A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
Phase: NA
Conditions: HIV/AIDS
Sponsor: RAND

Clinicaltrials.gov Cover Sheet 
 
Official Title: A Randomized Controlled Trial of an Antiretroviral Treatment Adherence 
Intervention for HIV+ African Americans   
 
NCT03331978 
 
Date: 4.5.22 
 
 

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ID: 2016-0940
 Study #:2016-0940 
Last Update from Study Team: Tue Apr 5 14:39:40 PDT 2022
1A Study Introduction
1A1 Study Description
1A1.1
** Title:
A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans
1A1.2
** Provide a brief summary or abstract for this study. Describes its purposes, study methods (i.e., participants,
procedures, data sources), and expected results. (5,000 character limit)
Compared to Whites, Black people living with HIV are less likely to adhere to antiretroviral treatment (ART) and be virally
suppressed. Our research has identified culturally relevant factors contributing to disparities among HIV-positive Black
Americans, including stigma and medical mistrust (e.g., “conspiracy beliefs,” that ART is poison), in addition to structural and
psychosocial factors related to poverty, healthcare access, and mental health. However, ART adherence interventions have
rarely been culturally congruent, which may explain why relatively few interventions have shown robust effects on adherence
or viral suppression. We propose to conduct a randomized controlled trial (RCT) of Rise, a culturally congruent adherence
counseling intervention for HIV-positive Black men and women. Rise counselors possess specialized HIV treatment
knowledge and are trained in motivational interviewing (MI) skills to overcome culturally relevant barriers to adherence and
retention in care; they also assist with linkage to social services. Rise is ideally implemented in community organizations,
enabling clients to seek services in non-medical settings, which helps to overcome mistrust of healthcare, and increase
readiness for adherence. In a pilot RCT, Rise led to increased adherence (measured by electronic monitoring) relative to a
wait-list control group over time, showing a large effect size (Cohen’s d=.87). However, the pilot did not evaluate effects on
viral suppression or include long-term follow-up. Thus, we propose to conduct an RCT of Rise that follows best practices for
evidence-based HIV treatment adherence intervention design and testing. The Specific Aims are: (1) To conduct a
randomized controlled trial to examine the effects of a culturally congruent adherence intervention on antiretroviral treatment
adherence, retention in care, and viral suppression among Black men and women living with HIV; (2) To examine culturally
relevant mediators (e.g., medical mistrust, stigma) that may help to explain the effects of the intervention on antiretroviral
treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; and (3) To
conduct a cost effectiveness analysis of the intervention. A total of 350 Black men and women will be randomly assigned to
the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and
downloaded bi-monthly) from 1-month pre-enrollment to 12-months post-baseline. Viral load will be assessed through
venipuncture at baseline and 6- and 12-months post-baseline. If Rise is found to be effective, the next step would be to
conduct research to determine effective and feasible methods for intervention implementation and dissemination to
community settings.
1A1.3
** Who is the intended audience for the results of this study? Where and in what form will you disseminate results? 
What are the potential benefits of the study to society?
Intended audience: Community stakeholders and academic researchers in the HIV 
Dissemination: via community and academic conference presentations, and journal articles
Benefits: to help reduce health disparities and ultimately make available an evidence-program that communities can use to
help people living with HIV be healthier through suppressed viral load and to be less likely to transmit HIV to others
1A1.4
** Research Unit(s):
Arroyo Center
Education and Labor
Global Research Talent
Health Care
HSOAC
Justice, Infrastructure, and Environment *
Labor and Population (Archive)

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ID: 2016-0940
National Security Research Division
Project AIR FORCE
Pardee RAND Graduate School
RAND Europe
Social and Economic Well-Being
Other
N/A
 
* JIE includes all work fomerly done under ISE, ICJ, and LBR.
1A2 Study Staff
1A2.1
** Principal Investigator. (If there are multiple PIs, please designate one PI here as being responsible for human subjects
protection. Include the other PIs in the study staff list asked for in the next question.) The PI will receive all emails on the
project from the HSPC. The PI in OASIS
 is the PI in RHINO.
Laura Bogart
1A2.2
Study Staff List.  Enter the names of all study staff whom you want to have view and edit privileges for the study file in
RHINO.  Note that these staff will receive all emails on the project from the HSPC. 
Last Name
First Name
Organization
There are no items to display
1A2.3
Primary HSPC Contact.  You can designate only one person as the primary contact. This can be the PI or a study staff
member listed above or anyone else you choose. The Primary HSPC Contact should be someone who can be reached
quickly if there is a question. The person designated a primary contact will receive all emails on the project from the HPSC.
Terry Marsh
1A2.4
Other Key Personnel.  In order to (1) determine the experience of the study staff and (2) avoid reviewer assignment
conflicts, please identify other key personnel involved in the study. The individuals you list here will not receive email
notifications or have view/edit rights on the study in RHINO. Note: To avoid reviewer assignment conflicts, you can see if
staff on your study would potentially be reviewers by looking at the HSPC membership list
.
 
Last Name
First Name
Organization
Role
View Ghosh Dastidar
Bonnie
Economics, Sociology and Statistics
Key Researcher
View Linnemayr
Sebastian
Economics, Sociology and Statistics
Key Researcher
View Wagner
Glenn
Behavioral and Policy Sciences
Key Researcher
1A2.5
Email List.  Specify any other RAND staff (i.e., beyond the study staff) who should receive email notifications about this
study. The persons you list here will have read-only access privileges to the study file.
Last Name
First Name
Organization
E-Mail
There are no items to display
1A3 Screen for Involvement of Human Subjects and Eligibility for Exemption
1A3.1
**  Before completing the full set of review questions, would you like to see if any of the population-procedure
components of your study do not require review or are exempt from review? 
A. Yes - I want to see if all of the population-procedure components are exempt or do not require review.
B. Yes - I want to see if some of the population-procedure components are exempt or do not require review.
C. No - Take me to the full set of the review questions.
1A3.4
You will be asked to list all of the component(s) of your study and then proceed to the full set of review questions for each
component. Each population and procedure combination that will be used will be defined as a component. A study that has
only one component will be routed through the population and procedure questions only one time.
Version 2.15

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ID: 2016-0940
 
1B Study Funding
1B1 Funding Status
1B1.1
* Funding Status:
Proposed
Sponsor requires review before funding (Just in Time Review)
Funded
Initiated, but not yet funded
1B2
* Funding Sources. 
Click Add to list a funding source. To edit, click on the [Edit] link. To delete, check the checkbox next to the funding source to
be removed, then click Delete.
 
Name
Project Task Number
Proposal Number
Funding Institution Type
Instiution Other
Status
View NIMH
HPH0175-1000
20161317
Federal Govt
 
Completed
1B3 Prime Contractor
1B3.1
* Which institution is the prime contractor or grantee?
RAND
Version 2.15
 
1C Populations and Procedures 
1C1
** Specify Populations - Click Add to list a population. To edit, click on the link. To delete, check the checkbox and
click Delete.
Population
Created
People Living with HIV
11/21/2016
1C2
** Specify Procedures - Click Add to list a procedure. To edit, click on the link. To delete, check the checkbox and
click Delete.
Procedure
Created
Cost Data
11/30/2016
COVID-19 Survey Items
4/29/2020
Electronic Adherence Assessment (MEMS)
11/29/2016
Intervention
11/21/2016
Medical Records Assessment
11/21/2016
Recruitment Discussion Groups
11/28/2018
Surveys
11/21/2016
Viral Load Assessment
11/21/2016
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ID: 2016-0940
1D Populations and Procedures Matrix
 
Population Procedures:
Population
Procedure
Check here if this
procedure applies
to this population
Check here to see
if your study
meets the criteria
for the abridged
set of review
questions
People
Living with
HIV
Cost Data
COVID-19 Survey Items
Electronic Adherence Assessment (MEMS)
Intervention
Medical Records Assessment
Recruitment Discussion Groups
Surveys
Viral Load Assessment
Version 2.15
ID: 2016-0940
 
 2 Is This Reviewable?
Population
Procedure
Complete screeners by clicking on all active links below
Status

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Population
Procedure
Complete screeners by clicking on all active links below
Status
People Living with HIV
Cost Data
2A Determining Human Subjects Involvement
Completed
Follow up questions not required
COVID-19 Survey
Items
2A Determining Human Subjects Involvement
Completed
Follow up questions required
Electronic Adherence
Assessment (MEMS)
On screen 1D you did not indicate that you wanted to answer the screening questions
for this component. The full set of review questions will be asked for this component.
Intervention
On screen 1D you did not indicate that you wanted to answer the screening questions
for this component. The full set of review questions will be asked for this component.
Medical Records
Assessment
On screen 1D you did not indicate that you wanted to answer the screening questions
for this component. The full set of review questions will be asked for this component.
Recruitment
Discussion Groups
2A Determining Human Subjects Involvement
Completed
Follow up questions not required
Surveys
On screen 1D you did not indicate that you wanted to answer the screening questions
for this component. The full set of review questions will be asked for this component.
Viral Load
Assessment
On screen 1D you did not indicate that you wanted to answer the screening questions
for this component. The full set of review questions will be asked for this component.
Your project may not involve human subjects of research.  For each component above that indicates "Follow up questions not required"
please go to Screen 7A and attach a data safeguarding plan as a Miscellaneous Document.  For those components that involve the
collection of new data, please also attach the consent protocol and questions.
 
  
People Living with HIV: Cost Data
2A Determining Human Subjects Involvement
2A1 Activities That Do Not Involve Human Subjects
2A1.1
 * Will you be doing any of the following activities which would not be classified as involving human subjects? 
You will be asked about other research activities later.
A. Providing advisory services or expert consultation without additional data collection (e.g., surveys) or use of
previously collected data (e.g., school records).
B. Convening a conference or meeting with no data collection other than an anonymous evaluation (for example, the
conference may not be used as a focus group).
C. Preparing a concept paper or op-ed piece, or otherwise developing an article that doesn’t require any new research
activity.
D. Conducting a review of published literature or historical research that doesn’t involve reviewing identifiable
information (unpublished) about living individuals.
E. Using existing anonymous unrestricted data from publicly available sources (e.g., Census, Current Population
Survey).
F.
Using previously collected data not provided at the individual person level (e.g., aggregate data, data
recorded at the transaction or event level that does not contain any indicator about individuals, data
recorded on operations or systems that does not contain any indicator about individuals).
G.
Interviewing individuals to gather factual information about organizations and their activities (e.g., weapons
acquisitions program, logistics workflow) if it would not lead to damage to employability if there was a
breach of confidentiality (e.g., identifying a whistleblower).
H. None of the above
2A1.2
 * Are you doing any activities not covered by 2A1.1?
no
2A1.3
If the reviewer determines that only the activities checked in 2A1.1 are being performed, they may determine that the study
component does not involve human subjects.

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2A4 Proprietary Information
2A4.1
* Could the research involve proprietary information (i.e., trade or business information that belongs to an
organization)? 
No
 
 
  
People Living with HIV: COVID-19 Survey Items
2A Determining Human Subjects Involvement
2A1 Activities That Do Not Involve Human Subjects
2A1.1
 * Will you be doing any of the following activities which would not be classified as involving human subjects? 
You will be asked about other research activities later.
A. Providing advisory services or expert consultation without additional data collection (e.g., surveys) or use of
previously collected data (e.g., school records).
B. Convening a conference or meeting with no data collection other than an anonymous evaluation (for example, the
conference may not be used as a focus group).
C. Preparing a concept paper or op-ed piece, or otherwise developing an article that doesn’t require any new research
activity.
D. Conducting a review of published literature or historical research that doesn’t involve reviewing identifiable
information (unpublished) about living individuals.
E. Using existing anonymous unrestricted data from publicly available sources (e.g., Census, Current Population
Survey).
F.
Using previously collected data not provided at the individual person level (e.g., aggregate data, data recorded at the
transaction or event level that does not contain any indicator about individuals, data recorded on operations or
systems that does not contain any indicator about individuals).
G.
Interviewing individuals to gather factual information about organizations and their activities (e.g., weapons
acquisitions program, logistics workflow) if it would not lead to damage to employability if there was a breach of
confidentiality (e.g., identifying a whistleblower).
H. None of the above
2A1.5
Since you selected "None of the above" on 2A1.1, an answer needs to be provided on 2A2.1 below.  If you do not believe
that you are doing any of the activities listed below in 2A2.1, please contact the HSPC Helpdesk at x4772.
2A2 Activities That Are Typically Classified to Involve Human Subjects
2A2.1
* Will you be doing any of the following activities which are typically considered to involve human subjects? (Check
all that apply) 
A.
Expert panel or workshop to
discuss current or future
concepts and systems
(e.g., meetings of experts to arrive at shared advice, decisions and
recommendations; obtain views on their utility; issues for system design)
B. Interview
(e.g., oral or background interviews with key individuals)
C. Survey
(e.g., written, internet, mail)
D.
Focus group or group
discussion for data collection
purposes
 
E. Observation of public behavior  
F.
Analysis of person-level data
from extant records or
previously collected datasets
(extant records such as educational, criminal, military, or medical records)
G. Tests or assessments related
to education/training
 
H. Psychological tests or
assessments
 
I. Physical exams or
measurements
 

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J. Social-behavioral intervention
(e.g., effect of counseling on drug use, effect of innovative educational practices on
learning, effects of training or new procedures on individual performance, assignment
to experimental conditions, or pilot demo programs)
K. Clinical treatment or
intervention
(e.g., nutritional supplementation)
L. Specimen collection
(e.g., collection of blood, urine, hair, or other material for tests, including genetic
testing)
M. Any other activities which will
gather person-level information  
2A3 - Information Acquired/Accessed
2A3.1
* Please specify the information that you will be acquiring, accessing, or recording as part of data collection. (Check
all that apply) 
A. Attitudes, opinions, judgments from a living individual, including
opinions about organizations and performance
 
B. Facts about organizations, programs, and systems, such as their policies
and procedures
(e.g., statistics whether estimated or
measured)
C. Personal data about or personal experiences of a living individual
(i.e., private information that is recorded
as part of data collection)
D. Other (specify below)
 
2A3.3
* Do you have the questions you will be asking participants (e.g., the interview protocol, survey instrument, or focus
group guide) in draft or final form or a list of domains to be covered?
yes
2A3.4
If "Yes", you will be able to upload in section 6 the questions you will be asking participants.
2A3.7
This study component does involve human subjects of research because attitudes, opinions, judgements, or personal
data/experiences will be collected.  In order for a reviewer to determine whether this study component is exempt, please
select an exemption category below.  This will expose questions on other screens that the reviewer will need to make this
determination.
2A4 Proprietary Information
2A4.1
* Could the research involve proprietary information (i.e., trade or business information that belongs to an
organization)? 
No
2A5 Choose Exemptions to Qualify For
2A5.1
This component may qualify for one of the exemptions listed below. Please check any boxes to see which
exemptions the component may qualify for. 
A. Adult Interviews and Surveys Exemption (Category 2: Educational Tests, Surveys, Interviews, Observations of Public
Behavior)
B. Existing Data Exemption (Category 4: Secondary Research for Which Consent is Not Required)
C. Regular Educational/Training Practices Exemption (Category 1: Research in Established or Commonly Accepted
Educational Settings)
D. Public Benefit Program Research Exemption (Category 5: Research and Demonstration Projects that Are Conducted
or Supported by a Federal Department or Agency)
E. Taste and Food Evaluation Exemption (Category 6: Taste and Food Quality Evaluation and Consumer Acceptance
Studies)
F. Elected Officials, Political Appointees Exemption (Needed for older studies only)
G. None of the Above
H. Category 3: Benign Behavioral Interventions in Conjunction with the Collection of Information From Adult Subjects
(NEW)
I. Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required (NEW)
J Category 8: Secondary Research for Which Broad Consent is Required (NEW)

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2A5.2
Because you selected "None of the Above" for 2A5.1, you will be asked the reviewable questions for this component.
 
 
  
People Living with HIV: Recruitment Discussion Groups
2A Determining Human Subjects Involvement
2A1 Activities That Do Not Involve Human Subjects
2A1.1
 * Will you be doing any of the following activities which would not be classified as involving human subjects? 
You will be asked about other research activities later.
A. Providing advisory services or expert consultation without additional data collection (e.g., surveys) or use of
previously collected data (e.g., school records).
B. Convening a conference or meeting with no data collection other than an anonymous evaluation (for
example, the conference may not be used as a focus group).
C. Preparing a concept paper or op-ed piece, or otherwise developing an article that doesn’t require any new research
activity.
D. Conducting a review of published literature or historical research that doesn’t involve reviewing identifiable
information (unpublished) about living individuals.
E. Using existing anonymous unrestricted data from publicly available sources (e.g., Census, Current Population
Survey).
F.
Using previously collected data not provided at the individual person level (e.g., aggregate data, data recorded at the
transaction or event level that does not contain any indicator about individuals, data recorded on operations or
systems that does not contain any indicator about individuals).
G.
Interviewing individuals to gather factual information about organizations and their activities (e.g., weapons
acquisitions program, logistics workflow) if it would not lead to damage to employability if there was a breach of
confidentiality (e.g., identifying a whistleblower).
H. None of the above
2A1.2
 * Are you doing any activities not covered by 2A1.1?
no
2A1.3
If the reviewer determines that only the activities checked in 2A1.1 are being performed, they may determine that the study
component does not involve human subjects.
2A4 Proprietary Information
2A4.1
* Could the research involve proprietary information (i.e., trade or business information that belongs to an
organization)? 
No
 
 
 
ID: 2016-0940

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3A Research Overview - Dates
3A1 Start Dates
3A1.1
* Project Start Date (mm/dd/yyyy): (Grant and non-FFRDC research should use the award date as the project start
date.  FFRDC research should use the date on which the project task number was opened.) 
5/1/2017
3A1.2
* Anticipated Data Acquisition Start Date (mm/dd/yyyy): (Note: This should include pilot/pretest activites) 
11/1/2017
3A2 End Dates
3A2.1
* Anticipated Data Acquisition End Date (mm/dd/yyyy): 
10/31/2021
3A2.2
* Anticipated Data Analysis End Date (mm/dd/yyyy): (The date on which data analysis is completed and reports or
articles have been published.) 
3/31/2024
Version 2.15
3B Research Overview - External Organizations Collaborating in the Research
 
3B
If a collaborating institution is participating in human subjects research as defined by the regulations, either its own
IRB must review its activities or it must arrange to have a registered IRB (e.g., RAND's HSPC) do the review. 
Organization
Status
AIDS Project Los Angeles
Completed
Children's Mercy Hospitals and Clinics (Kansas City, MO)
Completed
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3B Research Overview - External Organizations Collaborating in the Research
3B1
** Name of external organization.
AIDS Project Los Angeles
3B2 External Organization Staff Activities
3B2.1
* External organization staff will be involved in the following (Check all that apply):
A. Give RAND names and contact information to assist in subject recruitment without their prior written consent
B. Obtaining informed consent
C. Collecting data
D. Receive identifiable person-level data
E. Sharing responsibility for research design, data analysis, and/or interpreting and reporting results
F. Performing other activities
G. None of the above
3B2.4
If you check options A - E, it may be necessary for this external organization to obtain an IRB review because the activities
this organization will be performing could be considered to be human subjects research.
3B3 IRB Review
3B3.1
* Will the external organization be carrying out its own IRB review?
No
3B3.2
* Will the external organization be deferring IRB review?
A.
Yes - to RAND's HSPC
B.
Yes - to another IRB
C.
No
D.
Don't know
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3B Research Overview - External Organizations Collaborating in the Research
3B1
** Name of external organization.
Children's Mercy Hospitals and Clinics (Kansas City, MO)
3B2 External Organization Staff Activities
3B2.1
* External organization staff will be involved in the following (Check all that apply):
A. Give RAND names and contact information to assist in subject recruitment without their prior written consent
B. Obtaining informed consent
C. Collecting data
D. Receive identifiable person-level data
E. Sharing responsibility for research design, data analysis, and/or interpreting and reporting results
F. Performing other activities
G. None of the above
3B2.4
If you check options A - E, it may be necessary for this external organization to obtain an IRB review because the activities
this organization will be performing could be considered to be human subjects research.
3B3 IRB Review
3B3.1
* Will the external organization be carrying out its own IRB review?
No
3B3.2
* Will the external organization be deferring IRB review?
A.
Yes - to RAND's HSPC
B.
Yes - to another IRB
C.
No
D.
Don't know
Version 2.15
 
 
ID: 2016-0940
4A - Populations
 
Click on the link for each Population to answer the questions for that population.
Population
Status
People Living with HIV
Completed
 
Version 2.9
 
  
People Living with HIV
Related procedures:
Recruitment Discussion Groups (Does not involve human subjects)
Viral Load Assessment (Full Committee - Approved)
Intervention (Full Committee - Approved)
Electronic Adherence Assessment (MEMS) (Full Committee - Approved)

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Surveys (Full Committee - Approved)
Medical Records Assessment (Full Committee - Approved)
COVID-19 Survey Items
Cost Data (Full Committee - Approved)
 
Required fields are indicated with a red asterisk (*) to the left of the question.
4A1 Piloting or Pretesting Procedures
4A1.1
* Will you be piloting or pre-testing procedures or instruments for this population? 
no
4A2 Inclusion Criteria
4A2.1
* Please give the inclusion or selection criteria for participation in the research. Note: questions on exclusion criteria
will be asked later. 
Eligibility criteria include: (1) age ≥18 years; (2) self-identified as African American/Black (if mixed race, primarily identify as
Black); (3) currently prescribed antiretroviral treatment (ART) for at least 6 months; and (4a) any self-reported adherence
problems (i.e., missed at least 1 ART dose in the past week or <100% of doses in the past month) and/or (4b) detectable
viral load (verified by medical records). Participants also (5) must be willing to use MEMS for electronic adherence
monitoring. 
Participants will be ineligible if they are unable to understand or communicate in spoken English.
If individuals are screened via an online screener, we will also require that participants live in LA County, so that they can
attend study appointments in person, as required by the protocol.
Participants will have similar eligibility criteria for the discussion groups: 18 years or older, living with HIV, be prescribed
medications for at least 6 months, self-described adherence issues, and identify as Black/African American.
If participants wish, after they screen as eligible, we will offer ride assistance through the confidential Circulation program (a
program of Lyft) for their first study visit.
4A2.2
* Please indicate which, if any, of the following vulnerable populations would be intentionally included among your
research subjects as part of your study design. Do not check any that may be included incidentally. 
A. Children/minors
B. Prisoners, incarcerated individuals, detainees, parolees, probationers
C. Cognitively impaired persons
D. Seriously or terminally ill individuals, including those with serious mental illnesses
E. Illegal immigrants
F.
Economically or educationally disadvantaged individuals
G. Other potentially vulnerable participant groups
H. None of the above
4A2.5
* Could children/minors be included in your sample either inadvertently or by chance?
no
4A2.7
* Could prisoners, incarcerated individuals, detainees, parolees, or probationers be included in your sample either
inadvertently or by chance?
no
4A3 Exclusion Criteria
4A3.1
* Are you going to intentionally exclude anyone because of gender, racial/ethnic groups, or language fluency?
yes
4A3.2
* If "Yes", please explain why you are going to intentionally exclude someone on the basis of gender, racial/ethnic
groups, or language fluency:
The intervention has been specifically tailored for African Americans and thus we are excluding those of other racial/ethnic
groups
4A3.3
* Are there additional criteria for excluding individuals from participation not described above (such as minimum
time in current job, specific health conditions, cognitive impairment, literacy)?

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no
4A4 Coercion or Undue Pressure to Participate
4A4.1
* Are any of the participants in a situation, role, or position where they could be coerced or feel undue pressure to
participate (e.g., employer/employee, doctor/patient, supervisor/subordinate, student/teacher)?
no
4A5 Participant Recruitment
4A5.1
* Next we will be asking questions related to communication or interaction with potential study participants. These
questions will cover number of participants, recruitment procedures, recruitment materials to be used, obtaining
informed consent, and contact after the research ends.
How will the study staff (including subcontractors and vendors) be communicating or interacting with individuals
from this population?
A.
Recruiting/contacting participants
B.
Obtaining informed consent
4A5.2
Please answer the remaining questions based on your best estimates at this time.
4A5.3
* What is the earliest date at which you expect the project will have first contact with potential participants?
(mm/dd/yyyy)
10/3/2016
4A5.4
* How many potential participants does the study staff expect to contact or screen regarding participation (i.e., your
starting sample size)?
1000
4A5.5
* How many participants do you expect to have (i.e., number of respondents or participants)?
350
4A5.6
* Please describe the recruitment procedure.  Include who, what, where, when, and how. Note: questions on informed
consent will be asked later in Section 6.
Participants will be recruited via fliers in waiting areas and on bulletin boards at APLA, clinics, and other AIDS service
organizations (ASOs); radio, metro, newspaper, newsletter, and online ads; and fliers disseminated by APLA program staff to
their clients (e.g., case managers). 
Discussion Groups: APLA and RAND staff will also hold brief information sessions at client gatherings (e.g., support groups)
and staff meetings in different clinics and organizations. APLA staff will also hold discussion groups to help with recruitment;
the discussion groups will be conducted as focus groups, in which we will ask participants about their feedback on the Rise
intervention, and then offer study screening after the discussion group (data from the discussion groups will not be collected).
Fliers: The study fliers were designed by a graphic artist, with input from the community advisory board (CAB). Based on CAB
feedback, we are also creating fliers with pictures of CAB members (which includes HIV service organization staff and clients),
along with slogans that are developed by the CAB (e.g., Get back on track; Are you forgetting something…?; Take time for
yourself….; Rise up for yourself or life; Rise and shine…; Being undetectable is important for my health). Using community
members as models in social media campaigns was suggested by the CAB, who felt that such images would resonate with
potential participants, who may find comfort in seeing people who look like them being affiliated with the study. Permission to
take photos through APLA Health & Wellness is collected through the APLA Health Communications department, who provide
a waiver to be signed by the interested CAB member that states the likeness will not be shared with any other department
within the organization, or outside the organization, for any purpose. Whatever photos are taken will only be used for the
purpose of promoting Project Rise. In providing consent for being photographed, the CAB member has the right to rescind
their permission, and it will not affect their relationship with Project Rise, APLA Health, or any other organization/person/entity.
All signed paper copies are kept by the Communications department in a secure locked folder and office at APLA Health,
which cannot be accessed by anyone outside the department.
Recruitment Staffing: We hired a staff member from the local community for recruitment and tracking who is well-connected
with the local HIV population and community organizers, and familiar with local HIV services in Los Angeles County (LAC). We
also will recruit through several of APLA’s programs (housing, food bank) that attract a wide variety of clients, including those
not fully engaged in care. 
Screening: Interested participants will be screened in person or by phone by APLA study staff, and they will be asked to bring
proof of viral load to the first study visit. Prior to the baseline survey, the study coordinator will describe the details of the study,
including the nature of involvement in the study, the possible risks and benefits of participation, and the ability to withdraw from
the study at any time without consequence. The participant will have the opportunity to ask questions about the study, after
which informed consent will be obtained and documented by having the participant read and sign a consent form, which will be
stored in a locked file cabinet. Each participant will be given a copy of the consent form to keep. 

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We have used these recruitment procedures successfully for several prior studies.
Online Recruitment: Participants who are recruited online will have the opportunity to complete an online screener (instead of
an in person or phone screener). This will be done with a Confirmit questionnaire, which is accessible through the internet. The
Confirmit questionnaire has similar language as the in-person/phone recruitment screener. The survey will track individual
responses via IP address, which is specific and unique per device used to complete the tool. The survey tool will also
incorporate skip logic and disqualification, so those who complete the survey electronically will be notified if they are eligible or
not. Survey responses are stored electronically, in a secure account accessed only by the Senior Study Coordinator at APLA
Health and Wellness. The Senior Study Coordinator will check for new responses on a daily basis. Based on the responses
provided, the Seniors Study Coordinator and/or the Study Coordinator will determine if the individual is eligible for the study
using the pre-determined eligibility criteria for inclusion in the program. For eligible clients, the survey will include an option for
respondents to provide their name, contact number and email address so the Project Rise team can reach out to them. They
will be notified of their eligibility status, and asked if they might be interested in participating in the study. Those who are
interested will be scheduled for an appointment. All electronic responses will be transferred to a QDS warehouse for record
keeping and data analysis. Once the entries have been reviewed, they will be deleted from the electronic record. This survey
will be included in all electronically advertised media showcasing Project Rise. This includes social media websites, online
periodicals, and organizational newsletters. It will also be available on the APLA website as well. The link will be a click-
through, allowing people to complete the questionnaire from the convenience of an electronic device as an alternative to
calling in. The link will be maintained and administrated by the Senior Study Coordinator. 
Note that Project Rise is advertised as a Facebook Page that is managed by APLA Health project staff. Interested individuals
interact through the page, not with specific staff. When receiving messages on Facebook, they are received through the Page,
and all responses are done through the Page (rather than a staff-person’s profile). There is also an option to “Like” the page,
and show online support. We have set up security settings so no one can see or be notified that any individual has “Liked” the
page. Only Project Rise staff administering the page will be able to see the full list of individuals who have chosen to “Like” the
page; clients who like it, however, will not be able to see this list, protecting the identity and confidentiality of interested
individuals who may not be out and open about HIV status, gender identity, sexual orientation, or other personal information.
Incentivized recruitment: We will also offer incentives for participants in the study to recruit others in their social networks. All
participants who have registered for Project Rise will be able to receive recruitment incentives, including those who are already
participating in the program. Participants will be given study palm cards and materials to distribute to communities and
individuals they know. When interested clients call to screen, they will be asked how they heard about the program. If the
interested client provides the name of a specific individual, study staff will make a note in the electronic participant database.
Study staff will notify the participant that someone they referred to Project Rise screened for the study, but they will not be
provided the specific name of who it was. For each person screened (up to 3 people) and referred, the referring participant will
receive $10, for a maximum of $30. To ensure confidentiality, participants will not be told the names of the specific clients who
screened. Screening history and participation data will not be shared outside of the study team. All electronic screening
information is kept in a secure spreadsheet in a folder only accessible to study team staff, and on password-protected
computers and accounts. Paper screeners are kept in locked drawers at APLA Health’s office in Baldwin Hills, and not shared
with people outside the study team. 
Street Recruitment: SRG staff will screen participants can be screened at a variety of off-site locations (e.g., on Skid Row; in
front of clinics, service organizations, and homeless shelters). Screening data will be collected using Samsung TAB A Tablets
running the Android operating system using Open Data Kit (ODK) interviewing software. As interviews are conducted, data will
be stored on the tablet and later uploaded to an ODK Aggregate server hosted at RAND. We will provide a $2 cash incentive
for individuals who are screened by street recruiters. Street recruiters may use the brief screener (that is used for the online
screener) or the longer full screener (that is currently used when participants call in). They will ensure that anything confidential
is discussed in a space where the conversation cannot be overheard by others, in which others are not in earshot, and they
will stop the interview if other people enter the space and are able to overhear anything that should be confidential, consistent
with SRG protocols for field interviewing.
4A5.7
* Do you have recruitment materials (e.g., advertisements, flyers, letters of introduction) in draft or final form ready to
upload? 
yes
4A5.8
You will be asked to upload these recruitment materials in section 7.
Version 2.11
 
 
ID: 2016-0940
5 - Procedures
Procedure
Answer questions by clicking on all
Status

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active links below
COVID-19 Survey Items
5C Procedures -
Interactions with
Participants
Completed
5E Procedures - Risks
Completed
5F Procedures - Benefits,
Incentives, Costs
Completed
5G Procedures -
Confidentiality
Completed
Electronic Adherence Assessment
(MEMS)
5C Procedures -
Interactions with
Participants
Completed
5E Procedures - Risks
Completed
5F Procedures - Benefits,
Incentives, Costs
Completed
5G Procedures -
Confidentiality
Completed
Intervention
5A Procedures -
Interventions: Overview
Completed
5E Procedures - Risks
Completed
5F Procedures - Benefits,
Incentives, Costs
Completed
5G Procedures -
Confidentiality
Completed
Medical Records Assessment
5D Procedures -
Secondary Data
Completed
5E Procedures -
Risks
Completed
5G Procedures -
Confidentiality
Completed
Surveys
5C Procedures -
Interactions with
Participants
Completed
5E Procedures - Risks
Completed
5F Procedures - Benefits,
Incentives, Costs
Completed
5G Procedures -
Confidentiality
Completed
Viral Load Assessment
5A Procedures - Interventions:
Overview
Completed
5B Procedures - Interventions:
Biologic Samples or Specimens
Completed
5E Procedures - Risks
Completed
5F Procedures - Benefits,
Incentives, Costs
Completed
5G Procedures - Confidentiality
Completed
  
    
 
  

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COVID-19 Survey Items
3C Research Overview - Procedures
Related Populations:
People Living with HIV
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)
C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5C Procedures - Interactions
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5C Procedures - Interactions with Participants
5C1 Research Team Interaction with Participants
Note: Do not repeat details of interactions that apply only to recruitment procedures. Those details are addressed for the related
populations in 4A5.
5C1.1
* How will the research team be interacting with the participants for the purposes of data collection? (Check all that
apply)
A.
In person
B.
By phone
D.
Over the web (e.g., email, chat, blog)
5C1.3
* Will the research team be audio or video recording the interaction procedure?
no
5C2
* Provide a step-by-step description of this procedure.  Note: Details regarding whether the interaction procedure will be

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repeated are covered in 5C4.
We will call all current study participants and offer them an extra $10 to complete the COVID-19 items during their regularly
scheduled study appointment, or at another convenient time of their choosing. In addition, during all study appointments, as
we already do, we will ask participants if they need any resources and provide referrals. Study interviewers will refer patients
to relevant COVID-19 resources in Los Angeles County (e.g., testing) as needed. We will store these new survey data
securely using the same protocol as for the overall survey dataset, as described in the DSP. As we currently do for other
resources, we will follow up with individuals to whom we provide COVID-19-related resources (in about a week, or sooner if
needed) in order to determine if they were able to access the resources as needed. These additional procedures will
continue until COVID-19-related public health issues are no longer impacting the study. The questions will be asked by
phone during the COVID-19 crisis. If there is a return to some in person interviews in the future, but the COVID-19 crisis is
not yet resolved, we may ask these questions in person (and allow participants to complete them as a survey rather than an
interview, if they wish).
As with our current COVID-19 procedures, participants may wait to get the gift cards until they can come into APLA Health in
person, or they may meet a study staff member at the APLA Health food bank to receive their gift cards sooner.
5C3 Participant Questions
5C3.1
* Do you have the questions you will be asking participants (e.g., the interview protocol, survey instrument, focus
group guide) in draft or final form or a list of domains to be covered?
yes
5C3.2
If "Yes" and you did not upload the questions in Section 2, you will be asked to upload them in Section 7.
5C4 Repetition of the Interaction Procedure
5C4.1
* Will this interaction procedure be repeated with the same participants?  Note: If the repetition is described in another
procedure, indicate that below.
A.
Yes - described below in 5C4.2
B.
Yes - is or will be described in another procedure
C.
No
D.
Possibly
5C4.2
* If "A" or "D", indicate how often this interaction procedure will occur and at what intervals.  Note: If you already
provided this detail in 5C2, please indicate that below.
We anticipate that participants will answer the questions once. However, if the COVID-19 public health crisis lasts for over 6
months, we may check in again with participants who are still in the study in 6 months, to again determine how they are being
affected and whether resources are needed.
5C5 Previously Developed and Validated Surveys, Tests, or Assessments
5C5.1
* WIll previously developed and validated surveys, tests, or assessments be administered as part of this interaction
procedure?
Yes
No
Don't know
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk

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5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 
A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F.
No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically encountered
in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals, incarcerated
individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy individuals" would
face. The comparison is what the actual subject population would face in comparison to miminal risk as defined by everyday
life for healthy individuals in the United States. If a breach of confidentiality or participation would be dangerous in the
study population, it is above minimal risk.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
If an employer were to find out that a participant had COVID-19, they may not be able to get a job or may lose their job. As
with all data in the study, we have strict data safeguarding procedures for keeping data secure and confidential, including
using unique participant IDs rather than participant names for all survey data.
5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
no
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants may get distressed if others were to know their personal health information around COVID-19. As with all data in
the study, we have strict data safeguarding procedures for keeping data secure and confidential, including using unique
participant IDs rather than participant names for all survey data.
5F Procedures - Benefits, Incentives, and Costs
5F2 Incentives and Other Forms of Compensation
5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
Participants will receive an extra $10 gift card for answering the COVID-19 questions.
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
As with our current COVID-19 procedures, participants may wait to get the gift cards until they can come into APLA Health in
person, or they may meet a study staff member at the APLA Health food bank to receive their gift cards sooner, if a staff

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member is available. Participants are all eligible to get food at the APLA food bank and many do so; thus, they are already
going to the food bank and would not need to make an extra trip for the study.
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance
use
    including alcohol, drugs, and tobacco
B. Physical
health
    including diagnosis, treatment, or any other private physical health information
C. Mental health     including diagnosis, treatment, current mental health status (e.g., suicidality), or any other
private mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity     including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual
behavior
     
H. Abuse/neglect     including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location
and
contacting
information
including any address information smaller than state, telephone or fax numbers, email
addresses, web URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle identifiers
and serial numbers (e.g., license plates), and device identifiers and serial numbers (e.g., serial numbers
on surgical implants)
E.
Audio,
video, or
biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints

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F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
no
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes
B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 

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Electronic Adherence Assessment (MEMS)
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Full Committee - Approved)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)
C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C1.4
You will be asked to answer the questions on screen 5C "Procedures – Interactions." If those questions seem inappropriate
for this procedure, please contact the RHINO Helpdesk for assistance at ext 4772.
3C1.5
* If "N" above, please describe the interaction procedure.
Adherence will be measured continuously and electronically from 1 month prior to the baseline survey to 12-month follow-up
using MEMS. One and a half months prior to the baseline session (to decrease reactance to the adherence measurement for
a valid baseline measure), interviewers will assist clients with dispensing the medication with the most complex dosing
schedule or the base medication of the regimen if all medications have the same schedule (e.g., non-nucleoside reverse
transcriptase inhibitor, protease inhibitor, integrase inhibitor), into a MEMS bottle. Bi-monthly, starting at baseline, interviewers
will download adherence data and participants will complete a brief survey to assess instances in which the cap was not used
as intended in the past two weeks (i.e., how often the bottle was opened without removing a dose, a dose was taken from a
source other than the bottle, such as a pillbox, and whether multiple doses were removed at a time and pocketed for later
ingestion). Data for the past two weeks at each time-point will be adjusted using these responses for a more valid
assessment. MEMS software can calculate the percentage of total scheduled doses actually taken, which will be
dichotomized at ≥85% of doses taken at each time-point, following research suggesting that moderate adherence can have
clinically significant effects.
For participants who are not leaving home due to COVID-19 risk, program staff will drive to the participant’s address to pick
up the electronic monitoring device and get a signed HIPAA form. The participant will be asked to put the device into a
plastic/paper bag (which can be supplied by study staff if needed). The staff-person will confirm a time to pick up the device.
Once they arrive, the staff-person will knock on the participant’s door. They will step back from the door at least 6 feet, and
the participant will give the device to the staff-person by putting it in a bag outside their door. The staff-person will collect the
bag, and then provide the HIPAA form for the client to sign. The client will sign the form, put into a provided envelope, and
then leave the envelope outside for the staff-person to collect. The staff-person will collect the envelope and provide gift cards
to the participant. Once the signed HIPAA form and packaged device have been secured, the staff-person will wipe the device
with antiseptic, download data onto their study laptop at home or in APLA’s offices. If downloaded at home, the data will be

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immediately transferred to Kiteworks for data transfer and processing. HIPAA forms will be locked in APLA’s offices for
medical records data collection.
While in the field, program staff will be protected. APLA Health provides its staff with facemasks, gloves, antiseptic wipes and
hand sanitizer for all client interactions. It is APLA Health policy for staff to wear PPE while in the office, in the field, and when
interacting with participants. Program staff will maintain 6 feet of social distancing between themselves and the participant at
all times, and will also enforce that the participant wear a facemask during the interaction as well. Participant and program
staff will monitor themselves to see if they have any flu-like symptoms before the visit, and will postpone any scheduled
interactions if there is any concern of coronavirus transmission. Participants and program staff will also monitor themselves
after the visit to make sure their interaction did not facilitate coronavirus transmission. If there is any concern, program staff
will follow agency and LACDPH protocols for contact tracing and reporting of possible exposures/positive diagnoses.
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5C Procedures - Interactions
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5C Procedures - Interactions with Participants
5C1 Research Team Interaction with Participants
Note: Do not repeat details of interactions that apply only to recruitment procedures. Those details are addressed for the related
populations in 4A5.
5C1.1
* How will the research team be interacting with the participants for the purposes of data collection? (Check all that
apply)
A.
In person
B.
By phone
C.
Via mail
D.
Over the web (e.g., email, chat, blog)
5C1.3
* Will the research team be audio or video recording the interaction procedure?
no
5C2
* Provide a step-by-step description of this procedure.  Note: Details regarding whether the interaction procedure will be
repeated are covered in 5C4.
Adherence will be measured continuously and electronically from 1-month prior to the enrollment and randomization visit to
12-months post-intervention using MEMS. One month prior to the baseline session (to decrease reactance to the adherence
measurement for a valid baseline measure), interviewers will assist clients with dispensing the medication with the most
complex dosing schedule or the base medication of the regimen if all medications have the same schedule (e.g., non-
nucleoside reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor), into a MEMS bottle. Bi-monthly, starting at
enrollment, interviewers will download adherence data and participants will complete a brief survey to assess instances in
which the cap was not used as intended in the past two weeks (i.e., how often the bottle was opened without removing a
dose, a dose was taken from a source other than the bottle, such as a pillbox, and whether multiple doses were removed at
a time and pocketed for later ingestion). Data for the past two weeks at each time-point will be adjusted using these
responses for a more valid assessment. MEMS software can calculate the percentage of total scheduled doses actually
taken, which will be dichotomized at ≥85% of doses taken at each time-point, following research suggesting that moderate
adherence can have clinically significant effects.
In addition to in person, interviewers will interact with participants by phone, mail, and over the internet to set up
appointments and to remind participants about appointments.
Interviewers will use text to remind participants about appointments, using study cell phones that are not used for other
purposes, outside of the study.
For participants who are not leaving home due to COVID-19 risk, program staff will drive to the participant’s address to pick
up the electronic monitoring device and get a signed HIPAA form. The participant will be asked to put the device into a
plastic/paper bag (which can be supplied by study staff if needed). The staff-person will confirm a time to pick up the device.
Once they arrive, the staff-person will knock on the participant’s door. They will step back from the door at least 6 feet, and
the participant will give the device to the staff-person by putting it in a bag outside their door. The staff-person will collect the
bag, and then provide the HIPAA form for the client to sign. The client will sign the form, put into a provided envelope, and
then leave the envelope outside for the staff-person to collect. The staff-person will collect the envelope and provide gift
cards to the participant. Once the signed HIPAA form and packaged device have been secured, the staff-person will wipe the
device with antiseptic, download data onto their study laptop at home or in APLA’s offices. If downloaded at home, the data

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will be immediately transferred to Kiteworks for data transfer and processing. HIPAA forms will be locked in APLA’s offices for
medical records data collection.
While in the field, program staff will be protected. APLA Health provides its staff with facemasks, gloves, antiseptic wipes and
hand sanitizer for all client interactions. It is APLA Health policy for staff to wear PPE while in the office, in the field, and
when interacting with participants. Program staff will maintain 6 feet of social distancing between themselves and the
participant at all times, and will also enforce that the participant wear a facemask during the interaction as well. Participant
and program staff will monitor themselves to see if they have any flu-like symptoms before the visit, and will postpone any
scheduled interactions if there is any concern of coronavirus transmission. Participants and program staff will also monitor
themselves after the visit to make sure their interaction did not facilitate coronavirus transmission. If there is any concern,
program staff will follow agency and LACDPH protocols for contact tracing and reporting of possible exposures/positive
diagnoses.
5C3 Participant Questions
5C3.1
* Do you have the questions you will be asking participants (e.g., the interview protocol, survey instrument, focus
group guide) in draft or final form or a list of domains to be covered?
yes
5C3.2
If "Yes" and you did not upload the questions in Section 2, you will be asked to upload them in Section 7.
5C4 Repetition of the Interaction Procedure
5C4.1
* Will this interaction procedure be repeated with the same participants?  Note: If the repetition is described in another
procedure, indicate that below.
A.
Yes - described below in 5C4.2
B.
Yes - is or will be described in another procedure
C.
No
D.
Possibly
5C4.2
* If "A" or "D", indicate how often this interaction procedure will occur and at what intervals.  Note: If you already
provided this detail in 5C2, please indicate that below.
Please see 5C2
5C5 Previously Developed and Validated Surveys, Tests, or Assessments
5C5.1
* WIll previously developed and validated surveys, tests, or assessments be administered as part of this interaction
procedure?
Yes
No
Don't know
5C5.2
* If "Yes," please list the previously developed and validated surveys, tests, or assessments to be administered,
noting what each measures. Please indicate whether the standardized test or assessment has been altered.
MEMS adherence past-two weeks diary: Bangsberg DR, Hecht FM, Charlebois ED, et al. Adherence to protease inhibitors,
HIV-1 viral load, and development of drug resistance in an indigent population. AIDS. 2000;14(4):357-366.
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk

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5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 
A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F.
No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically encountered
in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals, incarcerated
individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy individuals" would
face. The comparison is what the actual subject population would face in comparison to miminal risk as defined by everyday
life for healthy individuals in the United States. If a breach of confidentiality or participation would be dangerous in the
study population, it is above minimal risk.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience financial harm if their HIV-positive serostatus became known to others, potentially leading to
employment discrimination. To protect confidentiality, the following steps will be taken: All research data will be kept in locked
file cabinets and will be available only to research staff directly involved in this project and state regulatory agency personnel.
Data will be identifiable only by study numbers and client initials. HIV status will not appear along with any personal
identifying information. Personal information used for tracking, including participant name, address, and phone number, will
be stored separately from all research data. To further protect confidentiality, the study will be covered by a federal Certificate
of Confidentiality.
5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm if their HIV-positive serostatus became known to others, potentially leading
to HIV stigma and discrimination. To protect confidentiality, the following steps will be taken: All research data will be kept in
locked file cabinets and will be available only to research staff directly involved in this project and state regulatory agency
personnel. Data will be identifiable only by study numbers and client initials. HIV status will not appear along with any
personal identifying information. Personal information used for tracking, including participant name, address, and phone
number, will be stored separately from all research data. To further protect confidentiality, the study will be covered by a
federal Certificate of Confidentiality.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes

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5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience social harm if their HIV-positive serostatus became known to others, potentially leading to HIV
stigma and discrimination. To protect confidentiality, the following steps will be taken: All research data will be kept in locked
file cabinets and will be available only to research staff directly involved in this project and state regulatory agency personnel.
Data will be identifiable only by study numbers and client initials. HIV status will not appear along with any personal
identifying information. Personal information used for tracking, including participant name, address, and phone number, will
be stored separately from all research data.To further protect confidentiality, the study will be covered by a federal Certificate
of Confidentiality.
5F Procedures - Benefits, Incentives, and Costs
5F2 Incentives and Other Forms of Compensation
5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
Participants will receive $20 per visit to download adherence data and update their contact information
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
All participants who visit APLA for a study visit to download adherence data will receive $20
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance use
    including alcohol, drugs, and tobacco
B. Physical health     including diagnosis, treatment, or any other private physical health information
C. Mental health
    including diagnosis, treatment, current mental health status (e.g., suicidality), or any other private
mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity
    including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual behavior      
H. Abuse/neglect
    including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     

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5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and emergency
contact lists
B.
Location
and
contacting
information
including any address information smaller than state, telephone or fax numbers, email addresses, web
URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle identifiers
and serial numbers (e.g., license plates), and device identifiers and serial numbers (e.g., serial numbers
on surgical implants)
E.
Audio,
video, or
biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
yes
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
yes
5G4.3
Note: If "Yes", this information must be included in the consent form.
5G4.4
* If "Yes", please provide a detailed explanation of who will be notified, what information will be provided (e.g.,
abnormal test results, reportable diseases), and how.
At the end of their participation in the study, all participants will be presented with their electronically monitored adherence
data and will go over it with the study research assistant.
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes
B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.4
* If "D" on 5G5.1, please describe the exceptions and why they are necessary.
There will be legal exceptions of suicidal ideation or harm to self or others and intent to harm others or child or elder

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abuse/neglect.
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 
  
Intervention
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Full Committee - Approved)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)

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C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5A Procedures - Interventions: Overview
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5A - Procedures - Interventions: Overview
5A1
* Provide a step-by-step description of this procedure for the studied groups of participants. Include both
alterations of their experiences (e.g., novel educational practices, new health services) and administration of any
treatments they might not otherwise receive (e.g., medications, nutritional supplements). Note: you will be asked
below in 5A2 about assignment of participants to different groups (e.g., different data collection or treatment/control groups).
Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4)
followed by two booster sessions (at weeks 12 and 20). If participants show treatment nonadherence during booster
sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if <85% of prescribed doses
were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster
sessions over the next four months. 
One-Month Intensive Intervention Period. Session 1: In the first session, the counselor provides information about the
importance of adherence and consequences of missed doses and appointments, provides education about viral load and
drug resistance, and explains the connection between dosing schedules and viral suppression. To address culturally relevant
factors, the counselor acknowledges health care discrimination and health disparities, and shares reasons for medical
mistrust and HIV misconceptions in Black communities. The counselor encourages the client to share any experiences and
perceptions they may have in this regard. To enhance instrumental (e.g., finding transportation to clinic) and emotional (e.g.,
encouraging/reinforcing adherence) support, the counselor assesses the availability of social supports to the client (e.g.,
whether individuals in clients’ social networks are aware of their HIV status). The counselor explores with the client whether
HIV disclosure is an option for obtaining social support, in the context of reviewing possible benefits as well as risks. The
counselor supplies accurate information to dispel any HIV-related misconceptions. 
Adherence Feedback/Review: Together with the client, the counselor reviews adherence and attendance at scheduled
medical appointments to provide a baseline of adherence levels that will be revisited in future sessions. Adherence will be
measured electronically and continuously using MEMS caps, which record times when the medication bottle is opened. (See
Assessment section for a full description.) MEMS software yields daily medication-taking reports and calculates percentage
of scheduled doses taken. Intervention counselors download MEMS data and generate and print out adherence summary
statistics and graphic depictions of patterns of doses taken and missed since baseline in Session 1 or since the last session
in later sessions.
After the counselor identifies instances of nonadherence using MEMS data, clients identify barriers that may contribute to
missed appointments and doses, such as lack of accurate treatment information (or belief in misconceptions), low motivation,
presence of or concern about side effects, mental health issues or substance use, internalized stigma, medical mistrust
and/or negative experiences with health care (e.g., discrimination). Stages of problem solving are reviewed: defining the
problem, deciding on a goal, generating possible solutions, selecting a potential solution, planning the solution’s
implementation, and evaluating the solution’s effectiveness (at the subsequent session). The counselor identifies contextual
cues that influence adherence (what occurred immediately before and after a missed dose/appointment) to derive strategies
for managing and controlling cues. Clients describe daily routines and together with the counselor determine optimal ways to

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integrate medication into routines. Doses are connected with routine daily activities that can serve as reminder triggers for
taking medications. Strategies for coping with and reducing side effects are discussed. 
The counselor conducts a needs assessment and provides referrals for any unmet basic needs (housing, food,
transportation) and mental health issues (depression, substance use), using pre-screeners for mental health and substance
use (PHQ-2 for depression; NIDA Quick Screen for substance use). Session 1 closes with the development of an Individual
Service Plan (ISP) of short- and long-term goals (e.g., following up on referrals, engaging a friend to support adherence),
which is revisited and updated in each session.
Sessions 2-3: These sessions are similar to Session 1, but with greater targeting of barriers to adherence and retention in
care. Together with the client, the counselor reviews adherence and attendance at scheduled medical appointments since
the last session, and discusses barriers and reasons for missed doses. The counselor assesses whether clients followed up
on referrals, offers new referrals as needed, and evaluates progress toward ISP goals. The counselor assesses the client’s
relationship with his/her HIV care provider in terms of satisfaction with care and trust in provider. With consent from the client,
the counselor contacts the provider via phone or email to inform him/her that the client is participating in Rise and working
with the counselor over the next 6 months to support the adherence and care retention. The client and counselor agree on
any adherence barriers that the counselor can convey to the provider (e.g., about housing status).
Booster Sessions. Booster Sessions 4 & 5: The goal of the booster sessions is to help clients sustain optimal adherence.
Clients who achieve ≥85% adherence (as measured by MEMS) during the 2 weeks preceding Weeks 12 and 20 receive a
session only at those weeks; others receive up to two biweekly added sessions at each time point. For example, if
adherence from Weeks 10-12 is ≥85%, the client receives a session at Week 12, and then returns again at Week 20 for the
next booster session. If the client’s adherence from Weeks 10-12 is <85%, the client receives booster sessions at Weeks 12
and 14, and if adherence from Weeks 12-14 is <85%, then s/he receives another session at Week 16. All clients return at
Week 20, but only clients with adherence <85% during Weeks 18-20 return at Week 22, and those with adherence <85%
during Weeks 20-22 have another session at Week 24. We use 85% adherence as the cutoff for determining good
adherence based on research suggesting that this level of adherence is associated with optimal treatment response and viral
suppression. The dose regulation (of 0-4 extra booster sessions) is intended to promote efficient use of limited community
resources by varying intensity depending on client need. Booster sessions are similar to the initial core sessions, with
continued emphasis on identification and resolution of barriers, use of MI to improve attitudes and motivation related to
adherence, side effect management, monitoring of adherence-related social support and self-efficacy, and medical mistrust. 
Intervention sessions take place at several APLA Health locations. If a client is unable to attend a session at APLA Health,
the intervention counselor can travel to meet the participant in his/her home or a confidential location. In such instances, the
counselor would find a confidential, private space in which the session cannot be overheard by others, in which others are
not in earshot (e.g., in fast food restaurants, coffee shops, parks, people’s homes), and would stop the session if other
people enter the space and are able to overhear anything, consistent with SRG protocols for field interviewing.
In addition, due to the COVID-19 situation, APLA Health staff have been told to work at home. Thus, the intervention
counselor will conduct intervention sessions by phone from home, using a dedicated study cell phone, and in a private space
in which others cannot overhear (the counselor lives alone). We will modify the sessions to be done without the electronic
adherence monitoring component, as that requires an in-person interaction.
5A2 Administered to All Members
5A2.1
* Will any subgroups of the population(s) referenced above receive different interventions? (Check all that apply)
A. Yes - not all participants will receive the same intervention (e.g., physical exams or biologic samples will be
collected/tested from only a subset)
B. Yes - some participants will receive the socio-behavioral or clinical intervention and others will be in the
control group
C. No - all participants will receive the same procedure(s) listed above
5A2.4
* If "B", please describe how individuals will be selected into the intervention/treatment and control groups (e.g.,
random assignment of individuals/groups or quasi-experimental designs comparing existing groups). If already
described above in 5A1, please indicate that below.
A blocked 1:1 randomization design with stratification by viral suppression (with randomly alternating blocks of 2, 4, and 6 to
prevent anticipation of condition) will help to ensure balance across arms. The statistician will use a random numbers
generator to devise a randomization log and a set of numbered randomization envelopes. In the log, treatment assignment
specifications will be left blank to prevent condition foreknowledge. After the project director records each ID in the log
(immediately after the baseline survey, using results from pre-baseline confirmation of viral load via medical records for
stratification), s/he will open the corresponding randomization envelope.
5A3
* Describe the qualifications and/or training for those who will conduct the intervention.
Counselors are trained peers with similar backgrounds and experiences as clients, with in-depth knowledge of local
communities and the experience of living with HIV; thus, they are seen as credible sources to address mistrust. Counselors
use an motivational interviewing (MI) style. MI is used to change behaviors and attitudes that are barriers to adherence and
care retention, and to develop positive attitudes and beliefs about treatment efficacy, expected treatment outcomes, and
adherence self-efficacy; counselors help clients to develop problem-solving skills to identify key barriers, and to implement
and evaluate strategies to overcome barriers. MI maximizes feelings of autonomy and increases the likelihood that strategies
will be adopted. Counselors are trained to ask open questions, use reflective listening, and motivate change by highlighting

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discrepancies between behavior or thoughts and stated health goals, as well as respecting client autonomy. 
Counselor training and ongoing supervision will ensure consistency in intervention implementation and protocol fidelity. The
training (conducted by Co-Is Goggin and Wagner) includes instruction on basic HIV disease, the importance of protecting
confidentiality and complying with HIPAA regulations, crisis intervention, referral resources, issues that can influence ART
adherence and retention in care among Black clients, and mental health and substance abuse assessment. The counselor is
trained to establish rapport and effective working relationships with clients and medical providers, and to locate community
resources, referrals, and linkages. The counselor is provided with and encouraged to further develop a comprehensive
referral list to HIV-related and supportive services (e.g., housing, mental health). All counseling sessions are recorded with
consent from the client. The supervisor listens to all sessions of the first two clients receiving the intervention, and then all
recorded sessions of every fifth participant. This serves as the basis for provision of feedback to the counselor during
biweekly supervision. Supervision also provides a time for the counselor to discuss challenging cases and review treatment
plans for newly enrolled participants. Co-I Goggin will work with Co-I Wagner to develop a detailed supervision protocol.
Wagner will supervise the counselor for the first six months while training the MA-level Project Director (who will have a
counseling or social work degree) to conduct supervision for the remaining sessions. Wagner and the Project Director will
complete a rating form after reviewing session transcripts for fidelity, for use in supervision. Goggin may listen to recordings
of initial participants to assist with the trainings and provide feedback. (She will receive recordings through a secure
SharePoint site, as noted in the DSP.)
5A4 Interim Outcome Monitoring
5A4.1
* Will interim outcomes be monitored in any way? For example, some intervention studies may have or be required
to have a Data and Safety Monitoring Plan (DSMP) to assess that the intervention is not harmful and/or is having a
positive effect.
yes
5A4.2
* If "Yes", explain what will be monitored, when, how, and why.
Given the low risk of the experimental intervention, we believe that a multiple-person data safety monitoring board (DSMB) is
an unnecessarily intensive approach to monitoring this trial. We propose here an alternative, less intensive approach which we
believe will effectively ensure the welfare of study subjects and the continued scientific validity of the study. Specifically, we
propose that a single, independent, behavioral HIV researcher to serve as an independent monitor for the study. The monitor
will be an expert in the treatment of substance use among people living with HIV who does not have a conflict of interest with
anyone on the study team, i.e., who does not have a prior (within 3 years) collaborative or financial relationship with any of the
study investigators and who is not employed currently or within 3 years in any of the primary study institutions.
To allow effective monitoring, the independent monitor will be provided with periodic reports which include subject enrollment,
subject retention, the number of patients who drop out of the study with reasons for dropping out, and a listing of all adverse
events (AEs) that are plausibly related to study procedures. Reports will be provided to the independent monitor at 6-month
intervals. After review of the periodic reports, the independent monitor may ask for clarification or additional information from
the principal investigator (PI). After such information is provided, if requested, the independent monitor will make a
recommendation regarding the continuation, modification, or termination of the study. All communications from the
independent monitor will be shared with the study institutional review boards (IRBs), as well as NIH. By utilizing a single
independent monitor rather than a multi-person DSMB, we believe the oversight of the study will be easier to implement, more
efficient, and more responsive to issues as they arise.
5A4.3
* Does your funder or the RAND HSPC require a Data and Safety Monitoring Plan (DSMP) for your study? The RAND
HSPC will make its determination during the review process.
Yes - by the funder and/or the HSPC
No (including not yet determined by the HSPC)
5A4.4
* Do you have the DSMP for this study ready to upload in draft or final form?
yes
5A4.5
You will be asked to upload the DSMP in section 7. A DSMP is typically done at the study level and you will be able to upload
a single DSMP in section 7 and associate it with as many components as necessary. This is done to ensure that all
components that should be covered are addressed in the DSMP.
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)

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D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk
5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 
A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F. No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically
encountered in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals,
incarcerated individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy
individuals" would face. The comparison is what the actual subject population would face in comparison to miminal risk as
defined by everyday life for healthy individuals in the United States. If a breach of confidentiality or participation would
be dangerous in the study population, it is above minimal risk.
5E4 Legal Risks Associated with a Breach of Confidentiality
5E4.1
* Might the degree or amount of legal harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E4.2
* Might the likelihood of legal harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily  life by individuals in the general U.S. population?
no
5E4.3
* Please explain the nature of the legal harm, what might cause it, and steps that would be taken to mitigate it.
Participants will be discussing barriers to adherence with the intervention counselor, which could include illegal substance
use.To protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will
be available only to research staff directly involved in this project and state regulatory agency personnel. Data will be
identifiable only by study numbers and client initials. HIV status will not appear along with any personal identifying
information. Personal information used for tracking, including participant name, address, and phone number, will be stored
separately from all research data. To further protect confidentiality, the study will be covered by a federal Certificate of
Confidentiality. 
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available
only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by
study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data. To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality.

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5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm if their HIV-positive serostatus became known to others, potentially
leading to HIV stigma and discrimination. To protect confidentiality, the following steps will be taken: All research data will be
kept in locked file cabinets and will be available only to research staff directly involved in this project and state regulatory
agency personnel. Data will be identifiable only by study numbers and client initials. HIV status will not appear along with
any personal identifying information. Personal information used for tracking, including participant name, address, and phone
number, will be stored separately from all research data. To further protect confidentiality, the study will be covered by a
federal Certificate of Confidentiality.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience social harm if their HIV-positive serostatus became known to others, due to HIV stigma. To
protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be
available only to research staff directly involved in this project and state regulatory agency personnel. Data will be
identifiable only by study numbers and client initials. HIV status will not appear along with any personal identifying
information. Personal information used for tracking, including participant name, address, and phone number, will be stored
separately from all research data. To further protect confidentiality, the study will be covered by a federal Certificate of
Confidentiality.
5E11 Psychological Risks Resulting from Participation
5E11.1
* Might the degree or amount of psychological harm resulting from participation in the procedure itself (i.e., other
than from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the
general U.S. population?
no
5E11.2
* Might the likelihood of psychological harm resulting from participation in the procedure itself (i.e., other than
from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the general
U.S. population?
no
5E11.3
* Please explain the nature of the psychological harm, what might cause it, and steps that would be taken to
mitigate it.
Participants may experience psychological distress while talking about issues raised during individual sessions.
Participating in the intervention could also lead to self-awareness about the limitations of one’s knowledge of HIV and/or
techniques related to HIV treatment care. There is also a possibility that participants who have not disclosed their HIV status
to individuals in their social network will do so (due to prompting from the counselor); depending on how the individual they
disclose to responds, it could either increase or decrease the participant’s psychological distress. If participants express a
great deal of psychological distress during the sessions, the intervention facilitator will provide appropriate referrals to local
mental health resources, including information about APLA’s mental health program, and answer any questions the
participant may have about these services.
5F Procedures - Benefits, Incentives, and Costs
5F2 Incentives and Other Forms of Compensation

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5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
$10 to compensate for transportation costs
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
Participants will get the incentive if they show up to an intervention session. The incentive will be distributed at the end of the
session.
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance
use
    including alcohol, drugs, and tobacco
B. Physical
health
    including diagnosis, treatment, or any other private physical health information
C. Mental health     including diagnosis, treatment, current mental health status (e.g., suicidality), or any other
private mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity     including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual
behavior
     
H. Abuse/neglect     including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G1.2
* If "Other", please explain.
electronically monitored HIV medication adherence data will be downloaded at each session. Participants may also bring
medical records information (e.g., viral load values) to go over with the intervention counselor.
5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location
and
contacting
information
including any address information smaller than state, telephone or fax numbers, email
addresses, web URLs, and IP addresses

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C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle identifiers
and serial numbers (e.g., license plates), and device identifiers and serial numbers (e.g., serial numbers
on surgical implants)
E.
Audio,
video, or
biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
yes
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
yes
5G4.3
Note: If "Yes", this information must be included in the consent form.
5G4.4
* If "Yes", please provide a detailed explanation of who will be notified, what information will be provided (e.g.,
abnormal test results, reportable diseases), and how.
Participants will be presented with their electronically monitored adherence data since the last session and will go over it with
the counselor. Counselors will also review with participants their medical information (e.g., viral load) and explain how to read
it. We will not notify participants' healthcare providers, since their healthcare providers will be already be aware if their viral
load is not suppressed. However, as part of the intervention,
with consent from the client, the counselor will contact the provider via phone or email to inform him/her that the client is
participating in Rise and working with the counselor over the next 6 months to support the adherence and care retention. The
client and counselor agree on any adherence barriers that the counselor can convey to the provider (e.g., about housing
status).
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes
B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.4
* If "D" on 5G5.1, please describe the exceptions and why they are necessary.
There will be legal exceptions of suicidal ideation or harm to self or others and intent to harm others or child or elder
abuse/neglect.
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes

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No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 
  
Medical Records Assessment
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Full Committee - Approved)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)

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C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs, demonstration
projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C2 Secondary Data Follow-Up Questions
We will ask a few secondary data questions at this point to determine whether some of the population and procedure questions on the
later screens can be skipped.
3C2.1
* Will the secondary data received by this RAND project (including RAND subcontractors) include any of the
following types of identifiers? (Check all that apply) Note:  You may have answered this question on screens 2B or 2C if
you applied for an exemption for one or more population-procedure components of your study. However, your information is
not carried over automatically because your prior answer was not at the procedure level and this may differ. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location and
contacting
information
including any address information smaller than state, telephone or fax numbers, email
addresses, web URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers,
account numbers, student ID numbers, certificate or license numbers (e.g., driver's license),
vehicle identifiers and serial numbers (e.g., license plates), and device identifiers and serial
numbers (e.g., serial numbers on surgical implants)
E.
Audio, video,
or biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
3C2.6
* Who will be able to identify a participant in the dataset? (Check all that apply) 
A. Research team members (whether or not they are RAND associates)
B. Person or organization providing the data (i.e., data provider)
C. Subcontractors, vendors, or other service providers hired by RAND (other than the data provider)
D. Anyone else who is not on the research team
3C2.7
* Is there a written agreement involved in obtaining the data (e.g. data use agreement, web based agreement, other
conditions on use)?
Yes
No
Don't know

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3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5D Procedures - Secondary Data
5E Procedures - Risks
5G Procedures - Confidentiality
5D Procedures - Secondary Data
5D1
* Which previously collected person-level information (e.g., medical records, census data, employment records,
education records, other existing datasets) will you acquire? If unsure, please list what you are considering.
Participants will provide consent for paper and electronic medical record data extraction from their usual HIV clinic. During
screening, we will obtain permission to extract the two most recent viral loads from medical records, for use in stratification
by viral suppression for the randomization process. After the 12-month follow-up, we will extract past 2-year viral load, CD4
counts, ART prescriptions, clinic visits, and associated dates. We have successfully used multiple methods to obtain such
data from multiple different clinics across Los Angeles County (e.g., confidential faxes, multiple calls, in-person clinic visits,
asking participants to bring lab print-outs to study visits) in prior studies. 
At study enrollment and 6- and 12-months post-enrollment (and post-intervention start), a member of the study team (trained
in phlebotomy) will draw participants’ blood for viral load assessment at the APLA Health and Wellness clinic. Alternately,
participants can go directly to a Quest lab (where Rise blood samples are sent for processing) to have their blood drawn for
the study. Viral load suppression will be defined as <200 copies of virus per milliliter of blood plasma.
If participants wish to go to a Quest lab, we will offer ride assistance, specifically, the Circulation program (e.g., to transport
clients from APLA Health & Wellness in Koreatown and Long Beach to Quest Diagnostics blood draw sites). For example,
APLA Health in Koreatown is at 611 S. Kingsley Drive, Los Angeles, CA 90005, a half mile away from the closest Quest draw
site at 500 S Virgil Ave Suite 202, Los Angeles, CA 90010. Prior to the appointment, APLA project staff will book a ride
through the Circulation portal. The client will meet the APLA staff person at APLA Health’s location. The Circulation ride will
take the staff person and participant to the Quest draw site, and then back to APLA Health, where the remainder of the
session will be completed.
At study enrollment and 6- and 12-months post-enrollment (and post-intervention start), a member of the study team (trained
in phlebotomy) will draw participants’ blood for viral load assessment at the APLA Health and Wellness clinic. Alternately,
participants can go directly to a Qwest lab (where Rise blood samples are sent for processing) to have their blood drawn for
the study. Viral load suppression will be defined as <200 copies of virus per milliliter of blood plasma.
If participants wish to go to a Quest lab, we will offer ride assistance, specifically, the Circulation program (e.g., to transport
clients from APLA Health & Wellness in Koreatown and Long Beach to Quest Diagnostics blood draw sites). For example,
APLA Health in Koreatown is at 611 S. Kingsley Drive, Los Angeles, CA 90005, a half mile away from the closest Quest draw
site at 500 S Virgil Ave Suite 202, Los Angeles, CA 90010. Prior to the appointment, APLA project staff will book a ride
through the Circulation portal. The client will meet the APLA staff person at APLA Health’s location. The Circulation ride will
take the staff person and participant to the Quest draw site, and then back to APLA Health, where the remainder of the
session will be completed.
In the event that participants do not want to get their blood drawn and see APLA Health staff in person due to COVID-19,
they will be asked to send photos or screenshots of their most recent HIV viral load lab results to the study team cell phone
using WhatsApp, which has end-to-end encryption. Study staff will tell participants to delete the photo from their phone
immediately after they send it. APLA staff will transcribe the results from these photos to the medical records data collection
spreadsheet (that has ID#s and not participant names), and will securely transmit the data to RAND via Kiteworks. Once the
data has been securely transmitted, study staff will delete the photo from the study cell phone.
5D2 Private Health Information
5D2.1
* Will private health information (e.g., medical records, health-related administrative data, health insurance claims,
pharmaceutical data) be acquired?
Yes
No
Don't know
5D2.2
* If "Yes", from whom will the private health information be acquired?
A. Participant
(including participant's parent/guardian)
B. Medical care
provider/insurer
(e.g., a doctor or other health care provider, hospital, insurance company, managed care
company, other covered entity under HIPAA)
C. Other
 

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5D2.3
* If "Other", please describe from which other individuals will the private health information be acquired.
Both A and B - Participant and Medical care provider. Participants will be asked for permission to contact their medical provider
to obtain medical records data; they will also be told that they can bring in the data if they obtain it themselves. Participants will
receive $50 for bringing their HIPAA form to their provider to obtain the data on their own, and then returning their data to the
study team.
5D4 Merging Data
5D4.1
* Do you plan to merge and retain person-level secondary data with person-level data from other sources (e.g.,
other existing records, datasets, interview data from this study)? Note: Do not consider data that will be used only to
contact participants and will not be retained in the study data
yes
5D4.2
* If "Yes", what other information will be merged with the person-level data? Note: This doesn't include data that will
not be retained in the data file, such as name or telephone number.
Surveys, viral load assessments, and electronically monitored adherence data
5D5 Destroying Data Identifiers/Link File
5D5.1
* Will the data identifiers or link file maintained by the project ever be destroyed?
Yes
No
Don't know
5D5.2
* If "Yes", when do you estimate that the data identifers or link files will be destroyed? (mm/dd/yyyy)
3/31/2023
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically encountered
in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals, incarcerated
individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy individuals" would
face. The comparison is what the actual subject population would face in comparison to miminal risk as defined by everyday
life for healthy individuals in the United States. If a breach of confidentiality or participation would be dangerous in the
study population, it is above minimal risk.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect

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confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available only
to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by study
numbers and client initials. HIV status will not appear along with any personal identifying information. Personal information
used for tracking, including participant name, address, and phone number, will be stored separately from all research data.To
further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff will
tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results from
these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will securely
transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the photo from
the study cell phone.
5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm from HIV stigma if their HIV-positive serostatus became known to others.
To protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be
available only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable
only by study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data. To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available only
to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by study
numbers and client initials. HIV status will not appear along with any personal identifying information. Personal information
used for tracking, including participant name, address, and phone number, will be stored separately from all research data.To
further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff will
tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results from
these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will securely
transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the photo from
the study cell phone.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience social harm from HIV stigma if their HIV-positive serostatus became known to others. To
protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be
available only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable
only by study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data. To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available only
to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by study
numbers and client initials. HIV status will not appear along with any personal identifying information. Personal information
used for tracking, including participant name, address, and phone number, will be stored separately from all research data.To

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further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff will
tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results from
these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will securely
transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the photo from
the study cell phone.
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance use
    including alcohol, drugs, and tobacco
B. Physical health     including diagnosis, treatment, or any other private physical health information
C. Mental health
    including diagnosis, treatment, current mental health status (e.g., suicidality), or any other private
mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity
    including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual behavior      
H. Abuse/neglect
    including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
no
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes

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B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 
  
Recruitment Discussion Groups
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Does not involve human subjects)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)
C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)

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F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5C Procedures - Interactions
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5C Procedures - Interactions with Participants
5C1 Research Team Interaction with Participants
Note: Do not repeat details of interactions that apply only to recruitment procedures. Those details are addressed for the related
populations in 4A5.
5C1.1
* How will the research team be interacting with the participants for the purposes of data collection? (Check all that
apply)
A.
In person
B.
By phone
D.
Over the web (e.g., email, chat, blog)
5C1.3
* Will the research team be audio or video recording the interaction procedure?
no
5C2
* Provide a step-by-step description of this procedure.  Note: Details regarding whether the interaction procedure will be
repeated are covered in 5C4.
Section 3 – Discussion Groups
In order to introduce community members to the Project Rise study and boost recruitment numbers, we would like to host
community discussion groups. Community discussion groups are useful for introducing community members to programs
and initiatives. As such, we believe a discussion group would be helpful for us to discuss treatment adherence with clients,
introduce Project Rise, and increase our client pool. Such an approach was used on a prior RAND study to increase
recruitment for a similar population [Kanouse, D. E., Bluthenthal, R. N., Bogart, L. M., Iguchi, M. Y., Perry, S., Sand, K., &
Shoptaw, S. (2005). Recruiting drug-using men who have sex with men into behavioral interventions: A two-stage approach.
Journal of Urban Health, 82(1), i109-i119.].
Recruiting for the discussion groups will be separate from recruiting for the Project Rise study. We will utilize a simplified
screener. To be eligible for participation, one must be 18 years or older, be living with HIV, be prescribed medications for at
least 6 months, have self-described adherence issues, and identify as Black/African American. Interested participants will
call members of our study team to screen for eligibility. 
These discussion groups will not be considered research; we do not intend to publish any information gleaned from the
discussion groups. The purpose of the discussion groups is to increase awareness about the study, knowledge of issues
related to the study, and boost recruitment for Project Rise.
After screening and being invited to participate in the group discussion, members of the study team will notify eligible
participants of a date for the group. Those who are available will be scheduled to attend. 
The group will incorporate a series of questions and probes, moderated by Project Rise study team. The questions will focus
on experiences with taking HIV medications and treatment, their views on treatment adherence, and the kinds of programs
and services they believe would help them improve and stay adherent to their regimens. The discussion group will last about
an hour and a half. The groups will also be used to introduce participants to Project Rise, and participants will be invited to
register for the program at the conclusion of the session. Participants will be given incentives of $40 in gift cards and

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provided with refreshments during the group.
All screening information will be tracked using paper forms. All screeners will be kept in locked drawers at APLA Health’s
location in Baldwin Hills that can only be accessed by the study team. No screening information is shared with anyone
outside the study team. A list of attendees of each discussion group will be kept electronically, and stored in a secure folder
and computer at APLA Health. Information on these rosters will be limited to name, phone number and email if available.
These rosters will not be shared with any individuals outside the study team, and any paper copies printed will be shredded
at the conclusion of each focus group discussion. Clients who decide to screen for the study will be treated like any other
clients as per our approved IRB protocol.
5C3 Participant Questions
5C3.1
* Do you have the questions you will be asking participants (e.g., the interview protocol, survey instrument, focus
group guide) in draft or final form or a list of domains to be covered?
yes
5C3.2
If "Yes" and you did not upload the questions in Section 2, you will be asked to upload them in Section 7.
5C4 Repetition of the Interaction Procedure
5C4.1
* Will this interaction procedure be repeated with the same participants?  Note: If the repetition is described in another
procedure, indicate that below.
A.
Yes - described below in 5C4.2
B.
Yes - is or will be described in another procedure
C.
No
D.
Possibly
5C5 Previously Developed and Validated Surveys, Tests, or Assessments
5C5.1
* WIll previously developed and validated surveys, tests, or assessments be administered as part of this interaction
procedure?
Yes
No
Don't know
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk
5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 
A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F.
No anticipated risk

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5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically encountered
in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals, incarcerated
individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy individuals" would
face. The comparison is what the actual subject population would face in comparison to miminal risk as defined by everyday
life for healthy individuals in the United States. If a breach of confidentiality or participation would be dangerous in the
study population, it is above minimal risk.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
no
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Section 3 – Discussion Groups
In order to introduce community members to the Project Rise study and boost recruitment numbers, we would like to host
community discussion groups. Community discussion groups are useful for introducing community members to programs
and initiatives. As such, we believe a discussion group would be helpful for us to discuss treatment adherence with clients,
introduce Project Rise, and increase our client pool. Such an approach was used on a prior RAND study to increase
recruitment for a similar population [Kanouse, D. E., Bluthenthal, R. N., Bogart, L. M., Iguchi, M. Y., Perry, S., Sand, K., &
Shoptaw, S. (2005). Recruiting drug-using men who have sex with men into behavioral interventions: A two-stage approach.
Journal of Urban Health, 82(1), i109-i119.].
Recruiting for the discussion groups will be separate from recruiting for the Project Rise study. We will utilize a simplified
screener. To be eligible for participation, one must be 18 years or older, be living with HIV, be prescribed medications for at
least 6 months, have self-described adherence issues, and identify as Black/African American. Interested participants will call
members of our study team to screen for eligibility. 
These discussion groups will not be considered research; we do not intend to publish any information gleaned from the
discussion groups. The purpose of the discussion groups is to increase awareness about the study, knowledge of issues
related to the study, and boost recruitment for Project Rise.
After screening and being invited to participate in the group discussion, members of the study team will notify eligible
participants of a date for the group. Those who are available will be scheduled to attend. 
The group will incorporate a series of questions and probes, moderated by Project Rise study team. The questions will focus
on experiences with taking HIV medications and treatment, their views on treatment adherence, and the kinds of programs
and services they believe would help them improve and stay adherent to their regimens. The discussion group will last about
an hour and a half. The groups will also be used to introduce participants to Project Rise, and participants will be invited to
register for the program at the conclusion of the session. Participants will be given incentives of $40 in gift cards and
provided with refreshments during the group.
All screening information will be tracked using paper forms. All screeners will be kept in locked drawers at APLA Health’s
location in Baldwin Hills that can only be accessed by the study team. No screening information is shared with anyone
outside the study team. A list of attendees of each discussion group will be kept electronically, and stored in a secure folder
and computer at APLA Health. Information on these rosters will be limited to name, phone number and email if available.
These rosters will not be shared with any individuals outside the study team, and any paper copies printed will be shredded
at the conclusion of each focus group discussion. Clients who decide to screen for the study will be treated like any other
clients as per our approved IRB protocol.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Section 3 – Discussion Groups
In order to introduce community members to the Project Rise study and boost recruitment numbers, we would like to host
community discussion groups. Community discussion groups are useful for introducing community members to programs

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and initiatives. As such, we believe a discussion group would be helpful for us to discuss treatment adherence with clients,
introduce Project Rise, and increase our client pool. Such an approach was used on a prior RAND study to increase
recruitment for a similar population [Kanouse, D. E., Bluthenthal, R. N., Bogart, L. M., Iguchi, M. Y., Perry, S., Sand, K., &
Shoptaw, S. (2005). Recruiting drug-using men who have sex with men into behavioral interventions: A two-stage approach.
Journal of Urban Health, 82(1), i109-i119.].
Recruiting for the discussion groups will be separate from recruiting for the Project Rise study. We will utilize a simplified
screener. To be eligible for participation, one must be 18 years or older, be living with HIV, be prescribed medications for at
least 6 months, have self-described adherence issues, and identify as Black/African American. Interested participants will call
members of our study team to screen for eligibility. 
These discussion groups will not be considered research; we do not intend to publish any information gleaned from the
discussion groups. The purpose of the discussion groups is to increase awareness about the study, knowledge of issues
related to the study, and boost recruitment for Project Rise.
After screening and being invited to participate in the group discussion, members of the study team will notify eligible
participants of a date for the group. Those who are available will be scheduled to attend. 
The group will incorporate a series of questions and probes, moderated by Project Rise study team. The questions will focus
on experiences with taking HIV medications and treatment, their views on treatment adherence, and the kinds of programs
and services they believe would help them improve and stay adherent to their regimens. The discussion group will last about
an hour and a half. The groups will also be used to introduce participants to Project Rise, and participants will be invited to
register for the program at the conclusion of the session. Participants will be given incentives of $40 in gift cards and
provided with refreshments during the group.
All screening information will be tracked using paper forms. All screeners will be kept in locked drawers at APLA Health’s
location in Baldwin Hills that can only be accessed by the study team. No screening information is shared with anyone
outside the study team. A list of attendees of each discussion group will be kept electronically, and stored in a secure folder
and computer at APLA Health. Information on these rosters will be limited to name, phone number and email if available.
These rosters will not be shared with any individuals outside the study team, and any paper copies printed will be shredded
at the conclusion of each focus group discussion. Clients who decide to screen for the study will be treated like any other
clients as per our approved IRB protocol.
5F Procedures - Benefits, Incentives, and Costs
5F2 Incentives and Other Forms of Compensation
5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
$40 in gift cards and refreshments
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
They will receive incentives after they participate in the discussion session
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance use
    including alcohol, drugs, and tobacco
B. Physical health     including diagnosis, treatment, or any other private physical health information
C. Mental health
    including diagnosis, treatment, current mental health status (e.g., suicidality), or any other private
mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity
    including illicit drug use, human trafficking, and terrorism

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F. Immigration
status
     
G. Sexual behavior      
H. Abuse/neglect
    including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location
and
contacting
information
including any address information smaller than state, telephone or fax numbers, email
addresses, web URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle identifiers
and serial numbers (e.g., license plates), and device identifiers and serial numbers (e.g., serial numbers
on surgical implants)
E.
Audio,
video, or
biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
no
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes

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B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 
  
Surveys
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Full Committee - Approved)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)
C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)

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G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5C Procedures - Interactions
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5C Procedures - Interactions with Participants
5C1 Research Team Interaction with Participants
Note: Do not repeat details of interactions that apply only to recruitment procedures. Those details are addressed for the related
populations in 4A5.
5C1.1
* How will the research team be interacting with the participants for the purposes of data collection? (Check all that
apply)
A.
In person
B.
By phone
C.
Via mail
D.
Over the web (e.g., email, chat, blog)
5C1.3
* Will the research team be audio or video recording the interaction procedure?
no
5C2
* Provide a step-by-step description of this procedure.  Note: Details regarding whether the interaction procedure will be
repeated are covered in 5C4.
At the pre-enrollment visit, and at 6-and 12-month post-intervention start (7 and 13 months after the first study visit),
participants will complete surveys using the Questionnaire Development System for audio computer-assisted self-interviews.
Surveys will be completed in a private space on a computer at APLA project offices, and a study interviewer will be available
to answer questions or administer the survey as needed for those of lower literacy. 
Interviews may also be conducted by phone on a dedicated study cellphone, from a private location (interviewers' homes) in
which the interviewer cannot be heard by others. This last option has been added because APLA Health staff have been told
to work at home during the COVID-19 situation. In this case, interviewers will upload all study data (from QDS, the ACASI
program) from their study laptop onto the secure Kiteworks data sharing site; study staff at RAND will download the data as
soon as it is received and tell APLA staff, so that it can be deleted from the study laptop. In addition, consent for the baseline
interview would be done by phone (verbally) for baseline phone interviews, and then written informed consent will be
obtained when the client next is seen in person (after the COVID-19 situation is resolved).
In some cases, we may also conduct study visits off-site, if a participant is screened as eligible and unable or unwilling to
travel to the study locations. We would find a confidential, private space in which the interview cannot be overheard by
others, in which others are not in earshot (e.g., in fast food restaurants, coffee shops, parks, people’s homes), and would
stop the interview if other people enter the space and are able to overhear the interview; the team will be trained on SRG's
protocols for field interviewing.
Interviewers will also interact with participants by phone, mail, and over the internet to set up appointments and to remind
participants about appointments. Interviewers will also use text to remind participants about appointments. Specifically, we

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will text reminders to participants using the dedicated study cell phone. Only the Project Rise staff team would have access
to the cell phone.
5C3 Participant Questions
5C3.1
* Do you have the questions you will be asking participants (e.g., the interview protocol, survey instrument, focus
group guide) in draft or final form or a list of domains to be covered?
yes
5C3.2
If "Yes" and you did not upload the questions in Section 2, you will be asked to upload them in Section 7.
5C4 Repetition of the Interaction Procedure
5C4.1
* Will this interaction procedure be repeated with the same participants?  Note: If the repetition is described in another
procedure, indicate that below.
A.
Yes - described below in 5C4.2
B.
Yes - is or will be described in another procedure
C.
No
D.
Possibly
5C4.2
* If "A" or "D", indicate how often this interaction procedure will occur and at what intervals.  Note: If you already
provided this detail in 5C2, please indicate that below.
Please see 5C2 above.
5C5 Previously Developed and Validated Surveys, Tests, or Assessments
5C5.1
* WIll previously developed and validated surveys, tests, or assessments be administered as part of this interaction
procedure?
Yes
No
Don't know
5C5.2
* If "Yes," please list the previously developed and validated surveys, tests, or assessments to be administered,
noting what each measures. Please indicate whether the standardized test or assessment has been altered.
Secondary Outcomes/Potential Mediators will be collected in surveys at baseline and at 6- and 12-month follow-up. The
LifeWindows IMB ART Adherence Questionnaire (LW-IMB-AAQ) includes measures of Adherence-related Information
(perceived knowledge and misinformation; alpha = .70); Adherence Motivation (negative consequences of medications,
alpha = .74; negative beliefs about medication taking, alpha  = .76); and Behavioral Adherence Skills (alpha  = .88).
Internalized Racism will be assessed with the Cross Racial Identity Scale-Self-Hatred subscale (alpha  =.89). We will also
include the Internalized-Homophobia Scale-Revised (  alpha =.88). We will use an Internalized Stigma subscale validated for
HIV-positive adults by Co-Investigator Cunningham (alpha  =.91). We will also adapt the Chronic illness Anticipated Stigma
Scale (alpha  =.95) for people living with HIV. Medical Mistrust will be measured with validated subscales (racism alpha  =
.76; mistrust alpha  = .74),39 as well as our HIV Conspiracy Beliefs Scale (alpha  = .85). Participants will rate the perceived
severity of 20 Side Effects associated with ART (alpha  = .89). Mental health will be assessed with the PHQ-9, a valid
screening tool for Depression. We will use the Risk Behavior Survey to assess substance use in the past 30 days. Problematic
drinking will be measured with the RAPS4-QF. Unmet Needs (financial/benefits, housing, mental health, food, transportation,
substance abuse) will be assessed with HCSUS items.
Potential Covariates will be assessed at baseline, and 6-and 12-months post-baseline. We will assess potential covariates that
have previously been related to HIV outcomes. Socio-demographics include race/ethnicity, gender, education level, age,
income, employment status, housing status, marital/relationship status, sexual orientation, and incarceration history. Spirituality
and Religiosity will be assessed with items from HCSUS. We will use the 6-item Social Support Questionnaire, Revised (alpha
=.94). To assess Trauma History, participants will indicate lifetime traumatic experiences on a checklist of 9 traumas from the
Posttraumatic Stress Diagnostic Scale. We will assess Usual Care by asking participants to complete a checklist of Standard
Clinic Practices for Adherence (e.g., pill boxes). To assess Exposure to Other Adherence Programs, we will ask participants
whether they received adherence counseling through medical case management (a Ryan White Care Act program) and extent
of exposure (number of sessions, information covered). They will complete a checklist of other Social Services Resources
accessed at APLA or elsewhere. 
We will assess self-reported adherence using items validated against viral load and pill counts: number of doses missed last
week; percentage of prescribed medications taken last month (on a visual analogue scale), and ability to take all medications
as prescribed in the past 4 weeks.
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in

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this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk
5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 
A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F. No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically
encountered in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals,
incarcerated individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy
individuals" would face. The comparison is what the actual subject population would face in comparison to miminal risk as
defined by everyday life for healthy individuals in the United States. If a breach of confidentiality or participation would
be dangerous in the study population, it is above minimal risk.
5E4 Legal Risks Associated with a Breach of Confidentiality
5E4.1
* Might the degree or amount of legal harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E4.2
* Might the likelihood of legal harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily  life by individuals in the general U.S. population?
no
5E4.3
* Please explain the nature of the legal harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience legal harm if their illegal behaviors related to substance use become known to others. To
protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be
available only to research staff directly involved in this project and state regulatory agency personnel. Data will be
identifiable only by study numbers and client initials. HIV status will not appear along with any personal identifying
information. Personal information used for tracking, including participant name, address, and phone number, will be stored
separately from all research data. To further protect confidentiality, the study will be covered by a federal Certificate of
Confidentiality.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience financial harm if their HIV-positive serostatus became known to others, potentially leading to
employment discrimination. To protect confidentiality, the following steps will be taken: All research data will be kept in

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locked file cabinets and will be available only to research staff directly involved in this project and state regulatory agency
personnel. Data will be identifiable only by study numbers and client initials. HIV status will not appear along with any
personal identifying information. Personal information used for tracking, including participant name, address, and phone
number, will be stored separately from all research data. To further protect confidentiality, the study will be covered by a
federal Certificate of Confidentiality.
5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm if their HIV-positive serostatus became known to others, potentially
leading to HIV stigma and discrimination. To protect confidentiality, the following steps will be taken: All research data will be
kept in locked file cabinets and will be available only to research staff directly involved in this project and state regulatory
agency personnel. Data will be identifiable only by study numbers and client initials. HIV status will not appear along with
any personal identifying information. Personal information used for tracking, including participant name, address, and phone
number, will be stored separately from all research data. To further protect confidentiality, the study will be covered by a
federal Certificate of Confidentiality.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience social harm if their HIV-positive serostatus became known to others, potentially leading to HIV
stigma and discrimination. To protect confidentiality, the following steps will be taken: All research data will be kept in locked
file cabinets and will be available only to research staff directly involved in this project and state regulatory agency
personnel. Data will be identifiable only by study numbers and client initials. HIV status will not appear along with any
personal identifying information. Personal information used for tracking, including participant name, address, and phone
number, will be stored separately from all research data. To further protect confidentiality, the study will be covered by a
federal Certificate of Confidentiality.
5E11 Psychological Risks Resulting from Participation
5E11.1
* Might the degree or amount of psychological harm resulting from participation in the procedure itself (i.e., other
than from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the
general U.S. population?
yes
5E11.2
* Might the likelihood of psychological harm resulting from participation in the procedure itself (i.e., other than
from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the general
U.S. population?
no
5E11.3
* Please explain the nature of the psychological harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm and distress from responding to questions about their serostatus, as well
as mental health and trauma. If participants express a great deal of psychological distress during the sessions, the
interviewer will provide appropriate referrals to local mental health resources, including information about APLA’s mental
health program, and answer any questions the participant may have about these services.
5F Procedures - Benefits, Incentives, and Costs

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5F2 Incentives and Other Forms of Compensation
5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
Assessments: Participants will receive $30 for the baseline survey (i.e., pre-enrollment, which will also include screening,
consent, and starting on MEMS), and $40 at 6-months, and $50 at 12-months for the follow-ups (which will also include
venipuncture for viral load assessment and downloading of MEMS data). 
Incentivized Recruitment: We will also offer incentives for participants in the study to recruit others in their social networks. All
participants who have registered for Project Rise will be able to receive recruitment incentives, including those who are already
participating in the program. Participants will be given study palm cards and materials to distribute to communities and
individuals they know. When interested clients call to screen, they will be asked how they heard about the program. If the
interested client provides the name of a specific individual, study staff will make a note in the electronic participant database.
Study staff will notify the participant that someone they referred to Project Rise screened for the study, but they will not be
provided the specific name of who it was. For each person screened (up to 3 people) and referred, the referring participant will
receive $10, for a maximum of $30. To ensure confidentiality, participants will not be told the names of the specific clients who
screened. Screening history and participation data will not be shared outside of the study team. All electronic screening
information is kept in a secure spreadsheet in a folder only accessible to study team staff, and on password-protected
computers and accounts. Paper screeners are kept in locked drawers at APLA Health’s office in Baldwin Hills, and not shared
with people outside the study team. 
Circulation Ride Assistance: Transportation historically has been an issue for many individuals in Los Angeles County to attend
appointments for medical and social service appointments. Some companies have begun using rideshare and assistance
programs to help cover this. APLA Health currently utilizes a program called Circulation, which works with Lyft to provide
transportation assistance to and from medical appointments, to government offices to receive required paperwork, and for
emergent needs (not including emergency medical care). We will use this service for participants in our program as well.
Administration of Circulation is done entirely by study staff. Participants will be offered the ability to use Circulation, and those
who are interested will be registered on the Circulation platform by study staff. To register, the study staff person must provide
the client’s name, home address, and phone number on the portal for contact. The portal requires the client to electronically
sign a consent form beforehand, which is done through the Circulation website. This form can be emailed by staff to the
individual beforehand through an electronic link. If a client prefers to complete consent through this portal, Circulation will
provide a safe and secure text/internet link for the client to complete prior to booking a ride. When the consent document is
completed, study staff will be notified and they can proceed with booking rides on behalf of the client.
To schedule a ride, a study staff person uses the Circulation portal to book it on their behalf of the client. The client does not
need to book rides through Circulation. When study staff members book the ride, the portal provides an estimated cost of the
ride. The person booking the ride selects whether the trip is one-way or round trip, and a specific address for pick-up and drop-
off. To ensure the client does not forget their ride, Circulation sends automated and secure text reminders when the ride is
booked, the day before, when the car is dispatched, when it has arrived, and when the ride is complete. These text reminders
just provide reminders about the ride, and do not list the address for drop-off, pick-up, or any details about the ride. For the
return ride, Circulation provides a code for the client to activate in order to receive their return ride. Study staff can monitor ride
progression as well. The portal also notifies staff when participants do not get into their ride, or if the ride is missed. Circulation
provides monthly invoices through the portal. In order to pay for them, APLA Health’s finances department determines the
appropriate grants used to pay the invoice.
Circulation abides by strict confidentiality policies. Their agreement signed with APLA Health states that no information about
the client is shared with anyone in their organization. Specific information such as name, address, phone number and/or email
is kept completely through the app, and is not shared with anyone else. Additionally, Circulation riders and the portal follow
specific requirements for patient confidentiality, in accordance to the Health Insurance Portability and Accountability Act
(HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). Through these statutes, no
information about clients utilizing circulation, such as the destination of rides, is shared with drivers. Additionally, no health
information about clients is shared with Circulation or drivers enlisted by Circulation. As such, client health information is
secure, as is their safety.
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
Participants will receive gift card incentives if they attend the study visit, even if they do not finish the entire survey
assessment. If they choose to do the MEMS download (at enrollment) or survey (at followup) but not undergo the venipuncture
, they will receive $20 .
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information

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5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance use     including alcohol, drugs, and tobacco
B. Physical health     including diagnosis, treatment, or any other private physical health information
C. Mental health
    including diagnosis, treatment, current mental health status (e.g., suicidality), or any other
private mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity
    including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual
behavior
     
H. Abuse/neglect
    including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 
A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location
and
contacting
information
including any address information smaller than state, telephone or fax numbers, email
addresses, web URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle identifiers
and serial numbers (e.g., license plates), and device identifiers and serial numbers (e.g., serial numbers
on surgical implants)
E.
Audio,
video, or
biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know

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5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
no
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes
B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)
5G5.4
* If "D" on 5G5.1, please describe the exceptions and why they are necessary.
There will be legal exceptions of suicidal ideation or harm to self or others and intent to harm others or child or elder
abuse/neglect.
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7

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Viral Load Assessment
3C Research Overview - Procedures
Related Populations:
People Living with HIV (Full Committee - Approved)
 
3C1 Procedure Description
3C1.1
* Which of the following describes this procedure? (Check all that apply) 
A. Acquiring previously collected person-level
information
(e.g., medical records, census data, employment records,
education records, other existing datasets)
B. Interview
(e.g., phone interview)
C. Survey (either oral or written)
(e.g., mail survey, web survey)
D. Group discussion
(e.g., focus group, expert panel)
E. Observation of individuals or groups
(e.g., in-person visual observation, video observation)
F. Educational testing
(e.g., aptitude testing, military/vocational training assessment)
G. Psychological testing, measurement, or
assessment
 
H. Physical exam, testing, measurement,
assessment (w/o specimen collection)
(e.g., blood pressure, weight measurement,)
I. Biologic sample collection
(e.g., tissue, blood, urine, saliva)
J. Testing of existing biological samples
(e.g., testing for the presence of disease or drugs)
K. Socio-behavioral or educational intervention
(e.g., randomized trials, quasi-experimental designs,
demonstration projects)
L. Clinical treatment
(e.g., administering drugs, therapy)
M. Other intervention research procedures
(e.g., physical procedures, manipulating environment to evaluate
impact on outcome)
N. Other interaction research procedures
(e.g., obtaining information from individuals)
3C3
You will be asked to complete the following screens in section 5 for this procedure based on your answers given above:
5A Procedures - Interventions: Overview
5B Procedures - Interventions: Biologic Samples
5E Procedures - Risks
5F Procedures - Benefits, Incentives, Costs
5G Procedures - Confidentiality
5A - Procedures - Interventions: Overview
5A1
* Provide a step-by-step description of this procedure for the studied groups of participants. Include both
alterations of their experiences (e.g., novel educational practices, new health services) and administration of any
treatments they might not otherwise receive (e.g., medications, nutritional supplements). Note: you will be asked
below in 5A2 about assignment of participants to different groups (e.g., different data collection or treatment/control groups).
At study enrollment and 6- and 12-months post-enrollment (and post-intervention start), a member of the study team (trained
in phlebotomy) will draw participants’ blood for viral load assessment at the APLA Health and Wellness clinic. Alternately,
participants can go directly to a Qwest lab (where Rise blood samples are sent for processing) to have their blood drawn for
the study. Viral load suppression will be defined as <200 copies of virus per milliliter of blood plasma.
If participants wish to go to a Quest lab, we will offer ride assistance, specifically, the Circulation program (e.g., to transport

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clients from APLA Health & Wellness in Koreatown and Long Beach to Quest Diagnostics blood draw sites). For example,
APLA Health in Koreatown is at 611 S. Kingsley Drive, Los Angeles, CA 90005, a half mile away from the closest Quest draw
site at 500 S Virgil Ave Suite 202, Los Angeles, CA 90010. Prior to the appointment, APLA project staff will book a ride
through the Circulation portal. The client will meet the APLA staff person at APLA Health’s location. The Circulation ride will
take the staff person and participant to the Quest draw site, and then back to APLA Health, where the remainder of the
session will be completed.
In the event that participants do not want to get their blood drawn and see APLA Health staff in person due to COVID-19,
they will be asked to send photos or screenshots of their most recent HIV viral load lab results to the study team cell phone
using WhatsApp, which has end-to-end encryption. Study staff will tell participants to delete the photo from their phone
immediately after they send it. APLA staff will transcribe the results from these photos to the medical records data collection
spreadsheet (that has ID#s and not participant names), and will securely transmit the data to RAND via Kiteworks. Once the
data has been securely transmitted, study staff will delete the photo from the study cell phone.
5A2 Administered to All Members
5A2.1
* Will any subgroups of the population(s) referenced above receive different interventions? (Check all that apply)
A. Yes - not all participants will receive the same intervention (e.g., physical exams or biologic samples will be
collected/tested from only a subset)
B. Yes - some participants will receive the socio-behavioral or clinical intervention and others will be in the control group
C. No - all participants will receive the same procedure(s) listed above
5A3
* Describe the qualifications and/or training for those who will conduct the intervention.
The team member will be trained and certified in phlebotomy.
5A4 Interim Outcome Monitoring
5A4.1
* Will interim outcomes be monitored in any way? For example, some intervention studies may have or be required
to have a Data and Safety Monitoring Plan (DSMP) to assess that the intervention is not harmful and/or is having a
positive effect.
yes
5A4.2
* If "Yes", explain what will be monitored, when, how, and why.
Given the low risk of the experimental intervention, we believe that a multiple-person data safety monitoring board (DSMB) is
an unnecessarily intensive approach to monitoring this trial. We propose here an alternative, less intensive approach which we
believe will effectively ensure the welfare of study subjects and the continued scientific validity of the study. Specifically, we
propose that a single, independent, behavioral HIV researcher to serve as an independent monitor for the study. The monitor
will be an expert in the treatment of depression and/or substance use among people living with HIV who does not have a
conflict of interest with anyone on the study team, i.e., who does not have a prior collaborative or financial relationship with any
of the study investigators and who is not employed currently or within 3 years in any of the primary study institutions.
To allow effective monitoring, the independent monitor will be provided with periodic reports which include subject enrollment,
subject retention, the number of patients who drop out of the study with reasons for dropping out, and a listing of all adverse
events (AEs) that are plausibly related to study procedures. Reports will be provided to the independent monitor at 6-month
intervals. After review of the periodic reports, the independent monitor may ask for clarification or additional information from
the principal investigator (PI). After such information is provided, if requested, the independent monitor will make a
recommendation regarding the continuation, modification, or termination of the study. All communications from the
independent monitor will be shared with the study institutional review boards (IRBs), as well as NIH. By utilizing a single
independent monitor rather than a multi-person DSMB, we believe the oversight of the study will be easier to implement, more
efficient, and more responsive to issues as they arise.
5A4.3
* Does your funder or the RAND HSPC require a Data and Safety Monitoring Plan (DSMP) for your study? The RAND
HSPC will make its determination during the review process.
Yes - by the funder and/or the HSPC
No (including not yet determined by the HSPC)
5A4.4
* Do you have the DSMP for this study ready to upload in draft or final form?
yes
5A4.5
You will be asked to upload the DSMP in section 7. A DSMP is typically done at the study level and you will be able to upload
a single DSMP in section 7 and associate it with as many components as necessary. This is done to ensure that all
components that should be covered are addressed in the DSMP.
5B Procedures - Interventions: Biologic Samples or Specimens

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5B1 Biologic Sample or Specimen Types
5B1.1
* Please indicate which biological sample types will be collected. (Check all that apply)
A.
Urine
B.
Blood
C.
Saliva
D.
Hair
E.
Tissue/cell sample
F.
Other, specify:
5B2
* Please provide an account of how, where, and when the samples or specimens will be collected. Include the
methods, the qualifications of and/or training provided to those who will collect the samples or specimens, and
other details (e.g., volume collected, how stored, safety considerations).
At enrollment and 6- and 12-months post-enrollment (post intervention start), a member of the study team (trained in
phlebotomy) will draw participants’ blood for viral load assessment at the APLA Health and Wellness clinic. 
APLA Health and Wellness Clinic staff regularly perform venipuncture for viral load assessment and the clinic has
mechanisms for storage and procedures for safety. Our study staff will be trained on the clinic's protocols as well as certified
in phlebotomy. 
5B3 Biologic Sample or Specimen Testing
5B3.1
* Will any of the samples or specimens be tested?
Yes - during this study
Yes - but testing will be done later
No
Don't know
5B3.2
* List the types of testing to be performed (e.g., specific biomarkers or diseases to be tested, generic tests to be
conducted) and why.
We will conduct viral load assessments. Viral load suppression, a main study outcome, will be defined as <200 copies of virus
per milliliter of blood plasma.
5B4 Biologic Sample or Specimen Disposition
5B4.1
* What will the be the ultimate disposition of the sample(s) or specimen(s) collected during this study?
A.
Destroyed at the end of this study
B.
Anonymous sample(s) banked for future research
C.
Identifiable sample(s) banked for future research
5E Procedures - Risks
5E1 Breach of Confidentiality Risk
5E1.1
* In the event a breach of confidentiality allowing someone outside of the research team to identify participants in
this study, which of the following types of harm might result? (Check all that apply) 
A.
Legal (i.e., criminal or civil liability)
B.
Financial/economic (e.g., damage to employability)
C.
Psychological (e.g., embarrassment, distress)
D.
Social (e.g., damage to reputation)
E.
Other
F.
No anticipated risk
5E2 Participation Risk
5E2.1
* Aside from the risks associated with a breach of confidentiality, which of the following types of harm might result
from participation in the procedure? (Check all that apply) 

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A. Financial/economic (e.g., damage to employability)
B. Physical consequences (e.g., pain, discomfort)
C. Psychological consequences (e.g., distress, embarrassment, pressure to participate)
D. Social (e.g., stigma of participation, damage to reputation)
E. Other
F. No anticipated risk
5E3
In the questions that follow, the phrase "individuals in the general U.S. population" refers to healthy individuals in the United
States who are not incarcerated. Thus, the high standard of minimal risk is based on the amount of risk typically
encountered in everyday life by healthy individuals in the United States. If the study population is unhealthy individuals,
incarcerated individuals, or individuals in another country, the appropriate comparison is now how much risk "healthy
individuals" would face. The comparison is what the actual subject population would face in comparison to miminal risk as
defined by everyday life for healthy individuals in the United States. If a breach of confidentiality or participation would
be dangerous in the study population, it is above minimal risk.
5E5 Financial/Economic Risks Associated with a Breach of Confidentiality
5E5.1
* Might the degree or amount of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E5.2
* Might the likelihood of financial/economic harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
no
5E5.3
* Please explain the nature of the financial/economic harm, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All samples will be stored according to standard clinic confidentiality
protocols. Test results will be provided to study staff and participants only and recorded in participants' confidential study
files. All hard copy research data will be kept in locked file cabinets and all hard and soft copy data will be available only to
research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by study
numbers and client initials. HIV status will not appear along with any personal identifying information. Personal information
used for tracking, including participant name, address, and phone number, will be stored separately from all research data.
To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available
only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by
study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data.To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff
will tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results
from these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will
securely transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the
photo from the study cell phone.
5E6 Psychological Risks Associated with a Breach of Confidentiality
5E6.1
* Might the degree or amount of psychological harm resulting from a breach of confidentiality be greater than
ordinarily encountered in daily life by individuals in the general U.S. population?
yes
5E6.2
* Might the likelihood of psychological harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E6.3
* Please explain the nature of the discomfort or distress, what might cause it, and steps that would be taken to
mitigate it.
Participants could experience psychological harm from HIV stigma if their HIV-positive serostatus became known to others.
To protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be

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available only to research staff directly involved in this project and state regulatory agency personnel. Data will be
identifiable only by study numbers and client initials. HIV status will not appear along with any personal identifying
information. Personal information used for tracking, including participant name, address, and phone number, will be stored
separately from all research data.To further protect confidentiality, the study will be covered by a federal Certificate of
Confidentiality. 
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available
only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by
study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data.To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff
will tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results
from these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will
securely transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the
photo from the study cell phone.
5E7 Social Risks Associated with a Breach of Confidentiality
5E7.1
* Might the degree or amount of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
yes
5E7.2
* Might the likelihood of social harm resulting from a breach of confidentiality be greater than ordinarily
encountered in daily life by individuals in the general U.S. population?
no
5E7.3
* Please explain the nature of the social harm, what might cause it, and steps that would be taken to mitigate it.
Participants could experience social harm from HIV stigma if their HIV-positive serostatus became known to others. To
protect confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be
available only to research staff directly involved in this project and state regulatory agency personnel. Data will be
identifiable only by study numbers and client initials. HIV status will not appear along with any personal identifying
information. Personal information used for tracking, including participant name, address, and phone number, will be stored
separately from all research data. To further protect confidentiality, the study will be covered by a federal Certificate of
Confidentiality. 
Participants could experience financial/economic harm if their HIV-positive serostatus became known to others. To protect
confidentiality, the following steps will be taken: All research data will be kept in locked file cabinets and will be available
only to research staff directly involved in this project and state regulatory agency personnel. Data will be identifiable only by
study numbers and client initials. HIV status will not appear along with any personal identifying information. Personal
information used for tracking, including participant name, address, and phone number, will be stored separately from all
research data.To further protect confidentiality, the study will be covered by a federal Certificate of Confidentiality. 
Photos of viral load levels will be sent to the study cell phone via WhatsApp, which has end-to-end encryption. Study staff
will tell participants to delete the photo from their phone immediately after they send it. APLA staff will transcribe the results
from these photos to the medical records data collection spreadsheet (that has ID#s and not participant names), and will
securely transmit the data to RAND via Kiteworks. Once the data has been securely transmitted, study staff will delete the
photo from the study cell phone.
5E11 Psychological Risks Resulting from Participation
5E11.1
* Might the degree or amount of psychological harm resulting from participation in the procedure itself (i.e., other
than from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the
general U.S. population?
no
5E11.2
* Might the likelihood of psychological harm resulting from participation in the procedure itself (i.e., other than
from a breach of confidentiality) be greater than ordinarily encountered in daily life by individuals in the general
U.S. population?
no
5E11.3
* Please explain the nature of the psychological harm, what might cause it, and steps that would be taken to
mitigate it.
Collection of blood samples could cause some physical discomfort and consequent psychological distress. However,
participants will routinely be going to a clinic for blood draws as part of their usual medical care, and the venipuncture in the

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proposed study will take place in a clinic setting with trained and certified phlebotomists who have experience working with
the research population.
5F Procedures - Benefits, Incentives, and Costs
5F2 Incentives and Other Forms of Compensation
5F2.1
* Will the participants receive incentives or some other form of compensation (e.g., cash, voucher, meals,
reimbursements)? 
yes
5F2.2
* If "Yes", what will the participants receive as an incentive or other forms of compensation?
Participants will receive $30 for the first venipuncture visit, $40 at the 6-month follow-up and $50 at 12-month followup.
Participants who are asked to travel to Quest labs for blood draws (when the APLA Health clinic cannot be used due to
restrictions in the time of COVID-19) will receive an extra $10 gift card.
5F2.3
* If "Yes", how and when will the incentives or other forms of compensation be distributed to participants? Include
any detail about conditions under which they might not receive the incentive or other form of compensation.
Participants will receive gift cards at these study visits. If they complete the venipuncture only, they will receive $20.
Participants who are asked to travel to Quest labs for blood draws (when the APLA Health clinic cannot be used due to
restrictions in the time of COVID-19) will receive an extra $10 gift card.
5F3 Costs
5F3.1
* Might the participants incur any financial costs that will not be reimbursed and that they would otherwise
not incur?
no
5G Procedures - Confidentiality
5G1 Sensitive Information
5G1.1
* Will any of the following types of sensitive information be intentionally accessed, acquired, or recorded as part of
data collection about an individual? (Check all that apply) Note: You may have answered this question 2H with regard to
a specific population if you applied for an exemption for one or more population-procedure components of your study.
However, we are asking this question again because the information may be sensitive with regard to another population in
your study that you have associated with this procedure. 
A. Substance use
    including alcohol, drugs, and tobacco
B. Physical health     including diagnosis, treatment, or any other private physical health information
C. Mental health
    including diagnosis, treatment, current mental health status (e.g., suicidality), or any other private
mental health information
D. Traumatic
events
    including victimization, bereavement, accidents, natural disasters, and military combat
E. Illegal activity
    including illicit drug use, human trafficking, and terrorism
F. Immigration
status
     
G. Sexual behavior      
H. Abuse/neglect
    including child, elder, domestic, and partner
I. Educational
records
    including status, history, or performance
J. Employment
records
    including status, history, or performance
K. Financial
information
     
L. Other
     
M. None of the
above
     
5G2 Identifying Information
5G2.1
* Check all types of identifying information that your research will acquire about these participants. Note: You may
have answered this question on screens 2B or 2C with regard to a specific population if you applied for an exemption for one
or more population-procedure components of your study. However, we are asking this question again because the
information may be identifiable with regard to another population in your study that you have associated with this procedure. 

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A. Names
including names appearing on consent forms, payment receipts, medical records, and
emergency contact lists
B.
Location and
contacting
information
including any address information smaller than state, telephone or fax numbers, email addresses, web
URLs, and IP addresses
C. Dates
including birth date, marriage date, and treatment or visit dates from medical records
D. Identification
numbers
including Social Security Numbers, medical record or health plan beneficiary numbers, account
numbers, student ID numbers, certificate or license numbers (e.g., driver's license), vehicle
identifiers and serial numbers (e.g., license plates), and device identifiers and serial numbers
(e.g., serial numbers on surgical implants)
E.
Audio, video,
or biometric
indicators
including photographic or video images, audio recordings, and finger or voice prints
F.
None of the
identifiers
listed above
by checking this box you certify that you are not obtaining any of the information listed above
5G3 Disclosure of Identifiable Person Level Data
5G3.1
* Will any information that you collect go into person level non-research records (e.g., medical, educational,
employment records) that are not maintained and controlled solely by the research team? Note: This is a relatively
rare occurence for research done at RAND and would require HSPC approval.
Yes
No
Don't know
5G3.2
* If "Yes", please provide details regarding information that you collect that will go into non-research records that are
not maintained and controlled solely by the research team.
If the participant is already a patient at APLA's Health and Wellness Clinic (where the blood will be drawn), their viral load
values will be put into their medical records. Participants will be notified of this.
5G4 Reasons for Breaking Confidentiality
5G4.1
* Could the procedure yield information potentially of importance to individual participants that they otherwise
would be unlikely to know? This includes information specifically gathered or spontaneously provided or observed.
yes
5G4.2
* If "Yes", will participants or others (e.g., doctors, teachers, parents) be notified?
yes
5G4.3
Note: If "Yes", this information must be included in the consent form.
5G4.4
* If "Yes", please provide a detailed explanation of who will be notified, what information will be provided (e.g.,
abnormal test results, reportable diseases), and how.
Participants in the intervention condition will be notified of the results of the blood draw, and the results will be discussed with
the intervention facilitator. Participants in the control condition will not be told of the results of the blood draw because it could
serve as an intervention that influences their adherence behavior (a primary study outcome). However, all participants will be
on medication and in medical care, and thus should be receiving regular viral load assessments from their medical provider
(outside of the study procedures). Thus, they will likely already be aware of their viral load status. The purpose of assessing
viral load as part of the study (in addition to the regular assessments provided by participants' clinics) is for the timing of the
viral load assessments from medical records to match the timing of the study survey and adherence assessments, which fall
before and after the intervention sessions. This will allow us to have a definitive test of the effects of the intervention on viral
suppression.
5G5 Promise of Confidentiality
5G5.1
* Is confidentiality being promised to participants with no additional exceptions aside from those noted in 5G4?
A. Yes
B. No, participants can choose to allow potentially identifiable information (e.g., quotes, performance information) to be
included in published reports
C. No, participants must agree to be attributable in published reports (this is a rare exception and might only occur in
studies of a single organization)
D. No, there will be other exceptions (e.g., intent to harm self or others, suspected child abuse)

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5G5.4
* If "D" on 5G5.1, please describe the exceptions and why they are necessary.
There will be legal exceptions of suicidal ideation or harm to self or others and intent to harm others or child or elder
abuse/neglect.
5G5.5
* Do you plan to apply for a Certificate of Confidentiality? Please note that such applications can be filed only after
consent protocols have been approved.
Yes
No
Don't know
5G6 Identifiability by Inference in Published Reports
5G6.1
* Might comments or other information included in published reports be identifiable by inference for participants
who do not agree to be identified and are being assured of confidentiality? 
no
5G7 Data Safeguarding Plan
5G7.1
* Based on previous answers, a Data Safeguarding Plan (DSP) is required. Are you ready to upload it in draft or final
form at this time?
yes
5G7.2
You will be able to upload the Data Safeguarding Plan (DSP) later in Section 7
 
 
Version 2.10
ID: 2016-0940
 
6 - Informed Consent
Population
Procedure
Answer questions by
clicking on all active links
below
Name
Status

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Population
Procedure
Answer questions by
clicking on all active links
below
Name
Status
People Living with HIV
Cost Data
Component does not
require review
Not Required
COVID-19 Survey Items
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
Consent Will Be Performed
- Document Uploaded
Electronic Adherence
Assessment (MEMS)
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
(duplicate)
Consent Will Be Performed
- Document Uploaded
Intervention
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
(duplicate)
Consent Will Be Performed
- Document Uploaded
Medical Records
Assessment
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
(duplicate)
Consent Will Be Performed
- Document Uploaded
Recruitment Discussion
Groups
Component does not
require review
Not Required
Surveys
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
(duplicate)
Consent Will Be Performed
- Document Uploaded
Viral Load Assessment
6A Informed Consent
Project Rise Consent Form
edited 2020-01-
17tc.docx  1/17/2020
(duplicate)
Consent Will Be Performed
- Document Uploaded
  
 
6A Informed Consent
6A1 Informed Consent Applies to Multiple Components
6A1.1
Which of the following population-procedure components does this Informed Consent apply to? (Check all that
apply)
Population
Procedure
This Informed Consent applies to
this population-procedure
component
People Living with HIV
6A2 Plan to Obtain Informed Consent
6A2
* Please explain how you plan to obtain informed consent (and/or assent from youth) for the population-procedure
component(s) checked above. Describe the processes and methods involved (e.g., written, oral, implicit, passive).
For additional explanation of these methods, refer to http://intranet.rand.org/groups/hspc/consent.html.
Prior to the discussion group (in which we are not collecting data), participants will be told that the purpose of the discussion
groups is to have an open forum and discussion about their experiences living with HIV, taking treatment, and perspectives
on medications; that the discussion group will last about 1.5-2 hours; that all the information being collected in the screener
will be kept completely private and confidential and is only used to schedule the groups.
6A3 Informed Consent Material Upload
6A3.1
* Do you have informed consent material(s) to upload now?
B. No - I am requesting a waiver of consent in its entirety (partial waiver of elements is requested later when selecting either
option A or C)

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6A8 Future Contract After Research Ends
6A8.1
* After the project ends, is there a possibility that the participants will be contacted to participate any in future
research (including research conducted on other topics or by other research teams)?
No
Version 2.15
 
 
  
 
6A Informed Consent
6A1 Informed Consent Applies to Multiple Components
6A1.1
Which of the following population-procedure components does this Informed Consent apply to? (Check all that
apply)
Population
Procedure
This Informed Consent applies to
this population-procedure
component
People Living with HIV
6A2 Plan to Obtain Informed Consent
6A2
* Please explain how you plan to obtain informed consent (and/or assent from youth) for the population-procedure
component(s) checked above. Describe the processes and methods involved (e.g., written, oral, implicit, passive).
For additional explanation of these methods, refer to http://intranet.rand.org/groups/hspc/consent.html.
Prior to the baseline survey (during the pre-baseline study visit), the study coordinator will meet with the participant in a
confidential space. After confirming eligibility criteria, he/she will describe the details of the study, including the nature of
involvement in the study, the possible risks and benefits of participation, and the ability to withdraw from the study at any
time without consequence. Participants will be told that their data, including data regarding their HIV status, will be kept
confidential. They will also be told that intervention counselors will not have access to their survey data. Participants will be
informed that they can skip any survey questions they prefer not to answer. The participant will have the opportunity to ask
questions about the study, after which informed consent will be obtained and documented by having the participant read
and sign a consent form, which will be stored in a locked file cabinet. Each participant will be given a copy of the consent
form to keep.
Note that, during the COVID-19 situation only, we are requesting verbal informed consent for the few scheduled participants
(3-5) left who have not yet completed the baseline appointment. These participants will complete phone interviews rather
than in person interviews and thus we will obtain verbal informed consent from them prior to the baseline interview. We will
ask them to sign the consent form at a later date, when we are able to have in person assessments again.
Update April 29 2020: For the added COVID-19 questions, the overall consent form covers the general study procedures.
We will ask for verbal consent prior to asking the specific COVID-19 items for the survey.
6A3 Informed Consent Material Upload
6A3.1
* Do you have informed consent material(s) to upload now?
A. Yes - ready to upload now
6A3.2
* Do you have variations (e.g., for students at different schools) of the informed consent material?
A. Yes - the variations are minor
6A3.4
* Please upload the informed consent material (e.g., consent form to be signed or script for oral consent). Note: If
you have variations that are substantive, refer to 6A3.3 before uploading.
Project Rise Consent Form edited 2020-01-17tc.docx(0.02)
6A3.7
* Please explain the variations. If you are uploading multiple variations in 6A3.6, please include references to the
specific documents in explaining the variations.
The Consent form attached will be used for different procedures or components of this study; while the HIPPA form will be
used to authorize the release of medical information by the participant. The HIPPA form has been uploaded under
additional materials. 

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Note that the consent form was revised on 10/16/17 to reflect changes suggested by the reviewer as well as community
stakeholder (to simplify the text),and new timing of study procedures (i.e., baseline survey will be given 1 month earlier).
Note that the consent form was again revised on 3/29/19 to reflect additions to the procedures regarding texting participants
appointment reminders.
Note that the consent form was revised on Jan 17, 2020 to reflect an additional incentive of $30 for participants obtaining
medical record data directly from their provider.
Note that we are requested verbal informed consent during the COVID-19 situation, when all assessments will be done by
phone. We will ask them to sign the consent form at a later date, when we are able to have in person assessments again.
(Please see above explanation.)
6A4 Elements Included
You must provide individuals with the information they need to make an informed decision about participating in your study. The list of
elements normally included in an informed consent is shown below. If you wish NOT to include any elements that are
normally included, you will need to ask the HSPC to grant a waiver..
6A4.1
* Check all of the following required elements that are/will be included in the informed consent document.  (Check
all that apply)
A. That the project is a research study
B. Purpose of the research
C. What organizations are conducting and sponsoring it
D. That participation is voluntary
E. Clear description of procedures (nature, duration, etc.)
F. Risks from participation, if any
G. Benefits to the individual from participation, if any
H. How the project will treat confidential data
I.
Point of contact for questions or problems regarding the study
J. Point of contact for the HSPC
K. Signature of participant and/or legally authorized representative (e.g., parent, guardian)
6A4.2
* Will any of the elements of informed consent that are checked above be altered or involve deception?
no
6A6 Language Translation
6A6.1
* Will informed consent be administered in languages other than English?
no
6A8 Future Contract After Research Ends
6A8.1
* After the project ends, is there a possibility that the participants will be contacted to participate any in future
research (including research conducted on other topics or by other research teams)?
Yes
6A8.2
* If "Yes" or "Maybe", you are advised to include a request for permission to recontact in your study's informed
consent document. Otherwise you or another researcher may face a situation in the future when the HSPC will not
approve recontact. Please describe when and for what purpose the study staff might re-contact this population of
participants. How likely is this to happen and when are the study staff be likely to know whether it will happen?
It is possible that we will get funded for another similar project with the same population during the study timeframe, in
which case we would re-contact participants for participation in another study. There are no plans to do so right now,
although we will be submitting other proposals in the next 1-2 years that would be relevant to this study population.
Version 2.15

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ID: 2016-0940
7A - Main Documents to Upload
Based on your prior answers, below RHINO displays a matrix that indicates the documents you need to upload for review.  Here you may
be asked to upload documents related to any of the following as applicable to your study:  participant questions, recruitment material, Data
and Safety Monitoring Plan (DSMP), Data Use Agreement (DUA), Data Safeguarding Plan (DSP), and miscellaneous documents other
than consent (which can be uploaded in section 6) .  A DSMP is not the same as a DSP.
Click on the hyperlink in the first column to add or replace a specific document.  You can click on the hyperlink in the second column to
directly open uploaded documents.  You will be able to associate a document with multiple population-procedure components (e.g.,
questionnaire, or DSP that applies to different populations or procedures) when you upload it.  Note: The reviewer may also ask to see
documents in addition to those you load below.
 
Population Procedure
Upload documents by
clicking on all active links
below
View Uploaded
Documents
Document Status
People
Living with
HIV
Cost Data
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017
Uploaded
7A2 Recruitment
Material
IRB Phone and in-person recruitment
Script 2018-04-24 IRB Modifications
KT.docx  4/25/2018
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017
Uploaded
7A6 Miscellaneous
Documents
R01Rise 9 1 16 310pmFINAL
UPDATEDFORHSPC.docx  11/30/2016
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
Uploaded
COVID-19 Survey Items
7A1 Participant
Questions
COVID-19 Rise Survey 4 28
20.docx  4/29/2020
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018
(duplicate)
Uploaded

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Population Procedure
Upload documents by
clicking on all active links
below
View Uploaded
Documents
Document Status
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017
(duplicate)
Uploaded
7A2 Recruitment
Material
COVID-
19RecruitmentScript.docx  4/29/2020
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17
20.docx  6/17/2020
Uploaded
7A6 Miscellaneous
Documents
 
Not Yet Uploaded
Electronic Adherence
Assessment (MEMS)
7A1 Participant
Questions
Cost effectiveness.xlsx  10/16/2017
Uploaded
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017 (duplicate)
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17 20.docx  6/17/2020
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
R01Rise 9 1 16 310pmFINAL
UPDATEDFORHSPC.docx  11/30/2016
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17 edited 2019-05-
10 kvt.docx  5/13/2019
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
(duplicate)
Uploaded

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Population Procedure
Upload documents by
clicking on all active links
below
View Uploaded
Documents
Document Status
7A6 Miscellaneous
Documents
CheckinvisitsandRandomizationform10-
16-17.docx  10/16/2017
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17.docx  9/26/2017
Uploaded
7A6 Miscellaneous
Documents
Project Rise Retention
LetterOct2020.docx  10/6/2020
Uploaded
7A6 Miscellaneous
Documents
Project Rise Consent Form edited
2019-05-10.docx  5/13/2019
Uploaded
Intervention
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017 (duplicate)
Uploaded
7A3 Data and
Safety Monitoring
Plan (DSMP)
DSMPforRisetc 3 20
18.docx  3/20/2018
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17 20.docx  6/17/2020
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
R01Rise 9 1 16 310pmFINAL
UPDATEDFORHSPC.docx  11/30/2016
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17 edited 2019-05-
10 kvt.docx  5/13/2019 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH FWA letter exp 01-2019
RM.pdf  1/20/2017
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
Uploaded

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Population Procedure
Upload documents by
clicking on all active links
below
View Uploaded
Documents
Document Status
(duplicate)
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17.docx  9/26/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
Rise2.0InterventionManual 9 26
17.docx  9/26/2017
Uploaded
7A6 Miscellaneous
Documents
Project Rise Consent Form edited
2019-05-10.docx  5/13/2019 (duplicate)
Uploaded
Medical Records
Assessment
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017 (duplicate)
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17 20.docx  6/17/2020
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
R01Rise 9 1 16 310pmFINAL
UPDATEDFORHSPC.docx  11/30/2016
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17 edited 2019-05-
10 kvt.docx  5/13/2019 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
CheckinvisitsandRandomizationform10-
16-17.docx  10/16/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17.docx  9/26/2017
(duplicate)
Uploaded

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2019-05-10.docx  5/13/2019 (duplicate)
Uploaded
Recruitment Discussion
Groups
7A2 Recruitment
Material
2018-11-19 RISE
Discussion Group
Flyer.docx  11/28/2018
Uploaded
7A6 Miscellaneous
Documents
2018-11-27 Project Rise
Focus Group Recruitment
and Contact Form v2
KVT.docx  11/28/2018
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17
edited 2019-05-10
kvt.docx  5/13/2019
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
Project Rise Consent
Form edited 2019-05-
10.docx  5/13/2019
(duplicate)
Uploaded
Surveys
7A1 Participant
Questions
Pre-enrollment and baseline 10-09-
2017.docx  10/16/2017
Uploaded
7A1 Participant
Questions
Pre-enrollment assessment 9 25 17lmb
Submitted to HSPC.docx  9/26/2017
Uploaded
7A1 Participant
Questions
Participant Tracking and Locator Form
09-25-17.docx  9/26/2017
Uploaded
7A1 Participant
Questions
Rise 10 13 17 Follow-
up.docx  10/16/2017
Uploaded
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017 (duplicate)
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17 20.docx  6/17/2020
(duplicate)
Uploaded
7A6 Miscellaneous
R01Rise 9 1 16 310pmFINAL
Uploaded

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UPDATEDFORHSPC.docx  11/30/2016
(duplicate)
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17 edited 2019-05-
10 kvt.docx  5/13/2019 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
CheckinvisitsandRandomizationform10-
16-17.docx  10/16/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17.docx  9/26/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
Project Rise Retention
LetterOct2020.docx  10/6/2020
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
Project Rise Consent Form edited
2019-05-10.docx  5/13/2019 (duplicate)
Uploaded
Viral Load Assessment
7A2 Recruitment
Material
Internet Recruitment Scriptrev 10 4
18.docx  10/4/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
2018-10-24 Rise Recruitment Screener
Bogart 10 26 18.docx  11/26/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Rise Flyer6.pdf  1/18/2018 (duplicate)
Uploaded
7A2 Recruitment
Material
Rise Card1b.pdf  11/8/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Internet Recruitment Script 9-25-
17.docx  9/26/2017 (duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
2018-10-04 IRB
Modifications.docx  10/4/2018
(duplicate)
Uploaded
7A2 Recruitment
Material
Phone and in-person recruitment Script
10.25.17.docx  10/25/2017 (duplicate)
Uploaded
7A3 Data and
Safety Monitoring
Plan (DSMP)
DSMPforRisetc 3 20
18.docx  3/20/2018 (duplicate)
Uploaded
7A5 Data
Safeguarding Plan
(DSP)
DSPforRiserev6 17 20.docx  6/17/2020
(duplicate)
Uploaded
7A6 Miscellaneous
QuestlettertoRAND - Sep 20,
Uploaded

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2019.pdf  9/24/2019
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Documents
R01Rise 9 1 16 310pmFINAL
UPDATEDFORHSPC.docx  11/30/2016
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17 edited 2019-05-
10 kvt.docx  5/13/2019 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH Request to Rely on External IRB
has been Approved
2:14:17.pdf  2/14/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
Patient Instructions for use of cap 09-
25-17.doc  9/26/2017 (duplicate)
Uploaded
7A6 Miscellaneous
Documents
CMH RAND HIV Adherence IAA
Goggin Feb^17.pdf  2/14/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
HIPPA Form 09-25-17.docx  9/26/2017
(duplicate)
Uploaded
7A6 Miscellaneous
Documents
Project Rise Consent Form edited
2019-05-10.docx  5/13/2019 (duplicate)
Uploaded
  
 
  
7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Cost effectiveness.xlsx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This spreadsheet will be used to collect data from APLA (on intervention costs and salaries), the intervention counselor
regarding how long each session takes, and the intervention supervisor (on how long supervision takes). No participant
identifying information will be included in this spreadsheet.
 
 
  
7A1 Participant Questions

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7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Pre-enrollment and baseline 10-09-2017.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This document combines what was previously the pre-enrollment and baseline survey questions. No questions have
been changed. The documents have been combined because all questions will now be asked at the first study visit,
rather than splitting the survey across the first 2 study visits. This will decrease participant burden in the second study
visit (which will also include MEMS downloading, blood draws, and a possible first intervention session).
 
 
  
 
  
7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
2018-11-26 Project Rise Focus Group Discussion Guidelmb.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Discussion Guide Questions
 
 
  
7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component

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Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Pre-enrollment assessment 9 25 17lmb Submitted to HSPC.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This is the pre-enrollment assessment and we have clarified its use in the consent form
 
 
  
7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Participant Tracking and Locator Form 09-25-17.docx(0.02) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
The participant tracking and location form will be used during the pre-enrollment assessment and during check-ins.
 
 
  
7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Rise_10 13 17_Follow-up.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This document is the follow-up survey. These questions were previously contained in the baseline survey and were
already approved. We have simply separated out the followup questions into a new document.

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7A1 Participant Questions
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
COVID-19_Rise_Survey 4 28 20.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Internet Recruitment Scriptrev 10 4 18.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised internet recruitment script to include instructions to click on a link to be screened.
 
 
  
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)

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Population
Procedure
This document applies to this
population-procedure component
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
2018-10-24 Rise Recruitment Screener_Bogart_10 26 18.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Rise Flyer6.pdf(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised flyer with APLA email address
 
 
  
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Rise Card1b.pdf(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Updated flyer text and layout, with pictures

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7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Internet Recruitment Script_9-25-17.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This script will be used to recruit people using Facebook and Twitter. This script will be used to recruit people for different
procedures.
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
2018-11-19 RISE Discussion Group Flyer.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Recruitment Flyer
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)

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Population
Procedure
This document applies to this
population-procedure component
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
IRB Phone and in-person recruitment Script 2018-04-24 IRB Modifications KT.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised recruitment script with added ineligibility criterion in track changes
 
 
  
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Phone and in-person recruitment Script 2018-10-04 IRB Modifications.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
New screener that includes extra question for people who are recruited online (with an inclusion criterion of living in LA
County or being willing to do in-person study assessments in LA County)
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Phone and in-person recruitment Script 10.25.17.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.

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Revised recruitment script that specifies participants must be prescribed antiretroviral treatment (not necessarily taking it)
 
 
  
7A2 Recruitment Material
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
COVID-19RecruitmentScript.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
 
 
  
 
  
7A3 Data and Safety Monitoring Plan (DSMP)
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
DSMPforRisetc_3 20 18.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Submitting a revised DSMP, base don our recent reportable event:
-Added to protocol around study staff handling of reportable events, to state that study staff will add any relevant text to
participant tracking form, so that all staff are aware of any necessary protocols specific to the participant (this was
suggested by our independent data and safety monitor)
-Added an additional staff member at APLA to whom incidents involving clients would be reported, who could help to
further protect the client as needed (APLA's Director of HIV Access and Community-Based Services and the site PI's
supervisor)
-Deleted extraneous text at the end that duplicated text in the DSP
Note that the revised DSMP was approved by the study's independent data and safety monitor.
 
 

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7A5 Data Safeguarding Plan (DSP)
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
DSPforRiserev6 17 20.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised DSP for transfer of HIV viral load photos via WhatsApp
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.

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ID: 2016-0940
QuestlettertoRAND - Sep 20, 2019.pdf(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Final letter from Quest resolving inappropriate sharing of participant data from Quest to LA County Dept of Public Health
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
2018-11-27 Project Rise Focus Group Recruitment and Contact Form v2 KVT.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Recruitment screener
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
R01Rise 9 1 16_310pmFINAL_UPDATEDFORHSPC.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This is the NIH R01 proposal
 
 
  

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7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
HIPPA Form 09-25-17 edited 2019-05-10 kvt.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised HIPAA form - only change is that APLA is not called "APLA Health & Wellness"
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
CMH_FWA letter exp 01-2019 RM.pdf(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Children's Mercy Hospital's (CMH) FWA letter; CMH will defer to the RAND HSPC for Co-I Goggin. Co-I Goggin will train
the intervention counselor; as part of the training, she may be sent recordings of counseling sessions of participants
through a secure SharePoint site. This will allow her to provide guidance about specific issues that may arise on which
the team would like her input.
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component

11/10/22, 12:39 AM
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Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
CMH_Request to Rely on External IRB has been Approved 2:14:17.pdf(0.03) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Children's Mercy Hospital IRB approval of reliance agreement
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Patient Instructions for use of cap 09-25-17.doc(0.02) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Signed APLA reliance agreement
We have also included the patient instructions for use of CAP
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
CMH_RAND_HIV Adherence IAA_Goggin Feb^17.pdf(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Children's Mercy Hospital IRB Reliance Agreement

11/10/22, 12:39 AM
Print: 2016-0940 - A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americ…
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ID: 2016-0940
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
CheckinvisitsandRandomizationform10-16-17.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Document for checking in with participants about updating contact information, downloading electronic adherence data,
and randomizing (1-month session only)
Replaces check-in and use of MEMS form combined (which was similar but did not include the randomization for the first
check-in)
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
HIPPA Form 09-25-17.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
This HIPPA form authorizes the release of medical information. It is also a consent form, but we already have another
consent form, so we are uploading the HIPPA in miscellaneous documents instead.
 
 
  

11/10/22, 12:39 AM
Print: 2016-0940 - A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americ…
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ID: 2016-0940
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Project Rise Retention LetterOct2020.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
We have approval to send a letter to participants' home (if they consent to being contacted via mail). This is a draft of the
letter that we will send.
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV
7AX.2a
** Please upload the document.
Rise2.0InterventionManual 9 26 17.docx(0.02) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
APLA's FWA letter; APLA will defer to the RAND HSPC.
We are also including the intervention manual.
 
 
  
7A6 Miscellaneous Documents
 
7AX.1b
* Which of the following population-procedure study components does this document apply to? (Check all that
apply)
Population
Procedure
This document applies to this
population-procedure component
People Living with HIV

11/10/22, 12:39 AM
Print: 2016-0940 - A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americ…
https://rhino.rand.org/Rhino/ResourceAdministration/Project/PrintSmartForms?Project=com.webridge.entity.Entity%5BOID%5B93ADB21269EC9C4…
86/86
ID: 2016-0940
7AX.2a
** Please upload the document.
Project Rise Consent Form edited 2019-05-10.docx(0.01) | History
7AX.3a
Please enter any comments that you wish to share with the reviewer regarding this document.
Revised consent form - only change is that APLA is not called "APLA Health & Wellness"
 
 
ID: 2016-0940
8A Conclusion
8A1 Other Ethical Issues
8A1.1
* Does the proposed study involve any ethical issues not already discussed in the study application? 
no
8A2
Please enter any other comments or information that you would like to share with the HSPC reviewer that would be
relevant to the review.
This study was funded on May 1, 2017. All study documents have now been uploaded (post-JIT review).
Note that this study is very closely related to 2011-0744-CR05, with similar procedures, setting, and study team. 
Version 2.10