Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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+ |
| Among those who initiate CAB/RPV LA, evaluate the effectiveness of CDTM+ on CAB/RPV LA adherence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Identify as female (cis- or trans-)
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaimie Meyer, MD, MS, FACP | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Clinical and Community Research | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29191440 | Background | 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. | |
| 34648131 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
Percent of on-time injections |
| Month 12 |
| 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 |
| Reach/penetration of the CDTM+ intervention | Enrollment rate (# of people enrolled/# of people screened for eligibility) | Baseline, Month 12 |
| Uptake/adoption of the CDTM+ intervention | Interaction time*frequency | Baseline, Month 12 |
| 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 |
| 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. |
| 23829330 | 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. |
| 32130806 | 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. |
| 32130809 | 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. |
| 20957426 | 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. |
| 35672552 | 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. |
| 36732685 | 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. |
| 36318433 | 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D006571 |
| Heterocyclic Compounds |