- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00633906
HORIZONS HIV Intervention (HORIZONS)
Reducing HIV Risk in Female Teens: A Tailored Approach
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:
- To evaluate the efficacy of the HORIZONS HIV intervention plus standard of care counseling versus the standard of care counseling alone in reducing self-reported HIV sexual risk behaviors and incident STDs over a 12 month follow-up period.
- To evaluate the cost-effectiveness of the HORIZONS HIV intervention plus standard of care counseling to the standard of care counseling alone with respect to reducing risky sexual behavior and averting incident STDs.
715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30303
- Fulton County Department of Health and Wellness
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Teen Clinic
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Atlanta, Georgia, Forenede Stater, 30303
- Planned Parenthood of GA
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female
- African American
- Ages 15-21
- Receiving care at participating clinic
- Vaginal sex in the past 60 days
- Ability to give written informed consent
Exclusion Criteria:
- Married
- Pregnant
- In a detention center
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
HORIZONS HIV Intervention.
Two-session, group-based interactive intervention.
|
Two-session, group-based interactive HIV prevention intervention
|
Aktiv komparator: 2
Enhanced standard-of-care session.
One hour, video-based and brief discussion.
|
1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Proportion of condom protected vaginal sex acts over the last 60 days
Tidsramme: 6 and 12 months post-randomization
|
6 and 12 months post-randomization
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Tidsramme: 6 and 12 months post-randomization
|
6 and 12 months post-randomization
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ralph J DiClemente, PhD, Emory University
Publikationer og nyttige links
Generelle publikationer
- Sales JM, DiClemente RJ, Rose ES, Wingood GM, Klein JD, Woods ER. Relationship of STD-related shame and stigma to female adolescents' condom-protected intercourse. J Adolesc Health. 2007 Jun;40(6):573.e1-6. doi: 10.1016/j.jadohealth.2007.01.007. Epub 2007 Mar 26.
- Crosby RA, DiClemente RJ, Wingood GM, Salazar LF, Rose E, Sales JM, Caliendo AM. Oral contraceptive use may not preclude condom use: a study of non-pregnant African-American adolescent females. Sex Transm Infect. 2007 Jun;83(3):216-8. doi: 10.1136/sti.2006.022442.
- Woods ER, Klein JD, Wingood GM, Rose ES, Wypij D, Harris SK, Diclemente RJ. Development of a new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV. J Adolesc Health. 2006 Jun;38(6):753.e1-7. doi: 10.1016/j.jadohealth.2005.08.013.
- Spitalnick JS, DiClemente RJ, Wingood GM, Crosby RA, Milhausen RR, Sales JM, McCarty F, Rose E, Younge SN. Brief report: sexual sensation seeking and its relationship to risky sexual behaviour among African-American adolescent females. J Adolesc. 2007 Feb;30(1):165-73. doi: 10.1016/j.adolescence.2006.10.002. Epub 2006 Nov 30.
- DiClemente RJ, Wingood GM, Crosby RA, Salazar LF, Rose E, Sales JM, Caliendo AM. Prevalence, correlates, and efficacy of selective avoidance as a sexually transmitted disease prevention strategy among African American adolescent females. Arch Pediatr Adolesc Med. 2008 Jan;162(1):60-5. doi: 10.1001/archpediatrics.2007.5.
- Salazar LF, Crosby RA, Diclemente RJ, Wingood GM, Rose E, Sales JM, Caliendo AM. Personal, relational, and peer-level risk factors for laboratory confirmed STD prevalence among low-income African American adolescent females. Sex Transm Dis. 2007 Oct;34(10):761-6. doi: 10.1097/01.olq.0000264496.94135.ac.
- Caliendo AM, Jordan JA, Green AM, Ingersoll J, Diclemente RJ, Wingood GM. Real-time PCR improves detection of Trichomonas vaginalis infection compared with culture using self-collected vaginal swabs. Infect Dis Obstet Gynecol. 2005 Sep;13(3):145-50. doi: 10.1080/10647440500068248.
- Rosenbaum JE, Zenilman JM, Rose E, Wingood GM, DiClemente RJ. Semen says: assessing the accuracy of adolescents' self-reported sexual abstinence using a semen Y-chromosome biomarker. Sex Transm Infect. 2017 Mar;93(2):145-147. doi: 10.1136/sextrans-2016-052605. Epub 2016 May 4.
- Swartzendruber A, Brown JL, Sales JM, Murray CC, DiClemente RJ. Sexually transmitted infections, sexual risk behavior, and intimate partner violence among African American adolescent females with a male sex partner recently released from incarceration. J Adolesc Health. 2012 Aug;51(2):156-63. doi: 10.1016/j.jadohealth.2011.11.014. Epub 2012 Feb 28.
- DiClemente RJ, Wingood GM, Rose ES, Sales JM, Lang DL, Caliendo AM, Hardin JW, Crosby RA. Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1112-21. doi: 10.1001/archpediatrics.2009.205.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00045957
- MH061210 (Anden identifikator: Other)
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