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HIV Prevention for African American Teens

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Emory University

Status and phase

Completed
Phase 3

Conditions

Sexually Transmitted Diseases

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00279799
NIMH 5 R01 MH070537-08
IRB00041131

Details and patient eligibility

About

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.

Full 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.

Enrollment

701 patients

Sex

Female

Ages

14 to 20 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

701 participants in 2 patient groups

Afiya group intervention + HIV prevention phone sessions
Experimental group
Description:
Afiya group-based intervention plus individually tailored HIV prevention phone sessions
Treatment:
Behavioral: Afiya HIV Prevention Intervention
Afiya group session + nutrition phone sessions
Active Comparator group
Description:
Afiya group-based intervention plus individually tailored nutrition phone sessions
Treatment:
Behavioral: Afiya HIV prevention intervention

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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