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

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ClinicalTrials.gov Identifier: NCT03897049
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
dfusion
Portland State University
Information provided by (Responsible Party):
ETR Associates

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Health Knowledge, Attitudes, Practice STI Behavioral: Trans Women Connected Behavioral: General Health App Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
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)
Masking Description: Participants are randomly assigned to their condition without being made aware of their assigned condition. Each condition downloads and uses an app so study activities are similar reducing the likelihood participants will be aware of their assigned condition.
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Trans Women Connected: a Mobile App Delivered Sexual Health Promotion Program
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TWC App
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
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.

Active Comparator: General Health App
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
The control group will download a mobile app that addresses general health behaviors and concerns, including sexual health topics.




Primary Outcome Measures :
  1. Self-reported STI/HIV testing in past three months [ Time Frame: 3-months post intervention ]
    Number of times reported having been tested for STI/HIV

  2. Self-reported STI/HIV testing in past three months [ Time Frame: 6-months post intervention ]
    Number of times reported having been tested for STI/HIV

  3. Receptive condomless anal intercourse or condomless vaginal intercourse [ Time Frame: 3-months post intervention ]
    Number of times receptive condomless anal intercourse or condomless vaginal intercourse

  4. Receptive condomless anal intercourse or condomless vaginal intercourse [ Time Frame: 6-months post intervention ]
    Number of times receptive condomless anal intercourse or condomless vaginal intercourse


Secondary Outcome Measures :
  1. Use of a condom at last receptive anal intercourse or vaginal intercourse [ Time Frame: Baseline, 3-month post, 6- month post ]
    Used a condom at last receptive anal intercourse or vaginal intercourse

  2. Sexual partners, unprotected, in last 3 months [ Time Frame: 3-months post intervention ]
    # partners with whom had anal or vaginal sex without using condoms or PrEP in past 3 months

  3. Sexual partners, unprotected, in last 3 months [ Time Frame: 6-months post intervention ]
    # partners with whom had anal or vaginal sex without using condoms or PrEP in past 3 months

  4. Health care visits [ Time Frame: 3-months post intervention ]
    Self-reported # of visits to a health care provider (of any type and by type)

  5. Health care visits [ Time Frame: 6-months post intervention ]
    Self-reported # of visits to a health care provider (of any type and by type)

  6. Multidimensional Scale of Perceived Social Support [ Time Frame: Baseline, Immediate post, 3- month post, 6-month post ]
    Perceptions of social support, mean score. Scale range is from 7 - 49 with a higher number indicating greater perceived social support which is a better outcome

  7. Engaged as/with mentor [ Time Frame: 3-months post intervention ]
    Self-reported number of contacts as a mentor/mentee for guidance or support

  8. Engaged as/with mentor [ Time Frame: 6-months post intervention ]
    Self-reported number of contacts as a mentor/mentee for guidance or support

  9. PrEP Uptake [ Time Frame: Baseline, Immediate post, 3- month post, 6-month post ]
    Self-reported uptake of PrEP among HIV since last measurement period- subsample

  10. HIV & Safer Sex: Self Efficacy Scale [ Time Frame: Immediate post ]
    Scale measures self-efficacy in decisions around safe sex behavior. Average of 7 items on a 5-point scale (1 to 5), with a range of 7 - 35, with a higher score indicating better outcomes

  11. HIV & Safer Sex: Self Efficacy Scale [ Time Frame: 3- month post ]
    Scale measures self-efficacy in decisions around safe sex behavior. Average of 7 items on a 5-point scale (1 to 5), with a range of 7 - 35, with a higher score indicating better outcomes

  12. HIV & Safer Sex: Self Efficacy Scale [ Time Frame: 6-month post ]
    Scale measures self-efficacy in decisions around safe sex behavior. Average of 7 items on a 5-point scale (1 to 5), with a range of 7 - 35, with a higher score indicating better outcomes

  13. Ask ,Understand, and Remember (AURA) [ Time Frame: Immediate post, 3- month post, 6-month post ]
    Scale measures patient communication self-efficacy within clinical encounters. Average of 4 items on a 4-point scale, with a range of 4 - 16, with a greater higher score indicating better outcomes

  14. Ask ,Understand, and Remember (AURA) [ Time Frame: Immediate post ]
    Scale measures patient communication self-efficacy within clinical encounters. Average of 4 items on a 4-point scale, with a range of 4 - 16, with a greater higher score indicating better outcomes

  15. Ask ,Understand, and Remember (AURA) [ Time Frame: 3- month post ]
    Scale measures patient communication self-efficacy within clinical encounters. Average of 4 items on a 4-point scale, with a range of 4 - 16, with a higher score indicating better outcomes

  16. Transgender Congruence Scale (TCS) [ Time Frame: Baseline, Immediate post, 3- month post, 6-month post ]
    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

  17. The Gender Identity Reflection and Rumination Scale [ Time Frame: Baseline, Immediate post, 3- month post, 6-month post ]
    Scale measures rumination in the context of gender identity among transgender persons. Average of 15 items on a 4-point scale, with a range of 15 - 60, with a lower score indicating less rumination and better outcomes


Other Outcome Measures:
  1. Reactions to Trans Women Connected [ Time Frame: Immediate post ]
    Reaction/satisfaction items related to the various components of the app, mean score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants must identify as transgender women.
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897049


Contacts
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Contact: Tamara Kuhn, MA 831.440.2104 tamara.kuhn@dfusioninc.com
Contact: Charles Klein, PhD 503-725-3316 chklein@pdx.edu

Locations
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United States, California
ETR Not yet recruiting
Scotts Valley, California, United States, 95066
Contact: Karin Coyle, PhD    831-440-2140    karin.coyle@etr.org   
Contact: Tamara Kuhn, MA    831-440-2104    tamara.kuhn@etr.org   
Sub-Investigator: Karin Coyle, PhD         
Sponsors and Collaborators
ETR Associates
dfusion
Portland State University
Investigators
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Principal Investigator: Tamara Kuhn dfusion

Publications:
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Responsible Party: ETR Associates
ClinicalTrials.gov Identifier: NCT03897049     History of Changes
Other Study ID Numbers: TransWomenConnected
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ETR Associates:
Transgender Women
STI
Sexual Health
HIV/AIDS