HORIZONS HIV Intervention (HORIZONS)

November 18, 2013 updated by: Ralph J. DiClemente, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

715

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Fulton County Department of Health and Wellness
      • Atlanta, Georgia, United States, 30303
        • Grady Teen Clinic
      • Atlanta, Georgia, United States, 30303
        • Planned Parenthood of GA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of condom protected vaginal sex acts over the last 60 days
Time Frame: 6 and 12 months post-randomization
6 and 12 months post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Time Frame: 6 and 12 months post-randomization
6 and 12 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ralph J DiClemente, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00045957
  • MH061210 (Other Identifier: Other)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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