Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior Among Transgender Women
Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior Among Transgender Women
The study is a 2-arm cluster randomized controlled trial to be conducted with 450 trans women
 to assess the effectiveness of the Trans Women Connected mobile app. Those in the treatment
 arm will be provided with the Trans Women Connected app, to be downloaded to their own
 device, and asked to use it during a three month period. Those in the control arm will be
 asked to download a general health app and use it during the same three-month period.
 Participants will complete brief online surveys at baseline, immediately following the
 app-use period, and at 3- and 6-months following the conclusion of the app-use period. The
 baseline and follow-up assessments will collect data on demographic characteristics, measures
 related to our primary and secondary outcomes, and psychosocial measures. The primary outcome
 measures are self-reported STI/HIV testing and sex without a condom, with secondary measures
 including sexual risk behaviors, health care visits, perceived social support/connectedness,
 PrEP use, self-efficacy in negotiation/communication, and comfort with gender identity and
 appearance. In addition, process data, such as forum content, and usage data will be
 collected and analyzed.
A 2-arm cluster randomized controlled trial will be conducted with 450 trans women to assess
 the effectiveness of the Trans Women Connected mobile app. The Trans Women Connected
 intervention will address the unique needs of transgender women and the lack of
 evidence-based, transgender-specific HIV prevention. It is a mobile app delivered sexual
 health promotion program that engages transgender women through a strengths-based approach to
 HIV prevention and sexual health that uses the power of social networks to identify and
 encourage protective factors that support the health of transgender women. This approach
 recognizes the social and structural barriers that transgender women face. In the context of
 these barriers, which include stigma and discrimination in a number of interconnected
 spheres, individually-focused behavioral interventions are insufficient. This intervention
 takes a more comprehensive approach that intentionally targets community strengths and
 challenges. The mobile app will include more than 30 interactive activities including
 resource maps, PrEP/PEP content, and communication forums.

 To be eligible, participants will be required to 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; be age 18-49 at baseline; own a smartphone; and reside in any state in the
 United States. Those in the treatment arm will be provided with the Trans Women Connected
 app, to be downloaded to their own device, and asked to use it during a three-month period.
 Those in the control arm will be asked to download a general health app and use it during the
 same three-month period. Participants will complete brief online surveys at baseline,
 immediately following the app-use period, and at 3- and 6-months following the conclusion of
 the app-use period.

 Participants will be recruited using a variety of methods, including: 1) Regional transwomen
 recruitment/retention specialists who are responsible for facilitating recruitment in their
 regions, addressing study questions, and maintaining connections with each participant to
 support study engagement; 2) Organizations. Organizations from across the U.S., at least one
 per state, that serve transgender women will be approached to help recruit participants
 through social media and in-person. 3) Google Adwords. Placing study advertisements on Google
 based on keyword for participant recruitment has been shown to be effective. 4) Social Media
 Advertising including targeted advertising on social media sites (Facebook/Instagram) and
 sponsoring study posts with social media influencers in the Transwomen community. Social
 media advertising has been shown to be favorable in terms of its cost-effectiveness,
 usability, and reach, especially with hard-to-reach populations, young adults and LGBT
 populations. 5) Participant Recruitment. Once recruited and successfully entered into the
 study each participant will receive three digital referral coupons and each coupon will
 generate $15 for a successfully screened participant. Participants will complete 4 web-based
 surveys and will receive $20 for baseline survey, $20 for an immediate posttest, $40 at
 3-month follow up, $60 at final 6-month follow up.

 Randomization. Because the evaluation is using cluster randomization, the participants will
 be randomized by cluster. There will be 150 seeds and the first person in a cluster. Each
 will be given 3 referral coupons. Upon completing a baseline survey the seed will be
 randomized into treatment or control. Any participant using a referral coupon will be placed
 in the same condition as the initial seed with which they are associated.

 Implementation. After randomization, participants in the treatment group, will be granted
 access to download and install the Trans Women Connected mobile app. They will have three
 months to use the program. Participants will agree to complete core activities and use the
 app as often as they can with a target of two times per week. Participants can use the app as
 often as they want. Those in the control group will download and install a general health app
 that includes some sexual health content.

 Data Collection. Participants will be surveyed at 4 time points. 1) before randomization, 2)
 after using the mobile app for 3 months, 3) three months after completion of the
 intervention, and 4) six months after completion of the intervention. Surveys will be
 completed online via Survey Gizmo through emailed or texted links. All survey data will be
 transferred to SPSS for analysis. Data will also be collected through the app. This includes
 usage data, such as what activities participants used and for how long, and process data,
 which includes content on the communication forum, text answers in the app, and visual
 content such as vision boards. Participants will receive an incentive of $20 for the baseline
 and immediate post-intervention survey, $40 for the 3-month follow up survey, and $60 for the
 6 month follow up survey.

 Study Hypotheses. Primary Hypotheses 1 (representing sexual health risk reduction through
 engagement in care 1) Women in the intervention group will report more STI testing (higher
 rates of STI testing in the prior 90 days) than the comparison group. Primary Hypotheses 2,
 women in the intervention group will report fewer acts of receptive condomless anal
 intercourse or condomless vaginal intercourse. Secondary Hypotheses (representing other
 important sexual health risk, and psychosocial outcomes):1) Participants in the intervention
 group will report reduced sexual risk taking including fewer acts of receptive condomless
 anal intercourse or condomless vaginal intercourse; greater use of condom use at last
 intercourse (receptive anal or vaginal); and increased use of PrEP for those that are HIV- 2)
 Participants in the intervention group will engage more with proactive health care and report
 more health care visits. 3) Participants in the treatment group will report more
 connectedness with other transgender women, including perceived social support and engagement
 with a mentor. 4) Participants in the intervention group will report greater efficacy in
 having safer sex and in communication both with partners and health care workers. 5) Those in
 the treatment group will have greater acceptance of their gender identity/comfort with gender
 identity.
Inclusion Criteria:

 1. aged 18-49 at the start of the study.

 2. self-identify as transgender women

 3. self-identify as sexually active with more than one partner in the prior 90 days

 4. at least one sexual partner in the last 90 days had a penis

 5. has a smartphone

 6. resides in the U.S.

 Exclusion Criteria:

 Anyone not meeting inclusion criteria