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HIV Prevention for African American Teens
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Emory University
National Institutes of Health (NIH)
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00279799
  Purpose

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.


Condition Intervention Phase
Sexually Transmitted Diseases
Behavioral: HIV Prevention for African American Teens
Phase III

MedlinePlus related topics: AIDS Sexually Transmitted Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: HIV Prevention Maintenance for African American Teens

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Proportion of condom protected acts over the last 90 days measured at 6, 12, and 18 months post-randomization. [ Time Frame: over the last 90 days measured at 6, 12, and 18 months post-randomization. ]

Secondary Outcome Measures:
  • Incident infection of chlamydia, gonorrhea or trichomonas as confirmed by laboratory PCR testing measured at 6, 12, and 18 months post-randomization. [ Time Frame: measured at 6, 12, and 18 months post-randomization ]

Estimated Enrollment: 700
Study Start Date: February 2005
Estimated Study Completion Date: December 2008
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 (Chlamydia, gonorrhea, and trichomonas). 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 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 enhance female adolescents use of HIV prevention strategies over an 18-month follow-up.

Primary Aim 2. To determine if adding a telephone educational component to a sexual health education program is cost-effective.

We will ask adolescents to come back to participating clinics to complete follow-up assessments at 6 months, 12-months and 18-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. If successful, the findings could have important implications for HIV prevention.

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279799

Locations
United States, Georgia
Planned Parenthood of GA
Atlanta, Georgia, United States, 30303
Fulton County Department of Health and Wellness
Atlanta, Georgia, United States, 30303
Grady Hospital Teen Clinic
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ralph J DiClemente, PhD Emory University
  More Information

Study ID Numbers: 816-2003, NIMH 5 R01 MH070537-05
Study First Received: January 18, 2006
Last Updated: November 20, 2007
ClinicalTrials.gov Identifier: NCT00279799  
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Sexually Transmitted Diseases, HIV, condom use, adolescents

Study placed in the following topic categories:
Genital Diseases, Female
Virus Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Genital Diseases, Male

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 16, 2009