HIV Prevention for African American Teens

November 18, 2013 updated by: Ralph J. DiClemente, Emory University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

701

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Fulton County Department of Health and Wellness
      • Atlanta, Georgia, United States, 30303
        • Planned Parenthood of GA
      • Atlanta, Georgia, United States, 30303
        • Grady Hospital Teen Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
Time Frame: 36 months post-randomization.
36 months post-randomization.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
36 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Ralph J DiClemente, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria

January 18, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00041131
  • NIMH 5 R01 MH070537-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexually Transmitted Diseases

Clinical Trials on Afiya HIV Prevention Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe