# RP5 MPT Study

> **NIH NIH UM2** · FLORIDA STATE UNIVERSITY · 2024 · $409,261

## Abstract

PROJECT SUMMARY
 Adolescents assigned female at birth (AFAB) in the United States (US) have unmet needs for pregnancy
and HIV prevention; 75% of pregnancies in adolescents are unplanned and 12% of new HIV diagnoses occur
in youth aged 13-24 years AFAB. Sexual and gender minority (SGM) youth may have particular vulnerabilities
and yet their sexual and reproductive health needs are often overlooked or misunderstood. Multi-purpose
prevention technology (MPT) products that can simultaneously prevent pregnancy, suppress menses, and
prevent HIV are desirable, may bring efficiencies to both users and healthcare systems, and may serve to
improve uptake of HIV prevention products among youth. Early studies suggest that adolescents AFAB would
prefer an MPT that is discreet and long-lasting, with injections being a preferred delivery modality. The success
of cabotegravir (CAB) as the first generally safe and highly effective long-acting systemic agent for HIV
prevention opens up opportunities for the development of an injectable MPT that combines CAB with an
effective contraceptive, like levonorgestrel (LNG); LNG has been widely used and has an established safety
track record. CONRAD has developed a first-in-class long acting systemic MPT that consists of a
bioresorbable injectable depot and that employs a novel drug delivery technology to deliver both CAB and LNG
together for at least three months, and possibly longer. Pre-clinical studies in rats and non-human primates
show promise. To advance the development of this injectable CAB/LNG MPT our team with complementary
expertise will conduct studies to 1) assess the values and preferences for a novel MPT for pregnancy and HIV
prevention in adolescent cisgender women (CW) and transgender men (TM) AFAB aged 16-24 years in the
USA, using a combination of qualitative interviews and participatory attitudinal ranking approaches to inform
the selection of attributes and levels for a Discrete Choice Experiment to be conducted in a sample of 200 CW
and 200 TM AFAB; and 2) conduct a multi-site, phase I, single arm PK trial of the CAB/LNG injectable
biodegradable depot in a sample of 16 healthy, HIV-negative adolescents and young adults AFAB, ages 18-24,
to assess the safety and pharmacokinetic profile of the products in CW and TM AFAB who are receiving
gender-affirming hormone therapy. Incorporation of end-user preferences for MPTs early on in product
development can enhance acceptability, optimize uptake and use, and ultimately ensure public health benefit.
The evaluation of the safety, acceptability and pharmacology of a first in-human CAB/LNG biodegradable
depot injection in CW and TM youth will ensure that data on adolescents across genders is available for
regulators should co-formulated CAB/LNG move forward for licensure. The availability of a highly effective,
long-acting MPT that places a premium on safety and acceptability in adolescents AFAB across genders, has
the potential to accelerate access to effectiv...

## Key facts

- **NIH application ID:** 10767972
- **Project number:** 5UM2HD111102-02
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Lisa B Hightow-Weidman
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $409,261
- **Award type:** 5
- **Project period:** 2023-01-25 → 2029-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10767972

## Citation

> US National Institutes of Health, RePORTER application 10767972, RP5 MPT Study (5UM2HD111102-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10767972. Licensed CC0.

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