HivNCT04240691
Instacare - Rapid ART Initiation Among Persons With HIV and Out of Care
An observational study of Hiv and HIV Infections, run by University of California, San Diego at 2 sites in United States.
Trial summary
This study aims to evaluate two ways to help people re-engage with healthcare. The first is to assess if providing HIV treatment on the first visit (or within 1 week) can help people re-engage with care and ultimately stay in care after 24 and 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hiv, HIV Infections
- What is being tested?
- 60-Minutes-For-Health
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2020to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Potential subjects from UCSD Owen Clinic that fulfill the entry criteria will be contacted and offered an appointment for study recruitment 2. Subjects identified in the UCSD emergency department HIV screening program will be contacted and offered an appointment for study recruitment 3. San Diego Public Health Department (SDPHD) has implemented routine evaluations of their local HIV surveillance data in conjunction with other data to identify PWH who may be OOC33. This Data to Care program results in the evaluation of ~ 250 new cases per year in San Diego (~20-21 PWH-OOC a month), many of whom are found to be viremic and out-of-care. Once located, SDPHD will offer immediate transportation vouchers (Lyft) to and from the AVRC to expedite study enrollment and rapid ART start.
Who may be able to join
- 18 years of age or older;
- Documented HIV infection status (or rapid HIV will be repeated);
- Out-of-care defined as not seen in HIV provider clinic for ≥6 months AND not receiving ART for ≥1 month (by self-report);
- Available for follow-up according to schedule of evaluations.
Who cannot join
- Co-morbid condition(s) that in the opinion of the investigator could limit the participant's ability to comply with the visit schedule or safely initiate rapid ART (e.g. psychiatric comorbidities or suspected central nervous system opportunistic infection);
- Prior ART regimens that in the opinion of the investigator precludes selection of a treatment option likely to result in virologic suppression (e.g. documented treatment failure on INSTI based regimen and multiple prior NRTI, NNRTI and PI regimens or documented resistance mutations likely to result in treatment failure)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
UC San Diego Owen Clinic
San Diego, California, 92103
About this study
Official title: Instacare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons With HIV and Out of Care
This study aims to evaluate two ways to help people re-engage with healthcare. The first is to assess if providing HIV treatment on the first visit (or within 1 week) can help people re-engage with care and ultimately stay in care after 24 and 48 weeks. It will also assess the success of starting treatment immediately by measuring the HIV virus in people's bloodstream after 24 and 48 weeks.
The second part of this study is to assess a new behavioral treatment called 60-Minutes-for-Health which aims to help people identify and overcome barriers to HIV care, to help with motivation maintaining in care, to help cope with negative feelings about HIV, and to help increase self-reliance in seeking healthcare amid other things that are happening in your life.
Read the detailed description
The human immunodeficiency virus (HIV) continues to cause significant illness and death in the USA despite availability of effective treatment. People who are aware of their HIV status, but who are out of care and not on medications, are therefore at risk of developing HIV related health problems. In addition, people with HIV who are out of care are at greater risk of transmitting HIV compared to people on HIV treatment with suppressed levels of virus in plasma. To date, there are no interventions that have been shown to successfully link this "out of care" population back into care and successfully maintain viral suppression.
This study will test a strategy of providing immediate HIV therapy drugs, linkage to care, and a randomized intervention (60-minutes for health or diet and nutrition session). The goal of the study is to demonstrate that the 60-Minutes-for-Health intervention improves the rate of viral suppression at 24 weeks.
The use of rapid antiretroviral therapy (rapid ART), defined as the initiation of ART within 7 days of HIV diagnosis, has been associated with improved rates of linkage to care, retention in care and virological suppression after 1 year among persons newly diagnoses with HIV. In addition, the behavioral intervention, "60-Minutes-for-Health", was shown in a pilot study to improve retention in care among PWH-OOC. We aim to undertake a study to evaluate the feasibility of providing rapid-ART to people who are aware of their HIV status, but have been out of care at the time they re-engage in care. In addition, study participants will be randomized to either the "60-Minutes-for-Health" intervention or a 60 minute diet and nutrition control session.
- Conditions
- Hiv, HIV Infections
- Being tested
- 60-Minutes-For-Health, Time-and-Attention Control Session
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-Minutes-For-HealthBehavioural
Refer to description under Groups
Time-and-Attention Control SessionOther
Refer to description under Groups
| Study group | Role | What they receive |
|---|---|---|
| 60-Minutes-For-Health | 60-Minutes-for Health: this is a psychological intervention which seeks to correct factors underlying decisions to delay or avoid HIV care and strengthen abilities to overcome HIV care utilization barriers. This is achieved through assistance identifying and reducing misinformation guiding HIV care attendance decisions; enhancing motivation to maintain HIV care via personal health goals; building skills for coping with negative feelings related to living with HIV; and increasing self-efficacy for navigating structural barriers and maintaining HIV care amidst competing priorities. Receives: Behavioral: 60-Minutes-For-Health | |
| Time-and-Attention Control Session | 60 Minute diet \& nutrition control session Receives: Other: Time-and-Attention Control Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
HIV VL ≤50 at week 24
Measured: Week 24
Retention in Care
Two clinical care visits between enrollment and week 24 at least 90 days apart
Measured: Week 24
Secondary outcomes (5)
ART Initiation
The self-reported initiation of ART
Measured: Week 4
Viral Suppression
The proportion of participants with HIV VL ≤50 at week 48
Measured: Week 48
Retention in care
The proportion of participants with ≥2 clinical care visits >90 days apart between enrollment and week 48
Measured: Week 48
Genotypic susceptibility score comparison
To compare discrete genoptypic susceptibility score (derived from banked archive genotype at enrolment) between individuals with and without virologic suppression at week 24 and 48
Measured: Week 24 and 48
Rapid ART acceptability
ACASI-delivered survey items administered to all participants.Responses are given on a 5-point Likert-type scale and recoded so that more favorable assessments are reflected in higher ratings (1=Least favorable, 5=Most favorable).A mean composite score will be created for sub-scales with ≥3-items. Mean scores for the seven acceptability metrics below will be computed for the total sample and each study arm (intervention, control).Among a subset of participants enrolled in four focus groups (10 participants each) will be held. Our interview guide will elicit feedback on the seven theory-based acceptability/feasibility metrics:affective attitudes towards rapid ART,perceived burden or reasons for discontinuation/dropout, perceived effectiveness, potential consequences (ethical, unintended, or side-effects) of rapid ART,willingness to participate in rapid ART,perceived costs (financial,social,emotional,physical) of rapid ART,perceived user experiences and satisfaction with rapid ART.
Measured: Week 4-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 May 2020
- Primary completion1 Sep 2022
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Susan Little, MD, University of California, San Diego
- Investigators
- Susan Little, MD, Principal investigator, UC San Diego AntiViral Research Center (AVRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240691
- Sponsor's protocol ID
- 191875
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2020
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Collaboration with other Academic Research Groups studying Rapid ART: Coded data, that have been stripped of identifiers, from HIV infected participants may be shared with research investigators in the U.S. and abroad, to better understand the acceptability and durability of Rapid ART and to gain a better understanding of this treatment strategy in all populations. InstaCare investigators will maintain the code book in order to access identifiers to link data sets outside of the InstaCare research study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instacare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons With HIV and Out of Care
- ClinicalTrials.gov ID
- NCT04240691
- Acronym / sponsor ID
- 191875
- Conditions
- Hiv, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate two ways to help people re-engage with healthcare. The first is to assess if providing HIV treatment on the first visit (or within 1 week) can help people re-engage with care and ultimately stay in care after 24 and 48 weeks. It will also assess the success of starting treatment immediately by measuring the HIV virus in people's bloodstream after 24 and 48 weeks.
The second part of this study is to assess a new behavioral treatment called 60-Minutes-for-Health which aims to help people identify and overcome barriers to HIV care, to help with motivation maintaining in care, to help cope with negative feelings about HIV, and to help increase self-reliance in seeking healthcare amid other things that are happening in your life.
Detailed description
The human immunodeficiency virus (HIV) continues to cause significant illness and death in the USA despite availability of effective treatment. People who are aware of their HIV status, but who are out of care and not on medications, are therefore at risk of developing HIV related health problems. In addition, people with HIV who are out of care are at greater risk of transmitting HIV compared to people on HIV treatment with suppressed levels of virus in plasma. To date, there are no interventions that have been shown to successfully link this "out of care" population back into care and successfully maintain viral suppression.
This study will test a strategy of providing immediate HIV therapy drugs, linkage to care, and a randomized intervention (60-minutes for health or diet and nutrition session). The goal of the study is to demonstrate that the 60-Minutes-for-Health intervention improves the rate of viral suppression at 24 weeks.
The use of rapid antiretroviral therapy (rapid ART), defined as the initiation of ART within 7 days of HIV diagnosis, has been associated with improved rates of linkage to care, retention in care and virological suppression after 1 year among persons newly diagnoses with HIV. In addition, the behavioral intervention, "60-Minutes-for-Health", was shown in a pilot study to improve retention in care among PWH-OOC. We aim to undertake a study to evaluate the feasibility of providing rapid-ART to people who are aware of their HIV status, but have been out of care at the time they re-engage in care. In addition, study participants will be randomized to either the "60-Minutes-for-Health" intervention or a 60 minute diet and nutrition control session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60-Minutes-For-Health | – | Behavioral: 60-Minutes-For-Health60-Minutes-for Health: this is a psychological intervention which seeks to correct factors underlying decisions to delay or avoid HIV care and strengthen abilities to overcome HIV care utilization barriers. This is achieved through assistance identifying and reducing misinformation guiding HIV care attendance decisions; enhancing motivation to maintain HIV care via personal health goals; building skills for coping with negative feelings related to living with HIV; and increasing self-efficacy for navigating structural barriers and maintaining HIV care amidst competing priorities. |
| Time-and-Attention Control Session | – | Other: Time-and-Attention Control Session60 Minute diet \& nutrition control session |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Potential subjects from UCSD Owen Clinic that fulfill the entry criteria will be contacted and offered an appointment for study recruitment 2. Subjects identified in the UCSD emergency department HIV screening program will be contacted and offered an appointment for study recruitment 3. San Diego Public Health Department (SDPHD) has implemented routine evaluations of their local HIV surveillance data in conjunction with other data to identify PWH who may be OOC33. This Data to Care program results in the evaluation of ~ 250 new cases per year in San Diego (~20-21 PWH-OOC a month), many of whom are found to be viremic and out-of-care. Once located, SDPHD will offer immediate transportation vouchers (Lyft) to and from the AVRC to expedite study enrollment and rapid ART start.
Key inclusion criteria (4 listed)
- 18 years of age or older;
- Documented HIV infection status (or rapid HIV will be repeated);
- Out-of-care defined as not seen in HIV provider clinic for ≥6 months AND not receiving ART for ≥1 month (by self-report);
- Available for follow-up according to schedule of evaluations.
Key exclusion criteria (2 listed)
- Co-morbid condition(s) that in the opinion of the investigator could limit the participant's ability to comply with the visit schedule or safely initiate rapid ART (e.g. psychiatric comorbidities or suspected central nervous system opportunistic infection);
- Prior ART regimens that in the opinion of the investigator precludes selection of a treatment option likely to result in virologic suppression (e.g. documented treatment failure on INSTI based regimen and multiple prior NRTI, NNRTI and PI regimens or documented resistance mutations likely to result in treatment failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60-Minutes-For-HealthRefer to description under Groups | Behavioural | 60-Minutes-For-Health |
| Time-and-Attention Control SessionRefer to description under Groups | Other | Time-and-Attention Control Session |
Primary outcome
Viral Suppression
Time frame: Week 24
HIV VL ≤50 at week 24
Retention in Care
Time frame: Week 24
Two clinical care visits between enrollment and week 24 at least 90 days apart
5 secondary outcomes
ART Initiation
Time frame: Week 4
Viral Suppression
Time frame: Week 48
Retention in care
Time frame: Week 48
Genotypic susceptibility score comparison
Time frame: Week 24 and 48
Rapid ART acceptability
Time frame: Week 4-8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided. Collaboration with other Academic Research Groups studying Rapid ART: Coded data, that have been stripped of identifiers, from HIV infected participants may be shared with research investigators in the U.S. and abroad, to better understand the acceptability and durability of Rapid ART and to gain a better understanding of this treatment strategy in all populations. InstaCare investigators will maintain the code book in order to access identifiers to link data sets outside of the InstaCare research study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Little, MD principal investigator
UC San Diego AntiViral Research Center (AVRC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and HIV Infections, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.