HIV Prevention for African American Teens
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130317080716im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
- Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over an 18 month follow-up. [ Time Frame: 18 months post-randomization. ] [ Designated as safety issue: No ]
- Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 18 month follow-up. [ Time Frame: 18 months post-randomization ] [ Designated as safety issue: No ]
Enrollment: | 701 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | February 2013 |
Estimated 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 an 18-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 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 and reduce incident STDs. If successful, the findings could have important implications for HIV prevention.
![](https://webarchive.library.unt.edu/web/20130317080716im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 14 Years to 20 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
![](https://webarchive.library.unt.edu/web/20130317080716im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 |
Principal Investigator: | Ralph J DiClemente, PhD | Emory University |
![](https://webarchive.library.unt.edu/web/20130317080716im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided by Emory University
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: | 816-2003, NIMH 5 R01 MH070537-08 |
Study First Received: | January 18, 2006 |
Last Updated: | May 23, 2012 |
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 Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on March 14, 2013