NCT03293875

Brief Summary

The proposed project is a research collaboration between the University of Texas at El Paso, The Alliance for Border Collaboratives in El Paso, Texas and Programa Companeros in Juarez City, Mexico to adapt, implement, and evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The intervention will target people who inject drugs (PWID) and consists of: 1) A social network HIV testing component, 2) a peer network psychoeducational intervention, and 3) community events. The intervention was developed in an area severely affected by violence and stigma towards people who use drugs (PWUD), El Salvador, which makes it particularly suitable for adaptation to meet the needs of PWUD 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 of HIV acquisition among PWUD. Violence has worsened structural factors which affect HIV risk such as, increasing police persecution, stigma and reducing access to harm reduction resources. The investigators will engage in formative research to understand the context of HIV risk for PWID 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 PWID in the region. Subsequently, the investigators propose to test intervention effectiveness and evaluate implementation barriers and facilitators. To accomplish study aims a mixed qualitative, quantitative approach will be employed. The investigators will begin with a formative phase by conducting in-depth interviews with PWID (n = 40) living in the region to understand how the context of drug use and HIV 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 PWID 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 3 waves of cross-sectional surveys administered to PWID (n=600). 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 significant as the investigators will be conducting parallel research on the effectiveness of interventions for Latino PWUD 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 PWUD.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

December 7, 2016

Last Update Submit

September 23, 2025

Conditions

Keywords

HIV Risk Reduction, Drug Use, Sexual Behavior, People who Inject Drugs, US-Mexico Border

Outcome Measures

Primary Outcomes (1)

  • Condomless sex in exchange for drugs

    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 Outcomes (2)

  • Frequency of Drug Use

    6 and 12 moths post intervention delivery

  • Syringe Sharing

    6 and 12 moths post intervention delivery

Other Outcomes (5)

  • Harm Reduction Behaviors

    6 and 12 moths post intervention delivery

  • HIV stigma

    6 and 12 moths post intervention delivery

  • Harm reduction norms

    6 and 12 moths post intervention delivery

  • +2 more other outcomes

Study Arms (3)

Social network HIV testing

OTHER

Participants will receive an HIV test

Behavioral: Social Network HIV Testing

Peer network intervention

OTHER

Participants will receive psychoeducational sessions

Behavioral: Peer Network Intervention

Community Events

OTHER

Participants will attend community events

Behavioral: Community Events

Interventions

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.

Community Events

The social network HIV testing intervention consisted of offering rapid HIV tests to PWID using a social network referral methodology.

Social network HIV testing

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.

Peer network intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alliance of Border Collaboratives

El Paso, Texas, 79912, United States

Location

Programa Compañeros

Ciudad Juárez, Chihuahua, 32330, Mexico

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julia Lechuga, PhD

    City University of New York, School of Public Health

    PRINCIPAL INVESTIGATOR
  • Rebeca Ramos, MPH

    Alliance of Border Collaboratives

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No Masking
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Quasi-experimental with sequential self-selective exposure to intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2016

First Posted

September 26, 2017

Study Start

September 7, 2017

Primary Completion

August 24, 2022

Study Completion

December 10, 2022

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified datasets and associated documentation (data dictionaries, annotated instruments, analytic code) will be deposited into a NIH-approved public repository within 12 months of the main publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
9/14/2025
Access Criteria
De-identified datasets and associated documentation (data dictionaries, annotated instruments, analytic code) will be deposited into a NIH-approved public repository within 12 months of the main publication

Locations