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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, Health Knowledge, Attitudes, Practice, STI

Intervention / Treatment
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* Behavioral: Trans Women Connected
* Behavioral: General Health App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-49 at the start of the study. self-identify as transgender women self-identify as sexually active with more than one partner in the prior 90 days at least one sexual partner in the last 90 days had a penis has a smartphone resides in the U.S. Exclusion Criteria: Anyone not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TWC App<br>The intervention is a mobile app delivered sexual health promotion program designed specifically for transgender women. The mobile app will include more than 30 interactive activities including resource maps, PrEP and PEP content, and communication forums for connecting with other transgender women. The intervention/app is intended to be used regularly, approximately two times per week during the 90 day active participation period. | Behavioral: Trans Women Connected<br>* 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.<br>|
| Active Comparator: General Health App<br>Participants will download a general health mobile app that contains sexual health information. The control mobile app is intended to be used regularly, approximately two times per week during the 90 day active participation period. | Behavioral: General Health App<br>* The control group will download a mobile app that addresses general health behaviors and concerns, including sexual health topics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported STI/HIV testing in past three months | Tested for STI/HIV in past three months | 3-months post intervention | 
| Self-reported STI/HIV testing in past three months | Tested for STI/HIV in past three months | 6-months post intervention | 
| Receptive condomless anal intercourse or condomless vaginal intercourse | Number of times receptive condomless anal intercourse or condomless vaginal intercourse | 3-months post intervention | 
| Receptive condomless anal intercourse or condomless vaginal intercourse | Number of times receptive condomless anal intercourse or condomless vaginal intercourse | 6-months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of a condom at last receptive anal intercourse or vaginal intercourse | Used a condom at last receptive anal intercourse or vaginal intercourse | Baseline, 3-month post, 6- month post | 
| Health care visits | Self-reported # of visits to a health care provider (of any type and by type) | 3-months post intervention | 
| Health care visits | Self-reported # of visits to a health care provider (of any type and by type) | 6-months post intervention | 
| mini-Medical Outcomes Study--Social Support Survey (mMOS-SS) | Perceptions of social support, mean score of 8 items measured on a five point scale (1-5). Scale range is from 8 - 40 with a higher number indicating greater perceived social support, which is a better outcome. Scale score can be transformed to a standardized score ranging from 0 to 100 using a formula provided by scale developers. | Baseline, Immediate post, 3- month post, 6-month post | 
| Engaged as/with mentor | Self-reported number of contacts as a mentor/mentee for guidance or support | 3-months post intervention | 
| Engaged as/with mentor | Self-reported number of contacts as a mentor/mentee for guidance or support | 6-months post intervention | 
| PrEP Uptake | Self-reported uptake of PrEP among HIV since last measurement period- subsample | Baseline, Immediate post, 3- month post, 6-month post | 
| Condom/Barrier Negotiation Self Efficacy Scale | Scale measures self-efficacy in decisions around using protective barriers during sex. Average of 8 items on a 7-point scale (1 to 7), with a range of 8 - 56, with a higher score indicating better outcomes, or greatder self-efficacy | Immediate post | 
| Condom/Barrier Negotiation Self Efficacy Scale | Average of 8 items on a 7-point scale (1 to 7), with a range of 8 - 56, with a higher score indicating better outcomes, or greatder self-efficacy | 3- month post | 
| Trans Pulse Survey Condom/Barrier Negotiation Self Efficacy Scale | Average of 8 items on a 7-point scale (1 to 7), with a range of 8 - 56, with a higher score indicating better outcomes, or greatder self-efficacy | 6-month post | 
| Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale | Sub-scale measures comfort navigating health services. Average of 5 items on a 4-point scale (1-4), with a range of 5 - 20, with a higher score indicating greater comfort navigating health services | Immediate post | 
| Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale | Sub-scale measures comfort navigating health services. Average of 5 items on a 4-point scale (1-4), with a range of 5 - 20, with a higher score indicating greater comfort navigating health services | 3-month post | 
| Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale | Sub-scale measures comfort navigating health services. Average of 5 items on a 4-point scale (1-4), with a range of 5 - 20, with a higher score indicating greater comfort navigating health services | 6- month post | 
| Transgender Congruence Scale (TCS) | Scale measures degree of comfort with external appearance as it relates to gender identity. Average of 12 items on a 5-point scale, with a range of 12 - 60, with a higher score indicating a perception that their appearance reflects their chosen gender identity | Baseline, Immediate post, 3- month post, 6-month post | 
| Trans Women Connected Satisfaction Survey | Scale measures participants' reactions to the app. Avereage of 3 items on a 5-point scale with a range of 3 to 15 with a higher score indicating greater levels of satisfaction with the app. | Immediate post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender Women, STI, Sexual Health, HIV/AIDS