Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

Prevention Clinical Trial

Official title:

Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016232
• Other study ID #: 1R34MH122499-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: University of California, Los Angeles
• Contact: Matthew J Mimiaga, ScD, MPH, MA
• Phone: 617-901-9276
• Email: mmimiaga[@]ph.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The "PrEP N' Shine" package includes two behavioral intervention components:

1. Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and

2. A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use.

Stage 1: TGW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.

Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEP N' Shine" adherence intervention or standard of care comparison condition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Prevention

Intervention

Behavioral:
• PrEP N' Shine: Strength Based Case Management (Stage 1)
Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
• PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)
Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 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.

Locations

Country	Name	City	State
United States	UCLA Center for LGBTQ+ Advocacy, Research & Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in sexual risk behavior based on self report	Change in sexual risk behavior to be measured using AIDS-Risk Behavior Assessment (ARBA), a computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to three types of sexual behavior (anal, oral, vaginal) and assess detailed sexual risk information by partner type (transactional, casual, main) and by HIV-status, whether protected or unprotected, and whether in the context of substance use in past 3 months.	Stage 2: Change from baseline sexual risk behavior at 6 months