# Treating insomnia to reduce inflammation in HIV

> **NIH NIH R21** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $192,956

## Abstract

PROJECT ABSTRACT
Serious non-AIDS events (SNAE), including emphysema, diabetes, osteoporosis, cardiovascular disease, and
cognitive impairment, have emerged as important contributors to HIV-related morbidity and mortality. SNAE
are likely driven by systemic inflammation, which remains heightened in people with HIV (PWH), compared to
HIV-negative persons, despite virologic suppression. Specifically, elevated circulating markers of systemic
inflammation [high sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6)] and evidence of monocyte
activation [sCD14, sCD163, CD14+CD16+ intermediate monocytes] are associated with greater risks of SNAE.
Insomnia is a known risk factor for poor health outcomes in the general population, perhaps via its link with
greater systemic inflammation. Fortunately, insomnia is modifiable, and the clear first-line treatment has been
identified. The 2016 American College of Physicians guideline concluded that the preferred treatment for
chronic insomnia in adults is not pharmacologic therapy but rather CBT for insomnia (CBT-I), given the strong
evidence that it is safe, effective, and broadly applicable with durable benefits. A feasible and effective internet
CBT-I tool called Sleep Healthy Using The Internet (SHUTi) was developed and validated by this application’s
consultant, Dr. Lee Ritterband. In multiple RCTs, SHUTi has proven effective for treating insomnia in the
general population. To our knowledge, internet CBT-I in PWH has not previously been studied. Thus, our
proposal represents an innovative application of an established intervention technology in a new patient
population. The central objective of this application is to evaluate SHUTI’s ability to reduce systemic
inflammation, and, in particular, monocyte activation in PWH. We will meet this objective by addressing the
following Specific Aim: To evaluate the effects of cognitive-behavioral therapy for insomnia (CBT-I) on
measures of systemic inflammation in virologically-suppressed, HIV-positive adults with insomnia disorder. We
will conduct a single-site, phase II RCT comparing SHUTi to an Active Comparator group receiving sleep
hygiene education program in 50 virologically-suppressed PWH with insomnia disorder to reduce biomarkers
of inflammation and monocyte activation. A positive phase II trial would provide the proof-of-concept data and
effect size estimates needed to justify and properly design a multisite, phase III RCT to establish the long-term
effects of SHUTi (a practical and readily scalable intervention) on HIV-related inflammation and prevention of
SNAE.

## Key facts

- **NIH application ID:** 10414994
- **Project number:** 5R21MH127206-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** SAMIR KUMAR GUPTA
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $192,956
- **Award type:** 5
- **Project period:** 2021-06-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10414994

## Citation

> US National Institutes of Health, RePORTER application 10414994, Treating insomnia to reduce inflammation in HIV (5R21MH127206-02). Retrieved via AI Analytics 2026-06-07 from https://api.ai-analytics.org/grant/nih/10414994. Licensed CC0.

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