Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Hiv Clinical Trial

Official title:

Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411223
• Other study ID #: 2000036673
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Carolina Price, MPA
• Phone: 2034998075
• Email: carolina.price[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• Collaborative drug therapy management model
CDTM+ is an interdisciplinary approach to patient care in which clinicians collaborate with pharmacists to provide and manage patient drug therapy.

Drug:
• Cabotegravir/Rilpivirine
Long-acting injectable treatment prescribed to treat HIV-1 infection in people 12 years and older and who weigh at least 77 lbs (35kg), to replace their current HIV-1 medicines when their healthcare provider determines they meet certain requirements.

Locations

Country	Name	City	State
United States	Yale Clinical and Community Research	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	ViiV Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View Citation

Loeliger KB, Altice FL, Desai MM, Ciarleglio MM, Gallagher C, Meyer JP. Predictors of linkage to HIV care and viral suppression after release from jails and prisons: a retrospective cohort study. Lancet HIV. 2018 Feb;5(2):e96-e106. doi: 10.1016/S2352-3018(17)30209-6. Epub 2017 Nov 27. — View Citation

Messer LC, Quinlivan EB, Parnell H, Roytburd K, Adimora AA, Bowditch N, DeSousa N. Barriers and facilitators to testing, treatment entry, and engagement in care by HIV-positive women of color. AIDS Patient Care STDS. 2013 Jul;27(7):398-407. doi: 10.1089/apc.2012.0435. — View 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. — View 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. — View Citation

Philbin MM, Bergen S, Parish C, Kerrigan D, Kinnard EN, Reed S, Cohen MH, Sosanya O, Sheth AN, Adimora AA, Cocohoba J, Goparaju L, Golub ET, Vaughn M, Gutierrez JI Jr, Fischl MA, Alcaide M, Metsch LR. Long-Acting Injectable ART and PrEP Among Women in Six Cities Across the United States: A Qualitative Analysis of Who Would Benefit the Most. AIDS Behav. 2022 Apr;26(4):1260-1269. doi: 10.1007/s10461-021-03483-7. Epub 2021 Oct 14. — View Citation

Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of CDTM+	Feasibility of CDTM+ assessed using the Intervention Measure: 4-item Likert scale, each item scored 1 (completely disagree) to 5 (completely agree) and averaged. Score range 4-20, higher scores reflect higher feasibility.	Baseline, Month 12
Primary	Acceptability of CDTM+	Assessed using the Theoretical Framework of Acceptability Questionnaire: 7-items, each scored on Likert scale 1 to 5 and averaged. Score range 7-35, higher scores reflect higher acceptability.	Baseline, Month 12
Primary	Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+	Assessed by the percentage of patients who have a documented 1st injection visit	Month 12
Secondary	Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA	How likely are you to switch from your current medication to CAB/RPV LA? 5-item Likert scale (1=not at all likely to 5=very likely; score range 1-5)	Baseline, immediately following CDTM+
Secondary	Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence	Percent of on-time injections	Month 12
Secondary	Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression	Percent of participants with HIV VL <50	Month 12
Secondary	Reach/penetration of the CDTM+ intervention	Enrollment rate (# of people enrolled/# of people screened for eligibility)	Baseline, Month 12
Secondary	Uptake/adoption of the CDTM+ intervention	Interaction time*frequency	Baseline, Month 12
Secondary	Barriers and facilitators to CAB/RPV LA initiation	Qualitative patient interview will be conducted to assess Barriers and facilitators to CAB/RPV LA initiation	Baseline, Month 6, Month 12