As part of the University of North Carolina/Emory Center for Innovative Technology (iTech) [
The aims of the research include the following:
Primary aim 1: conduct formative research to develop stepped care (text messaging, WebApp, and eCoaching) interventions and refine iterations through input from focus groups with trans youth and young adults at the 4 study sites (Houston, Texas; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania) and with a trans-specific youth advisory board (YAB).
Primary aim 2: in a 3-condition RCT (N=250), assess the differential immediate and sustained effects of a low-intensity information (
Hypothesis 1a: there will be significantly greater reductions in sexual risk behaviors among those in the text and WebApp conditions compared with the low-intensity info condition.
Hypothesis 1b: there will be significantly greater uptake of PrEP among those in the text and WebApp conditions compared with the low-intensity info condition.
Secondary aim 1: determine the added benefit of text messaging plus eCoaching (text+eCoaching) versus text messaging alone and of WebApp plus eCoaching (WebApp+eCoaching) versus WebApp alone to reduce sexual risk behaviors and increase PrEP uptake.
Secondary aim 2: assess the differential immediate and sustained effects of low-intensity information compared with text messaging only compared with WebApp only for reducing sexual risk behaviors and increasing PrEP uptake.
Secondary aim 3: determine the impact of structural-level (eg, transphobia, housing insecurity, educational attainment, access to health care) and individual-level (eg, identity formation, gender transition, gender expression, stigma, discrimination) trans-specific factors as moderators of intervention outcomes.
Hypothesis 2: structural- and individual-level trans-specific factors will moderate intervention outcomes, such that participants who report higher amounts and degrees of these factors will require more intensive intervention steps (ie, eCoaching).
The Institutional Review Board (IRB) at the University of North Carolina, Chapel Hill, NC, is the IRB on record for all participating institutions and subject recruitment venues (SRVs) participating in the study. The study procedures were approved by the University of North Carolina IRB 18-0519. A waiver of parental consent was obtained for participants aged 15 to 17 years. The study was registered as a clinical trial (Clinical Trials #NCT04000724).
The theoretical construct for the text message intervention was based on 3 proven theories of behavioral change, and the text messages will be equally distributed across the 3 behavioral change theories: Social Cognitive Theory, Health Belief Model, and Social Support Theory.
The Social Cognitive Theory posits interactive causal relationships among personal determinants, behavior, and environmental influences [
The Health Belief Model asserts that individuals’ beliefs regarding threats to their health, and that specific health behaviors can reduce these threats, predict their likelihood of engaging in protective health behaviors [
According to the Social Support Theory, social support encompasses instrumental, emotional, and informational assistance provided by members of one’s social network. These forms of social support have been shown to mediate the relationship between stressful events and health outcomes [
Participants assigned to the
Sample of scripted text messages by behavioral change theory.
| Social Support Theory | Health Belief Model | Social Cognitive Theory | |||||
| Informational support | Emotional support | Instrumental support | Health threat | Health behaviors to reduce threat | Awareness of health risks | Self-regulation skills | Self-efficacy |
| Think you might have been exposed to HIV? Start PEPa within 72 hours |
Your body and soul are beautiful. See a health care provider | PrEPb exists, take advantage of it! | Untreated STIsc can steal your beauty | Take care of yourself and your trans community. Check out resources at (hyperlink) | Lead your community by example, take your PrEP daily! | Taking care of yourself is loving your trans body | Know your health info, be empowered, see your doctor |
| Get the “T” on STI info and testing call (phone number) | Trans Pride is taking care of yourself | Seen your partner lately? See your doctor, too | We love you, don’t be a statistic, take your PrEP! | Be smart, safe |
Protect your cute trans body, see your doctor | Had unprotected sex? No shame, get on PrEP | Nothing compares to you, you can be safe |
aPEP: post-exposure prophylaxis.
bPrEP: pre-exposure prophylaxis.
cSTI: sexually transmitted infection.
The theoretical construct for the WebApp intervention was based on the Information Motivation Behavior (IMB) model of behavioral change (
TechStep WebApp components and the Information, Motivation, Behavior model. PrEP: pre-exposure prophylaxis.
The IMB model proposes that health behavior and behavior change results from being well and accurately informed, having the personal and social motivation to engage in the behavior, and having the appropriate behavioral skills and self-efficacy to use them [
The WebApp intervention will be developed as a safe digital space for sharing information and helping trans youth and young adults feel empowered and supported to make healthy sexual health choices. To be available to answer questions and enforce community standards (eg, no hostile exchanges), the WebApp will be moderated by research staff (primarily graduate-level students) trained by the study Protocol Co-Chair on how to identify and respond to problematic posts. Moderating includes reading through posted comments on the wall each day and identifying posts that are concerning (eg, suicidal ideation, pleas for assistance, and potentially hostile comments to other users). Posts made by participants are not delayed or held until
The WebApp homepage will consist of an interface for participants to asynchronously interact with one another through message posting (
Staff members who are a part of the community wrote brief informational pieces of content, called
Participants will have the ability to self-monitor one or more behaviors under the
Participants will be able to search for local trans-specific resources in their area through the
All participants will receive a weekly SMS (text) message that prompts and encourages them to visit the
The WebApp uses points that accumulate as youth use intervention components to reinforce engagement with the site. As points accumulate, youth move through higher levels (ie,
Participants in the text or the WebApp conditions who do not reduce sexual risk behaviors or who self-report a recent STI diagnosis and do not initiate PrEP or adhere to PrEP during the first 3 months of those interventions will be rerandomized to additionally receive eCoaching. The eCoaching intervention integrates theoretical constructs of Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) to assist trans youth and young adults in establishing health behavior goals, discussing facilitators and barriers to behavior change, and providing behavioral skills to enhance goal attainment [
MI is a style of communication fostering collaboration and goal setting to build personal motivation for behavior change [
CBT is an action-orientated treatment that addresses maladaptive cognitive beliefs and behaviors [
eCoaching sessions are conducted through a Zoom portal (Zoom Video Communications Inc) to have a common meeting place for video conferencing and electronically sharing intervention activity materials. Participants will be asked to join eCoaching sessions through their mobile device or desktop. Sessions are 30 to 40 min long and held weekly on an agreed-upon day and time.
Participants rerandomized to eCoaching are virtually introduced to their eCoach during the 3-month assessment appointment, called the First Contact session. The First Contact session is a 20-min mini session during which the participant meets their eCoach, learns about the eCoaching intervention, establishes rapport, introduces the functional assessment, and establishes an agreed-upon day and time for subsequent weekly virtual sessions. There are up to 8 sessions of content available to occur over a 12-week period. Sessions 1 to 4 are core sessions: session 1: Planning for My Plan; session 2: You Getting to Know You; session 3: Intimacy and Communication; and session 4: Getting PrEPared. Sessions 5 to 8 are optional and are based on answers to the functional assessment and subsequent collaborative treatment planning. Session 5: Keeping It Cool; session 6: Alcohol and Drugs; session 7: Checking In; and session 8: You Don’t Have to Do It Alone. The functional assessment is a 20-item survey completed between first contact and session 1 with yes, no, and maybe response options. Endorsing certain items (yes or maybe) map onto recommended modules for sessions 5 to 8 and allows the eCoach to work with the participant during the session 1 collaborative treatment plan to decide which sessions would be most beneficial.
eCoaching is facilitated by highly trained transgender and cisgender paraprofessionals centrally located at Hunter College. All eCoaches attend 5 days of MI, CBT, and protocol training conducted by a Motivational Interviewing Network of Trainers–certified trainer followed by mocking and supervision for session clearance. Fidelity is monitored through the completion of the MI coach ratings scale by the clinical supervisor and weekly supervision sessions [
The information control condition is a static website that comprises 6 pages:
The
A total of 2 trans-specific YABs will be convened throughout the life of the study. There is a physical YAB in Los Angeles, and a virtual cross-site YAB conducted via telecommunication comprised members from the Houston, New York, and Philadelphia SRVs. The YABs will meet at least biannually and will provide feedback on all aspects of the
We conducted 7 focus groups at 4 SRVs (n=34); 2 were held in Los Angeles (n=11), 2 in Houston (n=7), 2 in New York (n=11), and 1 in Philadelphia (n=5). The New York and Philadelphia focus groups gave feedback on the text messaging intervention, whereas the Los Angeles and Houston focus groups gave feedback on the WebApp. In each city, the focus groups were stratified by age, 1 focus group consisting of participants between the ages of 15 and 20 years and the other focus group consisting of participants between the ages of 21 and 24 years (only 1 focus group, with participants aged 21-24 years, occurred in Philadelphia). This stratification ensured that the perspectives of both youth and young adults were explored. Focus groups were transcribed verbatim, and content analysis was conducted using the iTech Analytic Core. Feedback from the focus groups was used to inform phase 2.
The focus group inclusion criteria were as follows: (1) self-identification as trans feminine, trans masculine, or gender nonconforming or birth sex and current gender differ; (2) self-reported 15 to 24 (inclusive) years of age at screening; (3) report any sex with another person in the previous 12 months; (4) self-reported HIV-negative serostatus; (5) live in the area and have the availability to attend the group; (6) have a mobile device with SMS and internet access capabilities; and (7) proficient in English as determined by study staff (as the focus groups were conducted in English).
All persons who screened eligible for a focus group were guided through the informed consent process on the day of the focus group. Following informed consent, participants completed a brief paper-and-pencil focus group participant survey (eg, additional demographics and technology use survey).
Focus groups were conducted by research staff and lasted approximately 120 min. Food was served in each group. Participants were compensated for their time once the focus group ended.
We propose to enroll 250 trans youth and young adults in the RCT (approximately n=83 for text, n=83 for WebApp, and n=83 for information control;
TechStep study design. eCoaching: electronic coaching.
All participants will receive one of the interventions for 6 months, with assessments occurring at baseline and every 3 months thereafter through Month 9. Trans youth and young adults randomized to either of the technology-based intervention conditions (text or WebApp) will be evaluated at the three-month follow-up assessment time points to determine whether they remain at the current level of intervention or whether they are eligible for rerandomization to also receive eCoaching sessions in addition to their originally assigned intervention (ie, text+eCoaching or WebApp+eCoaching). At the first follow-up assessment time point, information about their sexual behavior in the past 3 months and whether they began or stopped using PrEP will be used to determine whether they require a more intensive intervention approach. Participants who do not demonstrate intervention responsiveness at the 3-month follow-up assessment will be rerandomized, in a 2:1 ratio, to either add eCoaching to their original intervention (ie, text+eCoaching or WebApp+eCoaching) or remain in their original intervention (ie, text or WebApp). This rerandomization will allow for a comparison of intervention effects between the technology-based interventions (ie, text or WebApp) plus eCoaching with the technology-based intervention alone. The control condition will receive the same information-only intervention for the entire 6-month intervention period.
The RCT inclusion criteria were as follows: (1) self-identify as trans feminine, trans masculine, or gender nonconforming or birth sex and current gender differ; (2) aged 15 to 24 years (inclusive) at the enrollment visit; (3) self-report vaginal or anal sex (either insertive or receptive, excluding sex toys) with another person in the previous 12 months; (4) negative HIV rapid test; (5) live in the area and be available to meet with research staff at 1 of the 5 SRVs; (6) have a mobile device with SMS and internet access capabilities; and (7) be able to read and speak English (as the interventions will be built in English).
The following recruitment strategies will be used to ensure diversity of the participants enrolled:
Web-based: web-based banner advertisements will be placed through geomapping on websites and social media in the SRV cities. Digital flyers will be distributed to community leaders to disseminate to their email distribution lists.
SRV and community-based reach: flyers and posters will be distributed in SRVs and other community-based organizations and clinic settings that cater to trans youth and young adults.
Peer long-chain referral: participants who screen eligible will be asked to refer friends who are also trans youth and young adults.
Clinic: clinic-based recruitment may include reviewing the medical charts of existing patients for potential eligibility or referrals from other providers in the clinic.
Previous participants: participants from other studies who have previously given consent to be contacted for future research may also be contacted directly.
Print media: advertisements may be placed in print media identified through the YABs.
Street- and venue-based outreach: research assistants will use a semistructured time-space sampling methodology to conduct street- and venue-based outreach identified through the YABs [
All potential participants will complete a web-based screening survey to obtain consent or assent to be screened and verify all inclusion criteria. Screening may occur on the same day as enrollment (or beforehand, if screening on the web). The web-based screening survey will begin with a script to explain the purpose of screening and clarify that if they are eligible, they will be invited to participate in the study. The script will also provide general information about
All persons who screened eligible for the study will be guided through the informed consent process on the day of their enrollment appointment in person at one of the SRVs. Enrollment procedures will last approximately 120 min and consist of informed consent or assent; the baseline audio computer-assisted self-interview (ACASI) survey; HIV, STI, and drug screen testing; and Mitra blood analysis for detection of PrEP concentrations among those who self-reported PrEP use (
Study outcome variables and data collection schedule.
| Variables | Baseline | 3-month assessment | 6-month assessment | 9-month assessment |
| Rapid HIV test | ✓a | ✓ | ✓ | ✓ |
| STIb testsc | ✓ | ✓ | ✓ | ✓ |
| Blood microsampling for PrEPd,e | ✓ | ✓ | ✓ | ✓ |
| Sexual behavior | ✓ | ✓ | ✓ | ✓ |
| Demographics: date of birth, race and ethnicity, sex assigned at birth | ✓ | —f | — | — |
| Demographics: gender identity, sexual identity, education, employment status, health insurance, family income, housing stability, history in the criminal justice system | ✓ | ✓ | ✓ | ✓ |
| Health care utilization | ✓ | ✓ | ✓ | ✓ |
| Gender congruence, stress, and resilience | ✓ | ✓ | ✓ | ✓ |
| Substance use | ✓ | ✓ | ✓ | ✓ |
| Mental health | ✓ | ✓ | ✓ | ✓ |
| Technology adaptation and use | ✓ | ✓ | ✓ | ✓ |
| Intervention ease of use, acceptability, and satisfaction | — | ✓ | ✓ | — |
| User engagement | — | ✓ | ✓ | — |
aOutcome assessed in this data collection period.
bSTI: sexually transmitted infection.
cSTI tests include gonorrhea and chlamydia testing via throat and rectal swabs and urine and syphilis testing via a blood draw.
dPrEP: pre-exposure prophylaxis.
eMitra blood microsampling will be performed only when participants report PrEP use before a study visit.
f—: outcome not assessed in this data collection period.
Participants will be randomized 1:1:1 to the text intervention or WebApp intervention or control condition. Study staff will not be blinded to the condition that participants are randomized to. The randomization sequence will be stratified by city and use random permuted blocks of size 3.
Follow-up evaluations will occur at 3, 6, and 9 months postenrollment. The data collection schedule is presented in
Study outcome measures and the timing of their administration are provided in
Change in condomless intercourse events: participants will be asked to report the frequency of condom use during sex in the last 3 months (
Change in condomless intercourse events when high on drugs or alcohol: participants will be asked to report whether they or their partners used substances during the last 3 sexual encounters.
Change in condomless intercourse events during sex work: participants will be asked to report condom use and partner type for sexual encounters over the previous 3 months as well as during the last 3 sexual encounters.
PrEP adherence: participants will self-report PrEP medication uptake and adherence on the ACASI. PrEP adherence is measured by blood sample levels of tenofovir diphosphate and emtricitabine triphosphate (TFV-DP/FTC-TP) with blood concentrations consistent with >4 doses per week.
HIV seroconversion: HIV tests will be administered at each study visit. Reactive results after baseline will be recorded as a seroconversion.
Incident STIs: participants will be asked to self-report new STI diagnoses from the past 3 months on the ACASI and they will be tested for gonorrhea and chlamydia via throat and rectal swabs and urine and syphilis via a blood draw.
Transgender syndemic health index: participants will self-report education, employment status, housing stability, history in the criminal justice system, health care utilization, gender congruence, stress and resilience, substance use, and mental health.
Common demographic factors will be collected, including date of birth, race and ethnicity, gender identity, sex assigned at birth, sexual identity, education, employment status, health insurance, family income, housing stability, and history in the criminal justice system.
Participants will be asked to rate their own health and medical services they may have used, including primary health care location, recent hospitalization, access to a primary care provider, comfort in discussing sexual relationships and gender identity, and HIV and STI testing. PrEP knowledge and use will be assessed using the PrEP Motivational Cascade [
Gender congruence (ie, the alignment of gender expression and identity) is measured using items from the National Health Behavior Survey [
Substance use will be assessed via a urine screen to assess amphetamines, methamphetamines, cocaine, marijuana, and opiates using a generic 5-panel screening test (model HDOA-254; Confirm BioSciences) and an adapted version of the National Institute on Drug Abuse-modified alcohol, smoking, and substance involvement screening test [
Depression symptoms will be assessed using the 8-item Patient Health Questionnaire (PHQ-8) [
Experiences of relationship violence, including sexual assault, physical violence, isolation, privacy, and financial violations, are assessed [
Sexual behavior will be assessed by asking whether they have engaged in vaginal, anal, or oral sex in the past 3 months. If they reported having sex in the past 3 months, participants will be asked how many main, casual, and exchange partners they had in the past 3 months, and how frequently (from none of the time to all of the time) they used a condom during insertive and receptive anal sex and vaginal sex. Participants are then asked about their 3 most recent sexual encounters and are asked to report on the number, genders, and types (ie, main, casual, exchange) of partners, sexual positioning, condom use, HIV status of partners, partner PrEP use, viral suppression of HIV-positive partners, and substance use by either the participant or their partners before or during sex [
Technology use questions and items assessing participants’ attitudes toward technology were taken from items developed by the Pew Research Center’s Internet, Science, and Tech initiative. Participants are asked to report device ownership and operating system; how they access the internet; how they pay for service; how many hours a day they spend on the internet; how often they use mobile apps; frequency of internet use for social, sex-seeking, work, and health-seeking activities; and whether and how they may have faced discrimination when looking for partners on the web. In addition, the 8-item eHealth Literacy Scale will be used to assess participants’ perceptions of their skills for using the internet for health [
Participants in the WebApp condition will be asked to rate the ease of use of their activities at the 3- and 6-month follow-up visits using the System Usability Scale (SUS) [
The WebApp intervention uses data collected during the active trial period to assess user engagement with the intervention. Standard use data include (1) log-in date and time, (2) type of device used, and (3) total duration of the session. Intervention use data for each participant will include the following variables reflecting peer-to-peer interaction: (1) date and content of original posts and (2) the number and content of replies to the original post. Additional user engagement variables collected are (1) frequency of posts; (2) number of comments; (3) number of tips viewed or favorited; (4) number of tracking behaviors established, frequency of tracking, and for each tracked behavior, the frequency of endorsing that behavior; (5) frequency of resource locator use and subtypes of resources sought; (6) total number of active intervention days; (7) number of times the participant updated their outward-facing profile features; and (8) total points earned.
Individuals’ baseline characteristics will be summarized by randomization arm using appropriate measures of central tendency and variability. We define intervention effects based on the difference in the average cumulative number (for count-valued outcomes such as instances of condomless anal intercourse) or proportion (for binary-valued outcomes such as PrEP uptake) of outcomes observed over 9 months of follow-up comparing a given active condition (eg, text messaging or WebApp) versus the info condition. We will estimate these effects using longitudinal targeted minimum loss-based estimation (LTMLE) [
Implementation of LTMLE involves fitting several prespecified models that adjust for participant-level information. First, a sequence of outcome regressions is fit to model the average outcome (eg, average number of condomless anal intercourse events) at each time point, adjusting for baseline and time-varying covariates. Second, a regression is fit to model the cumulative probability of participant dropout, adjusting for baseline and time-varying covariates. These models will be fit using the super learner, a cross-validation–based technique for estimator selection [
We will use level 0.05 Wald tests for each hypothesis using influence function-based standard error estimates. More information on this approach can be found in the paper by Benkeser et al [
The sample size was determined using Monte Carlo simulations. We designed a program to simulate trial data and calibrate the simulation to an existing data source to determine the appropriate distributions of risk behaviors in the study population. We evaluated the power to detect treatment effects across a range of sample sizes, intervention effect sizes, levels of missingness, strength of prognostic measurements in predicting outcomes, and proportion of participants who become eligible for rerandomization. Overall, we found that there would be >80% power to detect a difference of about 1.5 events of risky sexual behavior between the 2 intervention arms with 250 participants enrolled in the trial.