Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

NCT05016232 | Completed

• 1 other identifier: 1R34MH122499-01A1
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).

Conditions

Prevention

Keywords

Transgender women (TGW); HIV Prevention; PrEP

Outcome Measures

Primary Outcomes (3)

• Verified medical visit and PrEP prescription

  Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.

  Stage 1: one month post-baseline

• Concentrations of TFV-DP in Dried Blood Spots at 3 months

  Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence.

  Stage 2: 3 months post-baseline

• Concentrations of TFV-DP in Dried Blood Spots at 6 months

  Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence

  Stage 2: 6 months post-baseline

Secondary Outcomes (1)

• Change in sexual risk behavior based on self report

  Stage 2: Change from baseline sexual risk behavior at 6 months

Study Arms (2)

Strength Based Case Management (SBCM) & PrEP adherence training and counseling

EXPERIMENTAL

Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. Stage 2: Stepped Intervention: 1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.

Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1); Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)

Standard of Care:Stage 1 and Stage 2

NO INTERVENTION

Stage 1: Referral to local PrEP clinic Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.

Interventions

PrEP N' Shine: Strength Based Case Management (Stage 1) BEHAVIORAL

Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.

Strength Based Case Management (SBCM) & PrEP adherence training and counseling

PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) BEHAVIORAL

1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.

Strength Based Case Management (SBCM) & PrEP adherence training and counseling

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Male sex at birth
• Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
• PrEP naïve
• PrEP indicated per CDC guidelines (incl. HIV negative)
• Owns a cell phone or willing to use one in the study
• Able to understand and speak English or Spanish

You may not qualify if:

• Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
• Has lived in RI for less than three months (as a means to enhance participant retention)
• Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
• Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Brown University: collaborator

Study Sites (1)

UCLA Center for LGBTQ+ Advocacy, Research & Health

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Matthew Mimiaga, ScD, MPH, MA

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 23, 2021
• Study Start: October 18, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)