Clinical trial NCT04240691: Instacare - Rapid ART Initiation Among Persons With HIV and Out of Care
Official title: Instacare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons With HIV and Out of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
HIV Infections
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-01-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Viral Suppression
timeFrame: Week 24
measure: Retention in Care
timeFrame: Week 24
Secondary outcomes:
measure: ART Initiation
timeFrame: Week 4
measure: Viral Suppression
timeFrame: Week 48
measure: Retention in care
timeFrame: Week 48
measure: Genotypic susceptibility score comparison
timeFrame: Week 24 and 48
measure: Rapid ART acceptability
timeFrame: Week 4-8
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego AntiViral Research Center (AVRC)
state: California
city: San Diego
country: United States
facility: UC San Diego Owen Clinic
state: California
Study officials:
affiliation: UC San Diego AntiViral Research Center (AVRC)
name: Susan Little, MD
role: PRINCIPAL_INVESTIGATOR
References: