NCT00279799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 19, 2013

Status Verified

September 1, 2013

Enrollment Period

8 years

First QC Date

January 18, 2006

Last Update Submit

November 18, 2013

Conditions

Sexually Transmitted Diseases

Keywords

Sexually Transmitted Diseases, HIV, condom use, adolescents

Outcome Measures

Primary Outcomes (1)

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

    36 months post-randomization.

Secondary Outcomes (1)

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

    36 months post-randomization

Study Arms (2)

Afiya group intervention + HIV prevention phone sessions

EXPERIMENTAL

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

Behavioral: Afiya HIV Prevention Intervention

Afiya group session + nutrition phone sessions

ACTIVE COMPARATOR

Afiya group-based intervention plus individually tailored nutrition phone sessions

Behavioral: Afiya HIV prevention intervention

Interventions

Afiya HIV prevention interventionBEHAVIORAL

Group-based session plus individually tailored HIV prevention phone sessions

Afiya group intervention + HIV prevention phone sessions

Eligibility Criteria

Age14 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant or trying to get pregnant; married; any condition that would preclude attending group-based intervention sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fulton County Department of Health and Wellness

Atlanta, Georgia, 30303, United States

Location

Grady Hospital Teen Clinic

Atlanta, Georgia, 30303, United States

Location

Planned Parenthood of GA

Atlanta, Georgia, 30303, United States

Location

Related Publications (9)

  • 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.

    PMID: 21553975BACKGROUND

  • 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.

    PMID: 21135341BACKGROUND

  • 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.

    PMID: 21843001BACKGROUND

  • 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.

    PMID: 21933811BACKGROUND

  • 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.

    PMID: 22051790BACKGROUND

  • 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.

    PMID: 22443842BACKGROUND

  • 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.

    PMID: 23479192BACKGROUND

  • 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.

    PMID: 25155070DERIVED

  • 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.

    PMID: 23236082DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph J DiClemente, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

February 1, 2005

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 19, 2013

Record last verified: 2013-09

Locations

US(3)