Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Phase: NA
Conditions: HIV/AIDS
Sponsor: Brown University

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Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV 
Patients 
NCT04201288 
Study Protocol – 8/30/21 
 
 

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BRIEF ACCEPTANCE-BASED RETENTION INTERVENTION FOR NEWLY 
DIAGNOSED HIV PATIENTS 
 
 
 
Manual of Procedures (MOP) 
 
 
 
 
 
INTRODUCTION 
The Manual of Operating Procedures (MOP) has been compiled to assist study 
personnel in conducting the study “Brief Acceptance-Based Retention Intervention 
for Newly Diagnosed HIV Patients.” It documents study flow so that the screening, 
initial evaluation, enrollment, and follow-up of all study participants are conducted 
in a standardized manner.  It details how data are to be observed, collected, and 
recorded, and specifies quality control procedures. The MOP defines methods for 
ensuring confidentiality of participant information.  
 
This MOP serves as a supplement to the protocol and contains study conduct 
information in the form of administrative or detailed technical information that is 
not detailed in the protocol or protocol amendment.  The MOP must be reviewed 
carefully in conjunction with the protocol by all study key personnel. 
 

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The MOP will be modified accordingly whenever a change in the protocol is 
approved or a study step has to be refined or re-defined for clarity and safety. The 
changes are captured by maintaining a version control numerically matching the 
progressing sequence of dates displayed on the cover page. 
 
 
 
 
 
 

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MOP CONTENTS AND ORGANIZATION 
STUDY PROCEDURES 
A. Responsibilities 
B. Training Plan 
C. Study Flow 
D. Screening and Eligibility Tracking 
E. Approaching/Assessing Patients 
F. Participant Payment (ClinCards) 
G. Baseline Assessment 
H. Post-Baseline Procedures 
I. REDCap Assessment Database 
J. Procedures for Withdrawal of Consent 
K. Procedure for when Patient Endorses Current Suicidal Ideation/Distress 
L. Safety Reporting 
 
 

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A. RESPONSIBILITIES 
The PI and investigative team are responsible for the implementation of the 
protocol, including: 
• Participating in protocol finalization and preparing study materials 
• Assuring that the study is conducted according to the protocol  
• Identifying, recruiting, screening and enrolling participants 
• Protecting participants' rights 
• Obtaining informed consent from each participant 
• Collecting study data and following participants through study 
completion 
• Preparing recruitment and enrollment, gender and minority breakdowns, 
adverse event reports 
• Assuring IRB review and approval 
• Preparing and sending reports to the Data Safety Monitoring Board 
(DSMB)  
• Preparing and sending annual reports to the funding agency, the National 
Institutes of Health (NIH) 
 
B. TRAINING PLAN 
The Research Assistant and Study Coordinator will be trained on all clinical 
assessments by the lead investigators. For all measures, the staff in training should 
familiarize themselves with the measures and complete mock interviews. The PI 
will lead all trainings on intervention and control condition delivery. 
Interventionist training will include mock session practice and review of audio 
recorded sessions. 
C. STUDY FLOW 
 
 
D. SCREENING AND ELIGIBILITY TRACKING  
Monitor new 
patient flow 
Baseline & 
Randomization 
Follow-Up Appointments 
(1-, 3-, 6-, 9-, & 12-
months post-baseline) 
Approach & 
Informed Consent 

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How are potentially eligible individuals identified? 
Intake nurses will reach out via email to notify when there is a new patient 
scheduled. We will find a convenient time during that appointment to approach the 
patient.  
How is the screening conducted? 
Study staff will use the screening form to determine eligibility. 
How do we know which patients to approach for enrollment? 
Staff use the following guidelines to determine whether patients are eligible or 
ineligible to be approached for study enrollment. The majority of the data to 
determine eligibility are available in the patient medical record; however, for any 
additional information not available in the medical record, the staff will need to 
consult with clinical intake staff. 
A patient must meet all of the eligibility criteria listed below before they are 
approached about enrolling in the Engage study. 
 
 
 
 
 
 
 
 
For 
each patient screened on that day, the RA will enter the following information into 
the study Key file: 
• ID: A unique screener ID will be generated for all individuals screened 
• Date: Date screened 
Table 1. Eligibility criteria 
Inclusion Criteria 
Exclusion Criteria 
• HIV+ 
• ≥18 years old 
• Entering HIV medical care 
services for the first time 
(that is, not transferring HIV 
care from another location) 
• Able to speak and read 
English at the level to be able 
to complete the study 
procedures 
• Have telephone access 
• Cognitive impairment that 
would interfere with 
adequate participation in the 
project (clinic staff will make 
this determination) 

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• Name: First only 
• Telephone number: At least one contact number 
• Permission to text appointment reminders: Yes / No 
• Permission to leave voicemails for appointment reminders: Yes / No 
• Permission to leave messages indicating research affiliation: Yes / No 
• Age 
• HIV status: Positive / Negative 
• Cell phone: Yes / No 
• Number of days in past 3 months when individual stopped using their cell 
phone 
 
E. APPROACHING / ASSESSING PATIENTS 
Before approaching the patient 
Confirm with intake nurse via email that the RA will approach the new patient at 
their upcoming intake visit.  
When heading to clinic, bring a clipboard with the: 
• Screening form 
• 2 copies of the consent form 
• Release of Information form 
• ClinCard FAQs and information documents 
• Response cards set 
• HIV education slides 
• Mental health resources document 
• Locator Form. 
• Also bring a baseline questionnaire packet in case the patient immediately 
enrolls and wants to complete the baseline assessment while in clinic. 
Remember, slides and consent show content related to the research study. 
Participants should be warned that these materials might reveal sensitive 
information. They can decline taking any of them. 
Numbering system 

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Please use the following numbering system for identifying patients (PSID) and 
enrolling participants (SID): PSIDs=101-n; SIDs=1001-n 
PSIDs should be assigned to every patient you identify and try to screen.  That 
means that completed screens will not be continuously numbered – this is ok.  The 
key is to assign a PSID to every new patient in the clinic. 
Approaching the Patient 
Patients are only approached and assessed during their free time during their 
clinical intake visit. Most staff are aware of this, but if the staff is not, please 
remind them that study staff are to only meet with patients during their free time.  
Once you have met the patient, introduce yourself and ask if they have a few 
minutes to talk to you about an ongoing research study at the clinic. If they agree, 
administer the screener, which includes a brief recruitment script. 
Patient consent 
If a patient agrees to participate in the study, the staff will guide the patient through 
the consent form, answer any questions, and ask the patient to sign a copy of the 
consent form for our records.  
After signing the consent form, the patient will need to complete the following: 
• Engage Contact Locator Form  
After completing these forms, the staff will set up a time to complete the baseline 
assessment with the patient later that day (if possible) or within 1 week.  
Record all patient approaches in the “Key – HIV Engage” tracking file 
 
F. PARTICIPANT PAYMENT (ClinCards) 
 
Participants will be paid $25 for completion of baseline and each follow-up 
assessment. They will not be paid for completing sessions with study 
interventionists. ClinCards will be used for all participant remuneration. These are 
MasterCards that function as reloadable debit cards. 

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Once the baseline appointment is completed, open up a ClinCard envelope and 
show the participant the card. Make note of the “Token” number, which is visible 
through the clear window on the front of the envelope. This links the participant to 
the specific ClinCard. As ClinCards are distributed, make note of the token number 
in LSUHSC’s tracking log and share the participant ID – token number assignment 
with PI Moitra. Review the Participant ClinCard Information sheet and the FAQ 
document with the participant. 
Highlight each section of the FAQ sheet, in particular noting: 
• The 3-ish business days for payment to load onto the card (at baseline, the 
ClinCard already has $25) 
• How to set up a PIN 
• When additional fees could be incurred 
• What to do if the card is lost 
At follow-up assessments, PI must initiate the upload of additional funds through 
Brown University. At the conclusion of follow-up assessments, inform the 
participant that their ClinCard will be loaded with an additional $25 within 2-3 
business days. Immediately contact PI at the conclusion of the assessment via 
email to ask him to initiate the reload process. He will then contact the relevant 
Brown University staff. Use the following template: 
Email to PI as follows: 
Subject Line – Grant: GR5271057 
Hello,  
Please approve my ___ AM/PM interview with Subject ID # XXXX in the 
amount of $25 for Month, Day, Year on grant #GR5271057 
Lost ClinCards 
We will give participants the benefit of the doubt if they report losing their 
ClinCard. If a lost or missing ClinCard is reported, immediately inform PI so that 
he can cancel the lost card and prevent misuse of funds. A replacement ClinCard 
will be given one time to participants; if they lose >1 ClinCard, all additional 
ClinCards will be loaded with a reduced amount to cover the expense of the 

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replacement card. All replacement ClinCards must be given in-person to the 
participant. 
G. BASELINE ASSESSMENT 
The baseline interviews should be completed in a private interview room in the 
clinic or research offices. All interviews will be audio-recorded. 
Baseline Assessment Schedule: 
Interviews 
Self-Reports (if possible) 
Sociodemographics 
Contemplation Ladder 
Thoughts about PrEP 
PROMIS Global Health Scale 
Alcohol Use Disorders Identification Test 
(AUDIT-3) 
Health Information 
Addiction Severity Index Drug Module 
(ASI) 
Well-Being Scale 
Patient Health Questionnaire-9 (PHQ-9) 
Impulsivity Scale 
Disclosure Scale (BHD & SSSES) 
Acceptance and Action Questionnaire-II 
(AAQ-II) 
Disclosure List 
Multidimensional Scale of Perceived Social 
Support (MSPSS) 
COVID-19 items 
Berger HIV Stigma Scale 
 
Healthcare System Distrust Scale 
 
Everyday Experience of Discrimination 
Scale 
 
Patient Satisfaction Survey 
 
After the interviews are completed, allow the patient to complete the self-report 
measures independently (if possible). Briefly go over the self-reports with the 
patient, and ask if they have any questions. Print all self-reports ONE-SIDED.  
In some cases, participants will consent to be in the study, but will leave the clinic 
before a baseline appointment can be started and/or completed. If this is the case, 
arrange a time for them to come complete the baseline appointment within 1 week. 
H. POST-BASELINE ASSESSMENT PROCEDURES 

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After the baseline has been completed, check-in with the PI to verify the patient’s 
eligibility for enrollment and for any questions in assessment/coding that may have 
arisen. If the PI agrees that the patient is eligible, and no problematic secondary 
characteristics have been identified that may hinder the patient’s participation in 
the study, the patient is officially enrolled into the study.  
Randomization: 
Randomization occurs in the REDCap database using information gathered during 
the baseline interview (participant’s depression and substance use scores). See the 
cover page of the baseline assessment for guidelines. This information can be 
directly entered into REDCap, which will then generate the allocation. 
Follow-Up Assessment Schedule: 
Follow-up assessments are conducted at 1-, 3-, 6-, 9-, and 12-months post-baseline. 
These assessments can be conducted remotely or in-person. All follow-up 
assessments are audio-recorded. 
Measure 
Self-
Repo
rt 
1-Mo 3-Mo 6-Mo 9-Mo 12-
Mo 
Sociodemographics II 
 
X 
X 
X 
X 
X 
Health Questionnaire (PHQ-9) 
 
X 
X 
X 
X 
X 
Disclosure Scale (BHD & SSSES) 
 
X 
X 
X 
X 
X 
Disclosure List 
 
X 
X 
X 
X 
X 
Self-Rating Scale Item (SRSI) 
X 
X 
X 
X 
X 
X 
Contemplation Ladder 
X 
X 
 
 
 
 
PROMIS Global Health 
X 
X 
X 
X 
 
 
Health Information 
X 
X 
X 
X 
X 
X 
Well-Being Scale 
X 
X 
X 
X 
X 
X 
Acceptance and Action Questionnaire-II (AAQ-
II) 
X 
X 
X 
X 
X 
X 
Multidimensional Scale of Perceived Social 
Support (MSPSS) 
X 
X 
X 
X 
X 
X 
Berger HIV Stigma Scale 
X 
X 
X 
X 
X 
X 
Healthcare System Distrust Scale 
X 
X 
X 
X 
X 
X 

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Everyday Discrimination Scale 
X 
X 
X 
X 
X 
X 
Visit Specific Satisfaction Questionnaire 
X 
X 
Client Satisfaction Questionnaire-Revised 
X 
X 
 
 
 
 
End-of-Treatment Questionnaire 
X 
X 
 
 
 
 
 
 
I. REDCap ASSESSMENT DATABASE 
This study uses a centralized REDCap database for all data collection and entry. 
 
J. PROCEDURES FOR WITHDRAWAL OF CONSENT 
If the participant communicates to research staff that they would like to withdraw 
their consent to be in the study at any point, the staff must document this in the 
Engage Tracking Log, and if possible, obtain written documentation from the 
participant via letter or in-person.  
Once the participant has withdrawn consent, the staff no longer has permission to 
contact the participant regarding the study and will not review any electronic 
health record information about the individual. 
K. PROCEDURE FOR WHEN PATIENT ENDORSES CURRENT 
SUICIDAL IDEATION/DISTRESS 
The PHQ-9 should be administered early in the assessment so that a clinician can 
promptly respond. If a patient endorses current suicidal ideation at any time during 
any assessment, and/or as assessed by the PHQ-9 (i.e., score >0 on item #9) or 
otherwise in conversation, study staff will take the following steps: 
• Immediately text a licensed study clinician to notify them that a risk assessment 
might be needed 
• Administer the Modified Scale for Suicidal Ideation (MSSI) at the end of the 
assessment, unless the participant is in distress and interrupting the appointment 
is warranted 
o After collecting the MSSI information, explain to the individual that our 
study values our participants and wants to offer resources or help if 
needed. 

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o Ask who knows about the patient’s suicidality (e.g., therapist, case 
manager). If there are providers who are aware of these issues, ask when 
the patient will speak to them next. 
• Pause the assessment and call the study clinician (outside of the appointment 
room if conducting the assessment in-person). The clinician will then determine 
next steps based on the information gathered by the study staff. 
If a patient endorses any homicidal ideation (HI) or violent ideation (VI) during the 
assessment, collect relevant information (frequency of thoughts, intent to act, plan, 
person/people in question) and report to on-call clinician to determine if patient is 
at imminent risk of harming others.  
If a clinical check-in is completed, the staff will complete a note, to be stored in the 
research PHI folder, detailing: 
• How the event was identified (e.g., follow-up appointment, phone call) 
• Pertinent clinical information indicating risk 
• Steps taken by the licensed clinical coverage staff to address the risk 
• Yes/No contraindications to continuing in the study 
• How symptoms will be monitored at the next visit 
If a participant is evaluated within the study by a licensed member of the 
investigative team and it is determined that no additional clinical services are 
needed, then the note will suffice as a research chart note to be stored with the 
research study folder. If the participant is seen by a clinic staff right away, 
document information you gathered at that point, and that they have been 
transferred to their clinic for further evaluation. This would constitute an adverse 
event that PI will need to report to the IRB and NIMH. The research chart note for 
transferred patients will also be stored in the research PHI folder. 
L. SAFETY REPORTING 
All adverse events related to the participant that come to the staff’s knowledge 
must be communicated to the PI immediately. He will then report to IRB and NIH, 
as appropriate.