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

HIV/AIDS Clinical Trial

— TWC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897049
• Other study ID #: TransWomenConnected
• Secondary ID: 5R44MD012279
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 7, 2022

Study information

• Verified date: December 2023
• Source: ETR Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 month period. Those in the control arm will be asked to download a general health app and use it during a month period. Participants will complete brief online surveys at baseline, immediately following the app-use period (1-month post baseline), and at 3- and 6-months following baseline. 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 sexually transmitted infection (STI)/HIV testing and sex without a condom, with secondary measures including sexual risk behaviors, health care visits, perceived social support/connectedness, pre-exposure prophylaxis (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.

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 content, post-exposure prophylaxis (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 month period. Those in the control arm will be asked to download a general health app and use it during a month period. Participants will complete brief online surveys at baseline, immediately following the app-use period (1-month post baseline), and at 3- and 6-months following baseline.

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 lesbian, gay, bisexual, and transgender (LGBT) populations. 5) Participant Recruitment (participants sharing information about the study within their networks). 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. The 2-arm randomized controlled trial involves randomizing individual participants using an equal allocation (allocation ratio 1:1) to receive the full TWC app or an attention control app. Participants were randomized after completing their baseline surveys using the randomizer feature of Qualtrics.

Data Collection. Participants will be surveyed at 4 time points. 1) before randomization, 2) after using the mobile app for 1 month, 3) three months after completion of the baseline, and 4) six months after completion of the baseline. Surveys will be completed online through emailed or texted links. Data will also be collected through the apps. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Trans Women Connected
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.
• General Health App
The control group will download a mobile app that addresses COVID and provides COVID resources.

Locations

Country	Name	City	State
United States	ETR	Scotts Valley	California

Sponsors (4)

Lead Sponsor	Collaborator
ETR Associates	dfusion Inc, National Institute on Minority Health and Health Disparities (NIMHD), Portland State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ramirez-Valles J, Heckathorn DD, Vazquez R, Diaz RM, Campbell RT. From networks to populations: the development and application of respondent-driven sampling among IDUs and Latino gay men. AIDS Behav. 2005 Dec;9(4):387-402. doi: 10.1007/s10461-005-9012-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported HIV or STI Testing in Past 3 Months	Participant reported having tested for HIV or STI in the past 3 months	3-months post intervention
Primary	Self-reported HIV or STI Testing in Past 3 Months	Participant reported having tested for HIV or STI in the past 3 months	6-months post intervention
Primary	Receptive Condomless Anal Intercourse or Condomless Vaginal Intercourse in Past 3 Months	Participant reported having had receptive anal intercourse without a condom or receptive vaginal intercourse without a condom in the past 3 months	3-months post intervention
Primary	Receptive Condomless Anal Intercourse or Condomless Vaginal Intercourse in Past 3 Months	Participant reported having had receptive anal intercourse without a condom or receptive vaginal intercourse without a condom in the past 3 months	6-months post intervention
Secondary	Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse	Participant reported using a condom at last receptive anal intercourse or vaginal intercourse	3-month post intervention
Secondary	Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse	Participant reported using a condom at last receptive anal intercourse or vaginal intercourse	6-month post intervention
Secondary	Health Care Visits in Past 3 Months	Average # of self-reported visits to a health care provider (of any type and by type)	3-months post intervention
Secondary	Health Care Visits in Past 3 Months	Average # of self-reported visits to a health care provider (of any type and by type)	6-months post intervention
Secondary	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 1 - 5 with a higher number indicating greater perceived social support, which is a better outcome.	1-month post intervention
Secondary	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 1 - 5 with a higher number indicating greater perceived social support, which is a better outcome.	3-month post intervention
Secondary	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 1 - 5 with a higher number indicating greater perceived social support, which is a better outcome.	6-month post intervention
Secondary	Engaged as/With Mentor in Past 3 Months	Self-reported number of contacts in the past 3 months as a mentor/mentee for guidance or support	3-months post intervention
Secondary	Engaged as/With Mentor in Past 3 Months	Self-reported number of contacts, in the past 3 months, as a mentor/mentee for guidance or support	6-months post intervention
Secondary	PrEP Uptake	Self-reported uptake of PrEP among HIV since last measurement period- subsample	1-month post intervention
Secondary	PrEP Uptake	Self-reported uptake of PrEP among HIV since last measurement period- subsample	3-month post intervention
Secondary	PrEP Uptake	Self-reported uptake of PrEP among HIV since last measurement period- subsample	6-month post intervention
Secondary	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 1 - 7, with a higher score indicating better outcomes, or greater self-efficacy	1 month post-intervention
Secondary	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 1 - 7, with a higher score indicating better outcomes, or greater self-efficacy	3- month post intervention
Secondary	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 1 - 7, with a higher score indicating better outcomes, or greater self-efficacy	6-month post intervention
Secondary	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 1 - 4, with a higher score indicating greater comfort navigating health services	1-month post intervention
Secondary	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 1 - 4, with a higher score indicating greater comfort navigating health services	3-month post intervention
Secondary	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 1 - 4, with a higher score indicating greater comfort navigating health services	6- month post intervention
Secondary	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 1 - 5, with a higher score indicating a perception that their appearance reflects their chosen gender identity	1-month post intervention
Secondary	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 1 - 5, with a higher score indicating a perception that their appearance reflects their chosen gender identity	3-month post intervention
Secondary	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 1 - 5, with a higher score indicating a perception that their appearance reflects their chosen gender identity	6-month post intervention
Secondary	Trans Women Connected Satisfaction Survey	Scale measures participants' reactions to the app. Average of 3 items on a 5-point scale with a range of 1 to 5 with a higher score indicating greater levels of satisfaction with the app.	1-month post intervention