N/A N=574 Randomized Prevention

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03897049 ↗

Enrolled (actual)

574

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Self-reported HIV or STI Testing in Past 3 Months — 76; 88 Participants — p=0.914

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Trans Women Connected (Behavioral); General Health App (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ETR Associates
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-reported HIV or STI Testing in Past 3 Months	77; 88	0.990
PRIMARY Self-reported HIV or STI Testing in Past 3 Months	77; 88	0.990
PRIMARY Receptive Condomless Anal Intercourse or Condomless Vaginal Intercourse in Past 3 Months	99; 96	0.118
PRIMARY Receptive Condomless Anal Intercourse or Condomless Vaginal Intercourse in Past 3 Months	99; 96	0.118
SECONDARY Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse	48; 52	0.971
SECONDARY Use of a Condom at Last Receptive Anal Intercourse or Vaginal Intercourse	48; 52	0.971
SECONDARY Health Care Visits in Past 3 Months	4.63; 4.61	0.741
SECONDARY Health Care Visits in Past 3 Months	4.63; 4.61	0.741
SECONDARY Mini-Medical Outcomes Study--Social Support Survey (mMOS-SS)	3.46; 3.16	0.022 sig
SECONDARY Mini-Medical Outcomes Study--Social Support Survey (mMOS-SS)	3.46; 3.16	0.022 sig
SECONDARY Mini-Medical Outcomes Study--Social Support Survey (mMOS-SS)	3.46; 3.16	0.022 sig
SECONDARY Engaged as/With Mentor in Past 3 Months	6.32; 3.25	0.218
SECONDARY Engaged as/With Mentor in Past 3 Months	6.32; 3.25	0.218
SECONDARY PrEP Uptake	8; 4	0.063
SECONDARY PrEP Uptake	8; 4	0.063
SECONDARY PrEP Uptake	8; 4	0.063
SECONDARY Condom/Barrier Negotiation Self Efficacy Scale	5.52; 5.55	0.761
SECONDARY Condom/Barrier Negotiation Self Efficacy Scale	5.52; 5.55	0.761
SECONDARY Condom/Barrier Negotiation Self Efficacy Scale	5.52; 5.55	0.761
SECONDARY Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale	3.18; 3.20	0.537
SECONDARY Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale	3.18; 3.20	0.537
SECONDARY Health Education Impact Questionnaire (heiQ) Health Services Navigation Sub-Scale	3.18; 3.20	0.537
SECONDARY Transgender Congruence Scale (TCS)	3.66; 3.51	0.308
SECONDARY Transgender Congruence Scale (TCS)	3.66; 3.51	0.308
SECONDARY Transgender Congruence Scale (TCS)	3.66; 3.51	0.308
SECONDARY Trans Women Connected Satisfaction Survey	4.06; 3.58	0.001 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03897049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.