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HIVNCT03293875

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

A study testing Community Events, Social Network HIV Testing and Peer Network Intervention in people with HIV, run by City University of New York at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Community Events, Social Network HIV Testing and Peer Network Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
2 sitesin 2 countries
Study dates
7 Sep 2017to 10 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Alliance of Border Collaboratives

    El Paso, Texas, 79912

Other trials in United States

Mexico1 site
  • Programa Compañeros

    Ciudad Juárez, Chihuahua, 32330

Other trials in Mexico

About this study

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.

Read the 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.

Conditions
HIV
Being tested
Community Events, Social Network HIV Testing, Peer Network Intervention
Keywords
HIV Risk Reduction, Drug Use, Sexual Behavior, People who Inject Drugs, US-Mexico Border
Medical subject headings
Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community EventsBehavioural

    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.

  • Social Network HIV TestingBehavioural

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

  • Peer Network InterventionBehavioural

    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.

Study groups in NCT03293875
Study groupRoleWhat they receive
Social network HIV testingOtherParticipants will receive an HIV test
Receives: Behavioral: Social Network HIV Testing
Peer network interventionOtherParticipants will receive psychoeducational sessions
Receives: Behavioral: Peer Network Intervention
Community EventsOtherParticipants will attend community events
Receives: Behavioral: Community Events

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 and 12 months post intervention delivery

Secondary outcomes (2)
  1. Frequency of Drug Use

    assessed by asking participants to report the number of days they used heroin and crack in the last 30 days.

    Measured: 6 and 12 moths post intervention delivery

  2. Syringe Sharing

    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.

    Measured: 6 and 12 moths post intervention delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start7 Sep 2017
  3. Primary completion24 Aug 2022
  4. Study completion10 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Quasi-experimental with sequential self-selective exposure to intervention
Masking
None (open label)
Enrolment
840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03293875
Sponsor's protocol ID
1U01MD010657-01
Status last verified
Sep 2025
First submitted
7 Dec 2016
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A study testing Community Events, Social Network HIV Testing and Peer Network Intervention in people with HIV, run by City University of New York at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Condomless sex in exchange for drugs (time frame: 6 and 12 months post intervention delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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