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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183456 |
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).
Condition | Intervention | Phase |
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HIV Infections Sexually Transmitted Diseases |
Behavioral: Peer-oriented intervention Behavioral: Group cognitive behavioral therapy (CBT) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Network HIV Prevention Intervention for Drug Users |
Estimated Enrollment: | 800 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2008 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive a network-oriented peer program for 6 months
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Behavioral: Peer-oriented intervention
The peer-oriented intervention program will emphasize social identity and the goals of protecting family and community. The peer program will also train participants to provide HIV/STD education to their peers.
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2: Active Comparator
Participants will receive group cognitive behavioral therapy for 6 months
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Behavioral: Group cognitive behavioral therapy (CBT)
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.
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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. Each intervention will last 6 months. Participants will be assessed at study entry and at the end of the study. 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 3, 6, 12, and 18 after the end of the study. Participants and peers will also complete the sexual health and behavior questionnaires at each follow-up visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for CBT or Peer Intervention Participants:
Inclusion Criteria for Peer Network Participants:
Exclusion Criteria for All Participants:
Contact: Carl A. Latkin, PhD | 410-502-5368 | clatkin@jhsph.edu |
United States, Maryland | |
The Lighthouse | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Carl A. Latkin, PhD 410-502-5368 clatkin@jhsph.edu |
Principal Investigator: | Carl A. Latkin, PhD | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | JHU ( Carl Latkin ) |
Study ID Numbers: | R01 MH66810, DAHBR 9A-ASI |
Study First Received: | September 13, 2005 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00183456 |
Health Authority: | United States: Federal Government |
Sex Education Peer Group Social Identity Theory HIV Seronegativity |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |