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Active, Not Recruiting

NCT Number: NCT06411223

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Personal Satisfaction Psychological Well-Being RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale Clinical and Community Research

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 3 years (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

Treatment and study plan

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.

Other names: CDTM+

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.

Other names: CAB/RPV LA

Primary outcomes

  1. Feasibility of CDTM+

    Time frame: Baseline, Month 12

    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.

  2. Acceptability of CDTM+

    Time frame: Baseline, Month 12

    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.

  3. Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+

    Time frame: Month 12

    Assessed by the percentage of patients who have a documented 1st injection visit

Secondary outcomes

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

    Time frame: Baseline, immediately following CDTM+

    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)

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

    Time frame: Month 12

    Percent of on-time injections

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

    Time frame: Month 12

    Percent of participants with HIV VL <50

  4. Reach/penetration of the CDTM+ intervention

    Time frame: Baseline, Month 12

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

  5. Uptake/adoption of the CDTM+ intervention

    Time frame: Baseline, Month 12

    Interaction time*frequency

  6. Barriers and facilitators to CAB/RPV LA initiation

    Time frame: Baseline, Month 6, Month 12

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 13, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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