Hiv
Conditions
Brief summary
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
Detailed description
The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.
Interventions
BEHAVIORALPeer PrEP Navigation
Ecological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum.
Sponsors
CrescentCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form * Declaration of willingness to comply with all study procedures and availability during the study * Age 18 years old or older * Male sex designated at birth * Identify as trans woman, woman or another gender identity not associated with being a man * Desire to use or re-start PrEP * HIV uninfected * Speaks English or Spanish * Live in the New Orleans metropolitan statistical area (which includes 8 parishes)
Exclusion criteria
* Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above) * Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity * Concurrent or planned enrollment in a research study that provides PrEP * Unwilling to attend quarterly follow-up visits, which will include survey participation * Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP uptake | 24 months | The proportion of participants enrolled in the study who begin to take PrEP |
| Social determinant stressors | 24 months | The proportion of participants enrolled in the study who address social determinant stressors |
| Health care empowerment | 24 months | The proportion of participants enrolled in the study who report improved healthcare empowerment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns and correlates of PrEP adherence | 24 months | Analysis of PrEP adherence among those who begin PrEP. Patterns and correlates of adherence will be measures using data from self report surveys and urine assays |
Countries
United States
Contacts
Primary ContactNarquis Barak, MS
Backup ContactErin Meek, DrPH
Outcome results
None listed