ContraceptionCHARANCT03301480
Contraceptive/HIV Affecting Risk in Adolescents
An observational study of Contraception and Hiv, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will evaluate the impact of hormonal contraceptives on HIV risk associated with changes to the innate immunity in the female genital tract in a cross-sectional study. HIV risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex vivo and correlated to the number of CD4 T… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception, Hiv
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 17 Sep 2018
- 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 18 to 45 years
- Women only
- Adult
Study population: non-pregnant, HIV negative, healthy 18-19 year old women and 25-45 year old women
Who may be able to join
- Meets one of the following age groups (at the time of sample collection):
- Adolescent aged 18-19
- Adult aged 25-45
- Meets one of the following contraception groups:
- Regular menstrual cycles by participant history (if not using hormonal contraception)
- Use of ENG-I (i.e. Implanon/Nexplanon) for at least 30 days by participant history
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- Use of LNG-IUS (Mirena or Skyla) for at least 30 days by participant history
- HIV uninfected Note: HIV testing will be done as part of screening. However, if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the study visit.
- Willing to undergo pelvic exam and collection of cervical biopsies
- Willing to provided written informed consent
- Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one week after the biopsies.
Who cannot join
- Use of any other hormonal contraception other than ENG-I or LNG-IUS
- Use of a diaphragm or spermicide for contraception
- Pregnant or pregnancy within 90 days
- Currently breastfeeding
- Currently menstruating/bleeding (at time of specimen collection) Note: participant can return after cessation of bleeding for specimen collection
- Past participation in more than one study involving cervical biopsies per participant report
Show all 17Show fewer
- Cervical biopsies within one month of specimen collection visit
- Abnormal vaginal discharge or other genital tract symptoms at the time of specimen collection
- Pelvic findings on the day of specimen collection consistent with cervicitis (i.e. MPC, erythema, edema) or anatomy making cervical biopsies difficult
- Menopausal
- Hysterectomy
- History of malignancy of the genital tract (including cervix, uterus, vagina, and vulva)
- History of immunosuppression (including HIV infection, diabetes, and chronic steroid use)
- Known history of a platelet/bleeding/clotting disorder
- Use of a systemic or vaginal antimicrobial agent within 7 days of specimen collection
- Use of any vaginal product (i.e. douching, spermicide, lubricant) or device within 7 days of specimen collection Note: tampon use is acceptable
- Any other condition that in the opinion of the Study Investigator would preclude provision of informed consent or make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
This study will evaluate the impact of hormonal contraceptives on HIV risk associated with changes to the innate immunity in the female genital tract in a cross-sectional study. HIV risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.
- Conditions
- Contraception, Hiv
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No contraception/18-19 years old | Not described | |
| Use of ENG-I/18 - 19 years old | Not described | |
| LNG-IUS/18-19 years old | Not described | |
| No Contraception/ 25 - 45 years old | Not described | |
| Use of ENG-I/25 - 45 years old | Not described | |
| LNG-IUS/25-45 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV replication in cervical tissue as measured by levels of HIV p24/viral transcripts
cervical tissue testing
Measured: baseline
number of immune cells in cervical tissue, including CD45, CD3, CD4, and CD8 and their expression of CCR5, CCR6 and CD69, and CD11c+ DCs and CD14+ macrophages
cervical tissue testing
Measured: baseline
Secondary outcomes (3)
Prevalence of bacterial vaginosis defined as a Nugent score ≥7 on a vaginal smear
vaginal specimen
Measured: baseline
prevalence and quantity of lactobacillus species and bacterial vaginosis associated bacteria as measured by traditional culture methods and quantitative PCR
vaginal specimen
Measured: baseline
HIV inhibitory activity in mucosal fluid; and soluble mucosal factors identified through pathway analyses and confirmed by targeted ELISA/multiplexing technology (proteases/ anti-proteases, keratin, IFNε, and other molecules)
mucosal fluid
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start31 Jul 2017
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Why it stopped: An interim review of the data revealed that there was broad inter-participant variability.The study was stopped due to futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Katherine Bunge, University of Pittsburgh
- Investigators
- Katherine Bunge, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301480
- Sponsor's protocol ID
- PRO17050002
- Acronym
- CHARA
- Status last verified
- Feb 2019
- First submitted
- 8 Aug 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive/HIV Affecting Risk in Adolescents
- ClinicalTrials.gov ID
- NCT03301480
- Acronym / sponsor ID
- CHARA / PRO17050002
- Conditions
- Contraception, Hiv
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: An interim review of the data revealed that there was broad inter-participant variability.The study was stopped due to futility.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 4 Oct 2017 (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.
This study will evaluate the impact of hormonal contraceptives on HIV risk associated with changes to the innate immunity in the female genital tract in a cross-sectional study. HIV risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| No contraception/18-19 years old | – | – |
| Use of ENG-I/18 - 19 years old | – | – |
| LNG-IUS/18-19 years old | – | – |
| No Contraception/ 25 - 45 years old | – | – |
| Use of ENG-I/25 - 45 years old | – | – |
| LNG-IUS/25-45 years old | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- non-pregnant, HIV negative, healthy 18-19 year old women and 25-45 year old women
Key inclusion criteria (11 listed)
- Meets one of the following age groups (at the time of sample collection):
- Meets one of the following contraception groups:
- HIV uninfected Note: HIV testing will be done as part of screening. However, if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the study visit.
- Willing to undergo pelvic exam and collection of cervical biopsies
- Willing to provided written informed consent
Key exclusion criteria (17 listed)
- Use of any other hormonal contraception other than ENG-I or LNG-IUS
- Use of a diaphragm or spermicide for contraception
- Pregnant or pregnancy within 90 days
- Currently breastfeeding
- Currently menstruating/bleeding (at time of specimen collection) Note: participant can return after cessation of bleeding for specimen collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV replication in cervical tissue as measured by levels of HIV p24/viral transcripts
Time frame: baseline
cervical tissue testing
number of immune cells in cervical tissue, including CD45, CD3, CD4, and CD8 and their expression of CCR5, CCR6 and CD69, and CD11c+ DCs and CD14+ macrophages
Time frame: baseline
cervical tissue testing
3 secondary outcomes
Prevalence of bacterial vaginosis defined as a Nugent score ≥7 on a vaginal smear
Time frame: baseline
prevalence and quantity of lactobacillus species and bacterial vaginosis associated bacteria as measured by traditional culture methods and quantitative PCR
Time frame: baseline
HIV inhibitory activity in mucosal fluid; and soluble mucosal factors identified through pathway analyses and confirmed by targeted ELISA/multiplexing technology (proteases/ anti-proteases, keratin, IFNε, and other molecules)
Time frame: baseline
Results and safety
The study was stopped early (reason given: An interim review of the data revealed that there was broad inter-participant variability.The study was stopped due to futility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
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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.
Katherine Bunge, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Hiv, run by University of Pittsburgh at 1 site 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: An interim review of the data revealed that there was broad inter-participant variability.The study was stopped due to futility.). Results are not available in the source record.
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?
HIV replication in cervical tissue as measured by levels of HIV p24/viral transcripts (time frame: baseline). The study lists 2 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 7 Feb 2019.