We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adaptive Intervention for PrEP Uptake and Adherence Among At-Risk TGW (PrEP N Shine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05016232
Recruitment Status : Not yet recruiting
First Posted : August 23, 2021
Last Update Posted : May 19, 2022
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles

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).

Condition or disease Intervention/treatment Phase
Prevention Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1) Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
Estimated Study Start Date : May 30, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : June 30, 2024

Arm Intervention/treatment
Experimental: Strength Based Case Management (SBCM)
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
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.

Experimental: PrEP adherence training and counseling

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: Stepped Adherence Training and Counseling (Stage 2)
  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.

No Intervention: Standard of Care:Stage 1
Stage 1: Referral to local PrEP clinic
No Intervention: Standard of Care: Stage 2
Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.



Primary Outcome Measures :
  1. Verified medical visit and PrEP prescription [ Time Frame: Stage 1: one month post-baseline ]
    Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.

  2. Concentrations of TFV-DP in Dried Blood Spots at 3 months [ Time Frame: Stage 2: 3 months post-baseline ]
    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.

  3. Concentrations of TFV-DP in Dried Blood Spots at 6 months [ Time Frame: Stage 2: 6 months post-baseline ]
    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


Secondary Outcome Measures :
  1. Change in sexual risk behavior based on self report [ Time Frame: Stage 2: Change from baseline sexual risk behavior at 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05016232


Contacts
Layout table for location contacts
Contact: Matthew J Mimiaga, ScD, MPH, MA 617-901-9276 mmimiaga@ph.ucla.edu
Contact: Katie Biello, PhD, MPH 401-863-3082 katie_biello@brown.edu

Locations
Layout table for location information
United States, California
UCLA
Los Angeles, California, United States, 90095
Contact: Matthew J Mimiaga, ScD, MPH, MA       mmimiaga@ph.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Brown University
Investigators
Layout table for investigator information
Principal Investigator: Matthew Mimiaga, ScD, MPH, MA University of California, Los Angeles
Layout table for additonal information
Responsible Party: Matthew Mimiaga, ScD, MPH, MA, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05016232    
Other Study ID Numbers: 1R34MH122499-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles:
Transgender women (TGW)
HIV Prevention
PrEP