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

Brief Summary:
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 or disease Intervention/treatment
HIV Infections Sexually Transmitted Diseases Behavioral: HORIZONS HIV Intervention Behavioral: enhanced standard-of-care

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing HIV Risk in Female Teens: A Tailored Approach
Study Start Date : April 2002
Primary Completion Date : August 2004
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
HORIZONS HIV Intervention. Two-session, group-based interactive intervention.
Behavioral: HORIZONS HIV Intervention
Two-session, group-based interactive HIV prevention intervention
Active Comparator: 2
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.

Primary Outcome Measures :
  1. Proportion of condom protected vaginal sex acts over the last 60 days [ Time Frame: 6 and 12 months post-randomization ]

Secondary Outcome Measures :
  1. Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing [ Time Frame: 6 and 12 months post-randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633906

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
National Institutes of Health (NIH)
Principal Investigator: Ralph J DiClemente, PhD Emory University

Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ralph J. DiClemente, Principal, Emory University Identifier: NCT00633906     History of Changes
Other Study ID Numbers: IRB00045957
MH061210 ( Other Identifier: Other )
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: June 2008

Keywords provided by Ralph J. DiClemente, Emory University:
Sexually Transmitted diseases
HIV Seronegativity

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