HIVPhase 4NCT02357368
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
A Phase 4 study testing Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD) in people with HIV and Contraception, run by Lisa Haddad at 4 sites in United States.
Trial summary
This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Contraception
- What is being tested?
- Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2015to 23 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age 18-45 years
- Normal menses (22-35 day intervals) for at least 3 cycles
- Intact uterus and cervix
- Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard
- Willing to delay initiation of hormonal contraception for up to 1 month
Show all 9Show fewer
- Willing to use condoms or abstain from sexual intercourse for at least 48 hours before each genital tract sampling (condoms will be made available)
- Able and willing to provide informed consent, and undergo serial blood and cervicovaginal lavage (CVL) sampling
- Negative HIV screening
Who cannot join
- Pregnant within the last 3 months
- Breastfeeding
- History of loop electrosurgical excision procedure, conization, or cryosurgery within the past year
- Use of hormonal contraception or IUD in the past 6 months
- Known history of medical condition that would interfere with the conduct of the study
- Symptomatic vaginal infection or genital ulcer disease at screening
- Taking medications that interact with selected contraceptive
- Contraindications to selected contraceptive per the Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Health System
Atlanta, Georgia, 30303
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, 30308
Emory Clinic
Atlanta, Georgia, 30322
Emory University Clinical Research Network
Atlanta, Georgia, 30322
About this study
This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.
Read the detailed description
The three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) on: (1) HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.
- Conditions
- HIV, Contraception
- Being tested
- Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), Levonorgestrel intrauterine device (Lng-IUD), ParaGard® T 380A Intrauterine Copper Contraceptive
- Keywords
- HIV-negative
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 Depo Provera
DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.
Etonogestrel implant (Eng-Implant)Device
Also called Nexplanon
A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
Levonorgestrel intrauterine device (Lng-IUD)Device
Also called Mirena
A standard Mirena IUD will be placed at study week 3 by a trained clinician.
ParaGard® T 380A Intrauterine Copper ContraceptiveDevice
Also called ParaGuard
A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
| Study group | Role | What they receive |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | Experimental | DMPA will be administered every 12 weeks at 150 mg by intramuscular (IM) injection at week 3 of study enrollment and repeated at week 15. Receives: Drug: Depot medroxyprogesterone acetate (DMPA) |
| Etonogestrel implant (Eng-Implant) | Experimental | A standard Nexplanon rod Implant will be placed at study week 3. Receives: Device: Etonogestrel implant (Eng-Implant) |
| Levonorgestrel intrauterine device (Lng-IUD) | Experimental | A standard Mirena IUD will be placed at study week 3. Receives: Device: Levonorgestrel intrauterine device (Lng-IUD) |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Experimental | A standard ParaGuard IUD will be placed at study week 3. Receives: Device: ParaGard® T 380A Intrauterine Copper Contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection.
Measured: Week 1, Week 17
Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection.
Measured: Week 1, Week 17
Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation.
Measured: Week 1, Week 17
Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms.
Measured: Week 1, Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Haddad
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Lisa Haddad, Emory University
- Investigators
- Lisa Haddad, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357368
- Sponsor's protocol ID
- IRB00072549
- Other IDs
- 5K23HD078153-05
- Status last verified
- Oct 2020
- First submitted
- 3 Feb 2015
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
- ClinicalTrials.gov ID
- NCT02357368
- Acronym / sponsor ID
- IRB00072549
- Conditions
- HIV, Contraception
- Keywords
- HIV-negative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Lisa HaddadUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2015
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.
Detailed description
The three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) on: (1) HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | Experimental | Drug: Depot medroxyprogesterone acetate (DMPA)DMPA will be administered every 12 weeks at 150 mg by intramuscular (IM) injection at week 3 of study enrollment and repeated at week 15. |
| Etonogestrel implant (Eng-Implant) | Experimental | Device: Etonogestrel implant (Eng-Implant)A standard Nexplanon rod Implant will be placed at study week 3. |
| Levonorgestrel intrauterine device (Lng-IUD) | Experimental | Device: Levonorgestrel intrauterine device (Lng-IUD)A standard Mirena IUD will be placed at study week 3. |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Experimental | Device: ParaGard® T 380A Intrauterine Copper ContraceptiveA standard ParaGuard IUD will be placed at study week 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female
- Age 18-45 years
- Normal menses (22-35 day intervals) for at least 3 cycles
- Intact uterus and cervix
- Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard
Key exclusion criteria (8 listed)
- Pregnant within the last 3 months
- Breastfeeding
- History of loop electrosurgical excision procedure, conization, or cryosurgery within the past year
- Use of hormonal contraception or IUD in the past 6 months
- Known history of medical condition that would interfere with the conduct of the study
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: Depo ProveraDMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15. | Drug | Depot medroxyprogesterone acetate (DMPA) |
| Etonogestrel implant (Eng-Implant)Also: NexplanonA standard nexplanon rod implant will be placed at study week 3 by a trained clinician. | Device | Etonogestrel implant (Eng-Implant) |
| Levonorgestrel intrauterine device (Lng-IUD)Also: MirenaA standard Mirena IUD will be placed at study week 3 by a trained clinician. | Device | Levonorgestrel intrauterine device (Lng-IUD) |
| ParaGard® T 380A Intrauterine Copper ContraceptiveAlso: ParaGuardA standard ParaGuard IUD will be placed at study week 3 by a trained clinician. | Device | ParaGard® T 380A Intrauterine Copper Contraceptive |
Primary outcome
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
Time frame: Week 1, Week 17
Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection.
Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
Time frame: Week 1, Week 17
CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection.
Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
Time frame: Week 1, Week 17
T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation.
Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
Time frame: Week 1, Week 17
The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa Haddad, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD) in people with HIV and Contraception, run by Lisa Haddad at 4 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 8 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood (time frame: Week 1, Week 17). The study lists 4 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 18 Nov 2020.