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Completed

NCT Number: NCT00633906

HORIZONS HIV Intervention

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.

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Key information

Age range

15 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fulton County Department of Health and Wellness, Atlanta, Georgia, United States

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HORIZONS HIV Intervention

Behavioral

Two-session, group-based interactive HIV prevention intervention

enhanced standard-of-care

Behavioral

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 outcomes

  1. Proportion of condom protected vaginal sex acts over the last 60 days

    Time frame: 6 and 12 months post-randomization

Secondary outcomes

  1. Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing

    Time frame: 6 and 12 months post-randomization

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Reducing HIV Risk in Female Teens: A Tailored Approach

Acronym: HORIZONS

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Mar 12, 2008
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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