på Family-Based HIV Prevention for Latinos
-
University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University och andra samarbetspartnersRekrytering