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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04240691
• Other study ID #: 191875
• Status: Active, not recruiting
• Start date: May 20, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: November 30, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hiv
• HIV Infections

Intervention

Behavioral:
• 60-Minutes-For-Health
Refer to description under Groups

Other:
• Time-and-Attention Control Session
Refer to description under Groups

Locations

Country	Name	City	State
United States	UC San Diego AntiViral Research Center (AVRC)	San Diego	California
United States	UC San Diego Owen Clinic	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression	HIV VL =50 at week 24	Week 24
Primary	Retention in Care	Two clinical care visits between enrollment and week 24 at least 90 days apart	Week 24
Secondary	ART Initiation	The self-reported initiation of ART	Week 4
Secondary	Viral Suppression	The proportion of participants with HIV VL =50 at week 48	Week 48
Secondary	Retention in care	The proportion of participants with =2 clinical care visits >90 days apart between enrollment and week 48	Week 48
Secondary	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
Secondary	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