Prevention
Conditions
Keywords
Transgender women (TGW), HIV Prevention, PrEP
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).
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.
Interventions
BEHAVIORALPrEP 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.
BEHAVIORALPrEP 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.
Sponsors
Brown University
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verified medical visit and PrEP prescription | 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. |
| Concentrations of TFV-DP in Dried Blood Spots at 3 months | 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. |
| Concentrations of TFV-DP in Dried Blood Spots at 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual risk behavior based on self report | 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. |
Countries
United States
Outcome results
None listed