HORIZONS HIV Intervention

Emory University

Status: Completed

Conditions: Sexually Transmitted Diseases; HIV Infections

Treatments: Behavioral: HORIZONS HIV Intervention; Behavioral: enhanced standard-of-care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00633906

MH061210 (Other Identifier)

IRB00045957

Details and patient eligibility

About

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.

Full 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.

Enrollment: 715 patients

Sex: Female

Ages: 15 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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715 participants in 2 patient groups

1

Experimental group

Description:

HORIZONS HIV Intervention. Two-session, group-based interactive intervention.

Treatment:

Behavioral: HORIZONS HIV Intervention

2

Active Comparator group

Description:

Enhanced standard-of-care session. One hour, video-based and brief discussion.

Treatment:

Behavioral: enhanced standard-of-care