# Long-Acting Injectables for Treatment of HIV among PWID (LIFT HIV)

> **NIH NIH DP1** · JOHNS HOPKINS UNIVERSITY · 2024 · $991,463

## Abstract

7. PROJECT SUMMARY/ABSTRACT
Achieving sustained viral suppression is the pinnacle of HIV management conferring individual-level benefits
by improving survival and societal benefits through secondary prevention. While there has been dramatic
progress to improve viral suppression among people living with HIV, this progress has been uneven. Globally,
15.2% of the 14.8 million people who inject drugs (PWID) are living with HIV and drug use accounts for 20% of
infections outside of Sub-Saharan Africa. PWID lag behind other populations with viral suppression <20% in
some settings resulting in high AIDS-related mortality and HIV incidence. Long-acting antiretroviral therapy (LA
ART) represents a new way to deliver ART that can improve viral suppression in a population where
sociostructural issues such as homelessness and unemployment in addition to substance use complicate
adherence to oral ART. Yet, to date, there has been no serious scholarship evaluating the role of LA ART in
virologically unsuppressed persons (including PWID) particularly in low- and middle-income countries.
Accordingly, our overarching objective is to evaluate the efficacy, safety, acceptability, and cost-effectiveness
of LA ART on viral suppression among virally unsuppressed PWID in New Delhi, India. We will utilize a mix of
ethnography, a randomized clinical trial and modeling to achieve these objectives. We will first conduct
ethnographic work to inform clinical trial design. Ethnography will be conducted among PWID living with HIV,
outreach workers and health care personnel. Key topics to be explored during this phase will be attributes of
LA-ART including duration of effect (one week vs. six months), mode (oral vs. intramuscular vs. subcutaneous)
and site of administration (facility vs. field-based). We anticipate conducting a three arm open-label
randomized clinical trial where treatment naïve and treatment experienced unsuppressed PWID will be
randomly assigned at an allocation ratio of 1:1:1 across three study arms – Arm 1: TLD (Tenofovir DF [300mg]
+ Lamivudine [300mg] + Dolutegravir [50mg]); Arm 2: CAB/RPV (Cabotegravir [900mg in 3ml] + Rilpivirine
[600mg in 3ml]); two intramuscular injections at Months 0, 1 and every 2 months thereafter); and Arm 3 –
CAB/RPV/LEN (Cabotegravir [900mg in 3ml] + Rilpivirine [600mg in 3ml] + Lenacapvir [927mg in 2 x 1.5ml
vials]). All participants will be followed for 24 months. The primary short-term and long-term endpoints of this
trial will be viral suppression (HIV RNA<50 copies/ml) at Months 6 and 24, respectively. We will then model the
impact of Treatment as Prevention on HIV transmission in PWID for each study arm by simulating HIV
transmission through injecting and sexual networks based on survey responses incorporating exposure to
other interventions (e.g., syringe service programs) and accounting for the cyclical patterns drug use. We will
extend transmission models to assess cost savings and cost-effectiveness of each of the inte...

## Key facts

- **NIH application ID:** 10908037
- **Project number:** 1DP1DA060602-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Sunil Suhas Solomon
- **Activity code:** DP1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $991,463
- **Award type:** 1
- **Project period:** 2024-05-01 → 2029-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908037

## Citation

> US National Institutes of Health, RePORTER application 10908037, Long-Acting Injectables for Treatment of HIV among PWID (LIFT HIV) (1DP1DA060602-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10908037. Licensed CC0.

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