- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279421
High Risk Crack Use Settings and HIV in El Salvador (Encuentro)
May 12, 2021 updated by: Julia Dickson-Gomez, Medical College of Wisconsin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4382
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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San Salvador, El Salvador
- Fundasalva
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Social Network HIV Testing
Participants in this arm will be recruited through social networks and will receive an HIV test.
|
Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing.
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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.
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Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Increased HIV testing rates among crack users
Time Frame: 24 months
|
24 months
|
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Decreased number of sexual risk behaviors among crack users
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Community and organizational factors associated with successful implementation of multi-level, community-based HIV prevention intervention
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (ACTUAL)
June 1, 2016
Study Completion (ACTUAL)
December 1, 2020
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (ESTIMATE)
January 19, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00013931
- R01DA020350 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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