Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care
Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care
The purpose of the mPeer2Peer Study (mP2P) is to see if we can use a smartphone and a Peer
 Navigator (PN) to improve medical care for HIV-positive people who have been out of HIV care
 for over one year.
Research Question

 Can real-time collection of patient-level data using smartphones be feasibly and effectively
 utilized by peer navigators to deliver timely and individualized support interventions
 outside of a clinical setting, thereby facilitating improved engagement in HIV care and
 medication adherence for HIV-infected drug users?

 Aims

 Optimal benefit from antiretroviral therapy (ART) is contingent upon consistent engagement in
 HIV care and reliable medication adherence. HIV-infected intravenous drug users (IDUs) delay
 entrance into and under-utilize medical care. Those who access HIV care are frequently lost
 to follow up or are intermittent users. Out-of-care IDUs are more likely to develop AIDS,
 have reduced survival, engage in risky behavior and place others at risk for HIV
 transmission; therefore, evidence-based tools to promote engagement of IDUs in care are
 urgently needed.

 Clinic-based, individualized support delivered by case managers or patient navigators
 improves engagement in HIV care for many patients, but few settings have sufficient resources
 to offer adaptive, individualized, long-term support to all who need it. Mobile health
 (mHealth) technologies able to collect patient-level data in real time and to facilitate
 responsive communication hold promise as an effective strategy to optimize HIV care and
 medication adherence for IDUs.

 The objective of this pilot feasibility trial planning grant is to obtain feasibility,
 acceptability and trial optimization data to inform the design and implementation of a
 randomized trial to fully evaluate the hypothesis. To accomplish this objective, specific
 aims include:

 Specific Aim 1. To evaluate the feasibility and participant acceptability of mHealth-enhanced
 peer navigation to improve retention in care for out-of-care, ART-eligible IDUs.

 In the mobile phone-based intervention, participants will utilize a smartphone interface to
 report perceived barriers to accessing care and adhering to prescribed therapies. Through
 repeated quantitative and qualitative evaluations, investigators will assess feasibility,
 participant acceptability and logistical challenges (e.g., retention, participant burden,
 device loss, data quality, response fatigue, perceived support) of the intervention sustained
 over one year of follow-up.

 Specific Aim 2. To define trial elements required for optimization of a future randomized
 clinical trial of mHealth-enhanced peer navigation.

 The long-term effectiveness of mHealth interventions (i.e., maintenance of sustained HIV RNA
 suppression over years), will require large and expensive clinical trials. In prudent
 preparation for a future trial, investigators will collect preliminary efficacy data
 comparing the peer-navigation/smartphone intervention to usual care for several alternative
 endpoints, including time to ART initiation, missed visit frequency, and rate of virologic
 suppression. Investigators will also define the optimal patient load and scope of work for
 peer navigators and the intensity and frequency of electronic communication that facilitate
 meaningful peer support.

 Background

 Patient navigators have been successfully employed to assist persons utilizing complex
 medical services. In contrast to the medical case management paradigm, which tends to involve
 delivery of specific, predefined services, patient navigation features responsive, flexible
 problem-solving to overcome perceived barriers to care. The World Health Organization (WHO)
 recommends psychosocial support for all HIV-infected persons and has promoted the use of
 peers in addressing care and retention needs. In resource-constrained settings, peers trained
 for specific health-related tasks represent a potentially cost-efficient and sustainable
 workforce. Besides addiction and mental health co-morbidity, HIV-infected IDUs often have
 limited income, education, insurance, and social support, unstable housing and food
 insecurity. Poor health literacy, negative experiences with medical institutions and negative
 health-related beliefs may pose additional barriers to care.

 The role of peer navigators in HIV care is to influence areas which impact engagement in
 care, namely to: 1) Educate and counsel regarding acceptance of HIV diagnosis and
 understanding of HIV prevention and treatment, 2) Assist in overcoming practical barriers to
 care (e.g., accessing social services like drug treatment, housing or transportation
 assistance, 3) Identify and reduce sources of instability, 4) Facilitate patient coping
 through life skills training, and 5) Improve patient-provider communication. Data suggest
 that peer-led interventions should be personalized and practical, addressing individual
 concerns and barriers rather than group-level support.8 The frequency and intensity of
 patient-peer interaction needed for this individualization and the extent to which mobile
 technology can improve communication toward this end need clarification.

 mHealth approaches to optimizing HIV care

 Use of mobile cellular devices has grown rapidly worldwide, increasing from 2 billion
 subscriptions in 2005 to an estimated 5.3 billion at the end of 2010.9 The promise of mobile
 health (mHealth) technologies for strengthening health care delivery in resource-limited
 settings has been acknowledged by the United Nations Joint Programme on HIV/AIDS (UNAIDS) in
 development of its strategic plan. Short Message Service (SMS) text messages were recently
 shown in a large randomized trial to be an effective intervention for smoking cessation. Text
 messages have also been effectively utilized to improve attendance at clinic appointments,
 although few data are available from HIV clinics. ART dose reminder messages sent with pagers
 or mobile phones have been used in several settings to improve adherence. Two recent
 randomized mHealth studies in sub-Saharan Africa have demonstrated benefit of weekly text
 messages for improving adherence and rates of viral suppression. Additional randomized trials
 of SMS adherence reminders are under development in India and Cameroon.

 Rationale

 The rationale for Peer Navigators (PNs) working with HIV-infected IDUs is that similar
 backgrounds and shared experiences will strengthen relationships and provide PNs access and
 credibility not easily achieved by medical professionals. HIV infection among IDUs is
 transmitted through drug-using networks. However, these same peer networks have also served
 as the vehicle for several peer-driven interventions with demonstrated efficacy in reducing
 HIV risk behavior, often outperforming traditional approaches. With lower-income, poorly
 educated, predominantly minority HIV-infected IDUs, investigators propose that having a
 knowledgeable 'peer' provide counsel and support during entrance to care and ART initiation,
 and remain a stable presence into the maintenance phase could directly addresses many of the
 barriers encountered by this community.

 Population Description

 Study participants will be primarily recruited from the existing ALIVE cohort. Additional
 participants will be recruited among patients who have received HIV care in the past at the
 Johns Hopkins Moore Clinic.

 Sample Size

 The total sample size for this study will be 60, with 30 participants in each study arm.
 Because the main objective of this study is to demonstrate feasibility and acceptance of a
 mHealth intervention, analysis of the data generated will largely be exploratory and
 descriptive, rather than driven by a priori hypotheses.

 In November 2012, the ALIVE Study identified 54 participants who meet the criteria for both
 being out of HIV care and recent drug use. The Moore Clinic clinical staff estimates that
 around 180 patients could meet these criteria, providing a combined pool of roughly 230
 individuals from which the study can begin recruitment.

 Recruitment

 Potential participants will be approached at their regular visit by their interviewer and the
 Research Coordinator about participating in a new study. Invitation will be determined by
 clinic interviewers or staff, who will notify the Research Coordinator if a participant is
 eligible. Potential participants will be contacted at the ALIVE Study or the Moore Clinic,
 based on recent data or records. If an ALIVE participant self-reports to a study interviewer
 that they have never been in care or have been out of care for over a year, they will be
 referred to the study coordinator for more information and screening. Eligible individuals
 who confirm they have not received any HIV care in the past year will be assisted in
 scheduling an appointment with a primary care provider at the Moore Clinic. Only participants
 who attend their first HIV care visit (confirmed through the electronic medical record) will
 undergo enrollment and randomization.

 As part of Moore clinic efforts to identify out-of-care persons, they periodically review
 their records and contact individuals directly to clarify if patients are seeing another
 provider or to support them to re-engage in care at the Moore clinic. The clinic (namely
 Jeanne Keruly and her staff) will share this information on out-of-care Moore clinic patients
 with the mP2P study and will assist us in identifying when out-of-care persons are scheduled
 for an appointment. At their subsequent visit, Moore Clinic patients will meet with the
 coordinator (preferably that day) for more information and screening. The study will use a
 recruitment script and screening tool.

 Potential participants may also be referred to the study coordinator for eligibility
 screening from Moore Clinic providers who encounter patients who have been lost to follow-up
 (i.e. have not seen their primary HIV provider for over one year), but present to the clinic
 for a new visit, because of an administrative issue or urgent care appointment. With provider
 assent, the recruiter will approach these patients, explain the study and if interested, and
 schedule them to attend an enrollment visit where consent will be obtained.

 Informed Consent Process

 The Research Coordinator will read the consent form aloud to each enrolling participant
 before providing training and instruction in the use of all devices. The study participant
 will sign then their name and date the form, as will the Coordinator. A copy of the consent
 form will be provided to the client.

 Individuals who are cognitively impaired to the extent that they either cannot give informed
 consent or cannot give self-report will be excluded. Self-report is a central outcome
 measure; including participants who cannot do it would invalidate the study.

 Part of the evaluation of the intervention will include elicitation of feedback from the peer
 navigator staff regarding their impressions about the effectiveness of the intervention,
 unforeseen challenges and best practices. As part of monthly staff meetings with the study
 coordinator and PN clinical supervisor, a 30-60 minute focus group will be conducted with
 peer navigators. Because their conversations will be audio recorded and analyzed, their
 participation in the focus groups constitutes research. Written informed consent will be
 obtained from PNs by the study coordinator at each of these sessions.

 Peer Health Navigation

 After the first HIV care visit, participants will return to the Wood Clinic for a baseline
 interview and randomization into one of the two study arms (PN or treatment as usual).
 Investigators modeled the peer navigation intervention after several HIV prevention trials
 that aimed to assist high-risk individuals in overcoming logistical barriers to receiving
 social services and medical care. Peer Navigators will be part-time employees of the study,
 hired through Johns Hopkins School of Public Health (JHSPH) Human Resources procedures, and
 will work approximately 10-15 hours per week, meeting study participants in person or by
 phone to discuss strategies to remain engaged in care and overcome logistical challenges
 encountered in the health care system. Persons living with HIV who have successfully
 navigated the health care system and who are receiving ongoing HIV care will be encouraged to
 apply, but HIV-positive status will not be a requirement of the position.

 The PN will log all PN-participant contacts daily using the eMOCHA system. This will allow an
 assessment of the level of intensity of PN-participant contact that may be associated with
 clinical benefit, as well as inform the appropriate caseload for PNs. The frequency,
 duration, and nature of each PN/patient interaction as well as an assessment of action plan
 goals and identified barriers will be compared to outcomes from the study aims, including
 time to ART initiation, missed visit frequency, and rate of virologic suppression.

 The study coordinator will serve as the operational supervisor for peer navigators, and will
 be responsible for facilitating communications among PNs and research staff. The study
 coordinator will provide technical assistance with the web-based patient tracking software
 and assist with review of participant-specific data. The coordinator will be responsible for
 matching PNs with eligible participants, ensuring that all data are collected according to
 the schedule and specifications in the research protocol, organizing the training and hiring
 of PNs, and for setting up regular operational supervision meetings.

 A co-investigator (Dr. Hutton) trained in clinical psychology with extensive experience with
 HIV-infected persons with substance abuse will serve as the clinical supervisor for peer
 navigators. She will be responsible for organizing regular clinical supervision sessions to
 review case studies, address issues of PN/counseling overlap and discuss issues arising from
 the execution of the work. These sessions should be a mix of group and individual level
 supervision. The clinical supervisor should help PNs deal with issues of setting boundaries
 with participants and developing methods for dealing with urgent issues. Clinical supervisors
 will ensure that clinical assistance is available for PNs when situations arise in which a
 licensed mental health worker's assistance is needed. Additional support will be provided by
 clinicians and HIV care providers who have been trained to address the specific medical needs
 of IDUs.

 Feedback about perceived logistical challenges related to PN/participant interaction and the
 overall conduct of the study will be collected at monthly meetings by the operational
 supervisor. The entire team of investigators will compile and review these comments at
 quarterly meetings throughout the study. At 3 months and 9 months after the start of the
 study, the monthly PN meeting will consist of a formal focus group, led by a co-investigator
 with qualitative research methods expertise.

 Ecologic Momentary Assessment (EMA)

 EMA refers to using electronic handheld data collection devices to collect real-time
 information about stress, drug cravings and drug use participants in the context of their
 daily routine, rather than in a research study. In this study, participants will be given a
 smartphone to carry for up to one year. The current phone model used is the Motorola Droid
 X2, running applications developed using a software platform created by the Center for
 Clinical Global Health Education (CCGHE) at the Johns Hopkins School of Medicine. The
 application, named the electronic Mobile Open-source Comprehensive Health Application
 (eMOCHA), has been used to support community health workers in resource poor areas heavily
 impacted by HIV. It has been modified by the CCGHE programming team specifically for this
 study. A staff member will train participants in how to use the eMOCHA interface and all
 relevant features of the smartphone. Participants will be required to show they can run a
 "demo" questionnaire before commencing use in the field.

 Smartphone-based data collection from participants in the intervention arm will commence two
 business days following randomization, to allow for troubleshooting of device problems and
 participants' increased familiarity with the eMOCHA interface. At scheduled data-collection
 times, the participant's phone will generate an audible alert and the eMOCHA application will
 automatically launch. To protect confidentiality, every eMOCHA session will begin with a
 password-entry screen containing no other information. Frequency and length of EMA sessions
 will be dynamic over the course of the study in order to individualize the intervention and
 collect process data related to Aim 2. By default, participants will receive two prompts
 daily for the first three months of the study. Based on participant feedback, rate of EMA
 response and level of engagement in HIV care, the protocol may be converted to a "maintenance
 phase" of less frequent prompts after the initial three-month in-person study visit.

 Each eMOCHA session will feature multiple-choice and free-text question items related to
 three domains: engagement in HIV care (retention and adherence), drug/alcohol use, and mood.
 The drug use items will query participants regarding the intensity of drug cravings and the
 occurrence of any drug use. The brief version of the Profile of Mood States (POMS) will be
 used to assess moods such as anger, depression and anxiety. Within each domain, the eMOCHA
 application will guide the participant through three steps that (1) assess the participant's
 current experiences or symptoms, (2) assess barriers to engagement in care, and (3) provide
 support messages or information. Peer navigators will monitor the responses of each
 participant over time, and will contact the participant if he or she reports specific
 problems, or appears to have increasing levels of self-reported negative mood states, drug
 use, or poor medication adherence.

 Twice each day, the smartphone will signal the participant to answer a questionnaire.
 Participants will have 15 minutes to respond after notification. The alarms can occur between
 9:00 am and 9:00 pm. One alarm will go off at a random time every day and the other alarm
 will always go off at 9:00 pm to recap what happened during your day. The questions should
 take about five minutes every day. Also, if participants use drugs or have a craving to use
 drugs, they should report this event using a questionnaire that is similar to the random
 questionnaire, but tailored to contain more drug-specific content.

 Global Positioning System (GPS) Data

 As a continuation of previous efforts during the EXACT Study, investigators will compare
 global positioning systems (GPS) data and neighborhood-level psychosocial stress indicators
 with drug-related EMA behavioral data. Participants' location will be recorded every five
 minutes using the smartphone's internal GPS. GPS data will be encrypted and transferred
 wirelessly to a secure server daily. The GPS data on the phone will be deleted after
 transfer. Participants' daily EMA data will be compared to weekly ACASI data and tagged with
 GPS data to construct a temporal and spatial profile of drug use and psychosocial stress.

 Biological Samples

 Every three months, a trained phlebotomist will draw 10mL of whole blood to place in a
 repository, using approved biosafety procedures. Current research is actively investigating
 several promising biological markers of stress. If, as anticipated, a valid and reliable
 biomarker of longer-term stress (on the order of weeks to months) is identified, blood
 samples from the repository will be tested at an appropriate laboratory. Genetic studies may
 include both host and viral genetics.

 Follow-up and assessment of HIV care utilization

 Participants in both study arms will return to the Wood clinic every three months to collect
 reimbursement for participation and to complete a follow-up questionnaire assessing the same
 domains evaluated in the baseline questionnaire. The study will also collect 10mL (2
 teaspoons) of blood serum for storage and future testing. This study visit should take about
 30 minutes.

 This study will uniquely benefit from an existing data sharing agreement with the Johns
 Hopkins HIV Clinical Cohort (JHHCC) study, which will allow highly accurate and timely
 ascertainment of care utilization endpoints ART prescription and pharmacy fill dates will be
 collected from this database to verify participant-reported dates of ART initiation.
 Appointment data are electronically managed through the Moore Clinic Registration System
 (Epic Enterprise Scheduling Software, Madison, WI). All ambulatory visits scheduled are input
 into this system at the point of service or through incoming calls by staff trained in the
 use of this database. When a patient registers on the day of the appointment, the visit is
 keyed as a completed visit. JHHCC data are available for download within approximately two
 weeks of being entered into the system. Importantly, assessing clinic attendance and
 prescription of ART using this external database will allow assessment of the main endpoints
 for all randomized participants even if some are not retained in this study.

 Study staff will conduct in-depth, qualitative interviews among the 30 participants in the
 intervention arm. Ten will be randomly selected to complete an interview after 3-6 months of
 the intervention, in order to provide feedback that may be used to refine the intervention
 during the subsequent trial period; the remaining 20 will be interviewed at the end of
 follow-up to collect data about their overall experience with the intervention. In order to
 start processing the data, memos will be developed by the interviewer as data are collected.
 Interviews will be semi-structured; interview guides will have predefined main themes, but
 these guides are meant to be dynamic and will allow new topics to emerge during the course of
 the interview. Important topics will include: (1) satisfaction and challenges with eMOCHA
 interface, (2) satisfaction with relationship to peer navigator (3), perceived intrusiveness
 of the intervention, (4) ongoing challenges to engagement in HIV care, (5) ways the
 smartphone may facilitate getting HIV care information/help (e.g. from informal support
 networks, the internet).

 Focus groups conducted with the peer navigator staff will allow the investigator team to get
 a better understanding about the effectiveness of the intervention, unforeseen challenges and
 best practices. These will occur as part of monthly staff meetings with the study coordinator
 and PN clinical supervisor, last 30-60 minutes, and will be audio-recorded for later thematic
 analysis.

 Blinding

 Neither investigators nor participants will be blinded to which of the study arms individuals
 are randomized.

 Rationale for use of a non-treatment group

 In order to justify spending resources for new, technology-based interventions, it is
 essential to demonstrate that they add value compared to currently available care. The Johns
 Hopkins Moore Clinic employs a limited number of full-time social workers, nurses, and peer
 advocates who share responsibility for coordinating outpatient HIV care and facilitating
 referrals for ancillary services. While this level of staffing is inadequate to provide
 comprehensive, individualized case management for every patient, patients who desire
 assistance with an aspect of their care have same-day access to this support, which
 represents the currently available standard of care. Nearly all new patients seen in the
 Moore Clinic meet with a social worker after completing the initial intake visit with their
 medical provider, and may schedule follow-up meetings as needed or be seen on a walk-in
 basis. Control-group participants will work with clinic-based support staff for coordination
 of their care, meaning peer navigators will not actively facilitate interaction between
 control group participants and clinic providers after the initial HIV care visit.

 Participant removal criteria

 Study participants may terminate their participation in the study at any time. If the
 smartphone is lost, stolen or damaged during use, the study will assign a new one at no
 charge. Participants never have to pay to replace a device. However, if a second smartphone
 is lost, stolen or damaged, they will be asked to leave the mP2P Study. This will not affect
 their participation in the ALIVE Study or their clinical care with the Moore clinic.

 Certificate of Confidentiality

 The mP2P study will collect data from a population of persons who formerly or currently
 engage in illegal reportable activities, namely drug use. As the mP2P study is designed as a
 sub-study of the ALIVE cohort, modifications will be made to the existing Certificate of
 Confidentiality issued by the National Institute on Drug Abuse (DA-87-042) to protect
 sensitive information reported by participants.

 Consent Process and Documentation

 Informed consent will take place at Johns Hopkins University, and will be carried out by the
 Project Coordinator. Additional study staff may be trained in consent procedures, to provide
 backup to the study. The Coordinator will read the consent form aloud while the potential
 participant reads along. The participant will be able to ask any questions during the consent
 process and before signing the form.

 Risks and Benefits

 Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research
 are not greater than those ordinarily encountered in daily life or during routine physical
 and psychological examinations or tests.

 Smartphone (EMA): Participants may feel hassled or annoyed by the EMA prompts. Also, some of
 the questions are personal and they might not feel comfortable answering those questions.
 Participants who are unfamiliar with smartphones or other electronic devices could feel some
 discomfort or frustration in dealing with these technologies.

 Smartphone (GPS): The main risk from carrying the GPS unit is loss of privacy. Using a GPS
 device will not significantly increase participants' risk burden more than they currently
 experience. Many participants already use mobile phones daily, which contain a system by
 which a user's location can be tracked. Encrypted data will be wirelessly uploaded to a
 secure server and erased from the device daily. The risks and procedures regarding the
 smartphone will be explained during both screening and consent.

 Phlebotomy: Phlebotomy is performed by drawing blood from a vein in the forearm or
 antecubital fossa. This may cause pain during the insertion of the needle or slight bruising
 afterward.

 ACASI: Some questions in the ACASI questionnaire are personal and participants might feel
 uncomfortable or upset about answering them. Participants may refuse to answer any question.

 Confidentiality: Although precautions will be taken to protect privacy, there is the chance
 that confidentiality can be broken. All data collected outside the study clinic are protected
 by the Certificates of Confidentiality for the ALIVE I and ALIVE II studies. Participants
 will be reminded of the legal requirements for confidentiality within the ALIVE Study.
 Confidentiality risks will be minimized by using study materials without personal
 identifiers, using only unique study numbers, and by following strict procedures in data
 collection, data entry, and data analysis.

 Peer Navigators will know participants by name and may have contact information for
 participants stored on their own mobile phones, but will not carry any information linking
 participants' identities with study-related information outside the locked offices of the
 Wood Clinic.

 Description of Level of Research Burden

 Volunteers in this project will have their normal daily activities interrupted twice per day.
 However, each interruption for an EMA response should take only 3-5 minutes. One purpose of
 this study is to find out if this is too high of a burden for this population. The maximum
 total daily time devoted to the study should be a no more than 15 to 20 minutes, even with
 event-generated responses. Each weekly visit should take about 30 minutes, not including time
 spent in the waiting room.

 Description of Potential Benefits

 Participants may not benefit directly for being in this study. Benefits to society include
 helping us to understand research techniques that can promote engagement in HIV care as well
 as improve data collection. The research may help society understand the environment in which
 people use drugs and the specific challenges IDUs may encounter when accessing HIV care.

 Reporting Unanticipated Problems/Adverse Events

 No adverse events are anticipated as part of the study. However, participants will be
 instructed to contact the Principal Investigator, Dr. Kirk, the Research Coordinator, Mr.
 Genz, or the Johns Hopkins Institutional Review Board (IRB) if they feel they have been
 harmed during the course of study procedures.

 Safety monitoring

 Participants will have 24-hour access to an on-call provider through the Moore Clinic. If
 needed, this communication will be facilitated by the study smartphone, which has important
 clinic and study-related numbers pre-programmed. Participants' will be formally evaluated
 with questionnaires and in-person interviews every three months at the ALIVE clinic by
 research staff, at which time they can report any unforeseen challenges related to their
 participation. They will have the ability to leave non-urgent messages for the study
 coordinator or peer navigator, which will be answered within one business day.
Inclusion Criteria:

 -  History of current or former injection drug use

 -  No clinic visits with an HIV provider in the preceding 12 months

 -  Not taking ART

 -  HIV RNA level of greater than 1,000 copies/mL

 -  Agree to attend at least one HIV care visit at the Johns Hopkins Moore clinic

 Exclusion Criteria:

 -  Any medical or psychiatric condition that would interfere with the participant's
 ability to comply with study procedures or make participation unsafe

 -  Current enrollment in another HIV retention-in-care study