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

NCT06411223 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 2000036673
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Hiv

Keywords

Criminal legal involvement; Unstably housed; unhoused; Food insecurity; Mental health; Substance use/ treatment engagement; women; Long-acting injectable antiretroviral treatment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA

  Baseline, immediately following CDTM+

• Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence

  Month 12

• Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression

  Month 12

• Reach/penetration of the CDTM+ intervention

  Baseline, Month 12

• Uptake/adoption of the CDTM+ intervention

  Baseline, Month 12

Study Arms (1)

Pharmacist lead CDTM+

OTHER

Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.

Behavioral: Collaborative drug therapy management model; Drug: Cabotegravir/Rilpivirine

Interventions

Cabotegravir/Rilpivirine DRUG

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.

Also known as: CAB/RPV LA

Pharmacist lead CDTM+

Collaborative drug therapy management model BEHAVIORAL

CDTM+ is an interdisciplinary approach to patient care in which clinicians collaborate with pharmacists to provide and manage patient drug therapy.

Also known as: CDTM+

Pharmacist lead CDTM+

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as female (cis- or trans-)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3 years (from self-report at screening).
• Able to converse comfortably in English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Yale Clinical and Community Research

New Haven, Connecticut, 06519, United States

Location

Related Publications (9)

• 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.

  PMID: 29191440 BACKGROUND

• 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.

  PMID: 34648131 BACKGROUND

• 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.

  PMID: 23829330 BACKGROUND

• 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.

  PMID: 32130806 BACKGROUND

• 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.

  PMID: 32130809 BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  PMID: 35672552 BACKGROUND

• 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.

  PMID: 36732685 BACKGROUND

• 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.

  PMID: 36318433 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Well-Being

Interventions

cabotegravir; Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jaimie Meyer, MD, MS, FACP

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)