Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279799
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2006-01-18
Brief Title:
HIV Prevention for African American Teens
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
HIV Prevention Maintenance for African American Teens
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 STIs 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-months18-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
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 STIs 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-months18-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIMH 5 R01 MH070537-08 | None | None | None |