NCT00633906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
715

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Apr 2002

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

November 19, 2013

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

March 5, 2008

Last Update Submit

November 18, 2013

Conditions

HIV InfectionsSexually Transmitted Diseases

Keywords

HIVSexually Transmitted diseasesAdolescentsPreventionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

    6 and 12 months post-randomization

Secondary Outcomes (1)

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

    6 and 12 months post-randomization

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: HORIZONS HIV Intervention

2

ACTIVE COMPARATOR

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

Behavioral: enhanced standard-of-care

Interventions

HORIZONS HIV InterventionBEHAVIORAL

Two-session, group-based interactive HIV prevention intervention

1
enhanced standard-of-careBEHAVIORAL

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.

2

Eligibility Criteria

Age15 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female
  • African American
  • Ages 15-21
  • Receiving care at participating clinic
  • Vaginal sex in the past 60 days
  • Ability to give written informed consent

You may not qualify if:

  • Married
  • Pregnant
  • In a detention center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fulton County Department of Health and Wellness

Atlanta, Georgia, 30303, United States

Location

Grady Teen Clinic

Atlanta, Georgia, 30303, United States

Location

Planned Parenthood of GA

Atlanta, Georgia, 30303, United States

Location

Related Publications (10)

  • 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.

    PMID: 17531767RESULT

  • 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.

    PMID: 17569720RESULT

  • 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.

    PMID: 16730606RESULT

  • 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.

    PMID: 17140653RESULT

  • 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.

    PMID: 18180414RESULT

  • 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.

    PMID: 17507835RESULT

  • 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.

    PMID: 16126499RESULT

  • 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.

    PMID: 27147615DERIVED

  • 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.

    PMID: 22824446DERIVED

  • 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.

    PMID: 19996048DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph J DiClemente, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

April 1, 2002

Primary Completion

August 1, 2004

Study Completion

October 1, 2005

Last Updated

November 19, 2013

Record last verified: 2008-06

Locations

US(3)