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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Instacare: A Prospective Study of Clinical Outcomes Following Rapid ART Initiation Among Persons With HIV and Out of Care

Conditions
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Hiv, HIV Infections

Intervention / Treatment
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* Behavioral: 60-Minutes-For-Health
* Other: Time-and-Attention Control Session


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 60-Minutes-For-Health<br>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. | Behavioral: 60-Minutes-For-Health<br>* Refer to description under Groups<br>|
| Time-and-Attention Control Session<br>60 Minute diet & nutrition control session | Other: Time-and-Attention Control Session<br>* Refer to description under Groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | HIV VL ≤50 at week 24 | Week 24 | 
| Retention in Care | Two clinical care visits between enrollment and week 24 at least 90 days apart | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ART Initiation | The self-reported initiation of ART | Week 4 | 
| Viral Suppression | The proportion of participants with HIV VL ≤50 at week 48 | Week 48 | 
| Retention in care | The proportion of participants with ≥2 clinical care visits >90 days apart between enrollment and week 48 | 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 | 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. | Week 4-8 |