The Multimedia HIV/STI Prevention for Drug-Involved Female Offenders (Project WORTH)
25. februar 2014 oppdatert av: Nabila El-Bassel, PhD, Columbia University
Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision.
This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system.
HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors.
This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.
Studietype
Intervensjonell
Registrering (Faktiske)
306
Fase
- Fase 2
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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New York, New York, Forente stater, 10027
- Columbia University School of Social Work
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- She is 18 or older.
- She is currently supervised by a criminal justice entity, such as a community court or probation.
- She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
- She reports any illicit drug use or binge drinking in the past 6 months.
Exclusion Criteria:In addition, potential participants will be ineligible if any of the following criteria are met:
- Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
- Having sex with more than one partner
- Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
- Sharing injection drug use needles or equipment
- The woman is actively trying to get pregnant/have a baby.
- Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- The participant was born male.
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: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Multimedia HIV/STI prevention
Multimedia WORTH is a 4-session group based gender specific HIV and drug abuse prevention intervention.
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The Multimedia WORTH intervention features the same core elements as the original version, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance group learning and individualized feedback. Participants will interact with Multimedia WORTH at two levels: (1) group materials will be delivered via computer projection onto a screen and (2) participants will complete individual activities and create journal logs tracking their progress on personalized goals on their personal user accounts using laptop computers. The computer multimedia support tool includes text, imagery, animations, audio and video in a format that guide the facilitator's delivery of the intervention. ***To view pilot features of the Multimedia WORTH intervention in development, please visit the following web address: http://ccnmtl.columbia.edu/projects/worth/presentation |
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Aktiv komparator: Traditional HIV/STI prevention
Traditional WORTH is a 4-session group-based HIV/STI and drug abuse prevention intervention that covers the same content as Multimedia WORTH without the use of interactive videos, computerized assessments, and other audiovisual tools.
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The basic format of each WORTH session remains consistent following a sequence of 5 steps: (1) an opening (quote, song, poem) which will provide a brief culturally relevant point of inspiration to engage participants (2) Check-in to review material from the previous session, and to discuss any incidents where participants engaged in risk behaviors and to acknowledge positive ways in which women used new skills to avoid HIV risk; (3) a discussion to raise awareness of links between IPV, drug-related activities, and HIV risks; (4) a skills-building component relevant to the discussion; and (5) review and update participant needs, homework assigned for skills-building at home, and a closing ritual.
The WORTH intervention consists of four 2-hour group sessions that are led by a female facilitator.
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Placebo komparator: Wellness Promotion
Wellness Promotion is a 4-session group based intervention that aims to improve diet, physical fitness and well-being which is designed as an attentional control condition.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The proportion of condom protected acts of vaginal and anal intercourse
Tidsramme: Up to 12 months
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Up to 12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)
Tidsramme: Up to 12 months
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Up to 12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nabila El-Bassel, Ph.D., Columbia University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hochstatter KR, Slavin MN, Gilbert L, Goddard-Eckrich D, El-Bassel N. Availability of informal social support and the impact on health services utilization among women in community corrections who engage in substance use and risky sexual behavior: New York City, 2009-2012. Health Justice. 2022 Feb 16;10(1):6. doi: 10.1186/s40352-022-00170-0.
- El-Bassel N, Gilbert L, Goddard-Eckrich D, Chang M, Wu E, Hunt T, Epperson M, Shaw SA, Rowe J, Almonte M, Witte S. Efficacy of a group-based multimedia HIV prevention intervention for drug-involved women under community supervision: project WORTH. PLoS One. 2014 Nov 5;9(11):e111528. doi: 10.1371/journal.pone.0111528. eCollection 2014.
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. november 2009
Primær fullføring (Faktiske)
1. mars 2013
Studiet fullført (Faktiske)
1. mars 2013
Datoer for studieregistrering
Først innsendt
4. februar 2013
Først innsendt som oppfylte QC-kriteriene
5. februar 2013
Først lagt ut (Anslag)
6. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AAAD5608
- R01DA025878 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .