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HIV Prevention for African American Teens

Primary Purpose

Sexually Transmitted Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Afiya HIV Prevention Intervention
Afiya HIV prevention intervention
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Sexually Transmitted Diseases, HIV, condom use, adolescents

Eligibility Criteria

14 Years - 20 Years (Child, Adult)FemaleAccepts 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.

Sites / Locations

  • Fulton County Department of Health and Wellness
  • Grady Hospital Teen Clinic
  • Planned Parenthood of GA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Afiya group intervention + HIV prevention phone sessions

Afiya group session + nutrition phone sessions

Arm Description

Afiya group-based intervention plus individually tailored HIV prevention phone sessions

Afiya group-based intervention plus individually tailored nutrition phone sessions

Outcomes

Primary Outcome Measures

Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.

Secondary Outcome Measures

Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up.

Full Information

First Posted
January 18, 2006
Last Updated
November 18, 2013
Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00279799
Brief Title
HIV Prevention for African American Teens
Official Title
HIV Prevention Maintenance for African American Teens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
Sexually Transmitted Diseases, HIV, condom use, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
701 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Afiya group intervention + HIV prevention phone sessions
Arm Type
Experimental
Arm Description
Afiya group-based intervention plus individually tailored HIV prevention phone sessions
Arm Title
Afiya group session + nutrition phone sessions
Arm Type
Active Comparator
Arm Description
Afiya group-based intervention plus individually tailored nutrition phone sessions
Intervention Type
Behavioral
Intervention Name(s)
Afiya HIV Prevention Intervention
Intervention Description
Group-based session plus individually tailored HIV prevention phone sessions
Intervention Type
Behavioral
Intervention Name(s)
Afiya HIV prevention intervention
Intervention Description
Afiya group-based intervention + nutrition phone sessions (attention control)
Primary Outcome Measure Information:
Title
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
Time Frame
36 months post-randomization.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J DiClemente, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fulton County Department of Health and Wellness
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Hospital Teen Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Planned Parenthood of GA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21553975
Citation
DePadilla L, Windle M, Wingood G, Cooper H, DiClemente R. Condom use among young women: modeling the theory of gender and power. Health Psychol. 2011 May;30(3):310-9. doi: 10.1037/a0022871.
Results Reference
background
PubMed Identifier
21135341
Citation
Sales JM, Latham TP, Diclemente RJ, Rose E. Differences between dual-method and non-dual-method protection use in a sample of young African American women residing in the Southeastern United States. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1125-31. doi: 10.1001/archpediatrics.2010.230.
Results Reference
background
PubMed Identifier
21843001
Citation
Sales JM, Lang DL, DiClemente RJ, Latham TP, Wingood GM, Hardin JW, Rose ES. The mediating role of partner communication frequency on condom use among African American adolescent females participating in an HIV prevention intervention. Health Psychol. 2012 Jan;31(1):63-9. doi: 10.1037/a0025073. Epub 2011 Aug 15.
Results Reference
background
PubMed Identifier
21933811
Citation
Sales JM, Brown JL, Diclemente RJ, Davis TL, Kottke MJ, Rose ES. Age differences in STDs, sexual behaviors, and correlates of risky sex among sexually experienced adolescent African-American females. J Pediatr Psychol. 2012 Jan-Feb;37(1):33-42. doi: 10.1093/jpepsy/jsr076. Epub 2011 Sep 20.
Results Reference
background
PubMed Identifier
22051790
Citation
Diclemente RJ, Young AM, Painter JL, Wingood GM, Rose E, Sales JM. Prevalence and correlates of recent vaginal douching among African American adolescent females. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):48-53. doi: 10.1016/j.jpag.2011.07.017. Epub 2011 Nov 3.
Results Reference
background
PubMed Identifier
22443842
Citation
Brown JL, Sales JM, Diclemente RJ, Latham Davis TP, Rose ES. Characteristics of African American adolescent females who perceive their current boyfriends have concurrent sexual partners. J Adolesc Health. 2012 Apr;50(4):377-82. doi: 10.1016/j.jadohealth.2011.07.008. Epub 2011 Sep 23.
Results Reference
background
PubMed Identifier
23479192
Citation
Sales JM, DiClemente RJ, Brody GH, Philibert RA, Rose E. Interaction between 5-HTTLPR polymorphism and abuse history on adolescent African-American females' condom use behavior following participation in an HIV prevention intervention. Prev Sci. 2014 Jun;15(3):257-67. doi: 10.1007/s11121-013-0378-6.
Results Reference
background
PubMed Identifier
25155070
Citation
DiClemente RJ, Wingood GM, Sales JM, Brown JL, Rose ES, Davis TL, Lang DL, Caliendo A, Hardin JW. Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):938-46. doi: 10.1001/jamapediatrics.2014.1436.
Results Reference
derived
PubMed Identifier
23236082
Citation
Swartzendruber A, Sales JM, Brown JL, Davis TL, DiClemente RJ, Rose E. Predictors of repeat Chlamydia trachomatis and/or Neisseria gonorrhoeae infections among African-American adolescent women. Sex Transm Infect. 2013 Feb;89(1):76-82. doi: 10.1136/sextrans-2012-050530. Epub 2012 Dec 12.
Results Reference
derived

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HIV Prevention for African American Teens

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