AURORA Study-A Transformative Approach to Support PrEP Medication Persistence
NCT ID: NCT06072443
Last Updated: 2024-06-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
105 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-11-30
Study Completion Date
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is designed to test the hypothesis that, compared to oral PrEP, use of CAB-LA in underserved populations in a real-world setting supported by a digital health companion program will be associated with greater medication adherence, persistence, retention-in-care, and improved PROs. Patients in the study will receive current standard care for HIV prevention and be offered enrollment in the digital health companion program.
Goal of the study is to evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program.
Goal of the study is to evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
HealthcAre sUppoRt fOr Remote HIV pAtients
NCT06563284
HIV Infections
COMPLETED
mHealth Facilitated Intervention to Improve HIV Pre-Exposure Prophylaxis Adherence
NCT04990583
Pre-Exposure Prophylaxis
Telemedicine
Medication Adherence
WITHDRAWN
NA
PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence
NCT07335289
HIV Pre-exposure Prophylaxis Use
NOT_YET_RECRUITING
NA
Scalable Interventions to Increase PrEP Adherence: Value Affirmation and Future Selves
NCT03278990
HIV Prevention
TERMINATED
NA
Using Smart Phone Technology to Support PrEP Uptake and Adherence
NCT04868383
HIV Prevention
PrEP
Adherence, Medication
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will evaluate the extent to which real-world use of CAB-LA for PrEP in underserved populations impacts PrEP adherence, persistence, retention-in-care, and PROs compared with oral PrEP. Additionally, the study will examine the implementation of a digital health companion program that leverages education and behavioral economics to support patients on PrEP, and assess clinician perspectives as well as barriers to, and facilitators for implementation of CAB-LA in a patient-centered medical home.
Primary Objective To evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program
Secondary Objectives Evaluate retention-in-care in patients receiving CAB-LA vs oral PrEP Evaluate PROs (including PrEP Medication Satisfaction, PrEP Acceptance, P Evaluate the acceptability, appropriateness, and helpfulness of a digital health companion program for PrEP Evaluate the acceptability, barriers to, and facilitators for implementation of CAB-LA
Study Design The research project follows a hybrid effectiveness-implementation research design, with the primary aim focused on evaluation of PrEP adherence, persistence and retention-in-care with CAB-LA compared with oral PrEP, and secondary aims focused on evaluating patient-reported outcomes (PROs), implementation of a digital health intervention to support adherence and persistence, and evaluating contextual factors around implementation of CAB-LA. The proposed study will utilize a digital health intervention with behavioral health economics and patient education from PRIME and Reciprocity to evaluate the adoption and implementation of a Digital Health Companion for PrEP adherence and persistence. The implementation aims of the study will leverage the RE-AIM framework as follows: Assessment of the digital health intervention will focus primarily on individual-level dimensions of RE-AIM, including reach and effectiveness. For example, in assessing reach of the digital health intervention, participant demographics will be compared to the intended audience to evaluate the extent to which populations with high unmet needs were engaged. Conversely, assessment of the implementation of CAB-LA will focus on system-level dimensions of RE-AIM, such as qualitative assessments of barriers to and facilitators for implementation of CAB-LA. In addition, evaluation of PROs will be informed by a review of validated instruments, including HIVSTQ (HIV Treatment Satisfaction Questionnaire), SMSQ (Study Medication Satisfaction Questionnaire), I-TAQ (Injection Treatment Acceptance Questionnaire), ACCEPT (Chronic Treatment Acceptance Questionnaire), and the PrEP Stigma Scale, with survey items tailored to evaluate PrEP acceptance, satisfaction, and perceptions of PrEP-related stigma for both the CAB-LA and oral PrEP arms.
Description of Study Procedures Before any screening procedure is performed, informed consent will be obtained. Labs will be taken at baseline and months 3, 5, 7, 9, and 11 for the CAB-LA cohort and at baseline and months 3, 6, 9, and 12 for the Oral PrEP cohort. Participants will complete a baseline evaluation and be introduced to a support group at baseline. Patients will complete assessments within the Reciprocity App. Clinicians will complete assessments outside of the app. Patients in both cohorts will complete baseline demographic surveys in month 0, patient reported outcomes (PRO) data collection set 1 in months 1, 5, and 11 and PRO data collection set 2 in months 3, 9, and 12. Patients in the CAB-LA PrEP cohort will complete persistence assessments in months 1, 3, 5, 7, 9, and 11. Patients in the Oral PrEP cohort will complete persistence assessments every month from months 1 through 12. Clinic staff will complete surveys at baseline, month 6, month 12, and at the end of the study.
Medication Persistence Definition: Continue to take medicines over time independent of adherence to the PrEP medication regimen.
Persistence Assessment CAB-LA The proportion of participants who received at least one PrEP injection who remained on injectable PrEP or oral bridging at months 3 and 11 measured by the self-report assessment and validated with claims data.
Persistence Assessment Oral PrEP The proportion of participants who initiated oral PrEP who remained on oral PrEP at months 3 and 12 measured by the self-report assessment and validated with claims data. period.
Adherence Definition: Taking PrEP in line with medical advice/using PrEP appropriately (critical for efficacy) .
Adherence Assessment CAB-LA
Adherence to the dosing schedule will be assessed at month 3 (early adherence) and end of study by:
A) Estimating the number of individuals who missed one or more consecutive injections without taking daily oral bridging PrEP while not on CAB-LA injections and mean and median number of injections missed during a 6- and a 12-month period.
B) Estimating the number of individuals who received the injections seven or more days later than their scheduled injection visit and the mean and median duration of delayed injections.Adherence Assessment Oral PrEP
Adherence to the dosing schedule will be assessed at months 3 (early adherence) and 12 by:
A) Estimating the number of individuals who reported three or more days of oral PrEP missed and the mean and median number of days they missed.
B) Estimating the number of individuals who had a gap of \>90 days between the end of the days of supply of a dispensing and the start date of the next fill.
Patient Reported Outcomes Patient Reported Outcomes Set 1: PrEP Medication Satisfaction, PrEP-Related Stigma, Acceptability of Intervention Measure (AIM) Patient Reported Outcomes Set 2: PrEP Acceptance, Intervention Appropriateness Measure (IAM) Helpfulness of the education modules and Health Literacy Evaluation
Clinician Instruments Baseline Provider Survey Information About You and Your Patients Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Barriers and Facilitators for Implementation of Long-Acting
Cabotegravir for PrEP Follow-up Provider Survey Information About You and Your Patients Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Barriers and Facilitators for Implementation of Long-Acting Cabotegravir for PrEP
Standard of Care Visits The standard of care for patient visits will not be affected. The patients will only be given additional surveys to complete.
Follow-Up Visits CAB-LA PrEP cohort: 2nd PrEP injection at month 1; follow-up labs and PrEP injections in months 3, 5, 7, 9, and 11.
Oral PrEP cohort: follow-up labs and prescription refills in months 3, 6, 9, and 12.
Switching between PrEP regimens .To be included in final data analysis, participants cannot switch between PrEP regimens before 6-months duration of initial PrEP.
PrEP Discontinuation Participants will be deemed as having discontinued PrEP if they miss more than 3 consecutive months for PrEP.
Participants will be called, texted and emailed for three consecutive months before considered them as discontinued.
STI Screening and Management Participants will receive STI screening at baseline and at every follow up clinic visit. Participants will be screened if they present with any type of symptoms that warrant STI testing. If a participant tests positive for an STI other than HIV, they will receive guideline-directed therapy at the discretion of their
HCP at WVHR. Suspected or Confirmed HIV Infection HIV screening will occur a minimum as recommended for every 2 months with CAB-LA (same time as injections) and every 3 months for oral PrEP.
PrEP Choice Counselling Patients will be counseled on the benefits and risks of both oral PrEP and PrEP injections. The selection of PrEP option will be done as the standard of care through shared-decision with the patient.
Possible Participant Pathways There will only be two observational cohort arms. Patients will either be placed into the injectable PrEP arm or the oral PrEP arm based on their baseline prescription.
Adherence Strategies Patients on oral PrEP will be encouraged to set a daily reminder on their smart phone as an alarm at the time their dose is due.
Patients on injectable PrEP will set a monthly calendar reminder on the day/time their injection is due.
Retention Strategies Follow-up appointments will be set up and conveyed at each appointment. Reminder calls will be made by a staff member a few days before the appointment.
Interventions: PrEP Initiation and Digital Health Companion Program Participants will be enrolled in the CAB-LA and Oral PrEP cohorts. Participants in the CAB-LA cohort will receive their first dose of the PrEP injection at month 0. Injections will also be administered in months 1, 3, 5, 7, 9, and 11. Participants in the Oral PrEP cohort will have their prescription filled at month 0, 3, 6, 9, and 12. The schedule of dosing is presented in Figure 6a.
Participants in both cohorts will complete education modules and health literacy evaluations in the Reciprocity App in months 2, 4, 6, 8, and 10 as presented in Figure 6a. Education Modules include PrEP Medicines (month 2), Protecting Yourself from HIV, STIs, and other infections (month 4), Building a Support System for HIV Prevention Month 6: Being an Active Participant in Your Own Care (month 8), and Overcoming Stigma and Becoming a Health Advocate (month 10).
Adherence to oral PrEP and reasons for PrEP discontinuation will be assessed through brief behavioral surveys every month after the initiation of PrEP. Barriers to adherence to CAB-LA injections and reasons for PrEP discontinuation will be assessed through brief behavioral surveys at months 1, 3, 5, 7, 9, and 11.
Implementation Outcomes for the Mobile App Acceptability of the mobile app to support patients in taking PrEP will be measured by the Acceptability of Intervention Measure (AIM) at months 1, 5, and 11. Appropriateness of the mobile app to support patients in taking PrEP will be measured by the Intervention Appropriateness Measure (IAM) at months 3, 9, and 12.
Clinic Staff Acceptability, Appropriateness, and Feasibility of Providing Long-acting Cabotegravir Injections Acceptability of the process for providing long-acting cabotegravir injections will be assessed by the Acceptability of Intervention Measure (AIM). Appropriateness of the process for providing long-acting cabotegravir injections will be assessed by the Intervention Appropriateness Measure (IAM).
Feasibility of long-term use of cabotegravir injections will be assessed by the Feasibility of Intervention Measure (FIM). Willingness to sustain provision of long-acting cabotegravir injections and barriers to and facilitators for provision of long-acting cabotegravir injections will be assessed through a brief survey. The clinic staff surveys will be administered at baseline, month 6, month 12, and end of study.
Primary Objective To evaluate medication adherence and persistence in patients receiving CAB-LA vs oral PrEP and who engage with a digital health companion program
Secondary Objectives Evaluate retention-in-care in patients receiving CAB-LA vs oral PrEP Evaluate PROs (including PrEP Medication Satisfaction, PrEP Acceptance, P Evaluate the acceptability, appropriateness, and helpfulness of a digital health companion program for PrEP Evaluate the acceptability, barriers to, and facilitators for implementation of CAB-LA
Study Design The research project follows a hybrid effectiveness-implementation research design, with the primary aim focused on evaluation of PrEP adherence, persistence and retention-in-care with CAB-LA compared with oral PrEP, and secondary aims focused on evaluating patient-reported outcomes (PROs), implementation of a digital health intervention to support adherence and persistence, and evaluating contextual factors around implementation of CAB-LA. The proposed study will utilize a digital health intervention with behavioral health economics and patient education from PRIME and Reciprocity to evaluate the adoption and implementation of a Digital Health Companion for PrEP adherence and persistence. The implementation aims of the study will leverage the RE-AIM framework as follows: Assessment of the digital health intervention will focus primarily on individual-level dimensions of RE-AIM, including reach and effectiveness. For example, in assessing reach of the digital health intervention, participant demographics will be compared to the intended audience to evaluate the extent to which populations with high unmet needs were engaged. Conversely, assessment of the implementation of CAB-LA will focus on system-level dimensions of RE-AIM, such as qualitative assessments of barriers to and facilitators for implementation of CAB-LA. In addition, evaluation of PROs will be informed by a review of validated instruments, including HIVSTQ (HIV Treatment Satisfaction Questionnaire), SMSQ (Study Medication Satisfaction Questionnaire), I-TAQ (Injection Treatment Acceptance Questionnaire), ACCEPT (Chronic Treatment Acceptance Questionnaire), and the PrEP Stigma Scale, with survey items tailored to evaluate PrEP acceptance, satisfaction, and perceptions of PrEP-related stigma for both the CAB-LA and oral PrEP arms.
Description of Study Procedures Before any screening procedure is performed, informed consent will be obtained. Labs will be taken at baseline and months 3, 5, 7, 9, and 11 for the CAB-LA cohort and at baseline and months 3, 6, 9, and 12 for the Oral PrEP cohort. Participants will complete a baseline evaluation and be introduced to a support group at baseline. Patients will complete assessments within the Reciprocity App. Clinicians will complete assessments outside of the app. Patients in both cohorts will complete baseline demographic surveys in month 0, patient reported outcomes (PRO) data collection set 1 in months 1, 5, and 11 and PRO data collection set 2 in months 3, 9, and 12. Patients in the CAB-LA PrEP cohort will complete persistence assessments in months 1, 3, 5, 7, 9, and 11. Patients in the Oral PrEP cohort will complete persistence assessments every month from months 1 through 12. Clinic staff will complete surveys at baseline, month 6, month 12, and at the end of the study.
Medication Persistence Definition: Continue to take medicines over time independent of adherence to the PrEP medication regimen.
Persistence Assessment CAB-LA The proportion of participants who received at least one PrEP injection who remained on injectable PrEP or oral bridging at months 3 and 11 measured by the self-report assessment and validated with claims data.
Persistence Assessment Oral PrEP The proportion of participants who initiated oral PrEP who remained on oral PrEP at months 3 and 12 measured by the self-report assessment and validated with claims data. period.
Adherence Definition: Taking PrEP in line with medical advice/using PrEP appropriately (critical for efficacy) .
Adherence Assessment CAB-LA
Adherence to the dosing schedule will be assessed at month 3 (early adherence) and end of study by:
A) Estimating the number of individuals who missed one or more consecutive injections without taking daily oral bridging PrEP while not on CAB-LA injections and mean and median number of injections missed during a 6- and a 12-month period.
B) Estimating the number of individuals who received the injections seven or more days later than their scheduled injection visit and the mean and median duration of delayed injections.Adherence Assessment Oral PrEP
Adherence to the dosing schedule will be assessed at months 3 (early adherence) and 12 by:
A) Estimating the number of individuals who reported three or more days of oral PrEP missed and the mean and median number of days they missed.
B) Estimating the number of individuals who had a gap of \>90 days between the end of the days of supply of a dispensing and the start date of the next fill.
Patient Reported Outcomes Patient Reported Outcomes Set 1: PrEP Medication Satisfaction, PrEP-Related Stigma, Acceptability of Intervention Measure (AIM) Patient Reported Outcomes Set 2: PrEP Acceptance, Intervention Appropriateness Measure (IAM) Helpfulness of the education modules and Health Literacy Evaluation
Clinician Instruments Baseline Provider Survey Information About You and Your Patients Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Barriers and Facilitators for Implementation of Long-Acting
Cabotegravir for PrEP Follow-up Provider Survey Information About You and Your Patients Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Barriers and Facilitators for Implementation of Long-Acting Cabotegravir for PrEP
Standard of Care Visits The standard of care for patient visits will not be affected. The patients will only be given additional surveys to complete.
Follow-Up Visits CAB-LA PrEP cohort: 2nd PrEP injection at month 1; follow-up labs and PrEP injections in months 3, 5, 7, 9, and 11.
Oral PrEP cohort: follow-up labs and prescription refills in months 3, 6, 9, and 12.
Switching between PrEP regimens .To be included in final data analysis, participants cannot switch between PrEP regimens before 6-months duration of initial PrEP.
PrEP Discontinuation Participants will be deemed as having discontinued PrEP if they miss more than 3 consecutive months for PrEP.
Participants will be called, texted and emailed for three consecutive months before considered them as discontinued.
STI Screening and Management Participants will receive STI screening at baseline and at every follow up clinic visit. Participants will be screened if they present with any type of symptoms that warrant STI testing. If a participant tests positive for an STI other than HIV, they will receive guideline-directed therapy at the discretion of their
HCP at WVHR. Suspected or Confirmed HIV Infection HIV screening will occur a minimum as recommended for every 2 months with CAB-LA (same time as injections) and every 3 months for oral PrEP.
PrEP Choice Counselling Patients will be counseled on the benefits and risks of both oral PrEP and PrEP injections. The selection of PrEP option will be done as the standard of care through shared-decision with the patient.
Possible Participant Pathways There will only be two observational cohort arms. Patients will either be placed into the injectable PrEP arm or the oral PrEP arm based on their baseline prescription.
Adherence Strategies Patients on oral PrEP will be encouraged to set a daily reminder on their smart phone as an alarm at the time their dose is due.
Patients on injectable PrEP will set a monthly calendar reminder on the day/time their injection is due.
Retention Strategies Follow-up appointments will be set up and conveyed at each appointment. Reminder calls will be made by a staff member a few days before the appointment.
Interventions: PrEP Initiation and Digital Health Companion Program Participants will be enrolled in the CAB-LA and Oral PrEP cohorts. Participants in the CAB-LA cohort will receive their first dose of the PrEP injection at month 0. Injections will also be administered in months 1, 3, 5, 7, 9, and 11. Participants in the Oral PrEP cohort will have their prescription filled at month 0, 3, 6, 9, and 12. The schedule of dosing is presented in Figure 6a.
Participants in both cohorts will complete education modules and health literacy evaluations in the Reciprocity App in months 2, 4, 6, 8, and 10 as presented in Figure 6a. Education Modules include PrEP Medicines (month 2), Protecting Yourself from HIV, STIs, and other infections (month 4), Building a Support System for HIV Prevention Month 6: Being an Active Participant in Your Own Care (month 8), and Overcoming Stigma and Becoming a Health Advocate (month 10).
Adherence to oral PrEP and reasons for PrEP discontinuation will be assessed through brief behavioral surveys every month after the initiation of PrEP. Barriers to adherence to CAB-LA injections and reasons for PrEP discontinuation will be assessed through brief behavioral surveys at months 1, 3, 5, 7, 9, and 11.
Implementation Outcomes for the Mobile App Acceptability of the mobile app to support patients in taking PrEP will be measured by the Acceptability of Intervention Measure (AIM) at months 1, 5, and 11. Appropriateness of the mobile app to support patients in taking PrEP will be measured by the Intervention Appropriateness Measure (IAM) at months 3, 9, and 12.
Clinic Staff Acceptability, Appropriateness, and Feasibility of Providing Long-acting Cabotegravir Injections Acceptability of the process for providing long-acting cabotegravir injections will be assessed by the Acceptability of Intervention Measure (AIM). Appropriateness of the process for providing long-acting cabotegravir injections will be assessed by the Intervention Appropriateness Measure (IAM).
Feasibility of long-term use of cabotegravir injections will be assessed by the Feasibility of Intervention Measure (FIM). Willingness to sustain provision of long-acting cabotegravir injections and barriers to and facilitators for provision of long-acting cabotegravir injections will be assessed through a brief survey. The clinic staff surveys will be administered at baseline, month 6, month 12, and end of study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
HIV Infections
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAB-LA PrEP Cohort
Prescribed CAB-LA PrEP as standard of care or current user of CAB-LA PrEP
Digital Health Companion (mobile App)
Intervention Type
BEHAVIORAL
Participants will complete education modules, health literacy evaluations, and PRO assessments in the Digital Health Companion.
Oral PrEP Cohort
Prescribed oral PrEP as standard of care or current user of oral PrEP
Digital Health Companion (mobile App)
Intervention Type
BEHAVIORAL
Participants will complete education modules, health literacy evaluations, and PRO assessments in the Digital Health Companion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Digital Health Companion (mobile App)
Participants will complete education modules, health literacy evaluations, and PRO assessments in the Digital Health Companion.
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Initiation of or current user of PrEP with CAB-LA, daily FTC/TDF, or daily FTC/TAF prescribed in accordance with the WVHR standard of care practices (based practices on CDC PrEP 2021 Clinical Practice Guidelines) by a licensed HCP
* PrEP dispensed by WVHR pharmacy
* Access to a smart phone
* PrEP dispensed by WVHR pharmacy
* Access to a smart phone
Exclusion Criteria
* Receiving HIV PrEP care outside of WVHR
* Positive HIV diagnosis
* Contraindication to oral or injectable PrEP therapy
* Receiving oral bridging therapy prior to injectable PrEP therapy
* Positive HIV diagnosis
* Contraindication to oral or injectable PrEP therapy
* Receiving oral bridging therapy prior to injectable PrEP therapy
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ViiV Healthcare
INDUSTRY
Sponsor Role
collaborator
WV Health Right, Inc.
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West Virginia Health Right
Charleston, West Virginia, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rhonda Francis
Role: primary
305-414-5930
References
Explore related publications, articles, or registry entries linked to this study.
Huang YA, Tao G, Smith DK, Hoover KW. Persistence With Human Immunodeficiency Virus Pre-exposure Prophylaxis in the United States, 2012-2017. Clin Infect Dis. 2021 Feb 1;72(3):379-385. doi: 10.1093/cid/ciaa037.
Reference Type
BACKGROUND
Keyes J, Crouse EC, DeJesus E, Rolle CP. Determinants of pre-exposure prophylaxis (PrEP) persistence in a high-risk population in Central Florida. J Investig Med. 2021 Feb;69(2):397-401. doi: 10.1136/jim-2020-001352. Epub 2020 Dec 1.
Reference Type
BACKGROUND
Spinelli MA, Scott HM, Vittinghoff E, Liu AY, Gonzalez R, Morehead-Gee A, Gandhi M, Buchbinder SP. Missed Visits Associated With Future Preexposure Prophylaxis (PrEP) Discontinuation Among PrEP Users in a Municipal Primary Care Health Network. Open Forum Infect Dis. 2019 Feb 26;6(4):ofz101. doi: 10.1093/ofid/ofz101. eCollection 2019 Apr.
Reference Type
BACKGROUND
Krakower D, Maloney KM, Powell VE, Levine K, Grasso C, Melbourne K, Marcus JL, Mayer KH. Patterns and clinical consequences of discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 2019 Feb;22(2):e25250. doi: 10.1002/jia2.25250.
Reference Type
BACKGROUND
Weitzman PF, Zhou Y, Kogelman L, Rodarte S, Vicente SR, Levkoff SE. mHealth for pre-exposure prophylaxis adherence by young adult men who have sex with men. Mhealth. 2021 Jul 20;7:44. doi: 10.21037/mhealth-20-51. eCollection 2021.
Reference Type
BACKGROUND
Garrison LE, Haberer JE. Pre-exposure Prophylaxis Uptake, Adherence, and Persistence: A Narrative Review of Interventions in the U.S. Am J Prev Med. 2021 Nov;61(5 Suppl 1):S73-S86. doi: 10.1016/j.amepre.2021.04.036.
Reference Type
BACKGROUND
Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res. 2001;10(6):517-31. doi: 10.1023/a:1013050904635.
Reference Type
BACKGROUND
Arnould B, Gilet H, Patrick DL, Acquadro C. Item Reduction, Scoring, and First Validation of the ACCEPTance by the Patients of their Treatment (ACCEPT(c)) Questionnaire. Patient. 2017 Feb;10(1):81-92. doi: 10.1007/s40271-016-0187-7.
Reference Type
BACKGROUND
Klein H, Washington TA. The Pre-Exposure Prophylaxis (PrEP) Stigma Scale: Preliminary findings from a pilot study. Int Public Health J. 2019;11(2):185-195.
Reference Type
BACKGROUND
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
Reference Type
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.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
220084
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
NCT02037594
COMPLETED
NA
Optimizing PrEP Uptake and Adherence Among Male Sex Workers
NCT05736614
RECRUITING
NA
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
NCT03842436
COMPLETED
PHASE4
Supporting Sustained HIV Treatment Adherence After Initiation
NCT05040841
ACTIVE_NOT_RECRUITING
NA
Using PrEP, Doing It for Ourselves
NCT06638892
NOT_YET_RECRUITING
NA
Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)
NCT05333679
ACTIVE_NOT_RECRUITING
NA
Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
NCT06661343
NOT_YET_RECRUITING
NA
Adaptive Intervention Strategies for HIV PrEP Care in Rural People Who Inject Drugs
NCT06666309
ENROLLING_BY_INVITATION
NA
Factors Affecting PrEP Adherence
NCT02411630
COMPLETED
Supporting Tailored And Responsive PrEP in Rural North Carolina
NCT05984030
COMPLETED
NA
Electronic Capture of Adherence Barriers for HIV Care
NCT04702412
UNKNOWN
NA
A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
NCT03896776
COMPLETED
NA
Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
NCT03086057
COMPLETED
NA
Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy
NCT02800655
UNKNOWN
PHASE4
A Waiting Room-Delivered Video to Enhance Clinical Outcomes Among Persons Living With HIV
NCT03508310
COMPLETED
NA
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
NCT02732730
COMPLETED
PHASE4
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
NCT06158607
RECRUITING
NA
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
NCT02945436
COMPLETED
NA
Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).
NCT03137342
COMPLETED
NA
The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial
NCT06845774
ENROLLING_BY_INVITATION
NA
PrEP iT! Mobile App Intervention
NCT04509076
COMPLETED
NA
Same-Day Antiretroviral Therapy as a Behavioral Design Intervention to Reduce Stigma in Key Affected Populations
NCT07053514
NOT_YET_RECRUITING
NA
Durability of Adherence in Self-Management of HIV
NCT00991302
COMPLETED
NA
Reducing Disparities in Rural HIV Prevention
NCT05319613
COMPLETED
NA