Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior Among Transgender Women
Condition: HIV/AIDS; Health Knowledge, Attitudes, Practice; STI
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Trans Women Connected; General Health App
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 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.; The control group will download a mobile app that addresses general health behaviors and concerns, including sexual health topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a two arm cluster randomized controlled trial. Because the evaluation is using cluster randomization, the participants will be randomized by cluster into the control or treatment group. 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, educators in the treatment group, will be granted access to download and install the Trans Women Connected mobile app.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transgender Women; STI; Sexual Health; HIV/AIDS