Hiv
Conditions
Keywords
Criminal legal involvement, Unstably housed; unhoused, Food insecurity, Mental health, Substance use/ treatment engagement, women, Long-acting injectable antiretroviral treatment
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.
Interventions
BEHAVIORALCollaborative 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.
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.
Sponsors
Yale University
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of CDTM+ | 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. |
| Acceptability of CDTM+ | 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. |
| Evaluate the adoption of CAB/RPV LA in the population receiving CDTM+ | Month 12 | Assessed by the percentage of patients who have a documented 1st injection visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of the CDTM+ intervention on intention to switch to CAB/RPV LA | 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) |
| Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence | Month 12 | Percent of on-time injections |
| Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA maintenance of virologic suppression | Month 12 | Percent of participants with HIV VL \<50 |
| Reach/penetration of the CDTM+ intervention | Baseline, Month 12 | Enrollment rate (# of people enrolled/# of people screened for eligibility) |
| Uptake/adoption of the CDTM+ intervention | Baseline, Month 12 | Interaction time\*frequency |
| Barriers and facilitators to CAB/RPV LA initiation | Baseline, Month 6, Month 12 | Qualitative patient interview will be conducted to assess Barriers and facilitators to CAB/RPV LA initiation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJaimie Meyer, MD, MS, FACP
Yale University
Outcome results
None listed