High Risk Crack Use Settings and HIV in El Salvador (Encuentro)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 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: November 25, 2013
Last verified: November 2013
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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:
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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279421
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
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: | November 25, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Genital Diseases, Female Genital Diseases, Male Infection Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015