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HIV Prevention for African American Teens

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ClinicalTrials.gov Identifier: NCT00279799
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University

Tracking Information
First Submitted Date  ICMJE January 18, 2006
First Posted Date  ICMJE January 20, 2006
Last Update Posted Date November 19, 2013
Study Start Date  ICMJE February 2005
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up. [ Time Frame: 36 months post-randomization. ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
Proportion of condom protected acts over the last 90 days measured at 6, 12, and 18 months post-randomization.
Change History Complete list of historical versions of study NCT00279799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up. [ Time Frame: 36 months post-randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
Incident infection of chlamydia, gonorrhea or trichomonas as confirmed by laboratory PCR testing measured at 6, 12, and 18 months post-randomization.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Prevention for African American Teens
Official Title  ICMJE HIV Prevention Maintenance for African American Teens
Brief Summary AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young African American females through a culturally and gender appropriate intervention (group sessions) coupled with an individualized HIV Telephone Maintenance Intervention.
Detailed Description

African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV educational programs can significantly reduce sexual risk behaviors among this vulnerable population over the short term. It is unclear as to whether these programs have long-term effects. Thus, the aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote long-term maintenance of HIV preventive sexual behaviors over a long follow-up period.

700 African-American female adolescents' between the ages of 14-20 will be enrolled in this trial. Adolescents will be recruited from youth currently seeking services at several family planning clinics in Atlanta, Georgia. Adolescents who are eligible and willing to participate in the project will complete an initial ACASI survey. The survey is designed to assess adolescents' sexual risk and preventive behaviors. Biological specimens are collected and tested for common STI's. Free DOT (Directly Observed Therapy) is provided through the clinics. Urine pregnancy screens will also be conducted. After they complete the assessment, adolescents will receive a sexual health education program that was developed by the Principal Investigator. This program (HORIZONS) has been shown to be effective in reducing sexual risk behaviors over the short-term. Trained African American female health educators will deliver the sexual health education program. Adolescents will then be assigned, by chance alone, to one of two groups: one group will get periodic telephone contacts designed to reinforce sexual health promotion and the other group will get periodic telephone contacts that promote healthy dietary practices. Thus, while all adolescents receive the same sexual health education program, half will get telephone calls emphasizing sexual health and half will get an equal number of telephone calls emphasizing nutritional health.

The primary aims of the proposed project are:

Primary Aim 1. To determine whether adding a telephone educational component to a sexual health education program will reduce incident STD infection over a 36-month follow-up.

Primary Aim 2. To determine if adding a telephone educational component to a sexual health education program can maintain HIV-preventive behaviors.

We will ask adolescents to come back to participating clinics to complete follow-up assessments at 6 months, 12-months,18-months, 24-months, 30-months and 36-months after completing the initial assessment. We will test the effects of adding the telephone sexual health educational program to maintain or enhance adolescents' use of HIV prevention behaviors and reduce incident STDs. If successful, the findings could have important implications for HIV prevention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sexually Transmitted Diseases
Intervention  ICMJE
  • Behavioral: Afiya HIV Prevention Intervention
    Group-based session plus individually tailored HIV prevention phone sessions
  • Behavioral: Afiya HIV prevention intervention
    Afiya group-based intervention + nutrition phone sessions (attention control)
Study Arms  ICMJE
  • Experimental: Afiya group intervention + HIV prevention phone sessions
    Afiya group-based intervention plus individually tailored HIV prevention phone sessions
    Intervention: Behavioral: Afiya HIV Prevention Intervention
  • Active Comparator: Afiya group session + nutrition phone sessions
    Afiya group-based intervention plus individually tailored nutrition phone sessions
    Intervention: Behavioral: Afiya HIV prevention intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2009)
701
Original Enrollment  ICMJE
 (submitted: January 18, 2006)
700
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female; African American; age 14-20; receiving care at participating clinic;report having unprotected vaginal sex in last 6 months; ability to give written informed consent

Exclusion Criteria:

  • pregnant or trying to get pregnant; married; any condition that would preclude attending group-based intervention sessions.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00279799
Other Study ID Numbers  ICMJE IRB00041131
NIMH 5 R01 MH070537-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ralph J. DiClemente, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Ralph J DiClemente, PhD Emory University
PRS Account Emory University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP