HIV Prevention for African American Teens

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HIV Prevention Maintenance for African American Teens

Conditions
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Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Afiya HIV Prevention Intervention
* Behavioral: Afiya HIV prevention intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afiya group intervention + HIV prevention phone sessions<br>Afiya group-based intervention plus individually tailored HIV prevention phone sessions | Behavioral: Afiya HIV Prevention Intervention<br>* Group-based session plus individually tailored HIV prevention phone sessions<br>|
| Active Comparator: Afiya group session + nutrition phone sessions<br>Afiya group-based intervention plus individually tailored nutrition phone sessions | Behavioral: Afiya HIV prevention intervention<br>* Afiya group-based intervention + nutrition phone sessions (attention control)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up. |  | 36 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexually Transmitted Diseases, HIV, condom use, adolescents