Improving HIV Outcomes Among African American Transgender Women

NCT05483686 | Completed Results

• 1 other identifier: R44MH117837
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized controlled trial to test the efficacy of the mobile HIV behavioral intervention for African American transgender women (Shine). Participants will be 215 trans women recruited by staff of the Trans Women of Color Collective via community events and social media. Participants must : 1) identify as a Black transgender woman using the 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in past 3 months (i.e., CAS with a serodiscordant or risky partner AND either \<90% ART adherence or \<5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak English. Eligible participants who subsequently provide informed consent will complete two confidential phone-based research surveys at different time points (baseline and 6 months post-baseline) and will be randomly assigned to one of two conditions (Shine or mobile HIV education for transgender women). Participants randomly assigned to the experimental condition will be instructed to text the word "Join" to the Shine study phone number. The intervention will take approximately 1-2 hours, with content delivered over several weeks. Participants randomly assigned to the control condition will be texted a link to a set of videos on healthy HIV-related behaviors for transgender women. These videos cover a variety of topics, including recommended testing frequencies, PrEP, and ART. After randomization, participants will complete the baseline research survey. This survey will assess the primary outcome of composite HIV transmission risk along with several secondary outcomes (individual behavioral components of the composite score; HIV medical care utilization and adherence; HIV testing; PrEP knowledge, interest, and uptake; gender affirmation; well-being; social support; sexual communication). Six months after the baseline research survey, all participants will complete a follow-up research survey assessing the same outcome measures in the baseline research survey. Binomial logistic regression will be the main analytic technique for the primary measure (composite risk for HIV transmission). For the secondary continuous measures, hierarchical linear modeling (HLM) will be used. All models will control for any demographic covariate (e.g., age) that varies at the .2 significance level due to randomization failure at baseline.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Participants With HIV Transmission Risk at Month 6

  Percentage of participants with a composite risk for HIV score of 1. The composite risk for HIV score combines participants' use of and adherence to biomedical and behavioral strategies over the past month into a binary indicator (0, 1) of HIV acquisition or transmission risk. 0 indicates some HIV transmission risk and 1 indicates no HIV transmission risk.

  Baseline and Month 6

Secondary Outcomes (7)

• Change in ART Adherence at Month 6

  Baseline and Month 6

• Change in Condom Use at Month 6

  Baseline and Month 6

• Change in Barriers to ART Use at Month 6

  Baseline and Month 6

• Change in Barriers to PrEP Use at Month 6

  Baseline and Month 6

• Change in Barriers to Condom Use at Month 6

  Baseline and Month 6

Study Arms (2)

Shine Intervention

EXPERIMENTAL

Experimental group participants will have access to the mobile Shine intervention.

Behavioral: Shine

Control Videos

ACTIVE COMPARATOR

Control condition participants will be texted an embedded link to a series of videos developed by the Centers for Disease Control. These videos describe healthy HIV-related behaviors for trans women of any status (e.g., recommended testing frequencies, PrEP, ART, condoms), includes videos of trans women describing their experiences with HIV. All control participants will have access to Shine at the end of the research study (i.e., approximately six months after recruitment).

Behavioral: Control

Interventions

Shine BEHAVIORAL

This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. The proposed intervention can be used by clinics and community-based organizations that serve transgender women.

Shine Intervention

Control BEHAVIORAL

A playlist of CDC-developed videos designed to provide information on HIV for transgender women

Control Videos

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as a Black transgender woman using the recommended 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American/Black
• identifies as a transgender woman using the recommended 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female)
• or older
• report risk of HIV transmission in past 3 months (i.e., CAS with a serodiscordant or risky partner AND either \<90% ART adherence or \<5 daily doses of PrEP per week)
• owns a mobile phone capable of SMS messaging and accessing webpages
• able to speak/understand English

Sponsors & Collaborators

• ISA Associates, Inc.: lead

Study Sites (1)

ISA Associates, Inc.

Alexandria, Virginia, 22314, United States

Location

MeSH Terms

Interventions

quadrant anterior shine

Limitations and Caveats

The number of participants recruited to the study was lower than the target sample size. Therefore, the analysis of the primary and secondary outcome measures were underpowered.

Results Point of Contact

• Title: Dr. Samantha Leaf
• Organization: ISA Associates, Inc.

sleaf@isagroup.com

703-739-0880

Study Officials

• Samantha Leaf, Ph.D.

  ISA Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 2, 2022
• Study Start: November 16, 2021
• Primary Completion: January 20, 2023
• Study Completion: January 30, 2023
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Datasets will be available at a minimum once the data have been accepted for peer-reviewed publication, and earlier if the data are deemed by the PI to be clean and the sharing of data is not expected to inhibit future opportunities for publication.
• Access Criteria: A data sharing agreement must be completed and signed by the requesting investigator and the Principal Investigator before this transfer of data can be made.

Locations

US (1)