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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
  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: Afiya HIV Prevention Intervention
Behavioral: Afiya HIV prevention intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention Maintenance for African American Teens

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 701
Study Start Date: February 2005
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afiya group intervention + HIV prevention phone sessions
Afiya group-based intervention plus individually tailored HIV prevention phone sessions
Behavioral: Afiya HIV Prevention Intervention
Group-based session plus individually tailored HIV prevention phone sessions
Active Comparator: Afiya group session + nutrition phone sessions
Afiya group-based intervention plus individually tailored nutrition phone sessions
Behavioral: Afiya HIV prevention intervention
Afiya group-based intervention + nutrition phone sessions (attention control)

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ralph J. DiClemente, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00279799     History of Changes
Other Study ID Numbers: IRB00041131, NIMH 5 R01 MH070537-08
Study First Received: January 18, 2006
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014