A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners
Phase: NA
Conditions: HIV Infections, HIV Primary Infection
Sponsor: University of Michigan

It Takes Two (T2): A couples-based approach to HIV prevention for transgender 
women and their partners 
 
NCT04067661 
 
September 12, 2022 

Study Application (Version 1.17)
1.0
General Information
*Enter the full title of your study:
It Takes Two: A couples-based approach to HIV prevention for transgender women and their 
partners
 
 
*Enter the study alias:
T2 
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is 
Primary? Department Name
UCSF - 
 - M_MED-CORE-DPSC
138342
UCSF - 
 - M_ObGyn-Bixby-ZSFG
123012
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who 
are not in the UCSF directory can be identified later in the Qualifications of 
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Johnson, Mallory PhD
Select if applicable
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Gamarel, Kristine E 
 Co-Principal Investigator
Neilands, Torsten PhD 
 Other Investigator
Sevelius, Jeanne PhD 
 Other Investigator

B) Research Support Staff
Johnson, Jack 
 Research Assistant
Stein, Ellen S 
 Study Coordinator
3.3 *Please add a Study Contact
 
Johnson, Mallory PhD 
Sevelius, Jeanne PhD 
Stein, Ellen S 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your 
Department (e.g. the Department Chair or Dean).
4.0
 
Initial Screening Questions 
Updated January 2019 - Revised Common Rule (January 2018) Compliant - v92
4.1  * 
:
PROJECT SUMMARY  (REQUIRED) Give a brief overview of this project (250 words or less). Tell us 
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH 
 
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
 
Transgender women (i.e., individuals with a feminine and/or female gender identity who were 
assigned
male at birth) are disproportionately affected by HIV and transmission risk, which has been 
attributed, in
part, to primary partnerships.
The overarching goal of the study is to test the efficacy of a promising couples-focused HIV
prevention intervention to reduce HIV transmission risk among transgender women and their 
primary
partners by integrating biomedical and behavioral risk reduction strategies to help couples choose 
the most
appropriate HIV prevention plan for their relationship.
4.2  
 
* 
:
HUD DEVICE (REQUIRED) 
 
Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 

4.3  * 
: 
TYPE OF RESEARCH (REQUIRED) 
(
Select the option that best fits your project Click the orange 
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use, 
other healthcare or health outcomes related activities, research database, biospecimen bank, 
or recruitment registry) 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is 
mainly social/behavioral but also involves specimen collection or blood draws to look at 
biological measures) 
4.4  * 
 
SUBJECT CONTACT: (REQUIRED) Does this study involve 
 contact or interactions with 
ANY
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  
 
* RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening 
:
procedures and study activities
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the 
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.7  
 
* EXPEDITED REVIEW CATEGORIES: (REQUIRED) If you think this study qualifies for expedited 
 
 
review, select the regulatory categories that the research falls under: (check all that apply)
Category 1: A very limited number of studies of approved drugs and devices
Category 2: Blood sampling
Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, 
etc.)
Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, 
MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.)
Category 5: Research involving materials (data, documents, records, or specimens) that were 
previously collected for either nonresearch or research purposes
Category 6: Use of recordings (voice, video, digital or image)
Category 7: Low risk behavioral research or research employing survey, interview, oral 
history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies
* Does the collection of blood samples meet requirements outlined by HHS 
Office for Human Research Protections for Expedited Review Research 
: 
Category 2
(REQUIRED)
For healthy, nonpregnant adults who weigh at least 110 pounds the 
amounts drawn may not exceed 550 ml in an 8 week period and 
collection may not occur more frequently than 2 times per week;
From other adults and children, considering the age, weight, and 
health of the subjects, the collection procedure, the amount of blood 
to be collected, and the frequency with which it will be collected, the 

amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in 
an 8 week period and collection may not occur more frequently than 2 
times per week
 Yes  
 No
4.9  
 
* DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study 
 involve records review and
ONLY
/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment database, or 
biospecimen repository):
  Yes  
  No
4.10  
 
* CLINICAL TRIAL: (REQUIRED)
 
Is this a clinical trial:   
According to The World Health Organization (WHO) and the 
International Committee of Medical Journal Editors (ICMJE) a 
clinical trial is:
Any research study that prospectively assigns human participants or 
groups of humans to one or more health-related interventions to 
evaluate the effects on health outcomes.
ICMJE requires 
 of a clinical trial in a public database (such as 
registration
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in 
member biomedical journals.
Public Law 110-85 requires that all investigators who perform 
Guidance: 
an 
 must ensure that the trial is registered on a 
applicable clinical trial
 
.
government web site called ClinicalTrials.gov
 
The FDA requires registration for 'applicable clinical trials,' defined 
as follows:
For any trials of drugs and biologics: controlled clinical investigations, 
other than Phase 1 investigations, of a product subject to FDA 
regulation.
For trials of biomedical devices: controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and pediatric post-market surveillance.
 
 
For additional information on the ClinicalTrials.gov registration process at 
UCSF and the definition of a clinical trial for purposes of registration, visit 
 
the ClinicalTrials.gov section of the UCSF Clinical Research Resource 
HUB.
 
 
 Yes  
 No
 - 'NCT' number for this trial:
Clinical Trial Registration
NCT04067661
4.11  * 
: 
CLINICAL TRIAL PHASE (REQUIRED) Check the applicable phase(s):

Phase 0
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  
: 
* INVESTIGATOR-INITIATED (REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
 of the 
 to 
The UCSF IRB recommends use
Virtual Regulatory Binder
manage your study.
4.13  
 
*
 
CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer 
or at risk for cancer, including behavioral research, epidemiological research, public policy research, 
specimen analysis, and chart reviews):
  Yes  
  No
4.14  * 
 
RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to patients
/subjects 
 from 
 
for 
 purposes (e.g., x-rays, CT-scans, DEXA, CT-
EITHER
standard care OR 
research
guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes  
  No
4.15  SCIENTIFIC REVIEW: If this study has undergone scientific or scholarly review, please indicate 
which entity performed the review (check all that apply):
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB 
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Departmental scientific review
Other:
4.16  
 
* STEM CELLS: (REQUIRED) 
 
Does this study involve human stem cells (including iPS cells and adult 
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.17  
 
 
*
 
FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse, 
 
 
registered domestic partner and/or dependent children thereof) have financial interests related to 
 
this study:
  Yes  
  No
5.0
 Funding

5.1  
 
* FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal 
funding, 
, OR has it received 
 Federal funding in the past:
even by a subcontract
ANY
 Yes  
 No
5.2  
 
* 
Is this project linked in any way to the Department of Defense (DoD):
DoD INVOLVEMENT: 
(REQUIRED)
  Yes  
  No
5.3  
 
SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a 
 
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
View 
Details
Sponsor Name
Sponsor Type
Awardee 
Institution:
Contract 
Type:
Project 
Number 
UCSF 
RAS 
System 
Award 
Number 
("A" + 
6 
digits) 
NIH Natl Institute 
of Mental Health 
01 
UCSF 
Subcontract P0527903  
Sponsor Name:
NIH Natl Institute of Mental Health 
Sponsor Type:
01 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
1R01MH115765 
Awardee Institution::
UCSF 
Is Institution the Primary 
Grant Holder:
No 
if No, then who is the Primary 
Grantee?
University of Michigan 
Contract Type:
Subcontract 
Project Number:
P0527903 
UCSF RAS System Award 
Number ("A" + 6 digits):
 
Grant Number for Studies Not 
Funded thru UCSF:
 
Grant Title:
A couples-based approach to HIV prevention for 
transgender women and their partners 
PI Name:
(If PI is not the same as 
identified on the study.)
Gamarel, K. (University of Michigan MPI) 
Explain Any Significant 
Discrepancy:
 
Other Funding Sources and Unfunded Research - Gift, Program, 
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)

Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project
6.0
 Sites, Programs, Resources, and External IRB Review
6.1  
 
 (check all that apply):
UCSF AND AFFILIATED SITES
UCSF Benioff Children's Hospital Oakland (BCHO)
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore 
Women's Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals)
Zuckerberg San Francisco General (ZSFG)
SF VA Medical Center (SF VAMC)
Fresno - UCSF Fresno OR Community Medical Center (CMC)
Gladstone
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
6.2  
At what locations will study visits and activities occur:
LOCATIONS: 
We intend to conduct study visits, activities, and procedures at the UCSF Alliance Health Project 
(AHP) offices located at 1930 Market Street, San Francisco, CA. 94102.
 
When on-site work is limited as a result of local county health department, California State, or 
Federal directives, or for participants residing outside of the immediate SF Bay Area, procedures 
and participant visits will be conducted remotely. 
 
CTSI will oversee an EHR Recruitment Letter service for UCSF Health patients who identify as 
transgender females. 
6.3  
Will any study procedures or tests be conducted off-site by non-UCSF 
OFF-SITE PROCEDURES: 
personnel:
  Yes  
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research 

 units or utilize 
:
Services (CRS)
CRS services
 Yes  
 No
 can be found at:
The CRS budget request form
 http://accelerate.
. Follow the instructions on 
ucsf.edu/files/crs/BudgetRequest.docx
the form to submit.
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:
By 
' we mean a study where the protocol is developed 
'multi-center trial
by an lead investigator, an industry sponsor, consortium, a disease-group, 
etc.,and multiple sites across the nation or in different countries participate 
in the trial. The local sites do not have any control over the design of the 
protocol.
  Yes  
  No
6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are 
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical 
trial, UCSF is just one of the sites, and neither UCSF nor one of its 
faculty-linked affiliates (SF VAMC, Gladstone, ZSFG) are the 
coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)
6.11  * OUTSIDE RELIANCES: (REQUIRED) Are any of the collaborating sites requesting to rely on UCSF's 
IRB:
 Yes  
 No
* List the sites that are requesting to rely (more details will be requested in 
the Outside Sites section): 
 
(REQUIRED)
University of Michigan is requesting to rely on / defer to UCSF IRB.
6.14  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an 
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus, 
commercial, or institutional):
  Yes  
  No
7.0
 Outside Site Information
7.1  
 
Outside Site Information

If you have more than 10 sites to add, list the outside sites in the 
Outside Sites List document and upload it in the Other Study 
Documents section of the Initial Review Submission Packet form. 
Any sites requesting to rely on UCSF's IRB must be listed below. 
Click "Add a new row" to enter information for a site. Click it again to add a second site again to 
add a third site, a fourth site, etc.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
University of Michigan
Contact name:
Kristi Gamarel
Email:
kgamarel@umich.edu
Phone:
(734) 647-3178
For Federally-funded studies only, corresponding FWA#:
 research at this site will be reviewed by:
* The
The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
Request for UCSF to Serve As the IRB of 
Record
The non-affiliated site has reviewed UCSF's guidance "When UCSF Can 
" and made an initial determination that UCSF's IRB 
Serve as IRB of Record
 
can serve as the IRB of record:

 Yes  
 No
If 
, do NOT submit your application until after the other site 
not
has completed this step.
List the collaborators and describe the scope of work that will be carried 
out at the non-affiliated site:
Kristi Gamarel, PhD - Multi- Principal Investigator - University of 
Michigan. Data
analysis of de-identified data only.
A letter from the non-affiliated site deferring IRB approval to the UCSF IRB 
is attached:
 Yes  
 No
Note: your application cannot be processed without this 
letter.
Collaborators' training certificates for Human Subjects Training Course are 
attached:
 Yes  
 No
Note: your application cannot be processed without the 
training certificates.
Outside Site Information
Non-UCSF affiliated site information:
Site name:
Columbia University, Research Foundation for Mental Hygiene
Contact name:
Jae Sevelius, PhD.
Email:
js6254@columbia.edu
Phone:
(646) 774-6931
For Federally-funded studies only, corresponding FWA#:
FWA00006105
 research at this site will be reviewed by:
* The

The non-affiliated site's IRB or a private IRB 
The non-affiliated site is requesting UCSF to be the IRB of 
record for this study 
The non-affiliated site is not engaged in the human subjects 
research and has provided a letter of support 
If the other site's IRB approval letter is available now, attach it to 
the application.  If the IRB approval letter is not yet available, 
submit it once you receive it. 
  
  Or, if the other site is 
 in human subjects 
 
not engaged
research, attach the letter of support to your application.
8.0
 Research Plan and Procedures
8.1  
Describe the hypothesis or what the study hopes to prove:
HYPOTHESIS: 
We hypothesize that couples in the intervention condition will have lower Composite Risk for HIV 
(CR-HIV) at 12-month follow-up compared to couples in the control condition.
8.2  
List the specific aims:
AIMS: 
The primary specific aim is to:
1. Evaluate the efficacy of the T2 couples HIV counseling intervention on Composite Risk for HIV 
(CR-HIV) compared to an enhanced standard of care (SOC) control condition.
The secondary aims are to:
1. Assess the effects of the T2 couples HIV counseling intervention on theory-based mediators (i.
e. couples' self-efficacy, communication and joint problem-solving skills, coping with gender-
based minority stress and social oppression).
2. Explore partner gender, couple HIV status (seroconcordant negative/seroconcordant positive
/serodiscordant) as moderators of the effect of the intervention on CR-HIV.
8.3  
Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
DESIGN: 
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
Using a two-arm randomized controlled trial (RCT) design, we will examine intervention effects on 
Composite Risk for HIV (CR-HIV) at 12-month follow-up comparing couples randomized to the 
intervention versus an enhanced standard of care (SOC). To achieve these aims, we will recruit 
and randomize 54 couples (108 participants) to test a theory-based couples-focused intervention 
that addresses within-couple and extra-dyadic sexual risk, structural factors related to risk, 
routine testing for HIV and other sexual transmitted infections (STI), preexposure prophylaxis 
(PrEP) uptake and adherence, and antiretroviral therapy (ART) adherence (for couples in which 
one partner is HIV-positive).
 
After completing baseline surveys, couples are randomized (stratified by couple serostatus at 
enrollment) to the intervention or enhanced standard of care using a computerized secure and 
fraud-resistant procedure employed in our teams prior studies.  UCF has used this method in 
several RCTs; our experience with over 700 participants indicates that it is sucessful in achieving 
balance across demographic, mediating, and outcome variables.  
 
Couples are followed quarterly over 12 months. Behavioral data and HIV viral load tests for HIV-
positive participants are collected and analyzed using state-of-the-science dyadic analyses. If the 
intervention demonstrates efficacy compared to enhanced standard of care control condition, 
there will be methodologically rigorous support for implementing this approach within HIV 
prevention and care settings in order to reduce disparities in HIV transmission and acquisition 
among some of the highest priority HIV prevention populations in the United States.
8.4  
 Briefly provide the background and significance of this study (e.g. 
BACKGROUND AND SIGNIFICANCE:
 
why is this study needed) (space limit: one half page):

If this is a first in humans study, please summarize the safety data from 
the animal studies. For pediatric drug or device studies, please identify if 
this is the first study in pediatric populations.  
Relationship dynamics influence seeking HIV prevention and care and reducing sexual 
risk behaviors among partnerships with trans women (TW). There is a robust body of literature 
documenting the role of well-functioning primary relationships in supporting preventative health 
behaviors and in buffering partners against stress. Our team’s study of 191 TW-male couples in 
San Francisco found that male partners who reported being highly motivated to strengthen their 
relationship also had lower odds of engaging in CAS with outside partners. By contrast, male 
partners who reported more individual appetitive motives (e.g., to have a satisfying and 
adventurous sex life) had greater odds of condomless anal sex (CAS) with outside 
partners. Additional evidence from our team illustrates that greater relationship commitment 
buffers TW from the negative effects of discrimination on health outcomes. However, our 
qualitative work with TW-couples also revealed complex interactions between relationship 
dynamics and HIV prevention behaviors, such that many TW fear having explicit conversations 
about HIV and prevention planning with their partners, due in part to anxiety about power 
differentials and the risk that their male partner will reject them. Thus, couples-based HIV 
prevention is a promising and urgently needed HIV intervention modality for couples. Despite 
acceptability of couples-based prevention interventions for heterosexual and MSM partnerships, to 
our knowledge, only our pilot Couples-focused HIV Intervention Program (CHIP) has
been developed to meet the unique prevention needs of TW couples (R34MH093232). Those 
results demonstrated that the CHIP intervention was feasible and promising in reducing HIV risk 
(i.e., sexual risk behavior) among TW couples. However, assessing the efficacy of this 
intervention is needed. The original design of the CHIP protocol predated the published results 
showing the protective effects of PrEP and viral suppression against HIV transmission, and thus 
CHIP lacked content related to biomedical HIV prevention strategies for TW couples. Although the 
CDC recently supported CHIP as the first “good” evidence-based intervention for reducing HIV 
risk among transgender people, the intervention needs to incorporate biomedical prevention 
strategies with longer follow-ups in order to be considered a “best” evidence-based intervention 
and to be relevant to current priorities in biobehavioral HIV prevention.
8.5  
Briefly summarize any preliminary studies relevant to your proposed 
PRELIMINARY STUDIES: 
research 
:
(space limit: one half page)
This RCT builds upon our previous qualitative study at UCSF: Study #18-25144. The previous 
qualitative study informed decisions about target populations, recruitment, retention, and 
intervention.
 
Development and pilot test of the Couples HIV Intervention Program (CHIP) for TW-male couples
Our team recently completed a pilot RCT of CHIP, an HIV prevention program for TW couples. 
CHIP was adapted from Project Connect, a CDC-endorsed “high impact” HIV intervention for 
couples that focuses on  relationship quality/functioning, communication, and shared 
commitment. The design of CHIP involved iterative rounds of quantitative and qualitative 
research with TW-male couples to identify intervention targets and gender-sensitive delivery 
processes for HIV prevention for racially/ethnically diverse TW-male partners across different age 
groups. Over a 13-month outreach and recruitment period, the study team recruited 56 TW-male 
partners (n=112 participants) and examined the acceptability, feasibility, and 3-month outcomes 
on sexual risk behavior (45.5 % Black, 14.3 % Hispanic, 24.1 Other, and 16.1 % White). Couples 
randomized to the control arm received basic HIV information. Couples in the intervention arm 
(CHIP) received three sessions designed to improve relationship and couples’ communication 
skills to promote HIV risk reduction. They received two couples-focused sessions in which the 
couple met with a counselor to promote positive relationship dynamics, communication skills, and 
to identify HIV risk reduction goals; each partner also had 1 individual session with the counselor 
to describe their personal HIV prevention concerns in the context of their relationship and with 
outside partners. At 3-month followup, participants in the intervention arm had lower odds of CAS 
with primary partners (OR=0.5, 95%CI: 0.3-1.0), reduced odds of engaging in sex with any 
casual partner (OR=0.3, 95%CI: 0.1-1.0), and reductions in overall number of casual partners 
(B=-1.45, SE=0.4) compared with the control arm. In exit interviews, TW and male intervention 
participants commented favorably on focusing on strengthening relationships, communication 
around HIV, and coping with gender minority stressors, and described interest in further couples-
focused programs with more than three sessions. These results provide support for the feasibility 
and acceptability of CHIP, and demonstrate the team’s ability to recruit and implement a couples-
focused intervention for TW and their primary partners.

8.6  
Is this a treatment study, i.e. does this study intend to provide treatment 
* TREATMENT PROTOCOL: 
to individuals with a medical or psychological condition: (REQUIRED)
  Yes  
  No
8.7  
 Does this study involve any procedures, lab tests or imaging studies that 
* BILLABLE PROCEDURES:
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other 
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
  Yes  
  No
, send 
If you are not sure if your study involves billable procedures
an email to the 
 for help 
UCSF Office of Clinical Research (OCR)
answering this question.
8.8  
Types of research activities that will be carried out. Check all that 
 COMMON RESEARCH ACTIVITIES: 
*
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs, 
etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above
8.9  
PROCEDURES / METHODS: 
* 
(REQUIRED)
Describe the research methods and study activities taking place at each site 
(e.g. what will participants be asked to do and what will members of the 
study team do?). If there will be multiple participant groups or study sites, 
explain what will happen with each group or study sites.
 
If some of the activities would occur even if the person were not in the 
study, as in the case of treatment or tests performed for diagnostic 
purposes, clearly differentiate between those activities that will be 
done solely for research purposes and those that are happening as 
part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the 
Expedited Review team if you need help differentiating between what parts 
are research and what parts aren't.

:
Recruitment   Participants are recruited by a team that is experienced in conducting transgender 
research, using a multi-pronged approach including recontacting potentially eligible participants 
from prior studies who gave permission for future contact; street, agency, and event-based 
outreach; posting and distribution of Recruitment Flyers; internet-based advertising on Facebook 
and Grynder.
 
Additionally, we are collaborating with the CTSI Consultation Service to provide cohort 
identification and direct mail for recruitment. The Dear Patient letter (attached) will be sent to 
UCSF patients identified from the APeX record systems via a data extraction by Academic 
Research Systems (ARS) of patients with a diagnosis of [XXX]. These patients [are/are not] 
known to or under the care of the researcher team. The CTSI Consultation Service will coordinate 
the mailing on behalf of the study. Interested subjects will contact the study staff as described in 
the letter. The data extract will be delivered to the CTSI Consultation Service’s MyResearch 
account in order to facilitate the direct mail activities while ensuring privacy and confidentiality of 
the patients identified. Protected data elements included in the data pull and delivered to the 
honest broker may include MRN, name, mailing address, and diagnosis or encounter date. 
Additional non-PHI data elements may also be collected to facilitate the mailing.
Pre-Screening: Potential participants are pre-screened by Research Assistants (RA) by 
telephone or in-person at the Alliance Health Project (AHP) site. RAs describe basic study 
eligibility criteria (>18 years of age, gender, in a relationship, English speaking). For those who 
provisionally qualify, Partner 1 is pre-screened using a Screening Form in REDCap that includes 
questions on recent HIV risk, and the name and contact information of the partner. Study RA 
contacts Partner 2 within one week to pre-screen using a  REDCap Screening Form. If the couple 
is provisionally eligibile AND both partners wish to enroll, they are scheduled for an Eligibility Visit 
at AHP to verifiy HIV status. If HIV-positive, they are asked to bring documentation of their 
status.     
 
:
Eligibility Visit
1. Visits occur at the AHP site. Both partners attend the Eligibility Visit together at AHP, and RAs 
conduct Oral Informed Consent with each partner in separate rooms. 
2. RA completes an Eligibility Visit Form in REDCap for each partner, and confidentially verifies 
HIV status by:  
    a. Review recent (last 30 days) HIV Letter of Diagnosis, HIV medication bottles, or medication 
prescription;
    b. Confirm prior participation in the Healthy Divas Study for HIV positive trans women;   
    c. Conduct basic HIV pre-test counseling, OraQuick point-of-care HIV antibody test with saliva 
from participants' mouth, and disclose result along with post-test counseling
. 
*
3. Enter HIV status of the partners in REDCap, which is programmed to inform the RA if the 
couple may enroll in the study based on their HIV status and responses to eligibility questions. If
    a potential participant indicates that study participation may pose safety risks to them, a 'flag' 
is generated in REDCap, and the RAs tell the couple that they are not eligible for the study at
    this time, but may rescreen in 6 months either together or with a new partner should they 
break up.
4. Study enrollment requires the participation of both partners, as a couple. If both agree, 
schedule Enrollment Visit at AHP or remotely. The Enrollment visit can immediately follow the 
eligibility Visit.    
5. RA provides each partner with a visit incentive, Resource List, condoms, and lubricant.  
* If a potential participant has a 
 positive HIV-antibody test result at the Eligibility Visit, the 
new
RA provides supportive counseling and provides a Referral List to clinics where HIV confirmatory 
testing can be obtained. They offer to help set up that appointment and/or accompany them. 
Care is taken to ensure there is no disclosure to the other partner and the couple is told that they 
are not eligible for the study at this time, but may rescreen in 6 months either together, or with a 
new partner should they break up. 
 
Enrollment Visit:
1. Visits occur at the AHP site or remotely. RAs obtain signed Informed Consent from both 
partners. 
2. RAs obtain signed Release of Information Forms to contact HIV medical provider for positive 
participants, should they be needed for future lab results.
3. RAs collect contact locator information from each partner.
4. For HIV positive participants, a trained phlebotomist draws 20 ml venous blood for viral load 
testing or the participant is asked to have blood drawn at a Quest Laboratory Service Center.
5. For HIV negative participants who have taken HIV pre-exposure prophyaxis (PrEP) medication 
in the last 3 months, dried blood spot (DBS) fingerstick procedures are conducted by the
    phlebotomist or a hair sample is collected for remotely conducted visits.  

6. Each partner completes an audio computer assisted self-interviewing (ACASI) survey in 
REDCap on a tablet, or for remote visits, the survey is interviewer-administered.
7. REDCap provides the RAs with the randomization arm for the couple, who are informed of 
the assignment. Couples are randomized (stratified by couple serostatus at
    enrollment) to either the study intervention
 or Standard of Care (SOC) using a computerized, 
*
secure, and fraud-resistant procedure. UCSF has used this method in several RCTs and our
    experience with over 700 participants indicates that it is successful in acheiving balance across 
demographic, mediating, and outcome variables.     
8. Couples assigned to the SOC controlarm watch a ~13 minute video set that reviews HIV 
Prevention; PrEP & PEP; Condom Use; and U equals U concepts. 
9. RAs schedule their 3, 6, 9, and 12-month quarterly follow-up visits and provide appointment 
information, visit incentives, a Resource List, condoms, and lubricant.   
10. Couples who are assigned to the study intervention arm
are introduced to the Health 
*
Counselor, who leads Intervention Session 1 (20 minutes). When completed, the Health Counselor
      schedules Intervention Sessions 2 /3 /4 and provides appointment cards, visit incentives, a 
Resource List, condoms, and lubricant.  
     
The Couples Study Intervention* includes four weekly counseling sessions with both 
members of the dyad. Sessions last 20-45 minutes, and focus on providing information about HIV 
risk reduction strategies, communication and joint problem solving in the relationship, identifying 
gender minority stressors and social oppression, supporting each other's health, and the 
development of an HIV prevention plan. Couples learn different HIV prevention strategies, discuss 
their unique HIV prevention needs and how relationship dynamics impact their risk. Sessions are 
designed to help couples identify how gender minority stressors (e.g., discrimination) and social-
structural oppression (e.g., poverty, unemployment) impact relationship functioning and 
interactions with healthcare settings to work towards empowering couples to communicate about 
these stressors. Through counseling facilitation, couples identify stressors specific and structural 
factors that are most relevant to their relationship dynamics. Partners learn and practice 
communication and conflict resolution skills, and practice problem-solving as a couple. The last 
session helps couples problem-solve barriers to effective communication, use those skills to 
develop an HIV prevention plan that meets both partners’ needs, and identify existing and 
potential sources of support. Importantly, The intervention program focuses on the future: 
partners will not be asked to reveal recent risk behaviors/exposures to each other. Instead the 
focus is on the couple building a prevention plan that reflects their relationship goals, risk 
behaviors, and serostatus. Foundational to the intervention is helping couples transform their 
motivations to protect their relationship and their partner, while building couples’ self-efficacy, 
communication, joint problem-solving skills, and effective coping with gender minority stressors 
and social-structural oppression so that couples can develop and adhere to an HIV prevention 
plan.
 
Intervention Session 1 (20 minutes) called ‘
’. In this first session, the couples 
Glad You Came
receive an overview of the intervention, work with the facilitator to develop session 
boundaries, identify relationship strengths, set one relationship goal and amplify a 
positive moment in the relationship.
Intervention Session 2 (45 minutes) is called ‘
’. In this session, 
In the Heat of the Moment
couples discuss their communication styles and where differences come up, learn and practice 
communication techniques, develop a plan for taking time outs, set one relationship goal and 
amplify a positive moment in the relationship.
Intervention Session 3 (45 minutes) is called ‘
’. In this session, 
Let’s Talk About (Safer) Sex
couples learn about sexual health and prevention strategies, identify their current strategies,
learn about relationship agreements, set one relationship goal and amplify a positive moment in 
the relationship.
Intervention Session 4 (45 minutes) is called ‘
’. In this final session, couples 
It Takes Two
review the sexual health and safer sex goals; identify ways to support each other in these 
strategies;
and plan for the future. The counselor also provides couples with linkage to services as needed.
All intervention sessions are audio-recorded for Quality Assurance and trainiing purposes, unless 
participants wish to opt out, which they may do during the informed consent process.
: 
Quarterly Follow-up visits  Couples complete quarterly follow-up visits at 3-, 6-, 9-, and 12-
months post-enrollment. The quarterly follow-up survey largely repeats questions from the 
baseline survey. Static information is not repeated, intimate partner violence (IPV) is assessed 
only at baseline, the 3-month assessment include measures of satisfaction with the intervention 
(for those randomized to it). When a relationship dissolution is reported at a follow-up visit, the 
survey will assses if the dissolution was linked to the intervention or to other factors. 

1.  
2.  
3.  
4.  
1.  
RAs update contact information for each partner.
For HIV positive participants, viral load testing is conducted. 
Each partner completes an audio computer assisted self-interviewing (ACASI) or 
interviewer-administered survey.
RA provides each partner with a visit incentive, Resource List, condoms, lubricant, and 
reminds the of the next visit date.  
 
 In our prior trials we developed procedures to maintain at minimum 80-
Retention Procedures:
90% follow-up rates. A computerized scheduling system tracks due dates and completion status 
of follow-ups. Calls are made to participants who have not been scheduled or missed an 
appointment. The RA will call participants 1 week, and 1 day before a follow-up is due to confirm 
the appointment. Couples come to visits together if break up has not occurred, but complete all 
assessment activities separately. Couples are followed individually in case of relationship break-
ups.
 
SARS-CoV-2 Safety Considerations: 
Study visits will take place at the Alliance Health Project (AHP) Offices. AHP is a division of 
the Department of Psychiatry and Behavioral Sciences with a Services Center located at 
1930 Market Street. At AHP, the following practices are in place to prevent transmission of 
COVID-19 for staff, clients, and research participants in accordance with guidance from 
UCSF and the San Francisco Department of Public Health (SFDPH):
On-site staffing is limited to a minimum number of staff necessary to provide essential 
services, with no more than 15 staff on-site at the same time and most staff reporting on-
site one day per week. An On-Site Supervisor is present for all shifts. All staff have 
completed the mandatory COVID-19 and Working Onsite at UCSF training. Visits are 
provided by appointment with a limited number of staggered slots to facilitate a maximum 
of six clients in the building at the same time and a maximum of 24 clients in the building 
per day.
All staff are required to complete the UCSF Daily Health Screen before entering AHP. The 
On-Site Supervisor and Project Director will monitor compliance with this requirement. The 
doors to AHP remain locked at all times, and clients and other visitors (i.e., delivery 
personnel or other service vendors) to the building are asked the same health screening 
questions by staff through the closed door or via intercom system before entering. These 
questions, along with other entry instructions, are posted on the front doors. 
Building signage provided by UCSF Facilities Services is deployed throughout the building 
to inform and remind staff, clients, and other visitors of COVID prevention measures. This 
includes signage at building entrances about health screening and masking requirements, 
handwashing reminders in restrooms and other sinks, instructions to use a paper towel to 
open refrigeration and microwave doors, and signs indicating the maximum number of 
occupants allowed in each room. Floor markers have also been placed outside the main 
entrance and in the lobby to indicate where clients should stand to maintain physical 
distancing.
All staff, clients, study participants and other visitors are expected to maintain a physical 
distance of at least six feet from other people at all times while on-site. Occupancy in all 
rooms has been limited to allow for at least 60 square feet per person. In the lobby, other 
common areas, and spaces where clients are seen for services, furniture has been 
removed and rearranged to maintain physical distance. In addition, clear plastic barriers 
have been added. 
All staff working at AHP are required to wash hands thoroughly with soap and water for 20 
seconds or longer upon entering, and frequently while on-site. Reminder signage provided 
by UCSF Facilities is posted in all restrooms and at other sinks. Hand sanitizer is available 
in the lobby and other common spaces.
All staff, clients, study participants and other visitors to the building are required to wear 
surgical masks provided to them. Staff are required to wear a personal face covering upon 
entering and once inside to wash their hands, then put on surgical face masks provided to 
them. Staff are required to wear these surgical face masks at all times while on-site and 
may be reused as long as they remain clean and dry. Phlebotomy staff must wear N95 
masks, gloves, and face shields when collecting blood or handling other biohazardous 
materials in accordance with the UCSF Supplemental Laboratory Safety Procedures to 
Reduce COVID-19 Transmission and the SFDPH Preferred and Alternative PPE Use by 
Behavioral Health Clinical Scenario.
AHP follows guidelines for cleaning shared work areas in the UCSF Protocol for Working 
Onsite. Using disinfecting wipes or other EPA-approved disinfectants, staff clean frequently 
touched surfaces in the lobby, other common areas, and spaces accessed by clients. 
Caddies containing cleaning supplies and instructions are provided in each area that 
requires daily disinfection. Rooms in which clients are seen for services are left vacant for 
at least 30 minutes after cleaning and before they can be used again for another client 

appointment. A janitorial service provides additional daily cleaning of kitchen, lab, and 
restrooms. 
AHP continuously assesses and revises COVID prevention policies and procedures based 
on direction from UCSF. The Medical Director and Operations Manager shares 
responsibility for reviewing new guidance, revising workplans accordingly, and notifies 
staff, clients, and other visitors as well as other UCSF entities (e.g., Emergency Operations 
Center, Environmental Health & Safety, Facilities) as needed.
2. 
 that in-person contact due to the SARS CoV-2 pandemic is restricted by UCSF, 
In the event
SFDPH, or any other entity, the following modifications will be made to conduct visits remotely: 
 
Remote Pre-Screening: Procedures will take place exclusively by telephone or using an 
approved teleconference platform (Zoom, Facebook Messenger video chat, Apple FaceTime, 
Google G Suite Hangouts video or Skype for business).  
 
Remote Eligibility Visit: RAs send the verbal ICF to the partners by email, surface mail, or 
DocuSign and schedule a time to review the ICF with each. Using their copy, each partner will 
follow along during the informed consent discussion which will occur by phone or on an approved 
videoconferencing platform (Zoom, Facebook Messenger video chat, Apple FaceTime, Google G 
Suite Hangouts video or Skype for business). RAs verify HIV status of each partner to determine 
couple eligibility by:  
    a. Participant can text a photo of a recent (last 30 days) HIV Letter of Diagnosis, HIV 
medication bottle, or medication prescription if HIV-positive;
    b. Participant may text a photo of a recent (last 30 days) PrEP medication bottle or prescription 
if HIV-negative and on PrEP;
    c. HIV-positive status can be verified for formerly participants of the Healthy Divas study for 
HIV-positive trans women;
    d. Participants self-administer an OraQuick HIV antibody test that is mailed to them with 
instructions, and text back a photo of the test result (See T2 Participant OraQuick Instruction
;
s)
    e. Participants self-administer an OraQuick HIV antibody test that is mailed to them while a 
trained HIV Pre/Post-test counselor provides step-by-step guidance by phone or using an 
approved video-conference platform.
    f. RA enters HIV status of partners into REDCap, which infroms the RA if the couple can enroll 
based on their HIV status and responses to eligibility questions. Study enrollment requires 
participation of each partner, as a couple. If both agree, an Enrollment Visit is scheduled. Each 
partner is emailed a Resource List. Visit incentives are provided in the form of an Amazon gift 
code emailed to participant, cash mailed to a secure address with the understanding that if lost 
by USPO it cannot be replaced, or sent via CashAp. 
Remote Enrollment Visit:
1. Each partner is sent the study ICF and a Release of Information for their care provider if HIV-
positive, via email, surface mail, or DocuSign. After reviewing the ICF and answering 
questions, RAs help participant to sign and return the ICF and ROI. If P1 and/or P2 are unable to 
use DocuSign, two paper copies of the ICF (and appropriate ROI form) are mailed along with a 
stamped, self-addressed envelope. When received, RA sets up a videoconference or phone call to 
review ICF (and ROI) and answer questions. Participants sign one copy to return in the stamped-
self-addressed envelope and retain the second copy.
2.  RAs collect Contact Locator Information from each partner on the phone or via an approved 
videoconference platform (Zoom, Facebook Messenger video chat, Apple FaceTime, Google G 
Suite Hangouts video or Skype for business).   
3. RAs complete REDCap Enrollment Visit Forms and conduct Baseline Survey separately with P1 
& P2 by phone, zoom, or on an approved video-conferencing platform.
4. RAs determine the correct labs to collect from P1 and P2. 
If participant is 
, no labs are required
HIV-negative and not taking PrEP
.
If participant is 
, the participant is asked to go to a 
HIV-positive
QUEST Patient Service 
 to have their blood drawn for HIV viral load test processing. See 
Center
Attachment T2 
.
Participant Instructions for Quest Blood Collection
If the participant cannot or will not agree to any of these methods, they may send us a 
recent (last 30 days) HIV viral load lab result OR using a ROI, we will request an HIV viral 
load result from within the last 30 days from the medical provider.  
5. REDCap provides the RAs with the couples' randomization arm and the RAs inform them of the 
assignment. 

6. Couples assigned to the control condition are emailed the HIV-risk reduction videoset to watch, 
and RAs schedule the 3, 6, 9, and 12-month follow-up visits for the couple.   
7. Couples assigned to the intervention arm are contacted by a Health Counselor, who schedules 
and conducts the four weekly intervention sessions on an approved videoconference 
platform,  ensuring the couple has adequate privacy. 
8. Each partner is emailed a Resource List. Visit incentives are provided in the form of an Amazon 
gift code emailed to participant, cash mailed to a secure address with the understanding that if 
lost by USPO it cannot be replaced, or sent via CashAp. 
 
Remote Quarterly Follow-up visits
1.  RAs collect Contact Locator Information from each partner on the phone or via an approved 
videoconference platform (Zoom, Facebook Messenger video chat, Apple FaceTime,
     Google G Suite Hangouts video or Skype for business). 
2.  Follow-up surveys are interviewer-administered on the phone or an approved teleconference 
platform. 
3.  RAs determine the correct labs to collect from P1 and P2.
If participant is 
, no labs are required
HIV-negative and not taking PrEP
.
If participant is 
, the participant is asked to go to a 
HIV-positive
QUEST Patient Service 
 to have their blood drawn for HIV viral load test processing. See 
Center
Attachment T2 
.
Participant Instructions for Quest Blood Collection
If the participant cannot or will not agree to any of these methods, they may send us a 
recent (last 30 days) HIV viral load lab result OR using a ROI, we will request an HIV viral 
load result from within the last 30 days from the medical provider.  
4.  Each partner is emailed a Resource List. Visit incentives are provided in the form of an 
Amazon gift code emailed to participant, cash mailed to a secure address with the understanding
     that if lost by USPO it cannot be replaced, or sent via CashAp. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.11  
List all questionnaires, surveys, interview, or focus group guides that will be used for 
INSTRUMENTS: 
this study:
If the instruments are not complete or not available because they will be 
developed as part of this study, describe the basic content or include an 
outline and submit the final versions to the IRB with a modification for 
approval prior to use.
 Assessments focus on: (1) predisposing factors related to our mechanisms and the CR-HIV 
outcome; (3) measures of feasibility/acceptability; (4) primary and secondary outcomes; (5) 
theory-based mechanisms of action.
1. Predisposing Factors. Stigma, oppression, and relationship functioning are extra-individual 
predisposing factors which may influence our hypothesized mechanisms of change and CR-HIV. 
Participants will complete measures of relationship functioning, which include the Dyadic 
Adjustment scale, Commitment scale, and the Power and Attitudes in Relationships scale. We will 
assess everyday experiences of transgender discrimination, including discrimination experienced 
by male partners due to being in a relationship with a TW, as well as our validated measure of 
relationship stigma. We will also assess upstream structural factors that may be associated with 
CR-HIV (e.g., poverty, employment status).
2. Mechanism of Change. Participants will complete the Couples Efficacy to Reduce HIV Threat 

scale which assesses each partner’s confidence in their ability to engage in joint effort, 
communication, and planning and decision making together to reduce HIV. Participants will 
complete the Communication Patterns Questionnaire, as well as an indicator of Joint problem-
solving skills, which will be assessed with the adherence problem solving / readiness scale. We 
will use the Dyadic Coping Inventory which assesses the extent to which couples work together, 
engage in mutual decision making, and engage in open communication to alleviate a stressor (e.
g., minority stress and social oppression).
3. Feasibility and Acceptability of Intervention. In regards to acceptability, participants will 
complete the Client Satisfaction Survey at their 3-month assessment, which is an 8-item measure 
assessing satisfaction with the intervention. Additionally, we will track session attendance.
4. CR-HIV (primary outcome) is a couple-level binary indicator of any HIV risk (e.g., yes=1 vs. 
no=0), which is an algorithm based on whether one or both partners report condomless anal or 
vaginal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 3 
months. Couples are coded as 0 if neither partner reports condomless anal or vaginal sex. If one 
or both partners in the dyad report condomless sex with a serodiscordant or status-unknown 
primary or other partner, then the couple is coded as 1 if (i) the HIV-negative participant is not 
adherent to PrEP and/or (ii) the HIV-positive participant is not virally suppressed. Sexual risk 
behavior will be measured using the assessment that we have used in our previous studies to 
explore the number of occasions of different sexual acts (vaginal, anal; receptive, insertive) with 
three different types of partners (primary partner, casual partner, paying partner), use of 
condoms during the past 3 months, and knowledge about partners’ HIV status. Assessments 
ascertain sexual behaviors with non-trans male, non-trans female, and transgender partners, and 
will be asked at each follow-up. At-risk sex will be defined as any vaginal or anal intercourse 
without condoms that occurs with a person of known positive or unknown serostatus during the 
follow-up period. Of the participants who report condomless sex with a serodiscordant or 
unknown serostatus partner, we will attempt to assess PrEP use using dried blood spot (DBS) 
procedures for biological measurement of adherence from tenofovir diphosphate concentrations in 
blood plasma. We will use dosing categories for quantification similar to those used in past drug-
level studies of PrEP adherence, allowing us to estimate the number of tablets participant are 
taking per week (e.g., 700-1249 fmol for 4-6x per week and > 1250 for daily dosing). HIV-
positive participants will have their blood drawn at each follow-up visit to determine viral 
suppression. Viral suppression is indicated by an undetectable HIV-1 level on the COBAS® 
AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.), which has a 
threshold for undetectability = < 20 copies/mL and is conducted at each follow-up assessment 
visit. Our secondary outcomes include self-report HIV and STI testing over the 12 months of 
follow-up.
5. Theory-based mechanisms of action. Covariates will include sociodemographic variables such 
as age, education and income level, employment, race/ethnicity, living situation, which have been 
previously found to be structural drivers of HIV risk. While the intervention does not target 
mental health or substance use, we will assess depressive symptoms using the Center for 
Epidemiologic Studies Depression Scale (CES-D), and anxiety symptoms will be measured with 
the Beck Anxiety Inventory. We will also assess alcohol use and other drugs with the AUDIT as 
well as the Alcohol, Smoking, and Substance Involvement Test (ASSIST) given their associations 
with HIV outcomes. We will also assess history/current health care engagement (i.e., HIV 
prevention, primary care, mental health).
Attach any unpublished instruments in the 'Other Study Documents' 
section of the Initial Review Submission Packet form after 
completing the study application. Published instruments should 
NOT be attached.
8.12  
Are you drawing any blood or collecting other biosamples (e.g. tissue, 
* BIOSPECIMEN COLLECTION: 
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future 
research: (REQUIRED)
 Yes  
 No
Could this study generate genetic data that may be broadly shared (e.g., submitted to 
* 
NIH in compliance with Genomic Data Sharing (GDS)/Genome-Wide Association 
 requirements): 
Studies (GWAS)
(REQUIRED)
  Yes  
  No
Please check the Resource Sharing Plan section of your funding 
notice. You will not be able to share the data as required by your 

funding agency if the consent form doesn't include the required 
language.
8.13  
Briefly summarize the methods and types of analyses that will be 
STATISTICAL METHODS: 
performed:
Preliminary analyses and missing data. Frequency tables for all variables and measures of 
central tendency and variability for continuous variables will characterize the sample and will be 
stratified by study arm to check for imbalances. If the intervention and control groups differ 
significantly at baseline on one or more covariates, we will use methods based on the Rubin 
causal model (e.g., propensity scores, double-robust estimation) to obtain the desired marginal 
effect estimates under the counterfactual assumption of balanced groups.81-85 We will address 
incomplete data with multiple imputation (MI)86 because MI makes the relatively mild 
assumption that incomplete data arise from a conditionally missing-at-random (MAR) mechanism.
87
Auxiliary variables will be included to help meet the MAR assumption;88, 89 sensitivity analyses 
will be conducted with weighted MI to assess the MAR assumption’s robustness90 using SAS91 
and Mplus.
. If the CHIP intervention is successful, a 
Primary analyses to address Primary Specific Aim 1
lower proportion of intervention participants will engage in CR-HIV relative to control group 
participants following intervention exposure. Therefore, to address Specific Aim 1 we hypothesize 
that the odds of CR-HIV will be lower for CHIP participants than for control participants 
(Hypothesis 1). Our primary interest is to estimate the marginal or population-average effects of 
CHIP exposure on CR-HIV rather than the effect for a hypothetical average subject or couple.92 
Moreover, within-subject and within-couple CR-HIV correlations are nuisance parameters rather 
than quantities of interest to be modeled explicitly. Finally, the statistical literature indicates
the superior performance of generalized estimating equations (GEE) relative to generalized linear 
mixed models (GLMMs) for the analysis of dyadic data with categorical outcomes such as CR-HIV.
93 Accordingly, we will use GEE for the proposed primary analysis to test Hypothesis 1 by a 
planned time-averaged comparison of post-baseline measurements of CR-HIV from the 
intervention group with the post-baseline measures of CRHIV from the control group. Alpha (α) 
will be set at .05 for this planned comparison. Any additional post-hoc comparisons (e.g., paired 
comparisons of groups at each time point) will maintain nominal alpha of .05 through the use of 
simulation-based stepdown multiple comparison methods.94 The alternating logistic regression
(ALR) approach implemented in SAS PROC GENMOD will be used to address the 3-level clustering 
of observations within participants and participants within dyads. Though GEE estimates are 
consistent even if the correlation structure is misspecified, GEE's statistical efficiency improves as 
the working correlation structure more closely approximates the actual correlation structure;95 
therefore, various correlation structures suitable for the study's design will be considered (e.g., 
exchangeable; nested-1).96 The QIC statistic will be used to select the final correlation structure.
97 Couple serostatus will be included as a covariate as required by the stratified randomized 
design.98 Additional relevant covariates such as relationship length, as well as intersectionality 
criteria and structural drivers (e.g., age, race/ethnicity, poverty, unemployment) will be 
included if they improve QIC. We will use Robust Huber-White "sandwich" standard errors to 
obtain correct inferences even if the chosen correlation structure remains slightly misspecified.
: Exploring mediation and 
Secondary analyses to address Secondary Specific Aims 1 and 2
moderation. To explore the effect of CHIP on hypothesized mechanisms of change, secondary 
analyses will explore whether participants assigned to CHIP report higher mean scores on theory-
based constructs such as couple selfefficacy, communication and joint problem-solving strategies, 
and dyadic coping with gender minority stressors following the intervention. These analyses will 
also investigate whether these constructs at 3, 6 and 9 months mediate the relationship between 
intervention group assignment and CR-HIV at 6, 9 and 12 months, respectively, and whether 
couple HIV-serostatus and (in line with NIH guidelines to consider sex as a biological variable) 
whether gender moderate these associations. Mediation and moderation will be assessed using 
the causal inference-based approach of Valeri and VanderWeele, which yields optimal estimates 
of indirect effects in the presence of moderators and non-continuous outcomes and mediators .99 
Mplus will be used to fit causal mediation-moderation models because it adjusts standard errors 
for clustering of participants within couples.
. 
Secondary analyses to address moderation and subgroup differences in intersectional variables
As noted above in C.1 Preliminary Studies, the intervention is designed to be equally efficacious 
across intersectional subgroups of participants, so we do not anticipate differential intervention 
effects by subgroup. However, we will conduct additional exploratory sensitivity analyses to 
evaluate the moderating effects of age, HIV status, race/ethnicity, poverty, and unemployment to 
explore whether these intersectionality criteria and structural drivers enhance or dampen the 
intervention’s effects on CR-HIV and the theory-based mediators listed above. Where cell sizes 
permit, subgroup analyses will be performed, stratifying on race/ethnicity, age, and 
poverty. While our study is not formally powered to examine subgroup differences and it would be 

infeasible to recruit sufficiently large numbers of participants in each intersectional category to 
formally test for differences, these
analyses may illuminate trends in group differences, which can inform future studies of specific 
subpopulations if trends are detected. Moderation and subgroup analyses will be performed using 
the same GEE and causal inference approaches described above to test for moderation and 
moderated mediation, respectively. 
Secondary exploratory dyadic analyses. Intact dyads enable analyses that explore how 
predisposing factors, such as relationship functioning and gender minority stressors affect 
behavior change in partnerships. We will extend the analyses described above to include actor 
and partner effects for covariates and mediators. Actor effects describe the influence that one’s 
standing on independent or mediating variables (e.g., the trans woman’s communication) has on 
one’s own dependent variables (e.g., self CR-HIV) whereas partner effects describe the influence 
that one’s standing on independent variables has on the dependent variables of one’s partner (e.
g., the trans woman’s effect on her partner’s CR-HIV). This technique illuminates the effects that
partners in intimate relationships can have on both their own and their partner’s behaviors. Actor 
and partner effects can be evaluated in models with either continuous101 (e.g., problem solving) 
or categorical dependent variables (e.g., CR-HIV).100 A closely related approach uses sums and 
differences of continuous covariates and mediators to quantify within-couple and between-couple 
effects. For continuous dependent variables, within-couple hypotheses will be tested with a GEE 
model in which couple-level difference scores on the outcome variable (e.g., communication) will 
be regressed onto both the couple-level difference and sum scores for the predictor variable (e.g., 
self-efficacy).102 Computing sums and differences for categorical outcomes is not feasible, but it 
is still possible to investigate the effects of sums and differences of individuals’ 
continuous covariates and mediators on individual-level categorical responses (e.g., CR-HIV ) to 
tease apart the separate influences of between-couple and within-couple effects of mediators on 
individuals’ categorical outcomes.
8.14  
List only the 5-10 most relevant references (a separate bibliography can be attached 
REFERENCES: 
 
for reference purposes if this study involves novel approaches, agents, or an emerging technology 
that the IRB may not be familiar with):
1. Baral SD, Poteat T, Stromdahl S, et al. Worldwide burden of HIV in transgender women: a 
systematic
review and meta-analysis. Lancet Infect Dis. 2013;13(3):214-222.
2. Operario D, Nemoto T, Iwamoto M, et al. Unprotected sexual behavior and HIV risk in the 
context of
primary partnerships for transgender women. AIDS Behav. 2011;15(3):674-682. PMC3049202
3. El-Bassel N, Gilbert L, Witte SS, et al. Couples-based HIV prevention in the United States: 
Advantages,
gaps, and future directions. J Acquir Immune Def Syndr. 2011;55:S98-101.
4. Sevelius JM, Keatley J, Calma N, et al. 'I am not a man': Trans-specific barriers and facilitators 
to PrEP
acceptability among transgender women. Glob Public Health. 2016; 11(7-8): 1060-75 26963756
5. Operario D, Nemoto T, Iwamoto M, et al. Risk for HIV and unprotected sexual behavior in male 
primary
partners of transgender women. Arch Sex Behav. 2011;40(6):1255-1261. PMID: 21604064
6. Gamarel KE, Reisner SL, Laurenceau J-P, et al. Gender minority stress, mental health, and 
relationship
quality: A dyadic investigator of transgender women and their cisgender male partners. J Fam 
Psychol.
2014;28(4):437-447. PMC4122619
7. Gamarel KE, Reisner SL, Darbes LA, et al. Dyadic dynamics of HIV risk among transgender 
women
and their primary male partners: The role of sexual agreement types and motivations. AIDS Care.
2015;28(1):104-111. PMC4713318
8. Operario D, Gamarel KE, Iwamoto M, et al. Couples-focused prevention program to reduce HIV 
risk
among transgender women and their primary male partners: Feasibility and promise of the 
Couples HIV
Intervention Program. AIDS Behav. 2017; 21(8): 2452-2463. PMC5179320
9. Reisner SL, Gamarel KE, Nemoto T, et al. Dyadic effects of gender minority stressors in 
substance
behaviors among transgender women and their non-transgender male partners. Psychology of 
Sexual
Orientation and Gender Diversity. 2014;1(1):63-71. PMC4311402
10. Deutsch M, Glidden D, Sevelius J, et al. Preexposure chemoprophylaxis for HIV prevention in
transgender women: A subgroup analysis of the iPrEx trial. Lancet HIV. 2015;2(12):e512-519. 
PMC5111857

 
9.0
 Biospecimen Collection and/or Bank Administration
9.1  
(check all that apply): 
TYPE OF SPECIMENS 
* 
(REQUIRED)
Blood (provide amount below)
Tissue (describe below)
Other type of biospecimen, such as sputum, cerebrospinal fluid, buccal swabs, etc. (describe 
below)
Existing/archival materials (name source below)
Briefly describe the types of biospecimens that will be collected. Provide the 
amount of blood, if applicable. For leftover/existing/archival material, 
identify the source:
1.  Oral swab for HIV-antibody testing conducted at the Eligibilty Visit 
2.  Fingerstick blood (3-5 drops) for DBS card to assess PrEP adherence at in-person Enrollment and 
Follow-up visits when not operating remotely.  
3. Venous Blood (20 ml) approximately 4 teaspoons for HIV RNA Viral Load at in-person Enrollment 
and Follow-up visits when not operating remotely.
 
 
ONLY FOR REMOTE VISITS: Quest Lab-collected blood sample for HIV RNA Viral Load at remote 
Enrollment and Follow-up visits (remunerated an additional $40.00).
This protocol is modified to clarify that hair sample analysis will not be pursued by the 
investigators due to futility.   
9.2  
(check all that apply): 
SPECIMENS ARE: 
* 
(REQUIRED)
Leftover specimens from a clinical diagnostic or therapeutic procedure
Specimens collected for research purposes only (including extra samples taken during a 
clinical procedure)
Other
9.3  
 
: Will any specimens or portions of specimens be retained after the study is 
* FUTURE SPECIMEN USE
over for possible use in future research studies: (REQUIRED)
  Yes  
  No
9.5  
Indicate where specimens will ultimately be stored: 
 SPECIMEN DESTINATION: 
*
(REQUIRED) 
Indicate where specimens will be sent if they will not 
Outside Entities: 
remain at UCSF (choose at least one; check all that apply):
Cooperative group bank
NIH
Other university or collaborator
Industry sponsor
Other

N/A - all specimens will remain at UCSF
Specify to what institution, cooperative group, or company specimens will 
be transferred:
1. DBS cards will be analyzed at a specialty lab at the University of Colorado
2. HIV viral loads will be processed by Quest (commercial laboratory)
: If specimens will remain at UCSF, in what kind of 
Internal Storage
facility will they reside (choose at least one; check all that apply):
UCSF repository/bank being established under this protocol
Existing UCSF specimen repository/bank with IRB approval
National cooperative group bank housed at UCSF
Other location at UCSF (please describe)
N/A - no specimens will be retained at UCSF facilities
9.6  
Will direct identifiers be associated with 
SPECIMENS SENT OUTSIDE UCSF - IDENTIFIABILITY: 
specimens or shared with other researchers and/or outside entities:
Yes 
No 
N/A - Specimens will not be shared with others 
10.0
 Drugs and Devices
10.1  
Are you 
 any drugs and/or biologics that are either 
* DRUGS AND/OR BIOLOGICS: 
STUDYING
approved or unapproved: (REQUIRED)
  Yes  
  No
 
Note: This question is frequently answered incorrectly. If any drugs 
or biologics, approved or unapproved, are being administered under 
this protocol, you should check 'Yes' unless you are 
 sure 
absolutely
that NONE of the drugs are part of the research protocol. Tip: Ask 
the PI or the sponsor if you are not sure how to answer this 
question.
10.3  
: Are you 
 any medical devices, in vitro diagnostics, or assays that are 
* MEDICAL DEVICES
STUDYING
 
either approved or unapproved:(REQUIRED)
  Yes  
  No
11.0
 Sample Size and Eligibility Criteria
11.1  
 
How many people will you enroll:
ENROLLMENT TARGET: 
108
 If there are multiple participant groups, indicate how many people will be 
in each group:
Control condition: 54 participants / 27 dyads

Intervention condition: 54 participants / 27 dyads
11.3  
Explain how and why the number of people was chosen. For multi-site 
SAMPLE SIZE JUSTIFICATION: 
studies, this is referring to the number that will be enrolled across all sites:
Power analyses were generated using the two-group repeated proportions module in NCSS PASS 
15104 to compute minimum detectable effect sizes for the primary analysis to address
Hypothesis 1. Our pilot study found standardized effect sizes ranging from .38 to .42,16 so we 
powered our study to detect similarly-sized effects in worst-case scenarios where within-
participant clustering of outcomes are substantial. The study will begin with 200 participants from 
100 couples evenly assigned to the intervention and control groups. Assuming 20% attrition, data 
from 160 participants from 80 couples will be available for analysis at all time points. Due to the 
clustered nature of the dyadic data, observations from participants who belong to the same 
couple will be correlated. In m-PI Operario’s previous study of 190 TW and their male partners, 
for instance, the average within-couple correlation of sexual risk measurements was r=.
07. Accordingly, we lowered the effective sample size (ESS) input for the power analyses to be 
ESS= N/DEFF, where DEFF is the design effect or variance inflation attributable to 
using correlated data. DEFF is computed as 1+(M-1)*r, where M is the number of participants per 
dyad (i.e., two). Therefore DEFF=1+(2-1)*.07=1.07, so ESS=160/1.07=149. Assuming, α=.05, 
power=.80, and ESS=149, we computed the minimum detectable odds ratio (OR), proportion 
difference (pdiff), and standardized proportion difference (h) for the proposed time-averaged 
comparisons, assuming four post-baseline measurements and a
wide range of CR-HIV base rates P0 for levels of risk for TW and their partners seen in the 
literature.4,5,20 Since the within-subject correlation ρ for repeated measures is unknown, we 
varied it across a wide range from .20 to .80 (see Table 2). The obtained minimum detectable 
effect size estimates are similar to or smaller than those detected in our pilot study, suggesting 
that our study is sufficiently powered to test primary Hypothesis 1.
Original Power Calculations. Originally, our sample size of 100 couples would allow us the 
statistical power to engage in meaningful comparisons between the two intervention arms. We 
assumed the 200 participants from 100 couples will be evenly assigned to the intervention arms: 
50 couples in intervention and 50 couples in control. Assuming 20% attrition, data from 160 
participants (80 couples) would have been available for analysis at all time points (i.e., 3-, 6-, 9, 
12-month follow up). Using NCSS PASS, we conducted as series of power calculations to 
determine the maximum sample size requested to address the primary study aims. We computed 
the minimum detectable odds ratio (OR), proportion difference (pdiff), and standardized 
proportion difference (h) across our two study arms for the proposed time-averaged comparisons, 
assuming four post-baseline measurements and a wide range of base proportions for levels of risk 
for TW and their partners seen in the literature (i.e., 10%-50%). Since the within-subject 
correlation ρ for repeated measures is unknown, we varied it across a wide range from .20 to .80. 
Under these conditions, ORs ranged from 0.17 to 0.56, raw proportion differences ranged from 
6.6% to 20.5%, and standardized proportion differences (h) ranged from .27 to .42. Revised 
Power Calculations. We repeated the power analysis approach utilized in our proposal submission. 
The revised power analysis again assumes alpha=0.05, power=0.80, 4 post-baseline 
measurements, and baseline reference proportions ranging from 0.10 to 0.50. The within-subject 
correlation for repeated measures was allowed to vary from 0.20 to 0.80. The N of participants 
was varied from 100 to 200 to illustrate the potential impact of various sample size reductions on 
the ranges of minimum detectable effect sizes. Conventional benchmarks for effect size are h=0.
20 for a small effect size, h=0.50 for a medium effect size, and h=0.80 for a large effect size. 
Assuming we reach at least 50% of our goal of recruiting 100 couples, under most circumstances 
we will still be able to detect a small-to-medium effect size. Even under the least advantageous 
combination of circumstances (recruiting only 50 couples, baseline reference proportions closer to 
10%, and very high correlations between repeated measures), a medium-to-large effect size is 
still detectable. 
Our Data Safety Monitoring Board (DSMB) reviewed and approved this request on February 14, 
2022, and our NIMH sponsor approved the request on July 26, 2022.   
11.4  
Eligible age ranges: 
* 
 AGE RANGE: 
PARTICIPANT
(REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
1.  
2.  
11.5  
 Data will be collected from or about the following types of people (check all 
STUDY POPULATIONS:
* 
 
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
11.6  
Check the populations that may be enrolled: 
SPECIAL SUBJECT GROUPS: 
* 
(REQUIRED)
Children / Minors
Adult subjects unable to consent for themselves
Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
11.7  
 Briefly describe the population(s) that will be involved in this study. Include 
INCLUSION CRITERIA: 
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers, 
providers, administrators, students, parents, family members, etc.):
Inclusion criteria:
Age 18 or older;
Self-reported primary partnership for at least 3 months;
Have had sex with primary partner in the last 6 months;
Either partner has had condomless sex with any partner in last 6 months;
At least one partner must be a trans woman;
Able to provide informed consent;
English speaking; and
Couples may be HIV-negative concordant, HIV-positive concordant, or HIV serodiscordant.
11.8  
 List any exclusion criteria (e.g. reasons why someone would not be included 
EXCLUSION CRITERIA:
in the study):
Exclusion criteria:
Appears to be psychotic, or otherwise unable to complete Informed Consent procedures. 
Participation would be unsafe. 
11.9  
Do any study activities take place on any 
* RESEARCH CONDUCTED ON PATIENT CARE WARDS: 
patient care units including inpatient wards, peri- or post-operative care units, operating rooms, or 
 
in the Emergency Department at UCSF Health medical facilities: (REQUIRED)
  Yes  
  No

11.11  
Does your protocol or study involve any of the following patient 
EMERGENCY DEPARTMENT: 
* 
related activities in the emergency department (e.g. subject identification, recruitment, consent, 
blood draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any 
other ED based procedures): (REQUIRED)
 
  Yes  
  No
12.0
 Recruitment and Consent
12.1  
Is this a competitive enrollment clinical trial? By competitive 
* COMPETITIVE ENROLLMENT: 
enrollment, we mean that sites who do not enroll participants early may not get to participate at all: 
(REQUIRED)  
  Yes  
  No
12.2  
 
What kinds of methods will be used to identify potential 
* SUBJECT IDENTIFICATION METHODS: 
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic, 
scheduled for surgery, a procedure, imaging, or tests, or seen in the Emergency Department 
as well as searching through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials 
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social 
media, presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial website
Other method (describe below)
Attach your recruitment materials (e.g., flyers, ads, recruitment 
letter templates, email text, etc.) in the Other Study Documents 
section of the Initial Review Submission Packet Form.
* Provide details about the subject identification methods: (REQUIRED)
A multi-pronged approach to recruitment will take place including:
1. Flyering at trans friendly venues; 
2. Outreach to agencies, clinics, single-room occupancy hotels;
3. Word-of-mouth referrals;
4. Participants from the previously conducted Healthy Divas study of HIV-positive trans women 
who have given permission to be
    contacted will ne informed about the T2 Study and invited to screen.
5. CTSI recruitment service. 
 Did all the participants of previous studies provide permission to be 
*
contacted for future studies: (REQUIRED)
 Yes  
 No
12.3  * SEARCHING OF MEDICAL RECORDS: (REQUIRED)
Whose patients are they:

Investigators' own patients or patients seen within the same practice
Patients not under the care of the investigators
How and by whom will records be accessed and searched (check all that 
apply):
Self-search in APeX or other medical records source
Self-search using UCSF's Research Cohort Selection Tool
CTSI Consultation Service Recruitment Services
UCSF Academic Research Services (ARS)
University of California Research Exchange (UC ReX)
Other method (describe below)
12.4  
How, when, and by whom will eligibility for recruitment be 
DETERMINATION OF ELIGIBILITY: 
determined:
Potential participants call the study recruitment line or come in person to our community site 
during drop-in hours. Trained Research Assistants (RAs) will describe the basic study eligiblity 
criteria and complete the Partner 1 Screening Form. If Partner 1 is provisionally eligible, Partner 2 
information is collected. Partner 2 is screened within one week by the RAs, using the Partner 2 
Screening Form. Both forms are in REDCap, which will inform the RAs if the couple can be 
scheduled for an Eligibility Visit.  At the Eligiblity Visit, oral informed consent to be screened is 
obtained, a brief eligibility survey is administered, and HIV status is verified. 
12.5  
Who initiates contact (check all that apply): 
INITIATION OF CONTACT: 
* 
(REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
12.6  
 (check all that apply): 
HOW IS CONTACT INITIATED:
* 
(REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study 
Documents section of the Initial Review Submission Packet Form. If 
potential participants will initiate contact, attach the telephone 
screening script that will be used to provide more information about 
the study and determine if callers are eligible to participate.
12.7  
Based on the checkboxes you chose above, please provide a narrative 
RECRUITMENT PLAN: 
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family 
members, providers, etc.), provide details about the recruitment plans for each group. 
(Recommended length - 100-250 words)
Consistent with our prior work, we will take a multifaceted approach to recruitment by 
using flyering in targeted venues, and outreach to agencies, clinics, bars, and CBOs. These 

connections, along with input from Dr. Sevelius’ community advisory boards (CAB) and strong 
working relationships with local agencies that serve TW, will be used in recruitment efforts to 
meet the proposed timeline. Those who are interested in the study may call the study recruitment 
line. Trained study Research Assistants (RA) will screen potential partners for eligibility. If partner 
1 of the couple is provisionally eligible, the name and contact information for partner 2 is 
collected. Partner 2 is contacted and screened within one week and if the partners are deemed 
preliminary eligible to participate as a couple AND both wish to pursue the study, the couple 
completes an Eligibility Visit. 
 
Additionally, we are collaborating with the CTSI Consultation Service to provide cohort 
identification and direct mail for recruitment. The Dear Patient letter (attached) will be sent to 
UCSF patients identified from the APeX record systems via a data extraction by Academic 
Research Systems (ARS) of patients who identify as transgender females. These patients are 
not known to or under the care of the researcher team. The CTSI Consultation Service will 
coordinate the mailing on behalf of the study. Interested subjects will contact the study staff as 
described in the letter. The data extract will be delivered to the CTSI Consultation Service’s 
MyResearch account in order to facilitate the direct mail activities while ensuring privacy and 
confidentiality of the patients identified. Protected data elements included in the data pull and 
delivered to the honest broker may include MRN, name, mailing address, and diagnosis or 
encounter date. Additional non-PHI data elements may also be collected to facilitate the mailing.
12.8  
How will permission to participate (i.e., informed consent) be obtained from 
CONSENT METHODS: 
* 
each potential participant. If there will be multiple groups and different plans for consenting each, 
  
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
 
Participants will (check all that apply): (REQUIRED)
Sign a consent form at the end of the consent discussion (signed consent)
Provide online 'eConsent' using an E-Signature system
Click through a link in a survey or email after reading about the study and then complete the 
study online (electronic consent)
Be told about the study and be given a handout/information sheet and be asked if they agree 
to participate (verbal consent)
Complete the study activities and turn in materials, as in the case of a completed survey that 
is placed in a drop box or mailed to the study team (implied consent)
Not be able to provide consent and will have a family member consent for them, as in the 
case of a critically ill or unconscious patient (surrogate consent)
Not be able to provide consent (emergency waiver of consent - allowed for minimal risk 
research or greater than minimal risk research with an approved community consultation plan)
Not know about the study, as in the case of chart reviews or observations of public behavior 
(waiver of consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent 
text in the Informed Consent Documents section of the Initial 
Review Submission Packet Form.
12.9  
Describe the process for obtaining informed consent, including details such as 
CONSENT PROCESS: 
* 
who will have the consent discussion and when participants will be asked to sign the consent form in 
relation to finding out about the study: (REQUIRED)   We encourage researchers to review our 
.
guidance on obtaining and documenting informed consent
If there are multiple groups being consented differently, provide details about the consent 
process for each group.
If you are relying on 
, provide details about how that will happen.
verbal or implied consent
For studies using online recruitment and consent or consent via mail, provide details here.
Two consent processes will take place: (1) Verbal Informed Consent will be conducted for the 
Eligibility Visit and
(2) Signed Informed Consent will be conducted at the Baseline Enrollment Visit.  
 
1. Verbal Informed Consent for the Eligibility Visit: After partner 1 and partner 2 have been 
screened and each express interest in participating in ther study as a couple, they complete an 

Eligibility Visit.  If the visit is in-person, a trained Research Assistant (RA) reads the Verbal 
Informed Consent to each partner separately. If eligible and interested in participating as a 
couple, they are scheduled for the Baseline Enrollment Visit.  Because this is a couples study, 
both partners in the couple must be eligible and interested in participating. If the visit must take 
place remotely, this occurs as described in Section 8.9 Procedures and Methods.  
 
2. Signed Informed Consent for T2 study enrollment:
If the visit is in-person: a trained RA meets with each partner to review the ICF in 
detail. The ICF can be read by the participant or read aloud to the participant by the RA, 
who confirms that the potential participant understands the risks, benefits, and procedures 
of the study, and all questions are answered. If both members of the couple wish to 
consent, they each sign the witnessed ICF and are enrolled together as a 
couple. Participants are informed that in the event of a break up after the enrollment visit, 
the individual partners should still complete all quarterly follow-up assessment visits at 3, 
6, 9, and 12-months post-enrollment. 
If the visit is remote: a trained RA will send P1 and P2 the study ICF and ROI through 
DocuSign and schedule a videoconference call to review, answer any questions, and help 
participant sign the ICF and ROI via DocuSign. If P1 and/or P2 are unable to use 
DocuSign, mail two paper copies of the ICFand ROI with a stamped-self-addressed 
envelope. When these are received by the participant, a videoconference or phone call is 
set up to review ICF and ROI and answer any questions. Participant signs one copy and 
returns in the stamped-self-addressed envelope, retaining the second copy.  
 
 It is important that the people obtaining consent are qualified to do so. 
*
Briefly describe the training and experience these individuals have in 
obtaining informed consent: (REQUIRED)
All indiviauls obtaining informed consent have completed the CITI training in Human Subjects 
Research and received study-specific training on obtaining voluntary informed consent. 
12.10  
Indicate how the study team will assess and enhance the subjects' 
CONSENT COMPREHENSION: 
* 
understanding of study procedures, risks, and benefits prior to signing the consent form (check all 
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help 
bubble at the right for specific questions that can be asked to assess comprehension, consider 
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining 
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended 
questions about the nature of the study or the experimental treatment, the risks and benefits 
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their 
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary 
nature of participation (especially appropriate when the consent process happens online or 
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another 
method to assess comprehension:
All participants will give informed consent to participate in the project. Research Assistants (RA) 
will read, review, and discuss the consent forms with all potential participants prior to asking 
them to sign. If the potential participant appears confused or indicates he/she doesn't understand 
the consent, the RA will attempt to identify the misunderstanding and to explain the consent 
again. If the potential participant still does not comprehend the consent, he/she will be excluded 
from the study. We will confirm that potential participants understand the material covered in the 
consent procedure by asking questions prior to asking the person sign the consent form. These 
will include openended (e.g., “Could you tell me what’s going to happen if you enroll in the 
study?”) and closed questions (e.g., Will you get free medications as part of this research 
study?”). Responses that suggest confusion or inaccuracies that staff cannot successfully clarify 
will result in exclusion from the study and direction to appropriate outside referrals. Interviewers 
will witness and date the consent after the participant signs.
12.11  
Does this study rely on some deception or misinformation about what the 
* DECEPTION: 

researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
12.13  
Select the regulatory category under which 
* WAIVER OF DOCUMENTATION OF SIGNED CONSENT: 
the IRB may waive the requirement to obtain 
consent for this study:
signed 
The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether they want documentation linking them with the research. 46.117(c) 
(1)  
The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context. 
46.117(c) (2)  
12.14  
What is the estimated time commitment for participants (per visit and in total):
TIME: 
The total estimted time commitment from participants will range from 480 - 755 minutes 
 dependant on HIV and medications staus and randomization 
(8 hours - 12.5 hours)
assignment. The estimated time per visit is: 
Pre-Screening (
Completion of P1 or P2 Screening Form  
15 minutes): 
Eligibility Visit (40-65 minutes):  Oral Informed Consent (15 minutes); eligibility survey 
(5 minutes); confirmation of HIV status (5-30 minutes) depending if verification is done via HIV 
Letter of Diagnosis/medication bottles, prior known HIV positive study participant, or HIV oral 
antibody test with pre- & post-test counseling (30 min); enter test results to REDCap (5 min); 
Schedule Baseline Enrollment Visit (5 min), Provide incentive (5 min).
Baseline Enrollment Visit (
Written Informed Consent (30 minutes); 
125-160 minutes): 
collect contact locator information (10 minutes); collect appropriate laboratory specimen (0-20 
minutes) depending on HIV status and PrEP medication - DBS collection if HIV negative and has 
taken PrEP in last 3 months or venous blood draw for HIV viral load testing if HIV positive, or no 
testing if HIV-negative and not taking PrEP; complete survey (60 min); obtain randomization arm 
and inform couple (5 min); observe control arm videos (10 min) or Intervention Counseling 
Session 1 (20 min); Schedule next visits (5 min); Provide incentive (5 min).
Intervention Sessions 2-4 (45 minutes each = 135 minutes)
Quarterly Follow-up Visits (75-95 minutes x 4): Update contact information (5 
minutes); Complete survey (60 min); collect appropriate laboratory specimen (0-20 minutes) 
depending on HIV status and PrEP medication - DBS collection if HIV negative and has taken PrEP 
in last 3 months or venous blood draw for HIV viral load testing if HIV positive, or no specimen if 
HIV negative and not on PrEP; schedule next visit (5 min), provide incentive (5 min).
 
IMPORTANT TIP: Ensure this information is consistent with the 
information provided in the consent form.
12.17  
Describe other alternatives to study participation, if any, that are available 
OTHER ALTERNATIVES: 
to prospective subjects:
Individuals are free to decline participation. Regardless of decision to participate, a list of 
community resources will be made available.
13.0
 

Waiver of Consent/Authorization for Recruitment 
Purposes
This section is required when medical records may be reviewed to 
determine eligibility for recruitment.
13.1  
Study personnel need to access 
* PRACTICABILITY OF OBTAINING CONSENT PRIOR TO ACCESS: 
protected health information (PHI) during the recruitment process and it is not practicable to obtain 
informed consent until potential subjects have been identified: (REQUIRED)
Yes 
If 
, a waiver of consent/authorization is NOT needed.
no
13.2  
 
A waiver for screening of health records to identify potential subjects poses no 
* RISK TO PRIVACY: 
more than minimal risk to privacy for participants:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
13.3  
Screening health records prior to obtaining consent will not adversely affect 
* RIGHTS/WELFARE: 
subjects' rights and welfare:
Yes 
If 
, a waiver of authorization can NOT be granted.
no
13.4  
Check all the identifiers that will be collected prior to obtaining informed consent:
* IDENTIFIERS: 
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
13.5  
 
Describe any health information that will be collected prior to obtaining 
* HEALTH INFORMATION: 
informed consent:

We are collaborating with the CTSI Consultation Service to provide cohort identification and direct 
mail for recruitment. The Dear Patient letter (attached) will be sent to UCSF patients identified 
from the APeX record systems via a data extraction by Academic Research Systems (ARS) of 
patients of female transgender. These patients are not known to or under the care of the 
researcher team. The CTSI Consultation Service will coordinate the mailing on behalf of the 
study. Interested subjects will contact the study staff as described in the letter. The data extract 
will be delivered to the CTSI Consultation Service’s MyResearch account in order to facilitate the 
direct mail activities while ensuring privacy and confidentiality of the patients identified. Protected 
data elements included in the data pull and delivered to the honest broker may include MRN, 
name, mailing address, and diagnosis or encounter date. Additional non-PHI data elements may 
also be collected to facilitate the mailing.
Note: HIPAA requires that you collect the minimum necessary.
13.6  
Describe your plan to destroy any identifiable data 
* DATA RETENTION/DESTRUCTION PLAN: 
collected to determine eligibility for recruitment. This should be done at the earliest opportunity. If 
you plan to retain identifiable recruitment data, provide the justification for doing so:
This information will be reviewed only by the study Principal Investigator and Project Director. It 
will be destroyed within 6 months of receipt and issuance of letters to potentially eligible 
participants. 
14.0
 Risks and Benefits
14.1  
Check if your study involves any of these specific research-related risks 
RESEARCH-RELATED RISKS: 
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a 
threat to self or others that they are required to report
For any boxes checked above, describe how you will minimize these risks 
* 
and discomforts, e.g., adding or increasing the frequency 
of monitoring, additional screening to identify and exclude people with 
diminished kidney or liver function, or modification of procedures such as 
changing imaging studies to avoid giving contrast agent to people who are 
more likely to suffer side effects from it, etc.: (REQUIRED)
Potential risks could include: 1) embarrassment and sensitivity related to questioning about HIV 
status, personal coping, and sexual behavior; 2) release of confidential information about the 
participant; 3) risks due to venipuncture. 
 
The risks associated with 
 by properly trained 
gathering information from participants
and supervised research staff are low and include risks of loss of privacy and distress or 
discomfort. We
have conducted previous large intervention and assessment protocols that involve vulnerable 
subjects and highly confidential or sensitive personal information. As a result, we have a staff of 
experienced interviewers, intervention facilitators, and supervisors, and have established 
protocols for quality assurance, emergency procedures, crisis intervention and referral, and initial 
and on-going staff training. Interviewers and intervention facilitators on staff have experience 
working with participants of low socioeconomic status and racial/ethnic minorities. We will have 
predominantly female interviewers and facilitators, and many of our research staff members self-
identify as racial or ethnic minorities and/or transgender. Typically, interviewers and intervention 
facilitators spend 40 hours in initial training sessions and observed practice. Training includes 
reading and discussing intervention protocols and selected articles about interviewing, tracking, 
and locating participants and attending lecture sessions regarding emergency procedures, 
mandatory reporting, confidentiality, and research ethics. All interviews and intervention sessions 
will be audio recorded; 20% of the recordings will be selected at random for review for quality 
assurance and training. We have developed assessment and intervention quality assurance 
protocols for
several other projects. Assessment and intervention staff will attend separate ongoing bi-

monthly supervision meetings where quality assurance and problem-solving topics will be 
discussed.
In addition, we collect oral swabs for HIV testing and blood samples for viral load and PrEP 
adherence assement. Staff members who are state certified as HIV test counselors will conduct 
pre- and post-test counseling. The viral load assays and PrEP adherence testing will be for the 
primary outcome analysis. We have established protocols for quality assurance, emergency 
procedures, crisis intervention and referral, and initial and on-going staff training.
 will be certified by the State of California, and will complete the UCSF 
Phlebotomists
Bloodborne Pathogens training upon hire and annually thereafter. We will strictly adhere to all 
UCSF safety policies and procedures regarding the collection and processing of biological 
substances. Although venipuncture (3 above) might cause minor physical pain at the site, this 
risk is no more than what individuals would experience at a routine healthcare appointment.
. All safety-related risks will be monitored routinely at all points of 
Safety monitoring procedures
participant contact. The security of confidential information will be monitored regularly.
Research interviewers will be trained in asking questions about sensitive topics in a caring and 
nonthreatening manner and will stop questioning at the first sign of discomfort or on request (1 
above). Privacy, confidentiality, and disclosure comfort will be emphasized in every session. All 
participants will be reminded that they are not required to disclose their HIV status (or any other 
personal information) to anyone at any time. Participants will be informed that assessment 
responses will be kept confidential and will not be used against them in any manner, including for 
reasons of legal action or medical treatment. Research interviewers will be trained to identify a 
participant who reports distress. For participants who report distress or suicidality (4 above), a 
protocol will facilitate staff action, including steps to assess the level of distress, to obtain 
emergency contact information for clinical supervisors, and to obtain up-to-date phone numbers 
for crisis centers, hotlines, and referral agencies.
. Research interviewers and intervention staff will 
Safety-related risk reporting and action plan
report breach of confidentiality risks incurred by participants to the Project Director, who will in 
turn inform the PI. Any participant in need of treatment due to distress will be referred for 
appropriate services after staff follow the participant distress protocol and inform the Project 
Director and PI. Finally, the PI will be responsible for informing the DSMB chair, IRB through the 
IRB adverse event reporting procedure and the Project Officer through immediate e-mail of any 
life-threatening incidents and through annual reports of other incidents. The PI will take 
appropriate action to stop the study, release a participant from the study, or modify procedures 
to reduce and/or eliminate the abovementioned risks if they occur at an unacceptable level.
14.2  
Describe any anticipated risks and discomforts not listed above: 
RISKS: 
* 
(REQUIRED)
COVID-19 related issues: Due to the COVID-19 public health crisis, thereis a chance we may 
be required to conduct research visits remotely. Approved videoconference platforms include 
Zoom, Facebook Messenger video chat, Google G Suite Hangouts video or Skype for business. 
However, use of these platforms may present some security risks and therefore may present 
additional risk to privacy and confidentiality for participants. 
14.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to 
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the 
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the 
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
Please see above.
14.5  
BENEFITS: 
* 
(REQUIRED) Note: These are the benefits that the IRB will consider during their review. 
They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at 
large (check all that apply):

Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility, 
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or 
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
14.6  
Explain why the risks to subjects are reasonable in relation to anticipated 
RISK TO BENEFIT RATIO: 
benefits, if any, to the participant or society:
There may be no direct benefit to participants in this research. However, they may learn new 
skills for interpersonal communication and HIV prevention. The larger public health community, 
as well as transgender women and their partners, may benefit if the intervention demonstrates 
efficacy. The minimal risks of this behavioral intervention are outweighed by the potential benefits 
of the research.
14.7  
Do you have a Data and Safety Monitoring Plan (DSMP) for this 
DATA AND SAFETY MONITORING: 
* 
study (
): (Click the Help link for guidance 
A DSMP is 
 for Greater than Minimal Risk research
required
 
on risk determination) (REQUIRED)
 Yes  
 No
This is not required for minimal risk research but the UCSF IRB strongly recommends 
one to ensure the data collected are adequate to meet the research aims:
15.0
 
Data and Safety Monitoring Plan
15.1  
DATA AND SAFETY MONITORING PLAN (DSMP): 
* 
(REQUIRED) Provide a summary of the DSMP:
All greater than minimal risk studies are required to provide a plan. 
Lack of an adequate plan is one of the most common reasons why 
IRB approval is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key 
areas that should be included in the plan are:
An explanation of the plan to monitor data collection, study progress, 
and safety
A description of who will perform the monitoring and at what 
frequency (e.g., the PI only, a contract research organization, a Data 
and Safety Monitoring Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse 
events, breaches of confidentiality, unanticipated problems involving 
risk to participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the 
UCSF IRB, the study sponsor, and other appropriate entities
As appropriate:

A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study 
interventions
ADVERSE EVENTS
An internal (on-site) adverse event that the investigators determine to be: 
1. Definitely, probably, or possibly related AND
2. Serious or unexpected will be reported within 5 working days of awareness. Internal, 
related deaths and life-threatening events will be reported immediately. These reports will be 
made using the iRIS Adverse Event Reporting Form.
 
An external (off-site) adverse event that the investigators determine: changes study risks 
/ benefits, OR necessitates modification to the IRB-approved consent document(s), and/or the 
IRB-approved application/protocol will be reported within 10 working days of UCSF PI awareness. 
These reports will be made using the iRIS Adverse Event Reporting Form.
 
OTHER TYPES of EVENTS or SAFETY INFORMATION
Audit or Monitoring Report with significant findings, DSMB/DMC Report, Hold on Study Activities 
due to unexpected risk or required by any oversight entity (e.g. UCSF, FDA, OHRP), and Updated 
Investigator Brochure will be reported within 10 working days of awareness using the iRIS 
Reporting Form. Other Safety Information or Publication and Pharmacy Packet Inserts for change 
to risk language will be reported within 10 working days of awareness using the iRIS Reporting 
Form. If there is no change to risk language, reporting is not required.
 
PROTOCOL VIOLATIONS and RESEARCH-RELATED INCIDENTS
Major violation including, but not limited to incorrect intervention given, enrollment of ineligible 
participant, key safety procedure/lab not done or done outside window will be reported within 10 
working days of awareness using the iRIS Protocol Violation/Incident Report Form. Immediate 
Protocol Change to Protect Participant Safety will be reported within 10 working days of occurance 
using the iRIS Protocol Violation/Incident Report Form. Major incident, including but not limited to 
problem with consent or recruitment process, significant complaint or concern, lapse in study 
approval, loss of adequate resources will be reported within 10 working days of awareness using 
the iRIS Protocol Violation/Incident Report Form. Potential breaches of privacy or confidentiality 
will be reported within 48 hours of awareness using the iRIS Protocol Violation/Incident Report 
Form.
 
In addition to adhering to the above UCSF IRB reporting requirements, we will implement the 
following:
Data risks and monitoring
Data-related risks. Data-related risks to participants could consist of circumstances where an 
insufficient amount of data was collected to answer the research questions or high/systematic 
attrition in the trial or intervention participation (insufficient dosing).
. Overall recruitment goals will be monitored monthly, as will missing 
Data monitoring procedures
data and follow-up failures. Torsten Neilands, Ph.D. will serve as the study’s biostatistician and 
will provide ongoing monitoring of study progress.
. We will carefully monitor attrition in the trial. 
Attrition reduction plan (i.e., retention plan)
Retention is facilitated by a “user-friendly” centrally located storefront walk-in site with flexible 
hours. Extensive contact information is collected at baseline to facilitate tracking, including the 
names of one to three contacts who may know the whereabouts of a participant if lost to follow-
up. With the participant's consent, upon enrollment these contacts are notified by a tracking 
specialist who introduces him or herself and lets them know that the participant is enrolled in a 
“Health Study.” The tracking specialist also indicates that individuals may be contacted later if we 
lose contact with the participant. Additional contact information includes addresses of sites that 
the participant frequents, such as needle exchanges, free food lines, shelters, bars, probation
/parole offices, and community-based organizations. Reminder messages are sent prior to each 
visit. Mobile outreach is used for participants more than 30 days late for scheduled 
appointments. Participants receive a business-sized card with the next scheduled interview, 
session, or assesment date.
Holiday and birthday cards are sent to each participant to help maintain participant morale and 
interest in the study. Finally, we will provide a welcoming environment with healthy snacks and a 
community resource board at the community site, and provide special gifts with the project logo 
(e.g. t-shirts, tote bags, sports bottles) at strategic follow-up points to foster a positive 
attachment with the study. In Dr. Johnson’s Balance Project with HIV-positive adults experiencing 
high ART side effects, we retained 93% of 249 randomized participants for 18 months.95 In 
another study using similar retention methods, we retained 92% for 6 months.96 In our PATH 
project with the urban poor living with HIV, we have retained 91% of 219 randomized 

participants for 12 months, despite high levels of incarceration, housing instability, substance 
use, and mental illness,97 which likely most closely approaches the life circumstances of the 
transgender women we propose to recruit for the trial.
. Research interviewers and recruitment staff will be 
Data-related risk reporting and action plan
responsible for compiling numbers of participants recruited, completing required assessments, 
maintaining databases, and identifying missing data and missing follow-up assessments. The data 
manager will prepare recruitment and missing data reports for weekly review by the Project 
Director, Statistician, Co-Is, and PI. All data are de-identified and stored on a firewall-protected 
server. Upon recognition of unacceptable recruitment or follow-up rates, or of missing data, the 
PI will intervene with strategies to remedy the shortcomings. Completion rates of the intervention 
will be monitored in a similar fashion.
Safety-related risks. Safety-related risks could include:
Potential risks could include: 1) embarrassment and sensitivity related to questioning about HIV 
status, personal coping, and sexual behavior; 2) release of confidential information about the 
participant; 3) risks due to venipuncture; and 4) recognition of the need for treatment for 
psychological distress/suicidality.
. All safety-related risks will be monitored routinely at the time of 
Safety monitoring procedures
the assessment or intervention session. The security of confidential information will be monitored 
regularly. Research interviewers will be trained in asking questions about sensitive topics in a 
caring and nonthreatening manner and will stop questioning at the first sign of discomfort or on 
request. Privacy, confidentiality, and disclosure comfort will be emphasized in every session. All 
participants will be reminded that they are not required to disclose their HIV status (or any other 
personal information) to anyone at any time. Participants will be informed that assessment 
responses will be kept confidential and will not be used against them in any manner, including for 
reasons of legal action or medical treatment. Research interviewers will be trained to identify a 
participant who reports distress. For participants who report distress or suicidality, a protocol will 
facilitate staff action, including steps to assess the level of distress, to obtain emergency contact 
information for clinical supervisors, and to obtain up-to-date phone numbers for crisis centers, 
hotlines, and referral agencies.
. Research interviewers and intervention staff will 
Safety-related risk reporting and action plan
report breach of confidentiality risks incurred by participants to the Project Director, who will in 
turn inform the PI. Any participant in need of treatment due to distress will be referred for 
appropriate services after staff follow the participant distress protocol and inform the Project 
Director and PI. Finally, the PI will be responsible for informing the DSMB chair, IRB through the 
IRB adverse event reporting procedure and the Project Officer through immediate e-mail of any 
life-threatening incidents and through annual reports of other incidents. The PI will take 
appropriate action to stop the study, release a participant from the study, or modify procedures 
to reduce and/or eliminate the abovementioned risks if they occur at an unacceptable level.
Adverse events. Adverse events will be tracked and follow-through will be conducted via referrals 
and follow-up. An adverse event form will be developed detailing the incident, actions taken, 
supervisor notes, and follow-up steps. The form, supplemented by regular session notes, will be 
sent immediately to appropriate agencies, including the DSMB chair, IRB and NIH. Any action 
recommended by the DSMB or IRB will be conveyed to the NIH. The DSMB will be responsible for 
the monitoring and reporting of any adverse events.
. All problems related to participant safety will 
The UCSF Institutional Review Board (IRB)
be reported to the IRB by the PI within 10 working days. Specifically, we will report in writing: 1) 
all serious
adverse events associated with study procedures, and 2) any incidents or problems involving the 
conduct of the study or patient participation, including problems with the recruitment or consent 
processes. The PI will provide a discussion of any side effects or problems noticed in the course of 
the study to the IRB on an annual basis.
15.2  
DATA AND SAFETY MONITORING BOARD (DSMB): 
* 
(REQUIRED) Will a Data and Safety Monitoring 
Board (DSMB) be established:
Yes 
No 
15.3  
Provide details about the DSMB, including meeting frequency, and the affiliations 
DSMB DETAILS: 
and qualifications of members:   
If 
Attach the DSMB charter to the Other Study Documents section. 
the DSMB has not yet been established, submit details and the charter to us as soon as they become 
available.
Data and Safety Monitoring Board (DSMB). With consultation from NIH, we have identied three 
people to serve as members of the DSMB. These members have expertise in behavioral clinical 
trials and research with transgender women. The DSMB members have met one time to date via 

teleconference, and will reconvene six months after the study launch, and annually thereafter 
to monitor study progress throughout the course of the trial.
16.0
 Confidentiality, Privacy, and Data Security
16.1  
Indicate how subject privacy will be protected:
PROTECTING PRIVACY: 
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be 
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added 
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
Describe the other methods for protecting privacy:
The following privacy protection steps will be taken: 1) interviewers and other staff will 
participate in initial training, follow-up training, and ongoing monitoring and supervision to ensure 
understanding of the ethical issues involved in this research; 2) only the trained staff will know 
the name, identification (ID) number, and contact information of participants. The list that links 
the participant’s name with the ID number will be kept in a locked file cabinet accessible only by 
the PI, the PD, and the interviewers; 3) consent forms will be kept in locked files; 4) any personal 
identifiers linked to data will be removed and replaced by code numbers in all records. 
Electronic copies of the data will be stored on a secure server and paper copies will be destroyed 
at the end of the study.
 
 
16.2  
Do any of the instruments ask about illegal or stigmatized behavior:
SENSITIVE DATA: 
 Yes  
 No
IMPORTANT NOTE: Indicate in the consent form what kinds of 
sensitive information will be collected.
16.3  
Could a breach of 
SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: 
privacy or confidentiality result in any significant consequences to participants, such as criminal or 
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing, 
employability, or reputation:
 Yes  
 No
Check all that apply:
Embarrassment
Criminal or civil liability
Loss of state or federal benefits
Damaging to the participant's financial standing, employability, or reputation
Potential risks to insurability (health, disability, or life insurance)
Describe the potential consequences:
Transgender or HIV status could be revealed.
16.4  
Explain any extra steps that will be taken to assure 
EXTRA CONFIDENTIALITY MEASURES: 
confidentiality and protect identifiable information from improper use and disclosure, if any:

We have conducted previous large intervention and assessment protocols that involve vulnerable 
subjects and highly confidential or sensitive personal information. As a result, we have a staff of 
experienced interviewers, intervention facilitators, and supervisors, and we have established 
protocols for quality assurance, emergency procedures, crisis intervention and referral, and initial 
and on-going staff training. Typically, interviewers and intervention facilitators spend 40 hours in 
initial training sessions and observed practice. Training includes reading and discussing 
intervention protocols and selected articles about interviewing, tracking, and locating participants 
and attending lecture sessions regarding emergency procedures, mandatory reporting, 
confidentiality, and research ethics. All intervention sessions will be audio recorded. We have 
developed assessment and intervention quality assurance protocols for several other projects. 
Assessment and intervention staff will attend separate ongoing bi-monthly supervision meetings 
where quality assurance and problem-solving topics will be discussed. Privacy, confidentiality, and 
disclosure comfort will be emphasized in every session. Research interviewers and intervention 
staff will report breach of confidentiality risks incurred by participants to the Project Director, who 
will in turn inform the PI. While couples will come for site visits together, all participants will 
undergo assessments and testing separately/individually.
16.5  
Do you anticipate that this study may collect information that State or Federal 
 REPORTABILITY: 
*
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or 
others: (REQUIRED)
  Yes  
  No
16.6  
Will this study obain a Certificate of Confidentiality:
CERTIFICATE OF CONFIDENTIALITY: 
 Yes  
 No
Please include the recommended Certificate of Confidentiality 
language in the consent form. 
16.7  
Will there be any sharing of 
 research test results 
SHARING OF RESEARCH RESULTS: 
EXPERIMENTAL
with subjects or their care providers:
  Yes  
  No
16.9  
Study data will be: 
* HIPAA APPLICABILITY: 
(REQUIRED)
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service 
(THREDS) at SFGH
In addition to signing a consent form, each subject will have to sign 
 
the UCSF Research Subject Authorization Form (HIPAA Form). 
Upload the HIPAA Authorization Form in the Other Study 
Documents section of the Initial Review Submission Packet Form. 
Failure to have patients sign the HIPAA Authorization is one of the 
 Please call 
most common findings from QIU Routine Site Visits.
the IRB office at 415-476-1814 if you have questions about HIPAA 
research requirements.  

If derived from a medical record, identify source:
SFDPH Carelink EMR; APEX
16.10  
Check all identifiers that will be collected and included in the research records, 
IDENTIFIERS: 
* 
even temporarily: (REQUIRED)
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Could study records include 
 photos or images (even 'unidentifiable' 
* 
ANY
ones): (REQUIRED)
  Yes  
  No
16.11  
 
Will health information or other clinical data be accessed from UCSF Health, 
* PATIENT RECORDS: 
Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General (ZSFG): (REQUIRED) 
 Yes  
 No
16.14  
Does the research require access to any of 
HIPAA - PERMISSION TO ACCESS SENSITIVE DATA: 
* 
the following types of health information from the medical record: (check all that apply) 
(REQUIRED) 
Drug or alcohol abuse, diagnosis or treatment
HIV/AIDS testing information
Genetic testing information
Mental health diagnosis or treatment
None of the above
Important note: Ensure that participants initial the corresponding 
line(s) in Section C of the HIPAA authorization form during the 
consent process.
16.18  
(check all that apply): 
* DATA COLLECTION AND STORAGE: 
(REQUIRED)

Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical trial 
management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)
Other:
What online survey or computer assisted interview tool will you use: 
* 
(REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
Data will be collected/stored in systems owned by (check all that apply): 
* 
(REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
SF VAMC
Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
16.19  
 Will patient records reviewed under this approval be 
* ADDITION OF RECORDS TO A REGISTRY:
added to a research database, repository, or registry (either already existing or established under 
this protocol): (REQUIRED) 
 Yes  
 No
This activity generally requires patient consent and HIPAA 
Authorization  A Waiver of Consent/Authorization may be granted 
.
for patients who are deceased or lost to follow up, but ongoing 
patients should be consented at their next clinic visit prior to 
accessing their health records or they may provide consent and 
HIPAA authorization for research use of their health information by 
mail or through a certified E-Signature system such as 
DocuSign. You may be asked to revise your consent plans.
16.20  
During the lifecycle of data collection, transmission, and storage, will identifiable 
DATA SHARING: 
* 
 
information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)

  Yes  
  No
17.0
 Financial Considerations
17.1  
Will subjects be paid for participation, reimbursed for time or expenses, or receive any 
* PAYMENT: 
other kind of compensation: (REQUIRED)
 Yes  
 No
17.2  
Subjects payment or compensation method (check all that apply):
PAYMENT METHODS: 
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card
UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:
17.3  
Describe the schedule and amounts of payments, including the total subjects 
PAYMENT SCHEDULE: 
can receive for completing the study:
If there are multiple visits over time, explain how payments will be prorated for partial 
completion
If deviating from recommendations in Subject Payment Guidelines, include specific 
justification below
Payment schedule
$0 for Pre-Screening
$20 per person for Eligibility Visit
$100 per person for In-Person Enrollment Visit; HIV-positive participants who 
complete Remote Enrollment visits with blood drawn at a Quest Service Center 
receive an additional $40USD ($140.00 total).
$20 per person per intervention session (x 3 sessions)
$50 per person per In-person Follow-up assessment visits (x 4 follow-ups); HIV-positive 
participants who complete Remote Follow-up visits with blood drawn at a Quest 
Service Center receive an additional $40USD ($90 total).   
Effective approximately September 8, 2023, currently enrolled participants who self-
report use of Pre-Exposure Prophylaxis medications (PrEP) will no longer be asked to 
provide a self-collected hair sample and will be advised that any previously collected 
samples will not be analyzed by the investigators.  
Effective approximately March 15, 2023, currently enrolled participants will be 
informed that if they complete all outstanding quarterly follow-up visits, they will 
receive an additional $50 bonus payable at completion of their 12-month visit.     
Requested approval in February 2023 to add a one-time bonus payment of $50 for 
currently enrolled participants who complete all outstanding quarterly follow-up visits, 
to be provided at the final 12-month follow-up visit.  
Total for participants assigned to control condition (including eligibility visit): $320 (if 
eligible for bonus payment, $370) 
Total for participants assigned to intervention (including the eligibility visit): $380 (if 
eligible for bonus payment, $430)

17.4  
Will subjects or their insurance be charged for any study activities:
COSTS TO SUBJECTS: 
  Yes  
  No
18.0
 Other Approvals and Registrations
18.4  
Indicate if this study involves other regulated materials and requires approval 
OTHER APPROVALS: 
and/or authorization from the following regulatory committees: 
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
19.0
 Qualifications of Key Study Personnel and Affiliated 
Personnel
 
NEW: January 2019 - Affiliated personnel who do not 
need access to iRIS no longer need to get a UCSF ID. 
Instead, add them below in the Affiliated Personnel 
table below. 
19.1    
  
  
  
Qualifications of Key Study Personnel:
 
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in 
 select the KSP 
Section 3.0,
from the drop down list and add a description of their study responsibilities, 
qualifications and training. In study responsibilities, identify every individual 
who will be involved in the consent process. Under qualifications, please 
include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
NOTE: This information is required and your application will be 
 
considered incomplete without it. If this study involves invasive or 
risky procedures, or procedures requiring special training or 
certification, please identify who will be conducting these 
procedures and provide details about their qualifications and 
training. Click the orange question mark for more information and 
examples. 
 

Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects 
Protection Training through 
 prior to approval of a new study, or a 
CITI
modification in which KSP are being added. More information on the CITI 
training requirement can be found on our 
. 
website  
 
* Definition of Key Study Personnel and CITI Training Requirements (Nov, 
 UCSF Key Study Personnel include the Principal Investigator, other investigators 
2015):
and research personnel who are directly involved in conducting research with study 
participants or who are directly involved in using study participants’ identifiable private 
information during the course of the research. Key Personnel also include faculty mentors
/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical 
Fellows serving as PI on the IRB application.
   
KSP Name
Description of Study 
Responsibilities - Briefly 
describe what will each 
person be doing on the study. 
If there are procedures 
requiring special expertise or 
certification, identify who will 
be carrying these out. Also 
identify who will be obtaining 
informed consent.
Qualifications, Licensure, and 
Training
Dr. Sevelius, Jeanne PhD
Jeanne ("Jae") Sevelius, 
PhD is a study Co-
Investigator. She will 
participate in scientific 
oversight of study 
activities including 
protocol development, 
assessment and 
intervention 
development, quality 
control, and manuscript 
preparation.
Dr. Sevelius has a PhD in 
clinical psychology, is a 
licensed clinical 
psychologist with a 
specialization in gender 
studies. She has a faculty 
appointment without 
salary in the Department 
of Medicine at UCSF and 
is faculty at the Columbia 
University, Research 
Foundation for Mental 
Hygiene.
Gamarel, Kristine E
Kristine Gamarel, PhD 
serves as a Principal 
Investigator (MPI) of the 
study. She provides 
scientific oversight for 
study decision-making, 
lead assessment 
development and data 
analysis, and contribute 
expertise on HIV 
prevention at the couple 
level.
Dr. Gamarel has a PhD in 
social psychology and is 
an Assistant Professor in 
Health Behavior and 
Health Education at the 
University of Michigan. 
As a social psychologist 
with expertise in health 
psychology and public 
health, the major focus 
of her work seeks to 
eliminate health 
inequities in partnership 
with sexual and gender 
minority communities. 
Her research includes 
cohort studies and 
couples-based and m-
health/e-health 
approaches to address 
HIV prevention and 
treatment, alcohol 
reduction, and tobacco 
control and prevention.

Stein, Ellen S
Ellen Stein serves as 
Project Director for the 
study. She will maintain 
close communication with 
the study investigators 
and statistical staff; 
supervise field research 
staff; oversee the 
collection of high-quality 
data and fidelity to the 
study protocol; act as the 
primary liaison between 
the study and the UCSF 
IRB; and participate in 
management of study 
finances.
Ms. Stein has more than 
20 years experience 
leading longitudinal 
research research studies 
domestically and 
internationally.
Johnson, Jack
Jack Johnson is a study 
Research Assistant who 
is responsible for 
recruitment, Informed 
Consent, and enrollment 
of eligible couples to the 
study.
Mr. Johnson has a 
background in HIV 
prevention work and 
advocacy in Sacramento 
and the Bay Area.
Dr. Johnson, Mallory PhD
Dr. Mallory Johnson is 
the UCSF study PI of 
record with respect to 
administrative 
management of the It 
Takes Two study grant 
award from NIH. He 
works in close 
collaboration with Drs. 
Gamarel and Sevelius.
Dr. Johnson, Professor in 
the UCSF Department of 
Medicine, is Co-Director 
of the NIH-funded Center 
for AIDS Prevention 
Studies (CAPS) and 
Director the the CAPS 
Developmental Core. 
19.2  Affiliated Personnel: 
Instructions:
 
This section is for personnel who are not listed in Section 3.0: Grant Key 
 because their names were not found in 
Personnel Access to the Study
the User Directory when 
 the iRIS Database and MyAccess directories 
both
were searched. Add any study personnel who fit 
 of the following criteria 
ALL
in the table below:
They meet the definition of Key Study Personnel (see above), and
They are associated with a UCSF-affiliated institution (e.g., VAMC, 
Gladstone, Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do 
 have a UCSF ID, 
not
and
They do 
 need access to the study application and other study 
not
materials in iRIS.
 in the 
Note: Attach a CITI Certificate for all persons listed below
Other 
 section of the 
Study Documents
Initial Review Submission Packet 
 after completing the 
.
Form
Study Application
 
Click the orange question mark icon to the right for more information on 
who to include and who not to include in this section.

 
Do 
 list personnel from outside sites/non-UCSF-affiliated institutions. 
not
Contacts for those sites (i.e. other institution, community-based site, 
foreign country, or Sovereign Native American nation) should be listed in 
the 
 section of the application.
Outside Sites
 
If there are no personnel on your study that meet the above 
criteria, leave this section blank.
 
Name
Institution
Telephone
E-mail
Role
No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated 
person listed above:
20.0
 End of Study Application
End of Study Application Form
 
:
To continue working on the Study Application
Click on the section you need to edit in the left-hand menu. Remember to save through 
the entire Study Application after making changes.
 
:
If you are done working on the Study Application
Before proceeding, please go back to Section 4.0 Initial Screening 
Important: 
Questions and 
 through the form to make sure all the relevant 
Save and Continue
sections and questions have been included. If you've changed any answers since you 
started, the branching may have changed. Your application will be incomplete and it will 
have to be returned for corrections. 
 
Once you are sure the form is complete, click 
. If this is a new 
Save and Continue
study, you will automatically enter the 
, 
Initial Review Submission Packet Form
where you can attach 
or other 
. Review the 
consent forms 
study documents
Initial 
 for a list of required attachments.
Review Submission Checklist
 
Answer all questions and attach all required documents to speed up your 
approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to 
answer a 
 about the application form.
survey