Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior Among Transgender Women — TWC  

HIV/AIDS Clinical Trial

Official title: A Randomized Controlled Trial of Trans Women Connected: a Mobile App Delivered Sexual Health Promotion Program

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Health Knowledge, Attitudes, Practice
• HIV Infections
• HIV/AIDS
• STI

• NCT number: NCT03897049
• Study type: Interventional
• Source: ETR Associates
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Completion date: September 7, 2022