The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633906
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : November 19, 2013
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University

March 5, 2008
March 12, 2008
November 19, 2013
April 2002
August 2004   (Final data collection date for primary outcome measure)
Proportion of condom protected vaginal sex acts over the last 60 days [ Time Frame: 6 and 12 months post-randomization ]
Same as current
Complete list of historical versions of study NCT00633906 on Archive Site
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing [ Time Frame: 6 and 12 months post-randomization ]
Same as current
Not Provided
Not Provided
HORIZONS HIV Intervention
Reducing HIV Risk in Female Teens: A Tailored Approach
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Diseases
  • Behavioral: HORIZONS HIV Intervention
    Two-session, group-based interactive HIV prevention intervention
  • 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.
  • Experimental: 1
    HORIZONS HIV Intervention. Two-session, group-based interactive intervention.
    Intervention: Behavioral: HORIZONS HIV Intervention
  • Active Comparator: 2
    Enhanced standard-of-care session. One hour, video-based and brief discussion.
    Intervention: Behavioral: enhanced standard-of-care

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2005
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
15 Years to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
MH061210 ( Other Identifier: Other )
Not Provided
Not Provided
Ralph J. DiClemente, Emory University
Emory University
National Institutes of Health (NIH)
Principal Investigator: Ralph J DiClemente, PhD Emory University
Emory University
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP