Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

antiviralsARTPrEPlong-actingcabotegravirrilpivirinetenofovirlenacapavirself-collectionsself-collected blood samplesdrug concentrations

Outcome Measures

Primary Outcomes (1)

Agreement of drug concentrations of antivirals and relevant metabolites/anabolites in blood samples
Drug concentrations will be quantified and compared between clinic-collected and at home self-collected samples.
Up to approximately 1 year

Secondary Outcomes (2)

Acceptability of at home self-collection of blood samples
One-time, approximately 1-2 weeks after first clinic-collection visit
Feasibility of at home self-collection of blood samples
One-time, approximately 1-2 weeks after first clinic-collection visit

Study Arms (5)

Oral Antivirals

Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention

Other: At Home Self-Collections

Q8W CAB±RPV Continuation

Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention

Other: At Home Self-Collections

Q8W CAB±RPV Initiation

Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention

Other: At Home Self-Collections

Q4W CAB±RPV Continuation/Initiation

Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention

Other: At Home Self-Collections

Q26W LEN Continuation/Initiation

Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention

Interventions

At Home Self-CollectionsOther

Directly observed at home self-collection of blood samples

Also known as: Tasso-M20, Tasso+, Mitra, DBS by fingerstick

Oral AntiviralsQ26W LEN Continuation/InitiationQ4W CAB±RPV Continuation/InitiationQ8W CAB±RPV ContinuationQ8W CAB±RPV Initiation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Study subjects will be invited to participate in the HOME-1 study by enrolling a convenience sample of people receiving TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals for HIV treatment or prevention at the UCH-IDGP. Study visits will only be conducted when blood is to be collected for routine SOC clinical laboratory tests and/or a SOC dose of LA antivirals is to be given.

You may qualify if:

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHcollaborator
University of Colorado, Denver
Otherlead

Study Sites (1)

University of Colorado Hospital (UCHealth)

Aurora, Colorado, 80045, United States

RECRUITING

Ryan Coyle, MPHCONTACT720-695-8020 ryan.coyle@cuanschutz.edu

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, dried blood samples, capillary blood, plasma, blood cells

Study Officials

Peter Anderson, PharmD
University of Colorado, Denver
PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Coyle, MPH

CONTACT

720-695-8020 ryan.coyle@cuanschutz.edu

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 28, 2021

Study Start

May 27, 2021

Actual (reported)

Primary Completion

June 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

Oral Antivirals

Q8W CAB±RPV Continuation

Q8W CAB±RPV Initiation

Q4W CAB±RPV Continuation/Initiation

Q26W LEN Continuation/Initiation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

Oral Antivirals

Q8W CAB±RPV Continuation

Q8W CAB±RPV Initiation

Q4W CAB±RPV Continuation/Initiation

Q26W LEN Continuation/Initiation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations