Enhanced Collaborative Implementation (ECI) for Human Immunodeficiency Virus (HIV) Infection

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Human Immunodeficiency Virus (HIV) InfectionCabotegravir tablet - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 48 Secondary · Reporting Duration: Month 1, 4, 5, 12 and 13

Month 4
Change from Baseline in FIM Score in SSPs for Implementation Strategies
Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13
Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13
Month 1
Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs
Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses
Month 1
Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies
Month 1
Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs
Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI
Month 1
Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs
Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13
Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses
FIM Score for APRETUDE in SSPs and PSPs
Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses
Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13
Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13
Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13
Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs
Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses
Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI
Month 4
Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs
Month 4
Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13
Month 4
Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13
Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13
Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs
Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC
Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI
Up to Month 13
Mean Intervention Appropriateness Measure (IAM) Score in SSPs
Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire
Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by Clinic Characteristics based on Site-level PrEP Information Questionnaire
Cis-Trans Test
Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire
Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire
Number of cis-and trans Black women who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on site-level PrEP Information Questionnaire
Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups
Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)
Proportion of PSPs completing target number of injections
Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE
Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics
Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups
Proportion of PSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm
Proportion of PSPs that have one Oral lead-in before CAB Injection
Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics
Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups
Proportion of SSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm
Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire
Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire
Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Standard Implementation (SI)
1 of 3
Enhanced Collaborative Implementation (ECI)
1 of 3
Enhanced Implementation (EI)
1 of 3

Active Control

Experimental Treatment

250 Total Participants · 3 Treatment Groups

Primary Treatment: Enhanced Collaborative Implementation (ECI) · No Placebo Group · Phase 4

Enhanced Collaborative Implementation (ECI)Experimental Group · 2 Interventions: Cabotegravir tablet, APRETUDE · Intervention Types: Drug, Drug
Enhanced Implementation (EI)Experimental Group · 2 Interventions: Cabotegravir tablet, APRETUDE · Intervention Types: Drug, Drug
Standard Implementation (SI)ActiveComparator Group · 2 Interventions: Cabotegravir tablet, APRETUDE · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 1, 4, 5, 12 and 13

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
335 Previous Clinical Trials
462,099 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,560 Previous Clinical Trials
6,129,230 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years of age or older.
HIV-1 test result is negative
You have no prior history of receiving oral CAB or CAB LA injections.