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HivPhase 2NCT06411223

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

A Phase 2 study testing Collaborative drug therapy management model and Cabotegravir/Rilpivirine in people with Hiv, run by Yale University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hiv
What is being tested?
Collaborative drug therapy management model and Cabotegravir/Rilpivirine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Aug 2024to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale Clinical and Community Research

    New Haven, Connecticut, 06519

Other trials in United States

About this study

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

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).

Read the 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.

Conditions
Hiv
Being tested
Collaborative drug therapy management model, Cabotegravir/Rilpivirine
Keywords
Criminal legal involvement, Unstably housed; unhoused, Food insecurity, Mental health, Substance use/ treatment engagement, women, Long-acting injectable antiretroviral treatment
Medical subject headings
Acquired Immunodeficiency Syndrome, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collaborative drug therapy management modelBehavioural

    Also called CDTM+

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

  • Cabotegravir/RilpivirineDrug

    Also called CAB/RPV LA

    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.

Study groups in NCT06411223
Study groupRoleWhat they receive
Pharmacist lead CDTM+OtherParticipants 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.
Receives: Behavioral: Collaborative drug therapy management model; Drug: Cabotegravir/Rilpivirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Month 12

  2. 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.

    Measured: Baseline, Month 12

  3. 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

    Measured: Month 12

Secondary outcomes (6)

  1. 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)

    Measured: Baseline, immediately following CDTM+

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

    Percent of on-time injections

    Measured: Month 12

  3. 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

    Measured: Month 12

  4. Reach/penetration of the CDTM+ intervention

    Enrollment rate (# of people enrolled/# of people screened for eligibility)

    Measured: Baseline, Month 12

  5. Uptake/adoption of the CDTM+ intervention

    Interaction time*frequency

    Measured: Baseline, Month 12

  6. Barriers and facilitators to CAB/RPV LA initiation

    Qualitative patient interview will be conducted to assess Barriers and facilitators to CAB/RPV LA initiation

    Measured: Baseline, Month 6, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start1 Aug 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06411223
Sponsor's protocol ID
2000036673
Status last verified
Oct 2026
First submitted
7 May 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29191440

  • 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.

    PubMed 34648131

  • 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.

    PubMed 23829330

  • 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.

    PubMed 32130806

  • 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.

    PubMed 32130809

  • 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.

    PubMed 20957426

  • 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.

    PubMed 35672552

  • 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.

    PubMed 36732685

  • 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.

    PubMed 36318433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Collaborative drug therapy management model and Cabotegravir/Rilpivirine in people with Hiv, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of CDTM+ (time frame: Baseline, Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06411223, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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