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High Risk Crack Use Settings and HIV in El Salvador (Encuentro)

This study is currently recruiting participants.
Verified March 2013 by Medical College of Wisconsin
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Julia Dickson-Gomez, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01279421
First received: January 17, 2011
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

This project will first increase the accessibility and acceptability of rapid HIV testing in health clinics located in or near four low-income communities in San Salvador, El Salvador. The investigators will use crack users' social networks and small incentives, as recommended by the CDC, in collaboration with the Salvadoran Ministry of Public Health and Social Assistance (MSPAS) to encourage crack users to receive HIV testing. The second part of the intervention consists of training 8 Peer Leaders to recruit and lead a Peer Network Intervention among 400 crack users to change norms supporting HIV protective behaviors. The intervention will include monthly meetings open to crack using and non-crack using community residents to reinforce HIV risk reduction skills, and discussion of other topics related to HIV such as illicit drug use and interpersonal violence and community-wide HIV awareness events. Our hypothesis is that these two intervention features will singly, and in combination, reduce HIV risk behaviors among Salvadoran crack users.


Condition Intervention Phase
HIV
Sexually Transmitted Diseases
 Behavioral: Social Network HIV Testing
Behavioral: Peer Network Intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: High Risk Crack Use Settings and HIV in El Salvador

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Increased HIV testing rates among crack users [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Decreased number of sexual risk behaviors among crack users [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1870
Study Start Date: November 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social Network HIV Testing
Participants in this arm will be recruited through social networks and will receive an HIV test.
 Behavioral: Social Network HIV Testing
Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing.
Experimental: Peer Network Intervention
Eight (8) current or former crack users will be recruited to facilitate small networks of crack users in a three-day intervention. They will also facilitate monthly meetings open to all community members regarding HIV prevention and interpersonal violence.
 Behavioral: Peer Network Intervention
Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • used crack cocaine in the last 2 weeks

Exclusion Criteria:

  • not giving informed consent
  • under 18 years of age
  • considered by research staff to be unfit or unable to give informed consent
  • engages in continued disruptive behavior while participating in the project
  • not using crack or cocaine in the last month
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279421

Contacts
Contact: Gloria Bodnar, Ph.D. 011.503.2236.0316 gbodnar@fundasalva.org.sv

Locations
El Salvador
Fundasalva Recruiting
San Salvador, El Salvador
Contact: Gloria Bodnar         g.bodnar@fundasalva.org.sv    
Sponsors and Collaborators
Medical College of Wisconsin
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Julia B. Dickson-Gomez, Ph.D. Medical College of Wisconsin
Study Director: Gloria Bodnar, Ph.D. Fundacion Antidrogas de El Salvador (FUNDASALVA)
  More Information

No publications provided

Responsible Party: Julia Dickson-Gomez, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01279421     History of Changes
Other Study ID Numbers: PRO00013931, R01DA020350
Study First Received: January 17, 2011
Last Updated: March 25, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
 HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013