HORIZONS HIV Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing HIV Risk in Female Teens: A Tailored Approach

Conditions
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HIV Infections, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: HORIZONS HIV Intervention
* Behavioral: enhanced standard-of-care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HORIZONS HIV Intervention. Two-session, group-based interactive intervention. | Behavioral: HORIZONS HIV Intervention<br>* Two-session, group-based interactive HIV prevention intervention<br>|
| Active Comparator: 2<br>Enhanced standard-of-care session. One hour, video-based and brief discussion. | Behavioral: enhanced standard-of-care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Sexually Transmitted diseases, Adolescents, Prevention, HIV Seronegativity