# Immunologic changes associated with three progestin-based contraceptives: characterizing immune profiles over one year and identifying factors that may alter HIV risk

> **NIH NIH R01** · EMORY UNIVERSITY · 2022 · $757,895

## Abstract

PROJECT SUMMARY/ABSTRACT
This proposal outlines a 5-year translational research project to explore the mechanisms underlying the HIV
risk associated with pharmacologic doses of exogenous sex hormones (via hormonal contraceptives).
Emerging data suggests that certain hormonal contraceptives may induce mucosal and systemic immune
changes that could increase the risk of infection with HIV. While several studies have aimed to characterize
immunologic changes in women using hormonal contraceptives, the nature and the magnitude of these
immune changes have not been adequately defined due to limitations in study design rigor, and small and
statistically underpowered sample sizes. There is limited comprehensive data or comparative data on the effect
of different types of contraceptives on innate and adaptive immunologic markers of HIV susceptibility. Without
this research, we cannot effectively counsel our patients on contraceptive selection. Characterization of
potential individual-level factors, such as the presence of bacterial vaginosis (BV), that may alter a woman's
risk profile with contraceptive use, could lead to individualized decision-making about contraceptive choice and
would have profound implications for global health especially in HIV-endemic areas. We propose to
prospectively recruit cohorts of HIV-uninfected women initiating hormonal contraception to characterize
systemic and lower genital track innate and adaptive immunologic changes that occur over the course of 1
year. This study will test the overarching hypothesis that hormonal contraceptives induce systemic and
mucosal immune changes capable of altering susceptibilities and/or responses to diseases including HIV
infection, and that these effects vary markedly in nature and magnitude by contraceptive type and will be
modified by the vaginal microenvironment. The aims are: 1) To determine the immunologic alterations in
female genital and systemic immune profile associated with depot medroxyprogesterone acetate (DMPA),
Etonogestrel impant (Eng-Implant) and Levonorgestrel IUD (Lng-IUD). We hypothesize that HIV target immune
cells within the female genital tract of HIV-uninfected at-risk women will increase following contraceptive
initiation. Further, because the anticipated mucosal immune changes with progestin-only contraceptives are, to
a large extent, mediated via estrogen suppression, we hypothesize the impact of the Lng-IUD (with minimal to
no anti-estrogen effect) and Eng-Implant (with milder anti-estrogen effect) will be significantly less pronounced
compared with that of DMPA. 2) To evaluate the vaginal microenvironment as a moderator of genital and
systemic immune profile changes and changes in tissue infectivity following exposure to these three commonly
used hormonal contraceptives. Based on our earlier findings, we hypothesize that immunologic changes
induced with hormonal contraception will be more pronounced in the setting of BV. The outcomes of the
proposed study could h...

## Key facts

- **NIH application ID:** 10440378
- **Project number:** 5R01HD095741-05
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Lisa Blake Haddad
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $757,895
- **Award type:** 5
- **Project period:** 2018-08-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10440378

## Citation

> US National Institutes of Health, RePORTER application 10440378, Immunologic changes associated with three progestin-based contraceptives: characterizing immune profiles over one year and identifying factors that may alter HIV risk (5R01HD095741-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10440378. Licensed CC0.

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