- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01387646
Behavioral Intervention for Minority Adolescent Women
1 juli 2011 uppdaterad av: The University of Texas Health Science Center at San Antonio
The purpose of this Stage II clinical trial is to test the efficacy of a culturally sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging contraceptive use.
Its primary goal is to expand risk-reduction interventions created in previous studies to further increase intervention efficacy for this particularly vulnerable, high-risk group.
An adolescent intervention has been created and pilot tested in developmental studies.
Results indicated reductions in substance use, risk behaviors, unintended pregnancy, STI and abuse without reports of adverse outcomes.
Specific aims of the current study include: 1) To obtain a more in-depth understanding of configurations of psychosocial and situational factors associated with high-risk sexual behavior, substance use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this group; 3) To evaluate the effects of the adolescent intervention model versus enhanced counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and STI/HIV at 6 and 12 months follow-up.
Participants will include a convenience sample of 600 Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or physical abuse and current STI.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
African-and Mexican-American adolescent women with a current STI and history of abuse will be identified at public health and STI clinics within the San Antonio Metropolitan Health District system.
Women who agree to participate and give informed consent will be randomized into the intervention or control arm.
Women in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling.
Women in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention.
Women in the intervention arm will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
All women in the study will be followed over one year, with follow-up interviews including an inquiry about any Adverse Events (AEs) or Serious Adverse Events (SAEs), and a targeted physical exams and contraception counseling at 6 and 12 months.
During the study period, women will be encouraged to return to the study clinic for problem visits if they suspect they have been infected with a STI or require contraception or abuse counseling.
All analyses of intervention effects will be performed on an intent-to-treat basis.
Studietyp
Interventionell
Inskrivning (Faktisk)
562
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Texas
-
San Antonio, Texas, Förenta staterna
- San Antonio Metropolitan Health District
-
-
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
14 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Aged 14-18 years, Mexican-or African-American female with a history of STI or abuse seeking health care through the San Antonio Metropolitan Health District.
Exclusion Criteria:
- No history of STI or abuse
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: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Control Group
Participants in the control arm will be interviewed at baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and will receive abuse and enhanced clinical counseling
|
Participants in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention.
The intervention will include 2 workshops, 5 support groups sessions and 2 individual counseling sessions.
They will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sexually transmitted infection
Tidsram: 12 months
|
Infection at 12 months with either chlamydia or gonorrhea
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Substance Use
Tidsram: 12 months
|
Frequency and type of substance use
|
12 months
|
|
Experience of abuse
Tidsram: 12 months
|
Type and frequency of experience of abuse
|
12 months
|
|
Unintended pregnancy
Tidsram: 12 months
|
Frequency of unintended pregnancy
|
12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Jane D Champion, PhD, The University of Texas Health Science Center at San Antonio
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Collins JL, Owen DC, Champion JD. The Meaning of Weight: A Big Way of Life for Rural Mexican-American Adolescent Men and Caregivers. Public Health Nurs. 2016 Sep;33(5):421-9. doi: 10.1111/phn.12263. Epub 2016 Apr 14.
- Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.
- Dimmitt Champion J, Harlin B, Collins JL. Sexual risk behavior and STI health literacy among ethnic minority adolescent women. Appl Nurs Res. 2013 Nov;26(4):204-9. doi: 10.1016/j.apnr.2013.06.003. Epub 2013 Jul 15.
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 oktober 2004
Primärt slutförande (Faktisk)
1 april 2009
Avslutad studie (Faktisk)
1 april 2009
Studieregistreringsdatum
Först inskickad
30 juni 2011
Först inskickad som uppfyllde QC-kriterierna
1 juli 2011
Första postat (Uppskatta)
4 juli 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 juli 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juli 2011
Senast verifierad
1 juni 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R01DA019180-01 (U.S.S. NIH-anslag/kontrakt)
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