ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01279421
Recruitment Status : Active, not recruiting
First Posted : January 19, 2011
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Julia Dickson-Gomez, Medical College of Wisconsin

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Sexually Transmitted Diseases Behavioral: Social Network HIV Testing Behavioral: Peer Network Intervention Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4382 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: High Risk Crack Use Settings and HIV in El Salvador
Study Start Date : November 2010
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Increased HIV testing rates among crack users [ Time Frame: 24 months ]
  2. Decreased number of sexual risk behaviors among crack users [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention [ Time Frame: 12 months ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279421


Locations
El Salvador
Fundasalva
San Salvador, El Salvador
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Julia Dickson-Gomez, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01279421     History of Changes
Other Study ID Numbers: PRO00013931
R01DA020350 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female