Trial Outcomes & Findings for Rapid HIV Treatment Initiation, Access and Engagement in Care (NCT NCT03512964)

NCT ID: NCT03512964

Last Updated: 2022-10-27

Results Overview

Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

12 months

Results posted on

2022-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rapid HIV Treatment Initiation Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid HIV Treatment Initiation, Access and Engagement in Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapid HIV Treatment Initiation n=32 Participants Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	30 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants
Race/Ethnicity, Customized Alaskan Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Some other race	0 Participants n=5 Participants
Race/Ethnicity, Customized Refused	0 Participants n=5 Participants
Race/Ethnicity, Customized Don't know	0 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered.

Outcome measures

Outcome measures
Measure	Rapid HIV Treatment Initiation n=32 Participants Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Number of Patients Who Receive Rapid HIV Treatment Initiation	32 Participants

SECONDARY outcome

Timeframe: 12 months

Number of patients who respond yes to starting ART same day versus those who respond no in the survey.

Outcome measures

Outcome measures
Measure	Rapid HIV Treatment Initiation n=32 Participants Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day	32 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Rapid HIV Treatment Initiation n=32 Participants Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Number of Patients Offered Rapid HIV Treatment Initiation	32 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Rapid HIV Treatment Initiation n=32 Participants Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Number of Patients Who Accepted Rapid HIV Treatment Initiation	32 Participants

Adverse Events

Rapid HIV Treatment Initiation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Rapid HIV Treatment Initiation n=32 participants at risk Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Cardiac disorders Death	3.1% 1/32 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Rapid HIV Treatment Initiation n=32 participants at risk Initiation and reinitiation of antiretroviral therapy with dolutegravir 50 mg by mouth once daily and descovy 1 tablet by mouth once daily the same-day as HIV diagnosis and/or first clinic visit for people newly diagnosed with HIV and patients previously diagnosed with HIV but not on medications and not in care for over six months. dolutegravir and descovy: Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
Product Issues Unnecessary ART initiation	3.1% 1/32 • Number of events 1 • 1 year

Additional Information

Joyce Jones, MD

Johns Hopkins University School of Medicine, Division of Infectious Diseases

Phone: 443-287-8530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place