NCT00183573

Brief Summary

This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,554

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Mar 2004

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

June 6, 2013

Conditions

HIV InfectionsSexually Transmitted Diseases

Keywords

STDsSexual BehaviorHealth BehaviorHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Sexual behavior

    12 months

Secondary Outcomes (1)

  • STD incidence

    12 months

Study Arms (6)

1

EXPERIMENTAL

Brief Motivational Intervention only

Behavioral: Brief Motivational Intervention

2

EXPERIMENTAL

Brief Informational Intervention only

Behavioral: Brief Informational Intervention

3

EXPERIMENTAL

Brief Motivational Intervention + Intensive Informational Intervention

Behavioral: Brief Motivational InterventionBehavioral: Intensive Informational Intervention

4

EXPERIMENTAL

Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention

Behavioral: Brief Motivational InterventionBehavioral: Intensive Info-Motivation-Behavioral Skills Intervention

5

EXPERIMENTAL

Brief Informational Intervention + Intensive Informational Intervention

Behavioral: Brief Informational InterventionBehavioral: Intensive Informational Intervention

6

EXPERIMENTAL

Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention

Behavioral: Brief Informational InterventionBehavioral: Intensive Info-Motivation-Behavioral Skills Intervention

Interventions

Brief Motivational InterventionBEHAVIORAL

15-20 minute, motivational one-on-one counseling

134
Brief Informational InterventionBEHAVIORAL

15 minute informational DVD on safer sex

256
Intensive Informational InterventionBEHAVIORAL

4-hour, information-only intensive group workshop

35
Intensive Info-Motivation-Behavioral Skills InterventionBEHAVIORAL

4-hour, intensive group workshop with emphasis on motivation and skills

46

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
  • Able to understand English

You may not qualify if:

  • Psychosis or impaired mental status that would prevent participant from providing informed consent
  • Have been tested for HIV within 3 months prior to study entry
  • HIV infected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesSexual BehaviorHealth Behavior

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 SymptomsBehavior

Study Officials

  • Michael P. Carey, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, CBPM

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

US(1)