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

Risk Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293875
• Other study ID #: 1U01MD010657-01
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2016
• Last updated: September 25, 2017
• Start date: August 2016
• Est. completion date: April 2021

Study information

• Verified date: September 2017
• Source: Lehigh University
• Contact: Julia Lechuga, PhD
• Phone: 6107584328
• Email: jul416[@]lehigh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: April 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Risk Behavior

Intervention

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

Locations

Country	Name	City	State
Mexico	Programa Compañeros	Ciudad Juarez	Chihuahua
United States	Alliance of Border Collaboratives	El Paso	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Lehigh University	Alliance of Border Collaboratives, Programa Compañeros

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV testing rates	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
Primary	Change in Sexual risk behaviors (questionnaire)	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
Primary	Change in Injection risk behaviors (questionnaire)	frequency of injection drug use, frequency of needle sharing	six and twelve months after the roll-out of the intervention components
Secondary	HIV risk reduction behavioral intentions (questionnaire)	strength of intentions to reduce HIV risk behaviors	six and twelve months after the roll-out of the intervention components
Secondary	HIV-related vulnerability beliefs (questionnaire)	perception of risk of contracting HIV	six and twelve months after the roll-out of the intervention components
Secondary	HIV risk reduction skills (questionnaire)	frequency with which participants engaged in HIV preventative behaviors	six and twelve months after the roll-out of the intervention components
Secondary	HIV risk network (questionnaire)	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