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A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peer-oriented intervention
Group cognitive behavioral therapy (CBT)
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for CBT or Peer Intervention Participants: Female Age 18-55 Did not inject drugs in the past 6 months Self-reported sex with at least 1 male partner in the past 6 months Had at least 1 of the following sexual risk factors: More than 2 sex partners in the past 6 months STI diagnosis in the past 6 months Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM) Inclusion Criteria for Peer Network Participants: 18 years old or older One of the following: Injected drugs Sex partner of index Social network member that the index felt comfortable talking to about HIV/STIs Exclusion Criteria for All Participants: Currently enrolled in another HIV prevention intervention

Sites / Locations

  • The Lighthouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

Intervention Condition: CHAT

Comparison Condition: Standard of Care

Network Participants

Non-randomized Baseline index participants

Arm Description

Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.

The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.

Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.

This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

Outcomes

Primary Outcome Measures

Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Number of participants that had 2 or more sex partners in the past 90 days.
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)

Secondary Outcome Measures

HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)

Full Information

First Posted
September 13, 2005
Last Updated
June 24, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183456
Brief Title
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
Official Title
Network HIV Prevention Intervention for Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).
Detailed Description
The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area. Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition: CHAT
Arm Type
Experimental
Arm Description
Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
Arm Title
Comparison Condition: Standard of Care
Arm Type
Active Comparator
Arm Description
The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Arm Title
Network Participants
Arm Type
No Intervention
Arm Description
Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Arm Title
Non-randomized Baseline index participants
Arm Type
No Intervention
Arm Description
This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Intervention Type
Behavioral
Intervention Name(s)
Peer-oriented intervention
Intervention Description
The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.
Intervention Type
Behavioral
Intervention Name(s)
Group cognitive behavioral therapy (CBT)
Intervention Description
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
Primary Outcome Measure Information:
Title
Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Description
Number of participants that had 2 or more sex partners in the past 90 days.
Time Frame
6 months
Title
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Time Frame
12 months
Title
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Time Frame
18 month
Title
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Time Frame
18 months
Title
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Time Frame
18 months
Title
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Time Frame
18 months
Title
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time Frame
6 months
Title
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time Frame
12 months
Title
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for CBT or Peer Intervention Participants: Female Age 18-55 Did not inject drugs in the past 6 months Self-reported sex with at least 1 male partner in the past 6 months Had at least 1 of the following sexual risk factors: More than 2 sex partners in the past 6 months STI diagnosis in the past 6 months Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM) Inclusion Criteria for Peer Network Participants: 18 years old or older One of the following: Injected drugs Sex partner of index Social network member that the index felt comfortable talking to about HIV/STIs Exclusion Criteria for All Participants: Currently enrolled in another HIV prevention intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl A. Latkin, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Lighthouse
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

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A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

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