- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01575938
HIV Prevention Intervention for Young Transgender Women (LifeSkills)
25. januar 2021 oppdatert av: Ann & Robert H Lurie Children's Hospital of Chicago
The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or transmission.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or transmission.
The study will test this intervention in a three-arm randomized controlled trial in two major U.S. cities with excellent access to and research experience with the population (Chicago, Boston).
We will enroll at risk YTW, ages 16-29; two-fifths of the sample randomized to the intervention will participate in the 6-session group-based and manualized Life Skills intervention; two-fifths will be randomized to the standard-of-care (SOC) control condition; and one-fifth will be randomized to the time-matched attention control condition and receive standard health promotion information in a group-based multi-session format.
All three arms will receive HIV and sexually transmitted infection (STI) (Chlamydia and gonorrhea) testing and pre-posttest risk reduction counseling (i.e., SOC).
Sexual risk will be assessed at baseline, 4, 8 and 12 months post-randomization.
Our specific aims are: 1) to determine the efficacy of the Life Skills intervention in comparison to a SOC arm and a time-matched attention control on the primary outcome: number of unprotected anal and vaginal sex acts in the previous 4 months among YTW, ages 16-29; and 2) to examine the degree to which improvements in sexual risk taking are mediated by the conceptual mediators of the intervention: transgender adaptation and integration, collective self-esteem/empowerment, information (HIV knowledge), motivation (attitudes, norms, and intentions for safer sex), and behavioral skills (discussing sex and condom use with sexual partners, acquiring and using condoms); and to explore whether reductions in sexual risk are associated with epidemiologically-linked moderators of sexual risk behavior: age, race/ethnicity, and psychosocial factors.
An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample; in the SOC arm, we will assess the natural trajectory of sexual risk behavior and the acquisition of HIV and STIs (incidence rate) in YTW over a 12-month follow-up period.
Studietype
Intervensjonell
Registrering (Faktiske)
300
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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Illinois
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Chicago, Illinois, Forente stater, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- The Fenway Institute
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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
16 år til 29 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- age 16-29
- self-identified as transgender, transsexual, and/or female with a male biological or birth sex
- self-reported history of unprotected anal or vaginal intercourse, anal or vaginal sex with more than one sexual partner, anal or vaginal sex in exchange for money, food, shelter, or diagnosis with HIV or another STI in the previous 4 months
- able to speak and understand English
- willing and able to provide informed consent/assent
- intention to reside in the local area throughout the 12 month follow-up period
Exclusion Criteria:
- unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- active suicidal ideation at the time of baseline interview
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: HIV group-based prevention intervention
The HIV prevention intervention is a 6-session group-based and manualized intervention.
Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
|
The 6-session HIV prevention intervention curriculum, "LifeSkills," incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help young transgender women develop, practice, and integrate new skills into "real-life" situations.
Activities address each aspect our theoretical framework (information, motivation, behavior), including experiences that may pre-dispose young transgender women to HIV/STI risk.
Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
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Aktiv komparator: Diet and nutrition
The comparison condition is a 6-session group-based and manualized health promotion intervention.
Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
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The comparison condition is a 6-session group-based and manualized health promotion intervention.
Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
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Ingen inngripen: Standard-of-care
This arm will receive HIV and STI testing and counseling only.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months
Tidsramme: Baseline, 4-months post-intervention
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Self-reported unprotected anal and vaginal sex acts in the previous 4 months assessed via computer-assisted self-interviewing.
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Baseline, 4-months post-intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Robert Garofalo, MD, Ann & Robert H Lurie Children's hospital of Chicago
- Hovedetterforsker: Matthew Mimiaga, ScD, MPH, Massachusetts General Hospital
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
- Garofalo R, Johnson AK, Kuhns LM, Cotten C, Joseph H, Margolis A. Life skills: evaluation of a theory-driven behavioral HIV prevention intervention for young transgender women. J Urban Health. 2012 Jun;89(3):419-31. doi: 10.1007/s11524-011-9638-6.
- Jin H, Restar A, Goedel WC, Ogunbajo A, Biello K, Operario D, Kuhns L, Reisner SL, Garofalo R, Mimiaga MJ. Maternal Support Is Protective Against Suicidal Ideation Among a Diverse Cohort of Young Transgender Women. LGBT Health. 2020 Oct;7(7):349-357. doi: 10.1089/lgbt.2020.0219. Epub 2020 Sep 4.
- Garofalo R, Kuhns LM, Reisner SL, Biello K, Mimiaga MJ. Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women: The Project LifeSkills Randomized Clinical Trial. JAMA Pediatr. 2018 Oct 1;172(10):916-923. doi: 10.1001/jamapediatrics.2018.1799.
- Kuhns LM, Mimiaga MJ, Reisner SL, Biello K, Garofalo R. Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol. BMC Public Health. 2017 Sep 16;17(1):713. doi: 10.1186/s12889-017-4734-5.
- Kuhns LM, Reisner SL, Mimiaga MJ, Gayles T, Shelendich M, Garofalo R. Correlates of PrEP Indication in a Multi-Site Cohort of Young HIV-Uninfected Transgender Women. AIDS Behav. 2016 Jul;20(7):1470-7. doi: 10.1007/s10461-015-1182-z.
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 (Faktiske)
1. mars 2012
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først innsendt
29. mars 2012
Først innsendt som oppfylte QC-kriteriene
10. april 2012
Først lagt ut (Anslag)
12. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01MH094323 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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