A Randomized Controlled Trial of Trans Women Connected: a Mobile App Delivered Sexual Health Promotion Program
Phase: NA
Conditions: HIV/AIDS, Health Knowledge, Attitudes, Practice, STI
Sponsor: ETR Associates

TWC Study Protocol with Impact Analysis Plan 
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TRANS WOMEN CONNECTED (TWC) 
STUDY PROTOCOL WITH IMPACT ANALYSIS PLAN 
 
 

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1) Research Questions That Address Program Effectiveness on Behavioral Outcomes 
 
These are consistent with outcomes listed on the www.ClinicalTrials.gov website. 
a. Primary research question(s): 
i. What is the impact of the full TWC app relative to the TWC COVID only app 
on the number of times participants report having been tested for STI and 
HIV in the past 3 months at follow-up, approximately three- and six-months 
post baseline?  
ii. What is the impact of the full TWC app relative to the TWC COVID only app 
on the number of times participants report receptive condomless anal or 
vaginal intercourse at follow-up, approximately three- and six-months post 
baseline?  
b. Secondary research question(s): Grouped by timepoints at which they are to 
be assessed per Clinical Trials Registration 
Assessed at all three follow-up timepoints  
i. What is the impact of the full TWC app relative to the TWC COVID only app 
on the perceptions of social support (based on mean score) at follow-up, 
approximately one-month, three-months, and six-months post baseline?  
ii. What is the impact of the full TWC app relative to the TWC COVID only app 
on self-reported uptake of PrEP since last measurement period, 
approximately one-month, three-months, and six-months post baseline? 
iii. What is the impact of the full TWC app relative to the TWC COVID only app 
on self-efficacy in decisions around safer sex behavior (i.e., the HIV & 
Safer Sex: Self Efficacy Scale) at follow-up, approximately one-month, 
three-months, and six-months post baseline? 
iv. What is the impact of the full TWC app relative to the TWC COVID only app 
on patient communication self-efficacy within clinical encounters (i.e., 
Ask ,Understand, and Remember, AURA, Scale) at follow-up, approximately 
one-month, three-months, and six-months post baseline? 
v. What is the impact of the full TWC app relative to the TWC COVID only app 
on participants’ degree of comfort with external appearance as it relates 
to gender identity (i.e., the Transgender Congruence Scale, or TCS) at 
follow-up, approximately one-month, three-months, and six-months post 
baseline? 
Assessed at three- and six-months post intervention only 

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vi. What is the impact of the full TWC app relative to the TWC COVID only app 
on whether participants reported using a condom at last receptive anal 
intercourse or vaginal intercourse at follow-up, approximately three- and 
six-months post baseline?  
vii. What is the impact of the full TWC app relative to the TWC COVID only app 
on the self-reported number of visits to a health care provider (of any 
type and by type) at follow-up, approximately three- and six-months post 
baseline? 
viii. What is the impact of the full TWC app relative to the TWC COVID only app 
on the self-reported number of contacts as/with a mentor/mentee for 
guidance or support at follow-up, approximately three-months and six-
months post baseline. 
 
 
 Reaction outcome—one-month follow-up full TWC app sub-group only 
ix. What are participants' reactions to the full TWC app at immediate follow-up 
(one-month post baseline)?  
 
Dropped outcomes  
 
Several outcomes were dropped before the study launch and were not included on the 
survey or asked in a way on the survey that allowed calculation. These include:   
• The Gender Identity Reflection and Rumination Scale: Scale measures rumination 
in the context of gender identity among transgender persons. Average of 15 items 
on a 4-point scale, with a range of 15 - 60, with a lower score indicating less 
rumination and better outcomes [Time Frame: Baseline, Immediate post, 3- month 
post, 6-month post]. Note: Scale dropped after pilot test.  
• Ask ,Understand, and Remember (AURA): Scale measures patient communication 
self-efficacy within clinical encounters. Average of 4 items on a 4-point scale, with 
a range of 4 - 16, with a greater higher score indicating better outcomes [Time 
Frame: Immediate post, 3- month post, 6-month post]. Note: Scale dropped after 
pilot test.  
• Sexual partners, unprotected, in last 3 months: # partners with whom had anal or 
vaginal sex without using condoms or PrEP in past 3 months [Time Frame: 3- and 
6-months post intervention]. Note: Study survey asked each separately (# partners 
and times unprotected, but not the intersection per feedback during pilot test). 
 
2) Description of the Intended Intervention and the Attention Control Conditions 
a. Intervention condition: The intervention is a mobile app delivered sexual health 
promotion program designed specifically for transgender women. The mobile app 
includes 42 interactive activities plus resource maps, opportunities for mentoring, and 

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communication forums for connecting with other transgender women (see Table 1 for 
content summary). The intervention/app is intended to be used regularly (e.g., two 
times per week) though participants control how often and when they use the app.  

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Table 1. TWC Intervention App Content. 
Activity or Feature Name 
Brief Description of Focus 
App functionality 
1-800-SEX-TALK Sexual Feedback 
Increase skills to talk about sex and give sexual 
feedback; Increase confidence in talking about sex with 
partners 
This activity describes approaches to providing 
feedback successfully, illustrates a variety of 
couples providing sexual feedback, then 
provides an opportunity for the user to add 
their own feedback in scenarios using the new 
techniques 
Affirmations 
Short messages of affirmation are sent to users to 
reinforce gender identity, social support, and HIV 
prevention messages. 
A database of affirming and motivational 
quotes are sent at random intervals to users as 
push notifications. 
A Trip to the Clinic - Getting Tested 
 
 
Increase knowledge of STI/HIV facts and 
misconceptions; Differentiate STI/HIV test types  
 
This activity uses a persona, Adriana, to allow 
the user to explore the HIV/STI testing process. 
Here the user learns about misconceptions 
about STIs and STI/HIV testing; the before, 
during; and after of testing; and the different 
types of testing that may be done 
Assertiveness Super Hero Academy 
 
Increase knowledge of assertive communication skills; 
increase comfort and skill in how to communicate 
assertively 
 
Users are introduced to nine custom trans 
women superhero characters who each have an 
assertiveness superpower they demonstrate in 
a scenario. Users self-select the technique they 
would like to focus on improving through 
practice in a scenario. 
Boundaries - My Life, My Way 
Increase awareness of why boundaries are important; 
increase skills and strategies to set boundaries  
Users are introduced to the importance of 
boundaries and are introduced to a video 
vignette of three friends and the three steps to 
address boundaries in relationships. 
Can You Hear Me Now  
 
Increase awareness and skills for assertive 
communication and navigating difficult conversations 
Users see examples of passive, aggressive, 
passive-aggressive, and assertive 
communication styles in relationship scenarios 
and practice the steps to be able to respond 
assertively to challenging relationship 
scenarios. 
Cards Against COVID 
Increase awareness of self care practices; increase ability 
to identify personal strengths in face of obstacles  
Users play a card game to practice different 
supportive strategies to respond to potentially 
stressful situations. 
Cleaning House - Breaking Up 
Increase confidence to end an unhealthy relationship; 
increase awareness of strategies to end a relationship in 
a healthy way  
Users are encouraged feel empowered to end a 
relationship if it no longer feels right. Using the 
analogy of cleaning up a messy room, users 
learn nine tips to improve their skills to end a 
relationship safely and calmly. 
Coping With Clocking 
Increase awareness and confidence to validate feelings 
about misrecognition; Increase understanding of 
Users view “social media story” style 
experiences of trans women who have faced 

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Activity or Feature Name 
Brief Description of Focus 
App functionality 
different responses to misrecognition; Increase social 
support by share the experiences of other women 
and addressed misrecognition. Users identify 
their own feelings about non-affirming 
encounters and hear from other trans women 
how they have overcome these feelings. 
COVID Connections  
 
Increase knowledge of strategies to prevent COVID 
transmission while dating and sex. 
Increase skill to develop a personal intimacy plan to 
identify what feels safe and appropriate dating during 
COVID. 
Users watch a simulated dating game show and 
select their preferred responses from the 
contestants to help construct their own 
intimacy plan that can be saved to My 
Creations. 
COVID Slam 
Increase knowledge of COVID transmission and 
prevention strategies. 
Users watch a simulated game show with a host 
and 3 trans women participants answer 
questions about COVID transmission and 
prevention. 
Cumming Soon...Orgasm!  
Increase knowledge about how orgasms work; Increase 
awareness of other trans women’s experiences of 
orgasm; Increase knowledge of different ways orgasm 
may change during transition  
User is introduced to features related to 
orgasm using a movie poster theme and are 
asked to create their own poster to identify 
what matters most to them for their own 
orgasm. The customized movie poster can be 
saved to My Creations. 
Forums 
A bulletin board feature where users can have 
conversations and discussions on a variety of topics. 
Users can post and comment on 
communication topics started y the forum 
moderator or other forum participants. 
Healthy Relationship Roots  
Increase knowledge and comfort to distinguish a healthy 
relationship from an unhealthy relationship  
Using a gardening theme, users learn qualities 
that are most important to healthy 
relationships and then reflect on different 
relationship scenarios and identify their own 
feelings in response to the situation. They also 
reflect on their own past relationship 
experiences to identify their feelings of what is 
healthy and unhealthy. 
Hook Me Up - HIV Linkage 
Increase knowledge of HIV care services; Increase 
confidence to get what you need from HIV care  
User view a video of a clinic walkthrough to 
illustrate the process of HIV testing and 
linkage. 
I Care About Me  
 
Increase awareness of why self-care is important; 
Increase knowledge of self-care activities; Increase 
confidence in identifying self-care activities they can 
participate in  
Users learn about different self-care practices 
and are asked to create their own “Self-care 
Playlist” by identifying activities that can help 
them reduce stress and replenish their energy. 
It's My Health and I'm in Charge 
Increase assertive communication skills when talking 
with healthcare provider; identify question to prepare for 
healthcare appointments. 
User hears from the assertiveness superhero 
characters about specific strategies to use with 
health care providers. Users complete their own 
assertive communication “prescription pad” to 

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Activity or Feature Name 
Brief Description of Focus 
App functionality 
prepare for conversations that can be saved to 
My Creations. 
Keep My Fire Lit 
Increase knowledge of the connection between 
compassion fatigue and risk factors like isolation, 
substance use, and sexual risk taking; Increase 
knowledge of the causes and symptoms of compassion 
fatigue; Increase skill to assess self for symptoms of 
compassion fatigue; Increase skill to identify next steps 
to address compassion fatigue  
Users complete a compassion fatigue quiz to 
identify their level of fatigue. They receive a 
score and suggestions on how to address their 
own level of compassion fatigue. The 
customized quiz results can be saved to My 
Creations. 
Let Me Tell You Something - STI 
Disclosure  
Increase confidence in talking to current, former, and 
future partners about STI status 
Users follow a character through a “maze” to 
practice the four steps of disclosing an STI 
diagnosis to current or future partners. 
Let's Put it Together - My Boundaries 
Plan 
Increase skills to set boundaries in relationships.  
Users follow a video vignette of three friends 
talking about the three steps to address 
boundaries in relationships. 
Let's Talk About Sex - Getting on the 
Same Page 
Increase skills to talk about sex and consent; Increase 
confidence in talking about sex  
Users help a character practice talking about 
sex with a new partner, identify the topics that 
should be discussed, the timing for 
discussions, and examples of ways to talk 
about the topics. 
Life's a Beach   
Increase self-awareness about life trajectories and the 
opportunities and challenges that may occur at different 
time periods in one’s life  
Users reflect on the current, past, and future 
selves and to identify what mattered most, their 
accomplishments, challenges, and transitions 
during different decades of their lives. 
Loud and Clear: Communicating 
Boundaries 
Increase skills to communicate boundaries in 
relationships.  
Users follow a video vignette of three friends 
talking about the three steps to address 
boundaries in relationships. 
Love Shouldn't Hurt 
Increase awareness that IPV happens in relationships 
and that it is not OK and that everyone deserves love in 
a relationship; increase ability to make a plan to leave or 
cope with IPV.  
In this activity, the incidence of IPV in trans 
women’s relationships is discussed and their 
right to have a safe and loving relationship is 
emphasized. User creates a safety plan for 
coping with IPV. 
Map  
Locator map of resources specifically relevant to the 
trans community across several categories.  
When the user opens the map feature, their geo 
location data opens the resources available in 
their region. Users can click on the resource 
and obtain the google maps information about 
the resource. 
Mentoring 
To encourage connection and support between users, 
mentors and mentees are matched based on survey 
results and encouraged to create their own informal 
mentoring relationship. 
Users complete a mentoring survey to request 
to be a mentor or a mentee. To be a mentor, 
users need to have completed a set number of 
activities in the TWC app. 

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Activity or Feature Name 
Brief Description of Focus 
App functionality 
Messaging 
To encourage connection and support between users, 
individuals can connect with other users individually. 
Users can send private messages to other users 
in the app. 
My Creations   
Screenshots of all of the personalized activity summaries 
are stored in one location on the individual user’s 
profile.  
If the user choses to save their personalized 
activity products (e.g. the orgasm movie poster, 
the assertive communication prescription, the 
list of sexual boundaries), they are privately 
stored. The user can choose to share, 
download, or review their own creations. 
My Gender Journey 
Increase awareness that each trans woman’s transition is 
an individual process that looks different; increase 
comfort to identify success and barriers in transition 
Users take a virtual journey through a map of 
fantasy style kingdom, identifying their own 
priorities and barriers along the journey. The 
customized map can be saved to My Creations. 
My Play Palette 
Increase knowledge of safer sex options; Increase 
decision-making skills; increase confidence to choose 
safer sex steps  
This activity describes 6 steps to support 
decision making for safer sex. Users then select 
a type of sex and practice using the six steps to 
make safe sex decisions in that situation.  
My Pleasure Box  
 
Increase confidence to talk about safer sex and different 
types of sex; Increase knowledge of resources for 
exploring sexual pleasure and safer sex  
This activity uses a chocolate shop setting to 
give users the opportunity to select and learn 
about different types of sex. 
My Umbrella - HIV Social Support 
 
Increase knowledge of qualities needed in a 
person/group for social support; Increase comfort to 
identify people/groups in current social network or 
outside current social network to strengthen and/or 
grow social support system; Increase knowledge how to 
navigate a conversation to express social support 
need(s) to another person  
The activity addressing the need for social 
support systems and types of social support. 
Alongside the character Alex, the user decides 
what they need in a person and what kind of 
social support that they need.  
PEP'd Up! 
Increase knowledge of the difference between PEP and 
PrEP;  
This activity presents essential facts about 
when and how to access and use PEP as well as 
ways to increase support and decrease stigma. 
Pick Your Protection - The Condom 
Lab   
Increase knowledge of the various condom types; 
Increase awareness of how to modify condoms for a 
variety of sex practices; Increase comfort to utilize 
condom types   
Three trans health care provider custom 
characters walk users through various types of 
condoms and lubricant and ways to increase 
the effectiveness of use.   
Pleasure Map 
Increase comfort with identifying where you do and 
don’t like being touched; Increase comfort with your 
own body; Increase confidence to discuss sex and 
sexual pleasure with a partner  
This activity guides users to explore and map 
their own preferences for their bodies and 
pleasure (with or without partners). The 
customized map can be saved to My Creations. 
Prep'n for PrEP 
Increase knowledge of the how PrEP can protect women 
from HIV; increase awareness that PrEP is safe and 
effective for trans women 
This activity presents a video of a trans woman 
talking to the user directly about the benefits 
of PrEP. 

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Activity or Feature Name 
Brief Description of Focus 
App functionality 
Relationship Bouquet  
 
Increase confidence to identify what is important to you 
in a relationship; Increase knowledge of skills to nurture 
intimacy  
 
This activity asks users to select the behaviors 
and actions that make them feel safe in a 
relationship. Their personalized bouquet of 
characteristics is summarized at end of activity. 
Safely Securing Your Bag 
 
Increase knowledge of ways to remain safer when 
exchanging sex for money or other goods 
Videos of trans women speaking to user 
providing practical and actionable tips to stay 
safe when engaging in sex work. 
Salad Greens and COVID Vaccines 
Increase awareness of vaccines and trans specific 
concerns; increase understanding of what a vaccine is 
and how they have been developed/used historically  
The user experiences a virtual interview-style 
chat with four characters introduced in other 
activities discussing the COVID-19 vaccine. 
They reference the C.R.A.P. test to evaluate 
vaccine information  
Sex Dice 
Increase confidence to explore sexual pleasure; Increase 
comfort with your own body; Increase confidence to 
have conversations with partners about sex and sexual 
pleasure  
This activity simulates rolling dice of body 
parts and types of touch to explore ways to 
experience pleasure. The user can customize 
which items are included on the dice and they 
are encouraged to try out the combinations on 
themselves or with a partner. 
Sex My Way  
 
Increase knowledge of sexual boundaries; Increase 
confidence to identify some of your own sexual 
boundaries  
This activity lists different types of sexual 
boundaries and the user is asked to swipe left 
or right to indicate if that is an important 
sexual boundary for themselves. Their 
personalized list of boundaries is summarized 
at end of activity and can be saved to My 
Creations. 
STI University 
Increase knowledge of different STIs; increase 
knowledge of safer sex options for specific STIs; 
Increase confidence and skills through practice telling a 
partner that you have an STI. 
This activity introduces the categories of STIs 
and common symptoms. The user hears a 
summary of someone recently diagnosed with 
3 different common STIs responds to questions 
about symptoms and treatments. 
Sticking With It: ART 
Increase motivation and encouragement for ART 
adherence; increase understanding of U=U 
This activity introduces the user to the benefits 
of anti-retroviral treatment for those living with 
HIV through vector characters speaking to the 
user. 
Super U & Telehealth 
Increase knowledge of the benefits of telehealth; 
increase awareness of  how telehealth helps to fulfill 
healthcare needs; Increase awareness of telehealth’s 
usefulness in the user’s health routine(s)  
 
This activity introduces the user to telehealth 
through a virtual, first person experience where 
the character explores what telehealth is, its 
pluses and challenges, the user reflects upon 
how they will address these challenges, sees 
how other trans women have identified their 
healthcare needs through telehealth, and 

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Activity or Feature Name 
Brief Description of Focus 
App functionality 
ultimately provides the user with a greater 
sense of self-efficacy about telehealth.  
The Adventures of Sleutherella 
Increase confidence and skills to find and evaluate 
health/COVID-related information to support informed 
decisions related to COVID mitigation, sexual health and 
health-care seeking practices.  
The users follow a detective character to 
identify and apply the “Current-Reliable-
Authority-Purpose Test” to assess the reliability 
of COVID messaging. 
Vision Board 
Identify goals for the future; visualize the realization of 
the goals by creating an image to guide and inspire the 
process. 
Users create a vision of the future they want 
using pictures, art, words, colors in a graphic 
interface to make a collage of what their goals 
look like.  
Where I Draw the Line - Deciding My 
Boundaries 
Increase knowledge of how to set relationship 
boundaries; increase confidence to set boundaries. 
Users follow a video vignette of three friends 
talking about the three steps to address 
boundaries in relationships. 
 

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b. Attention Control Condition: An alternate mobile app (TWC COVID only) was 
designed specifically for transgender women. The mobile app includes 7 interactive 
activities focused on COVID and COVID resources (see Table 2 for app content). The 
intervention/app is intended to be used regularly (e.g., two times per week) though 
participants control how often and when they use the app.  
 

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Table 21. TWC Control App Content. 
Activity or Feature Name 
Brief Description of Focus 
App functionality 
Super U & Telehealth 
Increase knowledge of the benefits of telehealth; 
increase awareness of  how telehealth helps to fulfill 
healthcare needs; Increase awareness of telehealth’s 
usefulness in the user’s health routine(s)  
 
This activity introduces the user to telehealth 
through a virtual, first person experience where 
the character explores what telehealth is, its 
pluses and challenges, the user reflects upon 
how they will address these challenges, sees 
how other trans women have identified their 
healthcare needs through telehealth, and 
ultimately provides the user with a greater 
sense of self-efficacy about telehealth.  
The Adventures of Sleutherella 
Increase confidence and skills to find and evaluate 
health/COVID-related information to support informed 
decisions related to COVID mitigation, sexual health and 
health-care seeking practices.  
The users follow a detective character to 
identify and apply the “Current-Reliable-
Authority-Purpose Test” to assess the reliability 
of COVID messaging. 
COVID Connections  
 
Increase knowledge of strategies to prevent COVID 
transmission while dating and sex. 
Increase skill to develop a personal intimacy plan to 
identify what feels safe and appropriate dating during 
COVID. 
Users watch a simulated dating game show and 
select their preferred responses from the 
contestants to help construct their own 
intimacy plan that can be saved to My 
Creations. 
COVID Slam 
Increase knowledge of COVID transmission and 
prevention strategies. 
Users watch a simulated game show with a host 
and 3 trans women participants answer 
questions about COVID transmission and 
prevention. 
Cards Against COVID 
Increase awareness of self care practices; increase ability 
to identify personal strengths in face of obstacles  
Users play a card game to practice different 
supportive strategies to respond to potentially 
stressful situations. 
My Creations   
Screenshots of all of the personalized activity summaries 
are stored in one location on the individual user’s 
profile.  
If the user choses to save their personalized 
activity products (e.g. the orgasm movie poster, 
the assertive communication prescription, the 
list of sexual boundaries), they are privately 
stored. The user can choose to share, 
download, or review their own creations. 
Salad Greens and COVID Vaccines 
Increase awareness of vaccines and trans specific 
concerns; increase understanding of what a vaccine is 
and how they have been developed/used historically  
The user experiences a virtual interview-style 
chat with four characters introduced in other 
activities discussing the COVID-19 vaccine. 
They reference the C.R.A.P. test to evaluate 
vaccine information  

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3) Study Design  
a. Sample   
The study is open to participants who self-identify as transgender women; report having 
had 2 or more sexual partners in the past 90 days with at least one of those partners 
having a penis; report being age 18-49 at baseline; own a smartphone; and reside in any 
state in the United States. 
b. Screening criteria and process 
Participants were invited to complete a screening survey (via Qualtrics) that assessed 
eligibility for the study. Those who did not meet eligibility criteria received an immediate 
message thanking them for this interest in the study and informing them that they were 
not eligible for participation. Those who met eligibility criteria were forwarded to the 
study consent form and asked to read and complete the form to indicate their interest 
in taking part.  
c. Consent process   
Participants who screened into the study were directed to an online consent form that 
explained the study expectations along with risks and benefits. Participants were asked 
to provide their consent if interested in taking part by clicking “yes” on the consent 
form and providing (add). Those who provided affirmative consent went through a 
further confirmation protocol to reduce the risk for bots, scams, or those out of the 
country to enroll. Once participants’ eligibility, consent, and geographic location (US) 
were confirmed, participants received a link to the baseline survey.  
d. Random assignment process  
The 2-arm randomized controlled trial involves randomizing individual participants 
using an equal allocation (allocation ratio 1:1) to receive the full TWC app or an 
attention control app. Participants were randomized after completing their baseline 
surveys using the randomizer feature of Qualtrics.   
e. Baseline and follow-up data collection 
The primary source of data for the outcome analyses is the self-report survey. The 
survey is administered four times: Baseline and at three follow-up timepoints, including 
1-month, 3-months, and 6-months post-baseline.  
Data collection was ongoing due to rolling enrollment. On a weekly basis, prospective 
participants who were screened in, consented to participate, and were determined to be 
a unique respondent in the United States were emailed invitations to participate in the 
study. These invitations sent through the Qualtrics platform contained links to the 
baseline survey. Weekly, study staff would review all baseline survey completions and 
set up invitations to take the survey 1 month later, 3 months later, and 6 months later. 
Qualtrics survey invitations for baseline, 1-month, 3-month and 6-month surveys were 
set-up with 5 automated reminders going out to non-completers (3 emails at 3, 5, and 

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10 days after the survey link was sent and text message reminders at 7 and 12 days after 
the survey link was sent).    
For those not responding to automated reminders, we used multiple follow-up 
strategies to encourage survey completion, including more intense follow-up by 
engagement specialists (trans women who did more intense follow-up via phone calls 
and texting), and extra time-anchored incentives to promote survey completion by a set 
date. 
4) Analysis 
Table 1. Behavioral outcomes used for primary impact analyses research questions. 
Outcome name 
Description of the outcome, and how it is 
operationalized.   
Source of the 
measure  
Timing of 
measure (e.g., 
6 months after 
program ends) 
i. Number of 
times tested for 
STI/HIV in 
past 3 months 
Binary indicator for whether or not a participant 
has tested for an STI or HIV in the past 3 
months. Yes/No response to “Have you been 
tested for STI in the past 3 months?”. “Yes” 
coded as “1” and “No” coded as “0”. “Have you 
been tested for HIV in the past 3 months?”. 
“Yes” to either question coded as “1” and “No” 
to both questions coded as “0”. 
 
3 and 6 
months 
following 
baseline 
ii. Number of 
times 
participants 
report 
receptive 
condomless 
anal or virginal 
intercourse at 
follow-upa,b 
 Count of number of times participants report 
receptive condomless anal or vaginal intercourse. 
“In the past 3 months, how many times have 
you had receptive vaginal or anal intercourse 
without you or your partner using a condom?”. 
 
3 and 6 
months 
following 
baseline 
a This outcome will be assigned a value of 0 if a respondent reported she has never had that type of sex or 
didn’t have that type of sex in the past 3 months. This will allow for the full sample to be included in 
analytic models. 
b If an outcome assessing the number of times has a very skewed distribution, it may be collapsed into a 
dichotomous variable (0 times, 1 or more times), depending on the final distribution.  
 
 
Table 2. Behavioral outcomes used for secondary impact analyses research questions. 
Outcome name 
Description of the outcome and how it is 
operationalized. 
Source of the 
measure (e.g. 
performance 
measure) 
Timing of 
measure 
(e.g., 6 
months after 
program 
ends) 
i. Perceptions of 
social support 
Average of 6 indicator variables. Responses 
ranged from “1 None of the time” to “5 All of 
the time”. Average was calculated if the 
 
one-month, 
three-
months, 

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Outcome name 
Description of the outcome and how it is 
operationalized. 
Source of the 
measure (e.g. 
performance 
measure) 
Timing of 
measure 
(e.g., 6 
months after 
program 
ends) 
(based on mean 
score) at follow-up 
participant answered 67% or more of the 
items. 
and six-
months 
post 
baseline 
ii. Self-reported 
uptake of PrEP 
since last 
measurement 
period 
The outcome is a response of “No, I have not 
used PrEP” or that the person has taken 
continuous PrEP or PrEP 2-1-1 or “don’t 
know/not sure.”  
 
one-month, 
three-
months, 
and six-
months 
post 
baseline 
iii. Self-efficacy in 
decisions around 
safer sex behavior 
(i.e., the HIV & 
Safer Sex: Self 
Efficacy Scale)  
Responses range from 1 “not certain at all” to 
8 “absolutely certain.” Self-efficacy scale was 
modified to ask about use of a “condom” 
rather than a barrier on an 8 item scale. 
Calculated if the participant reported 75% or 
more of the items in the scale. 
 
one-month, 
three-
months, 
and six-
months 
post 
baseline 
iv. Degree of comfort 
with external 
appearance as it 
relates to gender 
identity (i.e., the 
Transgender 
Congruence Scale, 
or TCS) 
Average of 12-items on the TCS. Responses 
range from “1 strongly disagree” to “5 
strongly agree” on a 12-item scale. Three 
questions are reverse coded: “The way my 
body currently looks does not represent my 
gender identity”; “I do not feel that my 
appearance reflects my gender identity” and “I 
am not proud of my gender identity.” Average 
scores were only calculated for participants 
who completed 75% or more of the scale 
items.  
 
one-month, 
three-
months, 
and six-
months 
post 
baseline 
v. Using a condom at 
last receptive anal 
intercourse or 
vaginal intercourse 
Participants were asked “In the past 3 months, 
how many times have you had receptive 
vaginal or anal intercourse without you or a 
partner using a condom?”. To include the full 
sample participants who reported never having 
receptive sex were coded as “0”. Participants 
who reported using a condom the last time 
they had receptive sex were coded as “0”. 
Participants who reported not using a condom 
the last time they had receptive sex were coded 
as a “1”. 
 
three- and 
six-months 
post 
baseline 
vi. Self-reported 
number of visits to 
Count of number of visits to a health care 
provider. “In the past 3 months, how many 
 
three- and 
six-months 

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Outcome name 
Description of the outcome and how it is 
operationalized. 
Source of the 
measure (e.g. 
performance 
measure) 
Timing of 
measure 
(e.g., 6 
months after 
program 
ends) 
a health care 
provider (of any 
type and by type) 
times have you seen a health care provider for 
transition-related care?”; “In the past 3 
months, how many times have you seen a 
psychiatrist/psychologist/social worker/MFT 
(marriage and family therapist) or other mental 
health care provider?” “In the past 3 months, 
how many times have you seen a doctor or 
other health care provider for any other reason 
(excluding mental health or transition-related 
care)?” 
post 
baseline 
vii. Self-reported 
number of contacts 
as/with a 
mentor/mentee for 
guidance or 
support 
Combined count of total contacts as a mentor 
and/or as a mentee. “About how many times 
have you connected with those you mentored 
(your mentee or mentees) in the past month?”. 
“About how many times have you connected 
with your mentor or mentors in the past 
month?” 
 
three- and 
six-months 
post 
baseline 
viii. What are 
participants' 
reactions to the full 
TWC app at 
immediate follow-
up 
TWC full app sub-group only per Clinical 
Trials.  
 
One month 
post baseline 
ix.  
 
 
 
a If an outcome assessing the number of sexual partners has a very skewed distribution, it may be collapsed 
into a dichotomous variable (0 partners, 1 or more partners) or trichotomous variable (0 partners, 1 partner, 
2 or more partners), depending on the final distribution.  
 
 
a. Analytic sample   
 
The analytic samples for both primary and secondary outcomes are dependent on the 
results of imputation of missing data. If we can successfully impute missing values 
(using multiple imputation) for data missing due to attrition at follow-up and item non-
response, the samples will be comprised of all youth who completed a baseline survey. 
If this first approach is unsuccessful, we will only impute missing values due to item 
non-response, in which case the sample will be comprised of youth who completed 
both the baseline and 3-month post-program follow-up surveys.   
 
b. Data cleaning 
Missing data. We will use listwise deletion for all outcomes and only included complete 
cases.  

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Inconsistencies. Because of forced skip patterns pre-programmed into the electronic data 
collection devices, we expect the sexual behavior outcome data to be relatively clean 
within time points. Within time consistencies will be checked on questions asking about 
the type of sex had in the last 3 months and the number of times respondents had the 
type of sex across all partners. Across time inconsistency will be checked on questions 
asking whether respondents have ever had vaginal or anal sex. The survey asks 
respondents to think about the different sexual partners they have had in the past 3 
months and to answer questions about the number of times they had each type of sex 
(vaginal, oral, and anal) with each partner and the number of times they used condoms 
or other barrier methods; these data are person specific, which may help recall.   
 
Extreme values. For questions asking about the number of times a behavior occurred we 
will examine extreme values in the context of other responses and apply a consistent 
decision rule. 
 
c. Assessment of baseline equivalence  
In addition to the baseline measures of the outcomes, the following variables will be 
used to assess equivalence of the intervention and control groups at baseline: age,  race, 
ethnicity, sexual orientation, and baseline measurements of the primary outcome 
variables. To assess equivalence between groups on each of these variables, we used 
regression analyses with the variable of interest as the dependent variable and the 
intervention indicator as the independent variable. The groups are considered not 
equivalent on a given variable if the p-value for the intervention indicator’s regression 
coefficient is < 0.05 using the Wald test.  
d. Condition crossover and contamination 
An intent to treat model will be used in the analysis so that participants will be analyzed 
as randomized to treatment or control and followed up regardless of whether they 
interact with women in the other condition. The survey asks respondents if they shared 
the app with anyone else; we will report summary statistics on this indicator. We do not 
have names who they shared the app with so we cannot assess contamination.  
e. Analytic approach for primary research questions 
i. Model specification:  
SPSS will be used to conduct the descriptive and bivariate analyses; Stata will 
be used to conduct the multivariable analyses. Statistical significance levels will 
be set at p<.05 unless otherwise noted.  
Separate data analyses will be performed on each outcome variable named 
above and will progress through the following stages: 
First, descriptive analyses will be used to explore the data on all model variables 
at baseline and each follow up for distributional assumptions and 

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unanticipated patterns that might affect subsequent analyses. For example, as 
noted in the outcomes table, some outcomes may need to be dichotomized if 
the distribution is too skewed towards 0.   
Second, bivariate analyses will be used (1) to compare the baseline demographic 
and background characteristics of the intervention and control groups and (2) 
to test for relationships between the outcome variable and potential covariates 
(confounders) being measures. A potential covariate will be included in the 
model if: (1) the variable is associated with the condition indicator at p<0.15; 
and (2) the variable is associated with the outcome at p<0.15 in individual 
bivariate analyses. Our plan for covariate screening is derived from those 
suggested in Altman (1991) and Hosmer and Lemeshow (1989). In the latter, 
it is suggested that p<.25 as a screening criterion may be more appropriate than 
p<.05 because the latter often fails to identify variables that may be important 
to control. We have traditionally “split the difference” and selected a p<.15 to 
preserve degrees of freedom of the model. We routinely include the baseline 
value of the outcome regardless of screening criteria (Pocock et al, 2002). 
Below, we clarify which covariates will be included regardless of these 
screening criteria. (4) Bivariate analyses will also be conducted to assess 
baseline equivalence for the final primary analytic samples.  
Third, multivariable analyses will be conducted using regression analyses (linear 
or logistic) to evaluate the research questions as definitively as possible.  
Each model will include an indicator variable denoting (1) intervention 
group, (2) the baseline outcome variable, (3) the number of days between the 
baseline and follow-up survey (if there is a large range), (4) the standard 
demographics of age at baseline and race/ethnicity at baseline, and (5) a set of 
a priori demographics and outcome-related covariates that screened positively 
as candidates for inclusion in the bivariate screening step. 
Covariates  
Covariates to be forced into all models on an a prior basis:  
1. Baseline value of outcome 
2. Adjustments for imbalances across conditions in baseline equivalence 
on demographic variables for those differences reaching statistical 
significance.   
 
A priori covariates to be screened into the models: 
1. 
Sexual orientation 
2. 
Relationship status 
3. 
Race/ethnicity 
4. 
Age 
5. 
Work status 
6. 
Rural location 
 

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NOTE: if there is high correlation (r>.5) between some of these indicators we 
will not include them all. 
 
 
ii. Sample attrition 
Attrition analyses will be conducted to examine the rate of attrition by 
condition, and what characteristics might be related to attrition. Results from 
the attrition analyses will help evaluate the need to temper interpretations of 
outcome results.  
iii. Adjustments for multiple comparisons (if applicable)  
Adjustments for multiple comparisons will be conducted for primary 
outcomes using the Benjamini-Hochberg correction as outlined in the WWC 
Procedures Handbook v4.1.  
f. Analytic approach for secondary research questions 
Analyses for secondary research questions will proceed using the same steps as 
described for the primary research questions.  
5) Additional planned analyses   
Additional exploratory analyses of the impact evaluation data may include the following.  
a. Subgroup analyses based on participants in each condition who downloaded their 
respective apps will be completed for the primary outcome variables.   
b. Subgroup analyses by various subsets of the sample, such as those defined by 
race/ethnicity variables, age group, or HIV and PrEP status (e.g., PrEP uptake on 
those who were HIV negative and not using PrEP at baseline) may be performed 
similarly to those described for the main analyses.