Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
The intervention framework of the proposed Intervention informs the study approach and aim of exerting change at multiple levels, through community based approaches. At the individual level, the intervention components will target reductions in behaviors that increase HIV acquisition and at the structural level, reduce HIV stigma. At the individual level, the investigators propose to modify peer normative beliefs around engagement in behaviors that place individuals at risk of HIV including normative behavior around risky sexual encounters and injection drug use behaviors. Strategies to be employed in each intervention component are delineated below.
Social Network HIV Testing. To prepare for the rolling-out of the social network HIV testing component, 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 PWID 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 throughout the duration of the study. Fidelity will be monitored by the partner organizations who have extensive experience delivering HIV testing.
The Peer Network Intervention. Two peer leaders will be selected from each city to deliver the intervention sessions. Eligibility criteria will be being former PWID, having extensive contacts, high degree of trust among peers, and motivation and demonstrated ability to work fixed hours. 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 PWID they know who will be asked, in turn, to recruit other PWID 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 PWID (150 per border city) in cycles composed of small social networks of 5-6 PWID. 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. 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 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 intervention sessions to assess intervention fidelity. Weekly meetings will be held with peer leaders and research staff to discuss problems, solutions.
Community-Wide Events. The community coalition in collaboration with the CAB and peer leaders will be asked to plan and convene meetings and implement events including health fairs at the community level with PWID to deliver health services and 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 PWID by police, human rights violations, and sexual violence. They will identify experts on topics identified and invite them as guest speakers. Fidelity will be assessed primarily assessed through process documentation (attendance logs, record-keeping) of event activities.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
Chihuahua
-
Ciudad Juárez, Chihuahua, Mexico, 32330
- Programa Compañeros
-
-
-
-
Texas
-
El Paso, Texas, United States, 79912
- Alliance of Border Collaboratives
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years old
- able to give informed consent
- injected drugs in the last month
- engaged in sexual risk behavior in the last 3 months
Exclusion Criteria:
- under 18 years of age
- unable to give informed consent
- not able to provide informed consent
- did not inject drugs in the last month
- did not engage in sexual risk behavior in the last 3 months
- does not engage in sexual risk behavior
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Social network HIV testing
Participants will receive an HIV test
|
The social network HIV testing intervention consisted of offering rapid HIV tests to PWID using a social network referral methodology.
|
|
Other: Peer network intervention
Participants will receive psychoeducational sessions
|
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 PWID.
|
|
Other: Community Events
Participants will attend community events
|
The coalitions in collaboration with CABs and peer leaders in their respective cities convened community meetings and events and invited PWID who had participated in other intervention components, who were receiving services at the partner organizations, and members at-large to participate.
Events and meetings were advertised at the partner organizations offices, by staff during delivery of harm reductions supplies at places where PWID congregated to use drugs, and through social media.
Events and meetings took place at community venues including parks, neighborhood gathering spaces, and at organizations.
Events covered topics about HIV, sexual health, and human rights and included health fairs.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Condomless sex in exchange for drugs
Time Frame: 6 and 12 months post intervention delivery
|
assessed by the ratio of number of sex acts in exchange for drugs and the number of those acts without a condom.
|
6 and 12 months post intervention delivery
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Drug Use
Time Frame: 6 and 12 moths post intervention delivery
|
assessed by asking participants to report the number of days they used heroin and crack in the last 30 days.
|
6 and 12 moths post intervention delivery
|
|
Syringe Sharing
Time Frame: 6 and 12 moths post intervention delivery
|
assessed by asking participants to report the frequency with which they injected with a syringe that had been used by another person and/or lent their used syringe to other people.
|
6 and 12 moths post intervention delivery
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harm Reduction Behaviors
Time Frame: 6 and 12 moths post intervention delivery
|
Mediator variable assessed by the number of harm reduction behaviors enacted in the last 30 days including condom use, use of sterile syringes, number of sexual partners, disseminating harm reduction information to peers, reducing substance use and injection with used syringes.
|
6 and 12 moths post intervention delivery
|
|
HIV stigma
Time Frame: 6 and 12 moths post intervention delivery
|
Mediatior variable assessed by degree of agreement with statements conveying stigmatizing beliefs about HIV
|
6 and 12 moths post intervention delivery
|
|
Harm reduction norms
Time Frame: 6 and 12 moths post intervention delivery
|
Process evaluation variable assessed with agreement with statements about perceived use of condoms, syringe sharing, and reduction in sexual partners by peers
|
6 and 12 moths post intervention delivery
|
|
Self-efficacy to enact harm reduction behaviors with peers
Time Frame: 6 and 12 moths post intervention delivery
|
Process evaluation variable assessed with agreement with statements measuring degree of confidence in enacting harm reduction with peers including condom use and disinfecting syringes
|
6 and 12 moths post intervention delivery
|
|
Number of HIV tests
Time Frame: Monthly from date of intervention delivery through study completion
|
A process and implementation evaluation measure assessed by the number of tests delivered during the intervention
|
Monthly from date of intervention delivery through study completion
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Julia Lechuga, PhD, City University of New York, School of Public Health
- Study Director: Rebeca Ramos, MPH, Alliance of Border Collaboratives
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1U01MD010657-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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