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:
Medical College of Wisconsin
Collaborator:
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 17, 2011 | ||||||||
| Last Updated Date | March 25, 2013 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01279421 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | High Risk Crack Use Settings and HIV in El Salvador | ||||||||
| Official Title ICMJE | High Risk Crack Use Settings and HIV in El Salvador | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1870 | ||||||||
| Estimated Completion Date | October 2017 | ||||||||
| Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | El Salvador | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01279421 | ||||||||
| Other Study ID Numbers ICMJE | PRO00013931, R01DA020350 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Julia Dickson-Gomez, Medical College of Wisconsin | ||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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