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HIV Prevention for African American Teens

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ralph J. DiClemente, Emory University
ClinicalTrials.gov Identifier:
NCT00279799
First received: January 18, 2006
Last updated: November 18, 2013
Last verified: September 2013

January 18, 2006
November 18, 2013
February 2005
February 2013   (final data collection date for primary outcome measure)
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up. [ Time Frame: 36 months post-randomization. ] [ Designated as safety issue: No ]
Proportion of condom protected acts over the last 90 days measured at 6, 12, and 18 months post-randomization.
Complete list of historical versions of study NCT00279799 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Incident infection of chlamydia, gonorrhea or trichomonas as confirmed by laboratory PCR testing measured at 6, 12, and 18 months post-randomization.
Not Provided
Not Provided
 
HIV Prevention for African American Teens
HIV Prevention Maintenance for African American Teens

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Sexually Transmitted Diseases
  • 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)
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
701
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Female
14 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279799
IRB00041131, NIMH 5 R01 MH070537-08
Yes
Ralph J. DiClemente, Emory University
Emory University
National Institutes of Health (NIH)
Principal Investigator: Ralph J DiClemente, PhD Emory University
Emory University
September 2013

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