Instacare - Rapid ART Initiation Among Persons With HIV and Out of Care

  • End date
    May 31, 2024
  • participants needed
  • sponsor
    University of California, San Diego
Updated on 24 January 2021
HIV Infection
HIV Vaccine


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.


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.

Condition HIV, HIV positive, HIV infection, Immunodeficiency, AIDS Vaccines, Primary Immunodeficiency Disorders, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment 60-Minutes-For-Health, Time-and-Attention Control Session
Clinical Study IdentifierNCT04240691
SponsorUniversity of California, San Diego
Last Modified on24 January 2021


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Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: HIV or AIDS Vaccines or Immunodeficiency or Primary Immunodeficiency Disorders or HIV Infections or HIV infection or HIV positive or HIV (Pediatric)?
Do you have any of these conditions: HIV (Pediatric) or human immunodeficiency virus or hiv vaccines or HIV infection or HIV Infections or Immunodeficiency or hiv disease or HIV positive ...?
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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