The bridge clinic: optimizing injectable prep delivery for transgender and non-binary people
Active Project Grant Awarded Last action
- Award ID
- R01MH132488
- Recipient
-
Public Health Foundation Enterprises, Inc. UEI L4EEW9SQX2F6
- Awarding agency
-
National Institute of Mental Health
National Institutes of Health, Department of Health and Human Services
- Obligated
- $3,111,789
Award facts
- Assistance listing
- 93.855 Allergy and Infectious Diseases Research
- Completion date 74% complete
- Funding agency
- National Institute of Allergy and Infectious Diseases National Institutes of Health, Department of Health and Human Services
- Place of performance
- San Francisco, CA 94102, USA
Award details come from USAspending.gov.
Description
- Abstract
- Transgender and nonbinary (TNB) people are disproportionately affected by HIV, with increasing numbers of new diagnoses from 2015-2019. Pre-exposure prophylaxis (PREP) has great potential to reduce new HIV infections, but has yet to improve HIV disparities among TNB populations. With the recent FDA approval of long-acting injectable cabotegravir (CAB-LA) for PREP, there is a critical opportunity to leverage this scientific advance to increase PREP use in TNB populations. In prior work, we piloted a flexible, low- threshold, trans-affirming PREP clinic (bridge clinic) which achieved higher PREP uptake and reached TNB individuals at higher risk for HIV acquisition than those receiving PREP in gender affirming primary care clinics. Key components of the bridge clinic model include a nurse-led PREP clinic with flexible hours; PREP support provided by a trans peer navigator; text-messaging support via prepmate, a CDC-endorsed evidence based intervention; transportation support; and a TNB community-led PREP awareness campaign. In this proposal, we will use rapid-cycle research (RCR) methods to enhance the bridge clinic to incorporate CAB-LA delivery, refine this model through iterative adaptations, and assess key implementation outcomes. We will also evaluate for any drug interactions between gender affirming hormones and CAB-LA, an important question to address for the TNB community. In aim 1, we will conduct a series of nominal groups with english- and spanish-speaking TNB people and semi-structured interviews with their providers to explore patient- and provider-identified barriers and facilitators to CAB-LA delivery in the TNB community. We will also elicit feedback on our implementation strategies to guide the enhancement of our protocol and engagement approaches to incorporate CAB-LA. In aim 2, we will implement the CAB-LA enhanced bridge clinic model in an open cohort of 200 TNB individuals over a 3-year period, with mid-course adaptations guided by the RCR process. Using the RE-aim framework, we will assess the reach, effectiveness, adoption, implementation, and maintenance of the enhanced bridge clinic model via surveys and interviews with providers, staff, and patients, and medical record data review. In aim 3, we will enroll a subset of participants receiving injectable PREP at the bridge clinic into two pharmacokinetic substudies to evaluate the bidirectional effects of gender affirming hormone therapy and cabotegravir plasma concentrations in TNB individuals. Our work across aims will be guided by a stakeholder advisory board comprised of local and national community activists, leaders, health professionals, and staff serving the TNB community who will meet quarterly to provide input on study design and implementation, prioritization of adaptations, and ensuring the bridge clinic model is generalizable to other practice settings. Upon study completion, we will have optimized and evaluated a novel PREP delivery model to increase uptake and persistence to long-acting injectable PREP in TNB people, and assessed for drug interactions between gender affirming hormones and CAB-LA in a real-world cohort of TNB individuals.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $519,514 | |
| Amendment | $519,781 | |
| Amendment | $519,781 | |
| Amendment | $52,734 | |
| Amendment | $474,611 | |
| Amendment | $474,611 | |
| Amendment | -$550,757 | |
| Amendment | -$550,757 | |
| Amendment | $550,757 | |
| Amendment | $550,757 | |
| Original award | $550,757 |
Show all 11
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| City And County Of San Francisco | $88,930 | |
| The Regents Of The University Of California. San Francisco | $84,925 | |
| City And County Of San Francisco | $88,930 | |
| The Regents Of The University Of California. San Francisco | $76,482 |
Quick answers
Who received award R01MH132488?
R01MH132488 was awarded to Public Health Foundation Enterprises, Inc. by National Institute of Mental Health (National Institutes of Health) on April 1, 2023.
How much is award R01MH132488 worth?
$3,111,789 has been obligated on R01MH132488.
Which agency awarded R01MH132488?
National Institute of Mental Health (National Institutes of Health) awarded R01MH132488, with funding from National Institute of Allergy and Infectious Diseases (National Institutes of Health).
On GovTribe
See this award's full record
- Every transaction and subaward
- The recipient's other awards and teaming partners
- Similar grant awards
- Ask GovTribe AI about this award