NCT00705705

Brief Summary

This study will determine whether an HIV prevention program that targets the inner workings of social networks at high risk for HIV and other sexually transmitted diseases is effective in reducing frequency of high-risk sexual behaviors among network members.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
852

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Jul 2004

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

4.7 years

First QC Date

June 24, 2008

Last Update Submit

November 10, 2011

Conditions

HIV Infections

Keywords

High-Risk BehaviorMen Who Have Sex With MenHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Frequency of high-risk sexual practices

    Measured at baseline and Months 12 and 24

Secondary Outcomes (1)

  • Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs

    Measured at baseline and Months 12 and 24

Study Arms (2)

1

EXPERIMENTAL

Participating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention.

Behavioral: Network leader trainingBehavioral: Standard HIV risk-reduction counseling

2

ACTIVE COMPARATOR

Participating social networks will receive standard HIV risk-reduction counseling.

Behavioral: Standard HIV risk-reduction counseling

Interventions

Network leader trainingBEHAVIORAL

Network leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk. The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network. Leaders will be asked to share these messages with other members of their groups.

1
Standard HIV risk-reduction counselingBEHAVIORAL

Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.

12

Eligibility Criteria

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

You may qualify if:

  • Identified by the network leader as a member of the social group (e.g., men who have sex with men, young heterosexual men and women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53202, United States

Location

MeSH Terms

Conditions

HIV InfectionsHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Yuri A. Amirkhanian, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

  • David W. Seal, PhD

    Medical College of Wisconsin

    STUDY DIRECTOR

  • Jeffrey A. Kelly, PhD

    Medical College of Wisconsin

    STUDY DIRECTOR

  • Carol L. Galletly, JD, PhD

    Medical College of Wisconsin

    STUDY DIRECTOR

  • Laura R. Glasman, PhD

    Medical College of Wisconsin

    STUDY DIRECTOR

  • Timothy L. McAuliffe, PhD

    Medical College of Wisconsin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Behavioral Medicine

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

July 1, 2004

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

US(1)