CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 574 enrolled
Drug / intervention
Trans Women Connected +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03897049
NCT03897049N/ACompleted

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

ETR Associates·interventional·Posted Apr 1, 2019·Updated May 6, 2024

In Brief

A clinical study evaluating Trans Women Connected and General Health App for HIV/AIDS and 2 related conditions. Completed, enrolled 574 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartApr 1, 2021
Primary CompletionSep 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.3 years ago

Interventions

Trans Women Connectedbehavioral

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 Appbehavioral

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