Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Prevention

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength Based Case Management (SBCM)<br>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)<br>* Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.<br>|
| Experimental: PrEP adherence training and counseling<br>Stage 2: Stepped Intervention: 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. | Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)<br>* 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.<br>|
| No Intervention: Standard of Care:Stage 1<br>Stage 1: Referral to local PrEP clinic | |
| No Intervention: Standard of Care: Stage 2<br>Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender women (TGW), HIV Prevention, PrEP