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Completed

NCT Number: NCT05016232

Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

"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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for LGBTQ+ Advocacy, Research & Health

Los Angeles, California, 90095, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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

Behavioral
  • 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Brown University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2021
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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