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HORIZONS HIV Intervention (HORIZONS)

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HORIZONS HIV Intervention
enhanced standard-of-care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Sexually Transmitted diseases, Adolescents, Prevention, HIV Seronegativity

Eligibility Criteria

15 Years - 21 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

  • Fulton County Department of Health and Wellness
  • Grady Teen Clinic
  • Planned Parenthood of GA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2008
Last Updated
November 18, 2013
Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00633906
Brief Title
HORIZONS HIV Intervention
Acronym
HORIZONS
Official Title
Reducing HIV Risk in Female Teens: A Tailored Approach
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
HIV, Sexually Transmitted diseases, Adolescents, Prevention, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
715 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HORIZONS HIV Intervention. Two-session, group-based interactive intervention.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Enhanced standard-of-care session. One hour, video-based and brief discussion.
Intervention Type
Behavioral
Intervention Name(s)
HORIZONS HIV Intervention
Intervention Description
Two-session, group-based interactive HIV prevention intervention
Intervention Type
Behavioral
Intervention Name(s)
enhanced standard-of-care
Intervention Description
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 Outcome Measure Information:
Title
Proportion of condom protected vaginal sex acts over the last 60 days
Time Frame
6 and 12 months post-randomization
Secondary Outcome Measure Information:
Title
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Time Frame
6 and 12 months post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J DiClemente, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fulton County Department of Health and Wellness
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Teen Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Planned Parenthood of GA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17531767
Citation
Sales JM, DiClemente RJ, Rose ES, Wingood GM, Klein JD, Woods ER. Relationship of STD-related shame and stigma to female adolescents' condom-protected intercourse. J Adolesc Health. 2007 Jun;40(6):573.e1-6. doi: 10.1016/j.jadohealth.2007.01.007. Epub 2007 Mar 26.
Results Reference
result
PubMed Identifier
17569720
Citation
Crosby RA, DiClemente RJ, Wingood GM, Salazar LF, Rose E, Sales JM, Caliendo AM. Oral contraceptive use may not preclude condom use: a study of non-pregnant African-American adolescent females. Sex Transm Infect. 2007 Jun;83(3):216-8. doi: 10.1136/sti.2006.022442.
Results Reference
result
PubMed Identifier
16730606
Citation
Woods ER, Klein JD, Wingood GM, Rose ES, Wypij D, Harris SK, Diclemente RJ. Development of a new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV. J Adolesc Health. 2006 Jun;38(6):753.e1-7. doi: 10.1016/j.jadohealth.2005.08.013.
Results Reference
result
PubMed Identifier
17140653
Citation
Spitalnick JS, DiClemente RJ, Wingood GM, Crosby RA, Milhausen RR, Sales JM, McCarty F, Rose E, Younge SN. Brief report: sexual sensation seeking and its relationship to risky sexual behaviour among African-American adolescent females. J Adolesc. 2007 Feb;30(1):165-73. doi: 10.1016/j.adolescence.2006.10.002. Epub 2006 Nov 30.
Results Reference
result
PubMed Identifier
18180414
Citation
DiClemente RJ, Wingood GM, Crosby RA, Salazar LF, Rose E, Sales JM, Caliendo AM. Prevalence, correlates, and efficacy of selective avoidance as a sexually transmitted disease prevention strategy among African American adolescent females. Arch Pediatr Adolesc Med. 2008 Jan;162(1):60-5. doi: 10.1001/archpediatrics.2007.5.
Results Reference
result
PubMed Identifier
17507835
Citation
Salazar LF, Crosby RA, Diclemente RJ, Wingood GM, Rose E, Sales JM, Caliendo AM. Personal, relational, and peer-level risk factors for laboratory confirmed STD prevalence among low-income African American adolescent females. Sex Transm Dis. 2007 Oct;34(10):761-6. doi: 10.1097/01.olq.0000264496.94135.ac.
Results Reference
result
PubMed Identifier
16126499
Citation
Caliendo AM, Jordan JA, Green AM, Ingersoll J, Diclemente RJ, Wingood GM. Real-time PCR improves detection of Trichomonas vaginalis infection compared with culture using self-collected vaginal swabs. Infect Dis Obstet Gynecol. 2005 Sep;13(3):145-50. doi: 10.1080/10647440500068248.
Results Reference
result
PubMed Identifier
27147615
Citation
Rosenbaum JE, Zenilman JM, Rose E, Wingood GM, DiClemente RJ. Semen says: assessing the accuracy of adolescents' self-reported sexual abstinence using a semen Y-chromosome biomarker. Sex Transm Infect. 2017 Mar;93(2):145-147. doi: 10.1136/sextrans-2016-052605. Epub 2016 May 4.
Results Reference
derived
PubMed Identifier
22824446
Citation
Swartzendruber A, Brown JL, Sales JM, Murray CC, DiClemente RJ. Sexually transmitted infections, sexual risk behavior, and intimate partner violence among African American adolescent females with a male sex partner recently released from incarceration. J Adolesc Health. 2012 Aug;51(2):156-63. doi: 10.1016/j.jadohealth.2011.11.014. Epub 2012 Feb 28.
Results Reference
derived
PubMed Identifier
19996048
Citation
DiClemente RJ, Wingood GM, Rose ES, Sales JM, Lang DL, Caliendo AM, Hardin JW, Crosby RA. Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1112-21. doi: 10.1001/archpediatrics.2009.205.
Results Reference
derived

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HORIZONS HIV Intervention

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