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Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border

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ClinicalTrials.gov Identifier: NCT03293875
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborators:
Alliance of Border Collaboratives
Programa Compañeros
Information provided by (Responsible Party):
Julia Lechuga, Lehigh University

Brief Summary:
The proposed project is a research collaboration between the University of Texas at El Paso, The Alliance for Border Collaboratives and Programa Companeros to adapt, implement, and evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The intervention will target active heroin and crack users and consists of increasing access to HIV testing via a social network HIV testing component and reducing sexual and drug use risk via a peer network brief behavioral Intervention. Encuentro also consists of conducting community awareness meeting to target structural factors affecting HIV risk. The intervention was developed in an area severely affected by violence and stigma towards drug users, El Salvador, which makes it particularly suitable for adaptation to meet the needs of drug users living in the proposed intervention site, the U.S.-Mexico border. The proposed intervention site also has been severely affected by violence which has curtailed any prior attempts to reduce the risk drug users' HIV risk. Violence has worsened structural factors which affect HIV risk such as, increasing police persecution and stigma and reducing access to resources. In our proposed project, we will engage in formative research to understand the context of HIV risk of drug users in the border region post violence and adapt the intervention accordingly. Findings will allow the investigators to tailor intervention components to meet the needs of drug users in the region. Subsequently, the investigators propose to test intervention effectiveness and evaluate implementation barriers and facilitators. To accomplish project aims we will use a mixed qualitative, quantitative approach. The investigators will begin with a formative phase by conducting in-depth interviews with drug users (n = 40) living in the region to understand how the context of drug use risk changed as a result of the violence and will administer a social network survey (n = 200) to characterize the configuration of risk networks. Findings will yield the necessary information to culturally adapt the intervention to meet the needs of drug users in the region and will help the investigators focus recruitment efforts where the riskiest networks are located. After the intervention is adapted with the help of the community advisory boards and the community coalitions, the investigators will implement the intervention and will assess the effectiveness and reach via 6 cross-sectional surveys administered to drug users (n=1,200). The investigators will assess the process of implementation by conducting ethnographic field notes of all intervention activities including community engagement and Community Advisory Board and coalition meetings. The investigators will assess the fidelity and quality of the intervention. Lastly, the investigators will conduct key informant interviews with key stakeholders involved in the project and interviews and observations will be coded to reflect key systems factors related to successful implementation of intervention components in two intervention sites (El Paso, Texas and Ciudad Juarez, Mexico). Findings will be highly significant as the investigators will be conducting parallel research on the effectiveness of interventions shown to be effective in Latino drug users in two very different contexts: El Salvador and the U.S-Mexico border. Findings will elucidate implementation challenges and barriers and such information can then be used to assess the effectiveness of diverse implementation strategies in organizations working to serve the needs of Latino drug users.

Condition or disease Intervention/treatment Phase
Risk Behavior Behavioral: Encuentro Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Quasi experimental design repeated time series analysis
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border
Study Start Date : August 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
HIV testing promoted by members of the social network
Research staff will initiate the recruitment of seeds by recruiting four to six seeds per city. Counselors, at the partner organizations, will begin by administering a rapid HIV test and provide pre and post-test counseling to seeds. Counselors, who will be trained in the social network assessment methodology, will then ask seeds to list other drug users in their social network who they believe are at risk of contracting HIV. Counselors will then provide participants with 3 coupons to recruit identified network members for an HIV test. Referred participants who engage in high-risk behavior will be also provided with 3 coupons to refer their own network members for an HIV test.
Behavioral: Encuentro
a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV

Peer network behavioral intervention
Two peer leaders will be selected from each city to deliver the intervention sessions. Peer leaders will recruit drug users they know who will be asked, in turn, to recruit other drug users in their networks. Peer leaders will deliver the intervention to 300 drug users (150 per border city) in cycles composed of small social networks of 5-6 drug users.
Behavioral: Encuentro
a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV




Primary Outcome Measures :
  1. HIV testing rates [ Time Frame: Every 30 days up to 192 weeks ]
    rates of number of individuals who get tested on a 30- day period for HIV using a coupon

  2. Change in Sexual risk behaviors (questionnaire) [ Time Frame: six and twelve months after the roll out of the intervention components ]
    number of sexual partners (primary and casual), number of instances of unprotected anal, vaginal, oral sex, engagement in sexual relations while using drugs

  3. Change in Injection risk behaviors (questionnaire) [ Time Frame: six and twelve months after the roll-out of the intervention components ]
    frequency of injection drug use, frequency of needle sharing


Secondary Outcome Measures :
  1. HIV risk reduction behavioral intentions (questionnaire) [ Time Frame: six and twelve months after the roll-out of the intervention components ]
    strength of intentions to reduce HIV risk behaviors

  2. HIV-related vulnerability beliefs (questionnaire) [ Time Frame: six and twelve months after the roll-out of the intervention components ]
    perception of risk of contracting HIV

  3. HIV risk reduction skills (questionnaire) [ Time Frame: six and twelve months after the roll-out of the intervention components ]
    frequency with which participants engaged in HIV preventative behaviors

  4. HIV risk network (questionnaire) [ Time Frame: six and twelve months after the roll-out of the intervention components ]
    the extent to which participant has engaged in conversations with members of the social network about engaging in behaviors to prevent HIV



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 18 years old
  • having engaged in sexual risk in the last 3 months
  • able to give informed consent
  • reported to have used crack or heroin in the last 30 days

Exclusion Criteria:

  • under 18 years of age
  • unable to give informed consent
  • engages in disruptive behavior while participating in the project not using crack or -heroin in the last month
  • not reporting having engaged in sexual risk

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): NCT03293875


Contacts
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Contact: Julia Lechuga, PhD 6107584328 jul416@lehigh.edu
Contact: Rebeca Ramos, MPH 9155842875 rebeca@utep.edu

Locations
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United States, Texas
Alliance of Border Collaboratives Recruiting
El Paso, Texas, United States, 79912
Contact: Rebeca Ramos, MPH    915-584-2875    rebeca@utep.edu   
Contact: Jose Alvarez, MSW    9155842875    arody_3@msn.com   
Mexico
Programa Compañeros Recruiting
Ciudad Juarez, Chihuahua, Mexico, 32330
Contact: Maria E Ramos    526566113792    pcompa@prodigy.net.mx   
Contact: Julian Rojas    526566113792    julianrojaspadilla@gmail.com   
Sponsors and Collaborators
Lehigh University
Alliance of Border Collaboratives
Programa Compañeros
Investigators
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Principal Investigator: Julia Lechuga, PhD Lehigh University
Study Director: Rebeca Ramos, MPH 9155842875

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Responsible Party: Julia Lechuga, Assistant Professor, Lehigh University
ClinicalTrials.gov Identifier: NCT03293875     History of Changes
Other Study ID Numbers: 1U01MD010657-01 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017