- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293875
Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border
Study Overview
Detailed Description
The intervention framework of the proposed Intervention is exerting change at multiple levels, through community based approaches. At the structural level, the investigators propose to increase the access to HIV testing of high risk drug users and to create change at the community level regarding factors that influence the risk of drug users such as stigma towards drug use and HIV among other topics. At the individual level, the investigators propose to modify normative beliefs around risky behaviors in a social network and hence, effecting change in participants by changing normative behavior around safer sexual encounters, HIV testing, and reduced risk in injection and non-injection drug use. Following, strategies to be employed in each intervention component are delineated.
Social Network HIV Testing Component. To prepare for the rolling-out of the social network HIV testing component (during month 6 of year 2), the investigators will convene a two day training with partner organizations from both sides of the border to train staff on the social network referral methodology. 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. Whenever social network HIV testing rates slow, research staff will re-seed in the communities to begin the recruitment process again. Counselors will make appointments for all participants who test positive for confirmatory HIV testing at the respective local governmental health care institutions. A research staff will follow-up with HIV positive participants to engage them in care. Throughout the duration of the project, monthly meetings will be convened between research staff involved in the project to ascertain that procedures are being followed and retrain if the need arises. The social network component of the intervention will continue until month 12 of year 5.
The Peer Network Intervention. During month 1 of year 4, we will roll-out the peer network behavioral intervention. Two peer leaders will be selected from each city to deliver the intervention sessions. Eligibility criteria will be being former drug users, having extensive contacts, high degree of trust among peers, and motivation and demonstrated ability to work fixed hours. During month 12 of year 3, training sessions, in collaboration with partner organization, will be conducted to train peer leaders over the course of two weeks during ten training sessions lasting 3 hours per session. Peer leaders will be trained in the curriculum as well as in psychosocial theory as the basis for behavioral interventions, interactive group management, HIV risk reduction, effective instruction for role-plays, and social network recruitment methods. Peer leaders will recruit drug users they know who will be asked, in turn, to recruit other drug users in their networks. If this initial contact is unable to recruit network members, peer leaders will select other initial contact. 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. Four intervention cycles will be held per month and will consist of 3 consecutive sessions of 2 hours in duration delivered in the early afternoon. Peer leaders will be expected to comply with a fixed work schedule of 10 hours per week and will be asked to actively recruit social networks for each intervention cycle. Although we expect the specific information and roles plays to change based on the findings of our formative phase and our sessions of acceptability and feasibility with our CAB and coalition, the peer network intervention will have the following structure. The first session of the intervention will cover training in social contexts of risk and strategies to avoid them through role plays, techniques for harm reduction for injection and non-injection drug use, and available community resources to deal with substance abuse. The second session will provide information about HIV and Sexually Transmitted Diseases through games, didactic sessions, and exercises to rank the risk of contracting HIV from various behaviors, negotiation skills for condom use in situations of high risk such as exchange of sex for drugs. The third session will consist of training in advocacy and sexual rights and establishment of a personal and social network risk reduction plan. Ethnographers will be trained to document the process of delivery such as number of participants per intervention cycle. Research staff will attend one intervention session per cycle to assess intervention fidelity. Weekly meetings will be held with peer leaders and research staff to discuss problems, solutions, and planning of community wide events.
Community-Wide Events. The community coalition in collaboration with the CAB and peer leaders will be asked to plan and convene educational meetings at the community level with drug and non-drug users to deliver information on topics such as drug use prevention and treatment, HIV and risk reduction skills, and other issues affecting the HIV risk of communities such as persecution of drug users by police, human rights violations, and sexual violence. They will identify experts on topics identified and invite them as guest speakers.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julia Lechuga, PhD
- Phone Number: 6107584328
- Email: jul416@lehigh.edu
Study Contact Backup
- Name: Rebeca Ramos, MPH
- Phone Number: 9155842875
- Email: rebeca@utep.edu
Study Locations
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-
Chihuahua
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Ciudad Juarez, Chihuahua, Mexico, 32330
- Recruiting
- Programa Compañeros
-
Contact:
- Maria E Ramos
- Phone Number: 526566113792
- Email: pcompa@prodigy.net.mx
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Contact:
- Julian Rojas
- Phone Number: 526566113792
- Email: julianrojaspadilla@gmail.com
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-
-
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Texas
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El Paso, Texas, United States, 79912
- Recruiting
- Alliance of Border Collaboratives
-
Contact:
- Rebeca Ramos, MPH
- Phone Number: 915-584-2875
- Email: rebeca@utep.edu
-
Contact:
- Jose Alvarez, MSW
- Phone Number: 9155842875
- Email: arody_3@msn.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV
|
Other: 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.
|
a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Every 30 days up to 192 weeks
|
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
|
six and twelve months after the roll out of the intervention components
|
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
|
six and twelve months after the roll-out of the intervention components
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
six and twelve months after the roll-out of the intervention components
|
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
|
six and twelve months after the roll-out of the intervention components
|
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
|
six and twelve months after the roll-out of the intervention components
|
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
|
six and twelve months after the roll-out of the intervention components
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Lechuga, PhD, Lehigh University
- Study Director: Rebeca Ramos, MPH, 9155842875
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1U01MD010657-01 (U.S. NIH Grant/Contract)
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