High Risk Crack Use Settings and HIV in El Salvador (Encuentro)
Primary Purpose
HIV, Sexually Transmitted Diseases
Status
Completed
Phase
Not Applicable
Locations
El Salvador
Study Type
Interventional
Intervention
Social Network HIV Testing
Peer Network Intervention
Sponsored by
About this trial
This is an interventional prevention trial for HIV
Eligibility 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
Sites / Locations
- Fundasalva
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Social Network HIV Testing
Peer Network Intervention
Arm Description
Participants in this arm will be recruited through social networks and will receive an HIV test.
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.
Outcomes
Primary Outcome Measures
Increased HIV testing rates among crack users
Decreased number of sexual risk behaviors among crack users
Secondary Outcome Measures
Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention
Full Information
NCT ID
NCT01279421
First Posted
January 17, 2011
Last Updated
May 12, 2021
Sponsor
Medical College of Wisconsin
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01279421
Brief Title
High Risk Crack Use Settings and HIV in El Salvador
Acronym
Encuentro
Official Title
High Risk Crack Use Settings and HIV in El Salvador
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Network HIV Testing
Arm Type
Experimental
Arm Description
Participants in this arm will be recruited through social networks and will receive an HIV test.
Arm Title
Peer Network Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Network HIV Testing
Intervention Description
Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing.
Intervention Type
Behavioral
Intervention Name(s)
Peer Network Intervention
Intervention Description
Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.
Primary Outcome Measure Information:
Title
Increased HIV testing rates among crack users
Time Frame
24 months
Title
Decreased number of sexual risk behaviors among crack users
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia B. Dickson-Gomez, Ph.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Bodnar, Ph.D.
Organizational Affiliation
Fundacion Antidrogas de El Salvador (FUNDASALVA)
Official's Role
Study Director
Facility Information:
Facility Name
Fundasalva
City
San Salvador
Country
El Salvador
12. IPD Sharing Statement
Citations:
PubMed Identifier
25595149
Citation
Dickson-Gomez J, Bodnar G, Petroll A, Johnson K, Glasman L. HIV Treatment for Alcohol and Non-Injection Drug Users in El Salvador. Qual Health Res. 2015 Dec;25(12):1719-32. doi: 10.1177/1049732314568322. Epub 2015 Jan 16.
Results Reference
background
PubMed Identifier
25070835
Citation
Dickson-Gomez J, Corbett AM, Bodnar G, Zuniga MO, Guevara CE, Rodriguez K, Navas V. Context and group dynamics in a CBPR-developed HIV prevention intervention. Health Promot Int. 2016 Mar;31(1):93-105. doi: 10.1093/heapro/dau058. Epub 2014 Jul 28.
Results Reference
background
PubMed Identifier
23186469
Citation
Dickson-Gomez J. Substance abuse disorders treatment in El Salvador: analysis of policy-making-related failure. Subst Use Misuse. 2012 Nov-Dec;47(13-14):1546-51. doi: 10.3109/10826084.2012.705698.
Results Reference
background
PubMed Identifier
22217125
Citation
Dickson-Gomez J, McAuliffe T, Rivas de Mendoza L, Glasman L, Gaborit M. The relationship between community structural characteristics, the context of crack use, and HIV risk behaviors in San Salvador, El Salvador. Subst Use Misuse. 2012 Feb;47(3):265-77. doi: 10.3109/10826084.2011.635325.
Results Reference
background
PubMed Identifier
20735191
Citation
Dickson-Gomez J, Bodnar G, Guevara CE, Rodriguez K, De Mendoza LR, Corbett AM. With God's help i can do it: crack users? Formal and informal recovery experiences in El Salvador. Subst Use Misuse. 2011;46(4):426-39. doi: 10.3109/10826084.2010.495762. Epub 2010 Aug 24.
Results Reference
background
PubMed Identifier
20550091
Citation
Dickson-Gomez J. Structural factors influencing patterns of drug selling and use and HIV risk in the San Salvador metropolitan area. Med Anthropol Q. 2010 Jun;24(2):157-81. doi: 10.1111/j.1548-1387.2010.01095.x.
Results Reference
background
PubMed Identifier
19910099
Citation
Dickson-Gomez J, Corbett AM, Bodnar G, Rodriguez K, Guevara CE. Resources and obstacles to developing and implementing a structural intervention to prevent HIV in San Salvador, El Salvador. Soc Sci Med. 2010 Feb;70(3):351-359. doi: 10.1016/j.socscimed.2009.10.029. Epub 2009 Nov 10. Erratum In: Soc Sci Med. 2010 Sep;71(5):1047.
Results Reference
background
PubMed Identifier
26687093
Citation
Glasman LR, Dickson-Gomez J, Lechuga J, Tarima S, Bodnar G, de Mendoza LR. Using Peer-Referral Chains with Incentives to Promote HIV Testing and Identify Undiagnosed HIV Infections Among Crack Users in San Salvador. AIDS Behav. 2016 Jun;20(6):1236-43. doi: 10.1007/s10461-015-1267-8.
Results Reference
result
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High Risk Crack Use Settings and HIV in El Salvador
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