Clinical trial NCT06411223: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
Official title: Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hiv
Keywords: Criminal legal involvement
Unstably housed; unhoused
Food insecurity
Mental health
Substance use/ treatment engagement
women
Long-acting injectable antiretroviral treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2024-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm prospective interventional pilot study. This study uses a hybrid type 3 implementation study design to evaluate an enhanced pharmacist-led collaborative drug therapy management model (CDTM+) for women with health-related social needs (HRSN), in terms of implementation (primary) and clinical (secondary) outcomes.
Primary purpose: PREVENTION

Brief summary: This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

Detailed description: The purpose of this study is to evaluate the implementation and delivery of CAB/RPV LA to women with HRSN by adopting a pharmacist-led CDTM. The project primarily addresses the real-world use of CAB + RPV LA among women who are under-represented in clinical trials and assesses the feasibility and acceptability of CDTM+, and adoption of CAB/RPV LA among participants receiving the CDTM+ model.

Investigators will enhance the existing CDTM to reduce important social and structural barriers to CAB/RPV LA for women with HRSN, by increasing accessibility- using telehealth to deliver CDTM outreach to clinical and community sites without a clinician referral (CDTM+), which is highly scalable. In addition to assessing engagement with the CDTM+ intervention and impact on key implementation (reach, feasibility, acceptability, uptake) and clinical outcomes (CAB/RPV LA initiation), investigators will also assess impact on patient engagement in non-HIV related care and psychological, sexual, and social well-being.

Eligibility criteria: Inclusion Criteria:

* Living with diagnosed HIV
* Receiving HIV care-related services from Yale New Haven Health (YNHH)
* Currently on oral ART and virally suppressed for at least 6 months (from electronic health review).
* Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 6 months (from self-report at screening).
* Able to converse comfortably in English or Spanish

Exclusion Criteria:

* Unable or unwilling to complete informed consent (e.g., have a conservator of person)
* Have initiated CAB/RPV oral lead-in prior to enrollment.
* Have a contraindication to CAB/RPV LA per label.
* Have known or suspected resistance to CAB/RPV
* Pregnant or breast-feeding

Primary outcomes:
measure: Feasibility of CDTM+
timeFrame: Baseline, Month 12
measure: Acceptability of CDTM+
timeFrame: Baseline, Month 12
measure: Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+
timeFrame: Month 12
Secondary outcomes:
measure: Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA
timeFrame: Baseline, immediately following CDTM+
measure: Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence
timeFrame: Month 12
measure: Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression
timeFrame: Month 12
measure: Reach/penetration of the CDTM+ intervention
timeFrame: Baseline, Month 12
measure: Uptake/adoption of the CDTM+ intervention
timeFrame: Baseline, Month 12
measure: Barriers and facilitators to CAB/RPV LA initiation
timeFrame: Baseline, Month 6, Month 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Clinical and Community Research
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaimie Meyer, MD, MS, FACP
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Orkin C, Arasteh K, Gorgolas Hernandez-Mora M, Pokrovsky V, Overton ET, Girard PM, Oka S, Walmsley S, Bettacchi C, Brinson C, Philibert P, Lombaard J, St Clair M, Crauwels H, Ford SL, Patel P, Chounta V, D'Amico R, Vanveggel S, Dorey D, Cutrell A, Griffith S, Margolis DA, Williams PE, Parys W, Smith KY, Spreen WR. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020 Mar 19;382(12):1124-1135. doi: 10.1056/NEJMoa1909512. Epub 2020 Mar 4.
citation: Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
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citation: Meyer JP, Price CR, Ye Y, Qin Y, Tracey D, Demidont AC, Melbourne K, Altice FL. A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks. AIDS Behav. 2022 Dec;26(12):3807-3817. doi: 10.1007/s10461-022-03709-2. Epub 2022 Jun 7.
citation: Baker O, Wellington C, Price CR, Tracey D, Powell L, Loffredo S, Moscariello S, Meyer JP. Experience delivering an integrated service model to people with criminal justice system involvement and housing insecurity. BMC Public Health. 2023 Feb 2;23(1):222. doi: 10.1186/s12889-023-15108-w.
citation: Harsono D, Deng Y, Chung S, Barakat LA, Friedland G, Meyer JP, Porter E, Villanueva M, Wolf MS, Yager JE, Edelman EJ. Correction to: Experiences with Telemedicine for HIV Care During the COVID-19 Pandemic: A Mixed-Methods Study. AIDS Behav. 2023 Jun;27(6):2054. doi: 10.1007/s10461-022-03907-y. No abstract available.