Hormonal ContraceptionCHIMENCT03660046
Contraceptive Hormones, Immunity, and Microbiome Evaluation
An observational study of Hormonal Contraception, run by Emory University at 3 sites in United States.
Trial summary
The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormonal Contraception
- What is being tested?
- Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel IUD (Lng-IUD)
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Dec 2018to 7 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be selected from several sites in the greater Atlanta community to include: family planning clinics, OB/GYN practice/reproductive heath clinics, community based recruitment through postings at community centers, community health fairs, coffee shops and local universities, as well as web-based recruitment through the national ResearchMatch.
Who may be able to join
- Female sex, defined by sex at birth.
- Age ≤ 45 years. If < 18 years of age, participant must be capable of providing assent, understanding and complying with all study procedures, and have written informed consent from a parent or legal guardian.
- Normal menses (occurring within 22-35 day intervals) for > 2 cycles. Women who are postpartum or post-abortion who have resumed menses are eligible.
- Intact uterus and cervix.
- Interested in initiating HC and willing to accept DMPA, Eng-Implant or Lng-IUD.
- Willing to delay initiation of HC for up to 1 month.
Show all 9Show fewer
- Able and willing to provide informed consent, and undergo study procedures.
- Negative HIV test by Ora-Quick© method at Screening Visit.
- Agree to abstain from vaginal intercourse or using intra-vaginal products for 1 day prior to each study visit.
Who cannot join
- Pregnant or planning to become pregnant within the next year.
- Breastfeeding, if not having active menstrual cycles. Breastfeeding is not exclusionary if the participant is actively cycling.
- History of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery within the past year.
- Current use of systemic HC or IUD, based on self-report and/or hormonal testing.
- Taking concurrent medications that interact with selected HC.
- Contraindications to selected contraceptive per the Center for Disease Control medical eligibility criteria or judgment of clinician.
- Allergy to lidocaine for cervical biopsies (if consenting to optional biopsies).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Health System
Atlanta, Georgia, 30303
The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE
Atlanta, Georgia, 30322
Atlanta Women's Center
Atlanta, Georgia, 30342
About this study
Official title: A Prospective Cohort Study Evaluating the Impact of Three Progestin-based Hormonal Contraceptive (HC) Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically
The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). The study seeks to test that HC induce immunologic changes capable of altering HIV susceptibilities, that these effects will vary by contraceptive type, and that they will be modified by the vaginal microenvironment.
Read the detailed description
This study is a 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.
The study will prospectively recruit cohorts of HIV-uninfected women initiating hormonal contraception to characterize systemic and lower genital tract innate and adaptive immunologic changes that occur over a course of up to 4 months. 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 main aim is to determine the immunologic alterations in female genital and systemic immune profile associated with depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel IUD (Lng-IUD).
- Conditions
- Hormonal Contraception
- Being tested
- Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), Levonorgestrel IUD (Lng-IUD)
- Keywords
- Human immunodeficiency virus, Sexually Transmitted Diseases, Contraceptives
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot medroxyprogesterone acetate (DMPA)Drug
Also called Medroxyprogesterone acetate (MPA), Depo-Provera
Depot medroxyprogesterone acetate (DMPA) will be dispensed from the Grady Pharmacy Service and will be administered every 12 weeks at the standard dose of 150 mg Intramuscular injection, beginning from week 3 of study enrollment and repeated every 13 weeks
Etonogestrel implant (Eng-Implant)Drug
Also called Nexplanon
A standard Nexplanon rod Implant that is a subdermal implant in the arm. This will be placed at study week 3 by Dr. Haddad or a trained clinician. It contains Etonogestrel 68mg.
Levonorgestrel IUD (Lng-IUD)Drug
Also called Mirena, Copper
The Levonorgestrel Intrauterine Device (Lng-IUD) (Mirena or copper) will be placed at study week 3 by Dr. Haddad or a trained clinician.
| Study group | Role | What they receive |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | This arm includes subjects that choose Depot medroxyprogesterone acetate (DMPA) as contraception. Receives: Drug: Depot medroxyprogesterone acetate (DMPA) | |
| Etonogestrel implant (Eng-Implant) | This arm includes subjects that choose Etonogestrel implant (Eng-Implant) as contraception. Receives: Drug: Etonogestrel implant (Eng-Implant) | |
| Levonorgestrel IUD (Lng-IUD) | This arm includes subjects that choose Levonorgestrel Intrauterine device (Lng-IUD) as contraception. Receives: Drug: Levonorgestrel IUD (Lng-IUD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean total leukocytes and CD4+ T-cells expressing CCR5 in the lower female genital tract (FGT) among the three intervention groups pre and post contraception
Using Fortessa flow cytometer and Luminex, effector memory Cluster Differentiation 4 (CD4) + Thymocytes (T) cells will be analyzed for surface expression of HIV coreceptors cell surface receptor C-C chemokine receptor type 5 (CCR5) and reported as percent of total leukocytes and CD4+ T-cells. The cytometry will use the cervicovaginal fluid (CVF) collected by cervicovaginal lavage (CVL).This test will characterize the alterations in female genital and systemic immune profiles associated with three long-acting progestin-only Hormonal Contraception.
Measured: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
Change in Nugent's score among the three intervention groups pre and post contraception
The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis. The Nugent score is calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2). A score of 7 to 10 is consistent with bacterial vaginosis without culture.
Measured: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
Percent of expression of 16S rRNA gene sequencing among the three intervention groups pre and post contraception
16 Svedberg ribosomal RNA (16S rRNA) is the component of the 30 Svedberg ribosomal RNA (30S rRNA) small subunit of a prokaryotic ribosome that binds to the Shine-Dalgarno sequence. The genes coding for it are referred to as 16S rRNA gene and are used in reconstructing phylogenies. 16S rRNA gene sequence analysis can better identify poorly described, rarely isolated, or phenotypically aberrant strains, can be routinely used for identification of mycobacteria, and can lead to the recognition of novel pathogens and uncultured bacteria.The term 16S refers to how it settles to when centrifuged (it's called a sedimentation rate, and it's measured in Svedberg (S) units).
Measured: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start7 Dec 2018
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal ContraceptionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Alicia K Smith, Emory University
- Investigators
- Alicia Smith, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660046
- Sponsor's protocol ID
- IRB00104017
- Other IDs
- R01HD095741-01A1
- Acronym
- CHIME
- Status last verified
- Oct 2024
- First submitted
- 4 Sep 2018
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Evaluating the Impact of Three Progestin-based Hormonal Contraceptive (HC) Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically
- ClinicalTrials.gov ID
- NCT03660046
- Acronym / sponsor ID
- CHIME / IRB00104017
- Conditions
- Hormonal Contraception
- Keywords
- Human immunodeficiency virus, Sexually Transmitted Diseases, Contraceptives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). The study seeks to test that HC induce immunologic changes capable of altering HIV susceptibilities, that these effects will vary by contraceptive type, and that they will be modified by the vaginal microenvironment.
Detailed description
This study is a 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.
The study will prospectively recruit cohorts of HIV-uninfected women initiating hormonal contraception to characterize systemic and lower genital tract innate and adaptive immunologic changes that occur over a course of up to 4 months. 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 main aim is to determine the immunologic alterations in female genital and systemic immune profile associated with depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel IUD (Lng-IUD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | – | Drug: Depot medroxyprogesterone acetate (DMPA)This arm includes subjects that choose Depot medroxyprogesterone acetate (DMPA) as contraception. |
| Etonogestrel implant (Eng-Implant) | – | Drug: Etonogestrel implant (Eng-Implant)This arm includes subjects that choose Etonogestrel implant (Eng-Implant) as contraception. |
| Levonorgestrel IUD (Lng-IUD) | – | Drug: Levonorgestrel IUD (Lng-IUD)This arm includes subjects that choose Levonorgestrel Intrauterine device (Lng-IUD) as contraception. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be selected from several sites in the greater Atlanta community to include: family planning clinics, OB/GYN practice/reproductive heath clinics, community based recruitment through postings at community centers, community health fairs, coffee shops and local universities, as well as web-based recruitment through the national ResearchMatch.
Key inclusion criteria (9 listed)
- Female sex, defined by sex at birth.
- Age ≤ 45 years. If < 18 years of age, participant must be capable of providing assent, understanding and complying with all study procedures, and have written informed consent from a parent or legal guardian.
- Normal menses (occurring within 22-35 day intervals) for > 2 cycles. Women who are postpartum or post-abortion who have resumed menses are eligible.
- Intact uterus and cervix.
- Interested in initiating HC and willing to accept DMPA, Eng-Implant or Lng-IUD.
Key exclusion criteria (7 listed)
- Pregnant or planning to become pregnant within the next year.
- Breastfeeding, if not having active menstrual cycles. Breastfeeding is not exclusionary if the participant is actively cycling.
- History of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery within the past year.
- Current use of systemic HC or IUD, based on self-report and/or hormonal testing.
- Taking concurrent medications that interact with selected HC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA)Also: Medroxyprogesterone acetate (MPA), Depo-ProveraDepot medroxyprogesterone acetate (DMPA) will be dispensed from the Grady Pharmacy Service and will be administered every 12 weeks at the standard dose of 150 mg Intramuscular injection, beginning from week 3 of study enrollment and repeated every 13 weeks | Drug | Depot medroxyprogesterone acetate (DMPA) |
| Etonogestrel implant (Eng-Implant)Also: NexplanonA standard Nexplanon rod Implant that is a subdermal implant in the arm. This will be placed at study week 3 by Dr. Haddad or a trained clinician. It contains Etonogestrel 68mg. | Drug | Etonogestrel implant (Eng-Implant) |
| Levonorgestrel IUD (Lng-IUD)Also: Mirena, CopperThe Levonorgestrel Intrauterine Device (Lng-IUD) (Mirena or copper) will be placed at study week 3 by Dr. Haddad or a trained clinician. | Drug | Levonorgestrel IUD (Lng-IUD) |
Primary outcome
Change in mean total leukocytes and CD4+ T-cells expressing CCR5 in the lower female genital tract (FGT) among the three intervention groups pre and post contraception
Time frame: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
Using Fortessa flow cytometer and Luminex, effector memory Cluster Differentiation 4 (CD4) + Thymocytes (T) cells will be analyzed for surface expression of HIV coreceptors cell surface receptor C-C chemokine receptor type 5 (CCR5) and reported as percent of total leukocytes and CD4+ T-cells. The cytometry will use the cervicovaginal fluid (CVF) collected by cervicovaginal lavage (CVL).This test will characterize the alterations in female genital and systemic immune profiles associated with three long-acting progestin-only Hormonal Contraception.
Change in Nugent's score among the three intervention groups pre and post contraception
Time frame: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis. The Nugent score is calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2). A score of 7 to 10 is consistent with bacterial vaginosis without culture.
Percent of expression of 16S rRNA gene sequencing among the three intervention groups pre and post contraception
Time frame: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
16 Svedberg ribosomal RNA (16S rRNA) is the component of the 30 Svedberg ribosomal RNA (30S rRNA) small subunit of a prokaryotic ribosome that binds to the Shine-Dalgarno sequence. The genes coding for it are referred to as 16S rRNA gene and are used in reconstructing phylogenies. 16S rRNA gene sequence analysis can better identify poorly described, rarely isolated, or phenotypically aberrant strains, can be routinely used for identification of mycobacteria, and can lead to the recognition of novel pathogens and uncultured bacteria.The term 16S refers to how it settles to when centrifuged (it's called a sedimentation rate, and it's measured in Svedberg (S) units).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Smith, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormonal Contraception, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean total leukocytes and CD4+ T-cells expressing CCR5 in the lower female genital tract (FGT) among the three intervention groups pre and post contraception (time frame: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.