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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HD078153-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Etonogestrel implant (Eng-Implant) | Experimental | A standard Nexplanon rod Implant will be placed at study week 3. |
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| Levonorgestrel intrauterine device (Lng-IUD) | Experimental | A standard Mirena IUD will be placed at study week 3. |
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| ParaGard® T 380A Intrauterine Copper Contraceptive | Experimental | A standard ParaGuard IUD will be placed at study week 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depot medroxyprogesterone acetate (DMPA) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Haddad, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States | ||
| The Ponce de Leon Center of the Grady Health System |
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Participants were enrolled between February 2015 and follow up was completed on October 23, 2019. Participants were recruited from the Grady Family Planning Clinic within Grady Memorial Hospital, the Emory Clinic, and the Ponce de Leon Center of the Grady Health System, in Atlanta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Depot Medroxyprogesterone Acetate (DMPA) | Participants receiving depot medroxyprogesterone acetate (DMPA) administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15 |
| FG001 | Etonogestrel Impant (Eng-Implant) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2017 |
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| Etonogestrel implant (Eng-Implant) | Device | A standard nexplanon rod implant will be placed at study week 3 by a trained clinician. |
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| Levonorgestrel intrauterine device (Lng-IUD) | Device | A standard Mirena IUD will be placed at study week 3 by a trained clinician. |
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| ParaGard® T 380A Intrauterine Copper Contraceptive | Device | A standard ParaGuard IUD will be placed at study week 3 by a trained clinician. |
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| Week 1, Week 17 |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Emory University Clinical Research Network | Atlanta | Georgia | 30322 | United States |
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician |
| FG002 | Levonorgestrel Intrauterine Device (Lng-IUD) | Participants receiving a standard Mirena intrauterine device (IUD) that was placed at study Week 3 by a trained clinician |
| FG003 | ParaGard® T 380A Intrauterine Copper Contraceptive | Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Depot Medroxyprogesterone Acetate (DMPA) | Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15 |
| BG001 | Etonogestrel Impant (Eng-Implant) | Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician |
| BG002 | Levonorgestrel Intrauterine Device (Lng-IUD) | Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician |
| BG003 | ParaGard® T 380A Intrauterine Copper Contraceptive | Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Continuous age is not available for the ParaGard® T 380A Intrauterine Copper Contraceptive study arm. This group was added late in the study and the study procedures differed slightly from the initial three study arms. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity is not available for the ParaGard® T 380A Intrauterine Copper Contraceptive study arm. This group was added late in the study and the study procedures differed slightly from the initial three study arms. | Count of Participants | Participants |
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| Race (NIH/OMB) | Race is not available for the ParaGard® T 380A Intrauterine Copper Contraceptive study arm. This group was added late in the study and the study procedures differed slightly from the initial three study arms. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | Standard Deviation | percentage of HIV target immune cells | Week 1, Week 17 |
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| Primary | 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. | Posted | Mean | Standard Deviation | CD4/CD8 | Week 1, Week 17 |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | This analysis includes participants with samples that were able to be analyzed. Missing values are due to the inability to quantify the outcomes due to low cell counts when looking at the percent + of few cells for those samples. | Posted | Mean | Standard Deviation | percentage of T cell activation markers | Week 1, Week 17 |
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| Primary | 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. | The ParaGard® T 380A Intrauterine Copper Contraceptive study arm was added late in the study the study procedures differed slightly from the initial three study arms. Funding to add this study arm covered the evaluation of the clinical study activities and cellular markers and there was not funding for analysis of cytokines and chemokines. | Posted | Mean | Standard Deviation | pg/mL | Week 1, Week 17 |
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Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depot Medroxyprogesterone Acetate (DMPA) | Participants receiving DMPA administered every 12 weeks at the standard dose of 150 mg intramuscular injection, beginning from Week 3 of study enrollment and repeated at Week 15 | 0 | 19 | 0 | 19 | 1 | 19 |
| EG001 | Etonogestrel Impant (Eng-Implant) | Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Levonorgestrel Intrauterine Device (Lng-IUD) | Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician | 0 | 14 | 0 | 14 | 1 | 14 |
| EG003 | ParaGard® T 380A Intrauterine Copper Contraceptive | Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician | 0 | 8 | 0 | 8 | 1 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extended spotting 7 days before start of menstrual cycle | Reproductive system and breast disorders | Non-systematic Assessment |
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| Extended menstrual bleeding with blood clots | Reproductive system and breast disorders | Non-systematic Assessment |
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| Heavy irregular menstrual bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Haddad, MD | Emory University | 404-778-1385 | lisa.haddad@emory.edu |
| Oct 20, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2017 | Oct 23, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| CCR5+ CD4 T-cells CVL Week 17 |
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| CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 |
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| CCR5+ CD4 T-cells PBMC Week 17 |
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| CD4% CVL Week 1 |
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| CD4% CVL Week 17 |
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Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician |
| OG003 | ParaGard® T 380A Intrauterine Copper Contraceptive | Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician |
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| OG002 |
| Levonorgestrel Intrauterine Device (Lng-IUD) |
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician |
| OG003 | ParaGard® T 380A Intrauterine Copper Contraceptive | Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician |
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