NCT00353405

Brief Summary

This study will evaluate the joint and separate effectiveness of two HIV/STD prevention programs in providing protection against acquiring STDs and maintaining safer sex behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,650

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Oct 2006

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

July 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

4.2 years

First QC Date

July 14, 2006

Last Update Submit

January 18, 2012

Conditions

HIV InfectionsSexually Transmitted Diseases

Keywords

AdolescentsSexually Transmitted InfectionsGonorrheaChlamydia Infections

Outcome Measures

Primary Outcomes (1)

  • STD incidence

    Measured at Months 6, 12, and 18 post-treatment

Secondary Outcomes (1)

  • Number of unprotected sexual occasions

    Measured at Months 6, 12, and 18 post-treatment

Study Arms (4)

1

EXPERIMENTAL

Participants receiving social skills training and mass media messages

Behavioral: Social Skills TrainingBehavioral: Mass media

2

EXPERIMENTAL

Participants receiving social skills training and no mass media messages

Behavioral: Social Skills Training

3

EXPERIMENTAL

Participants receiving mass media messages and no social skills training

Behavioral: Mass media

4

EXPERIMENTAL

Participants receiving no social skills training and no mass media messages

Behavioral: Control

Interventions

Social Skills TrainingBEHAVIORAL

Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.

12
Mass mediaBEHAVIORAL

Mass media provides messages that support sexual health skills.

13
ControlBEHAVIORAL

Control group received no social skills training and no media mass media messages.

4

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Currently resides in one of the test cities

You may not qualify if:

  • Presence of mental impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University, Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

Syracuse University, Department of Psychology

Syracuse, New York, 13244, United States

Location

Brown University, Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of South Carolina, Arnold School of Public Health

Columbia, South Carolina, 29208, United States

Location

Related Publications (2)

  • Foley JD, Vanable PA, Brown LK, Carey MP, DiClemente RJ, Romer D, Valois RF. Depressive symptoms as a longitudinal predictor of sexual risk behaviors among African-American adolescents. Health Psychol. 2019 Nov;38(11):1001-1009. doi: 10.1037/hea0000780. Epub 2019 Aug 5.

    PMID: 31380687DERIVED

  • Hennessy M, Romer D, Valois RF, Vanable P, Carey MP, Stanton B, Brown L, DiClemente R, Salazar LF. Safer sex media messages and adolescent sexual behavior: 3-year follow-up results from project iMPPACS. Am J Public Health. 2013 Jan;103(1):134-40. doi: 10.2105/AJPH.2012.300856. Epub 2012 Nov 15.

    PMID: 23153149DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesGonorrheaChlamydia Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae Infections

Study Officials

  • Daniel Romer, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Ralph DiClemente, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Lawrence Brown, MD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Peter Vanable, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

  • Robert Valois, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 18, 2006

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

US(4)