- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01850576
Project TEACH-Kenya (TEACH)
7. mai 2015 oppdatert av: Yvette Calderon,MD, MS, North Bronx Healthcare Network
Project Tailoring Effective And Community-based HIV Interventions in Kenya
Public health programs and policies have utilized the "combination prevention" model of bringing together tailored, proven interventions in order to reduce the global impact of HIV.
Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings, Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV prevention) to increase HIV testing and counseling rates, implement proven risk reduction programs, and improve rates of linkage to care and ART initiation among adolescents in Kenya.
The collaboration with St. Francis Community Hospital and input from the Kasarani community will increase the breadth, reach, and impact of this HIV prevention intervention in Kenya.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In 2010, HIV/AIDS accounted for up to 29% of all deaths and 24% of all disabilities in Kenya.
There is a particular need to concentrate HIV education, testing, and linkage-to-care efforts among high-risk adolescents; by age 18, 47% of women and 58% of men have had sexual intercourse.
Only one in four young Kenyans used condoms the first time they had sex, and only half of 15-24 year olds had comprehensive HIV knowledge.
The goal of this intervention, Project TEACH-Kenya, is to adapt two proven HIV interventions, Project BRIEF and STEP, to an urban setting in the Kasarani District of the Nairobi Province, Kenya.
According to the US President's Emergency Plan for AIDS Relief (PEPFAR) Five-Year Strategy, a successful prevention program brings together a combination of evaluated, tailored interventions, to stem the spread of HIV infection among high-risk populations.
This synergistic model, referred to as combination prevention, serves as the basis for adapting the current intervention encompassing HIV testing and counseling, risk behavior reduction programs, and linkage to care and ART initiation to the Kenyan context.
Project TEACH-Kenya will develop tailored, theory-based educational videos, linkage procedures, and a tailored prevention program for adolescents 13-18 years old and pilot and test the intervention at St. Francis Community Hospital, a high volume community-based hospital in Kasarani.
The majority of adolescents that access St. Francis's services are orphan and vulnerable children affected by HIV/AIDS (OVC-HIV) who are disproportionately poor and malnourished and are at increased risk for acquiring HIV, stressing the need for this intervention.
The outcome of this project will be a feasible, evidence-based, cost- and time-effective program to improve HIV education and increase testing and linkage-to-care rates among adolescents in Kenya.
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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Bronx, New York, Forente stater, 10461
- Albert Einstein College of Medicine
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Kasarani
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Nairobi, Kasarani, Kenya
- St. Francis Community Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
13 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Women and minorities will not be excluded from this research study. We will include only adolescents ages 13-18 at time of recruitment in this study, because that is the age group that we are targetting for this intervention. Residents must be of the St. Francis Hospital catchment area
Exclusion Criteria:
- Over the age of 18 and under the age of 13. Unable to understand the consent process for the study; or otherwise unable to consent to HIV testing.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention
Those randomized to the intervention group will be invited to attend the risk reduction intervention.
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STEP is based on social learning theory and provides age-appropriate and culturally acceptable HIV prevention information in a format that encourages information growth and skills enhancement.
The program is delivered by 'Instructors,' undergraduate college students aged 18-24, one hour per week for 10 weeks.
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Ingen inngripen: Control
The control group will receive usual care.
Both treatment and control groups will have received the video-based risk reduction intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility
Tidsramme: up to 15 months
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Feasibility of implementing project STEP will be measured by acceptance and participation rates. Evaluation outputs include:
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up to 15 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Risk Reduction
Tidsramme: up to 15 months
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HIV related knowledge will be measured using the HIV KQ-18; stigma will be measured using the AIDS-Related Stigma Scale.
Sexual history will also be measured using the traditional Project B.R.I.E.F.
survey.
The questionnaire will be piloted for receptiveness.
We will ask for ratings of satisfaction with the video-based pre-counseling and education/prevention post test using measures used by Calderon.
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up to 15 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Rosy Chhabra, PsyD, Albert Einstein College of Medicine
- Hovedetterforsker: Yvette Calderon, MD, MS, North Central Bronx Healthcare Network
- Studieleder: Erick Nyambedha, St. Francis Community Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Forventet)
1. september 2015
Studiet fullført (Forventet)
1. september 2015
Datoer for studieregistrering
Først innsendt
2. mai 2013
Først innsendt som oppfylte QC-kriteriene
8. mai 2013
Først lagt ut (Anslag)
9. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2015
Sist bekreftet
1. mai 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2013-PA-12-231
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