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HORIZONS HIV Intervention
This study has been completed.
First Received: March 5, 2008   Last Updated: June 16, 2008   History of Changes
Sponsors and Collaborators: Emory University
National Institutes of Health (NIH)
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00633906
  Purpose

The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.


Condition Intervention
HIV Infections
Sexually Transmitted Diseases
Behavioral: HORIZONS HIV Intervention
Behavioral: enhanced standard-of-care

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Reducing HIV Risk in Female Teens: A Tailored Approach

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Proportion of condom protected vaginal sex acts over the last 60 days [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing [ Time Frame: 6 and 12 months post-randomization ] [ Designated as safety issue: No ]

Enrollment: 715
Study Start Date: April 2002
Study Completion Date: October 2005
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
HORIZONS HIV Intervention. Two-session, group-based interactive intervention.
Behavioral: HORIZONS HIV Intervention
Two-session, group-based interactive HIV prevention intervention
2: Active Comparator
Enhanced standard-of-care session. One hour, video-based and brief discussion.
Behavioral: enhanced standard-of-care
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.

Detailed Description:

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:

  1. 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.
  2. 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.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633906

Locations
United States, Georgia
Fulton County Department of Health and Wellness
Atlanta, Georgia, United States, 30303
Grady Teen Clinic
Atlanta, Georgia, United States, 30303
Planned Parenthood of GA
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ralph J DiClemente, PhD Emory University
  More Information

Publications:
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. 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.
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.
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. 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.
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.
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.

Responsible Party: Emory University ( Ralph J. DiClemente )
Study ID Numbers: MH061210
Study First Received: March 5, 2008
Last Updated: June 16, 2008
ClinicalTrials.gov Identifier: NCT00633906     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV
Sexually Transmitted diseases
Adolescents
Prevention
HIV Seronegativity

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Genital Diseases, Male
Immunologic Deficiency Syndromes
Genital Diseases, Female
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009