HORIZONS HIV Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT00633906
First received: March 5, 2008
Last updated: November 18, 2013
Last verified: June 2008
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ralph J. DiClemente, Principal, Emory University
ClinicalTrials.gov Identifier: NCT00633906     History of Changes
Other Study ID Numbers: IRB00045957, MH061210
Study First Received: March 5, 2008
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 18, 2014