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

NCT03897049 | Completed Results

• 2 other identifiers: TransWomenConnected5R44MD012279
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Transgender Women; STI; Sexual Health; HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (22)

• Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse

  3-month post intervention

• Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse

  6-month post intervention

• Health Care Visits in Past 3 Months

  3-months post intervention

• Health Care Visits in Past 3 Months

  6-months post intervention

• Mini-Medical Outcomes Study--Social Support Survey (mMOS-SS)

  1-month post intervention

Study Arms (2)

TWC App

EXPERIMENTAL

The intervention is a mobile app delivered sexual health promotion program designed specifically for transgender women. The mobile app includes 42 interactive activities plus resource maps, opportunities for mentoring, and communication forums for connecting with other transgender women.

Behavioral: Trans Women Connected

General Health App

ACTIVE COMPARATOR

An alternate mobile app (TWC COVID only) designed specifically for transgender women. The mobile app includes 7 interactive activities focused on COVID and COVID resources.

Behavioral: General Health App

Interventions

Trans Women Connected BEHAVIORAL

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.

TWC App

General Health App BEHAVIORAL

The control group will download a mobile app that addresses COVID and provides COVID resources.

General Health App

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: All participants must identify as transgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• ETR Associates: lead
• dfusion Inc: collaborator
• Portland State University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

ETR

Scotts Valley, California, 95066, United States

Location

Related 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.

  PMID: 16235135 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Relatively brief follow-up period (6 months) limits insights on longer-term impacts; some participants reported struggles with app download (affected both conditions), which may be linked to lack of more robust treatment effects; COVID impacted study progression and likely impacted behavior related to some outcomes (e.g., HIV/STI testing due to service shifts affected by COVID).

Results Point of Contact

• Title: Tamara Kuhn, Vice President & Research Scientist
• Organization: dfusion, Inc

tamara.kuhn@dfusioninc.com

831-222-5003

Study Officials

• Tamara Kuhn

  dfusion Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two arm randomized controlled trial. Implementation. After randomization, participants will be granted access to download and install their respective Trans Women Connected mobile apps (intervention or attention control).

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 1, 2019
• Study Start: April 1, 2021
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)