Contraception, HIV
Conditions
Keywords
HIV-negative
Brief 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 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.
Interventions
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.
A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
DEVICELevonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3 by a trained clinician.
DEVICEParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lisa Haddad
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Etonogestrel Impant (Eng-Implant) Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician | 18 |
| Levonorgestrel Intrauterine Device (Lng-IUD) Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician | 14 |
| ParaGard® T 380A Intrauterine Copper Contraceptive Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician | 8 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Pregnancy | 3 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Depot Medroxyprogesterone Acetate (DMPA) | Etonogestrel Impant (Eng-Implant) | Levonorgestrel Intrauterine Device (Lng-IUD) | ParaGard® T 380A Intrauterine Copper Contraceptive | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 14 Participants | 8 Participants | 59 Participants |
| Age, Continuous | 34.1 years STANDARD_DEVIATION 7.8 | 27.7 years STANDARD_DEVIATION 7.2 | 31.1 years STANDARD_DEVIATION 7.9 | — | 31.0 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | — | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 14 Participants | — | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 15 Participants | 7 Participants | — | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | — | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 7 Participants | — | 10 Participants |
| Region of Enrollment United States | 19 Participants | 18 Participants | 14 Participants | 8 Participants | 59 Participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 14 Participants | 8 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 | 0 / 14 | 0 / 8 |
| other Total, other adverse events | 1 / 19 | 0 / 18 | 1 / 14 | 1 / 8 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 | 0 / 14 | 0 / 8 |
Outcome results
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.
Time frame: Week 1, Week 17
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Cervicovaginal Lavage (CVL) Week 1 | 689.8 pg/mL | Standard Deviation 1052.5 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 CVL Week 17 | 445.8 pg/mL | Standard Deviation 996.1 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 3298.5 pg/mL | Standard Deviation 2066.1 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 PBMC Week 17 | 3114.4 pg/mL | Standard Deviation 1843.8 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 1 | 752.2 pg/mL | Standard Deviation 1616.8 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 17 | 550.7 pg/mL | Standard Deviation 695.8 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 1 | 58.5 pg/mL | Standard Deviation 154.2 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 17 | 47.8 pg/mL | Standard Deviation 118.2 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 1 | 32.9 pg/mL | Standard Deviation 50.3 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 17 | 21.1 pg/mL | Standard Deviation 42 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 1 | 20.0 pg/mL | Standard Deviation 11.2 |
| Depot Medroxyprogesterone Acetate (DMPA) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 17 | 20.8 pg/mL | Standard Deviation 10.8 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 17 | 46.5 pg/mL | Standard Deviation 58.1 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Cervicovaginal Lavage (CVL) Week 1 | 2551.1 pg/mL | Standard Deviation 2936.2 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 1 | 156.2 pg/mL | Standard Deviation 233.2 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 1 | 583.4 pg/mL | Standard Deviation 1569.9 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 CVL Week 17 | 2417.6 pg/mL | Standard Deviation 3667.7 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 17 | 2120.6 pg/mL | Standard Deviation 2569.5 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 1 | 51.4 pg/mL | Standard Deviation 73.2 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 4107.3 pg/mL | Standard Deviation 1455.4 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 17 | 144.1 pg/mL | Standard Deviation 235.9 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 1 | 1640.2 pg/mL | Standard Deviation 2051.6 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 PBMC Week 17 | 3954.3 pg/mL | Standard Deviation 1617 |
| Etonogestrel Impant (Eng-Implant) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 17 | 485.8 pg/mL | Standard Deviation 971.9 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 PBMC Week 17 | 209.6 pg/mL | Standard Deviation 75.7 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 1 | 256.4 pg/mL | Standard Deviation 413.1 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 17 | 37.1 pg/mL | Standard Deviation 30.8 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a CVL Week 17 | 184.7 pg/mL | Standard Deviation 251 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 1 | 54.6 pg/mL | Standard Deviation 87.7 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1a PBMC Week 17 | 65.1 pg/mL | Standard Deviation 78.5 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 1 | 4.2 pg/mL | Standard Deviation 2.3 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Cervicovaginal Lavage (CVL) Week 1 | 1100.2 pg/mL | Standard Deviation 1974.1 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 CVL Week 17 | 1241.5 pg/mL | Standard Deviation 1088.5 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b CVL Week 1 | 43.9 pg/mL | Standard Deviation 91.3 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 204.4 pg/mL | Standard Deviation 83.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood | IL-1b PBMC Week 17 | 4.3 pg/mL | Standard Deviation 1.9 |
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.
Time frame: Week 1, Week 17
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells CVL Week 17 | 39.2 percentage of HIV target immune cells | Standard Deviation 27.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 1 | 47.2 percentage of HIV target immune cells | Standard Deviation 17.5 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 26.6 percentage of HIV target immune cells | Standard Deviation 22.3 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 17 | 47.4 percentage of HIV target immune cells | Standard Deviation 18.2 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 1 | 65.6 percentage of HIV target immune cells | Standard Deviation 10.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 4.1 percentage of HIV target immune cells | Standard Deviation 2.9 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 17 | 63.9 percentage of HIV target immune cells | Standard Deviation 10.1 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells PBMC Week 17 | 5.7 percentage of HIV target immune cells | Standard Deviation 3.5 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 1 | 67.4 percentage of HIV target immune cells | Standard Deviation 8 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 3.9 percentage of HIV target immune cells | Standard Deviation 2.5 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 1 | 48.7 percentage of HIV target immune cells | Standard Deviation 16.7 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells PBMC Week 17 | 4.2 percentage of HIV target immune cells | Standard Deviation 2.7 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells CVL Week 17 | 32.2 percentage of HIV target immune cells | Standard Deviation 21.1 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 22.8 percentage of HIV target immune cells | Standard Deviation 20.5 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 17 | 47.0 percentage of HIV target immune cells | Standard Deviation 16.3 |
| Etonogestrel Impant (Eng-Implant) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 17 | 67.5 percentage of HIV target immune cells | Standard Deviation 9.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells CVL Week 17 | 23.3 percentage of HIV target immune cells | Standard Deviation 20.6 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 1 | 65.7 percentage of HIV target immune cells | Standard Deviation 9.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 16.9 percentage of HIV target immune cells | Standard Deviation 16.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 17 | 63.4 percentage of HIV target immune cells | Standard Deviation 10.8 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 2.9 percentage of HIV target immune cells | Standard Deviation 1.7 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 17 | 48.8 percentage of HIV target immune cells | Standard Deviation 23.5 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells PBMC Week 17 | 2.6 percentage of HIV target immune cells | Standard Deviation 1.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 1 | 54.0 percentage of HIV target immune cells | Standard Deviation 20.5 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 17 | 71.1 percentage of HIV target immune cells | Standard Deviation 13.7 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 22.4 percentage of HIV target immune cells | Standard Deviation 20.3 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells CVL Week 17 | 15.3 percentage of HIV target immune cells | Standard Deviation 8.1 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 8.3 percentage of HIV target immune cells | Standard Deviation 2.9 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CCR5+ CD4 T-cells PBMC Week 17 | 7.5 percentage of HIV target immune cells | Standard Deviation 1.6 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 1 | 63.4 percentage of HIV target immune cells | Standard Deviation 11.2 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% CVL Week 17 | 47.5 percentage of HIV target immune cells | Standard Deviation 22.7 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood | CD4% PBMC Week 1 | 73.3 percentage of HIV target immune cells | Standard Deviation 4.9 |
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.
Time frame: Week 1, Week 17
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 1 | 25.0 percentage of T cell activation markers | Standard Deviation 18.3 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells CVL Week 17 | 35.9 percentage of T cell activation markers | Standard Deviation 18.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 17.1 percentage of T cell activation markers | Standard Deviation 7.3 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells PBMC Week 17 | 17.7 percentage of T cell activation markers | Standard Deviation 6.9 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 36.7 percentage of T cell activation markers | Standard Deviation 18.4 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 17 | 21.2 percentage of T cell activation markers | Standard Deviation 16.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 1 | 4.8 percentage of T cell activation markers | Standard Deviation 3.4 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 17 | 4.4 percentage of T cell activation markers | Standard Deviation 2.9 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 1 | 62.5 percentage of T cell activation markers | Standard Deviation 20.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 17 | 52.5 percentage of T cell activation markers | Standard Deviation 20.7 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 22.7 percentage of T cell activation markers | Standard Deviation 8.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 24.1 percentage of T cell activation markers | Standard Deviation 9.2 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1 | 30.7 percentage of T cell activation markers | Standard Deviation 21.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17 | 30.0 percentage of T cell activation markers | Standard Deviation 17.6 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 24.4 percentage of T cell activation markers | Standard Deviation 10.4 |
| Depot Medroxyprogesterone Acetate (DMPA) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 23.2 percentage of T cell activation markers | Standard Deviation 10.4 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 17 | 17.8 percentage of T cell activation markers | Standard Deviation 13.8 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 1 | 64.5 percentage of T cell activation markers | Standard Deviation 26.9 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 21.6 percentage of T cell activation markers | Standard Deviation 7.6 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 29.6 percentage of T cell activation markers | Standard Deviation 12.1 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 22.6 percentage of T cell activation markers | Standard Deviation 7.4 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 17 | 61.6 percentage of T cell activation markers | Standard Deviation 14.7 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 17.6 percentage of T cell activation markers | Standard Deviation 10.1 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 26.0 percentage of T cell activation markers | Standard Deviation 12.8 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 1 | 26.9 percentage of T cell activation markers | Standard Deviation 22.8 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 1 | 3.0 percentage of T cell activation markers | Standard Deviation 1.5 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells PBMC Week 17 | 17.6 percentage of T cell activation markers | Standard Deviation 8.4 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells CVL Week 17 | 41.7 percentage of T cell activation markers | Standard Deviation 14.8 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1 | 41.3 percentage of T cell activation markers | Standard Deviation 24.8 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 17 | 2.3 percentage of T cell activation markers | Standard Deviation 0.9 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17 | 25.5 percentage of T cell activation markers | Standard Deviation 17.9 |
| Etonogestrel Impant (Eng-Implant) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 36.9 percentage of T cell activation markers | Standard Deviation 17.6 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 17 | 11.4 percentage of T cell activation markers | Standard Deviation 6.9 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 1 | 15.4 percentage of T cell activation markers | Standard Deviation 10.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17 | 17.6 percentage of T cell activation markers | Standard Deviation 11.9 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 1 | 3.3 percentage of T cell activation markers | Standard Deviation 2.1 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 17 | 3.6 percentage of T cell activation markers | Standard Deviation 6.2 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 25.5 percentage of T cell activation markers | Standard Deviation 11.6 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 1 | 66.2 percentage of T cell activation markers | Standard Deviation 18.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 17 | 70.8 percentage of T cell activation markers | Standard Deviation 18.9 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 28.3 percentage of T cell activation markers | Standard Deviation 10.1 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 28.2 percentage of T cell activation markers | Standard Deviation 10.6 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 31.7 percentage of T cell activation markers | Standard Deviation 9.7 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 32.6 percentage of T cell activation markers | Standard Deviation 11.6 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells CVL Week 17 | 44.0 percentage of T cell activation markers | Standard Deviation 15.4 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1 | 28.2 percentage of T cell activation markers | Standard Deviation 16.3 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 17.0 percentage of T cell activation markers | Standard Deviation 9 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells PBMC Week 17 | 17.2 percentage of T cell activation markers | Standard Deviation 7 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 10.1 percentage of T cell activation markers | Standard Deviation 7.3 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 17 | 2.5 percentage of T cell activation markers | Standard Deviation 1.6 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 25.2 percentage of T cell activation markers | Standard Deviation 10.4 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1 | 23.2 percentage of T cell activation markers | Standard Deviation 22.4 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17 | 26.5 percentage of T cell activation markers | Standard Deviation 18.7 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells PBMC Week 1 | 3.4 percentage of T cell activation markers | Standard Deviation 1.4 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1 | 20.1 percentage of T cell activation markers | Standard Deviation 12.9 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells CVL Week 17 | 45.5 percentage of T cell activation markers | Standard Deviation 21.4 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 1 | 8.7 percentage of T cell activation markers | Standard Deviation 6.1 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 17 | 42.4 percentage of T cell activation markers | Standard Deviation 29.4 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ CD4 T-cells CVL Week 17 | 21.1 percentage of T cell activation markers | Standard Deviation 19.1 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 18.6 percentage of T cell activation markers | Standard Deviation 12.6 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1 | 16.5 percentage of T cell activation markers | Standard Deviation 9.9 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells CVL Week 1 | 12.7 percentage of T cell activation markers | Standard Deviation 13.9 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ CD4 T-cells PBMC Week 17 | 36.3 percentage of T cell activation markers | Standard Deviation 25 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood | CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17 | 30.9 percentage of T cell activation markers | Standard Deviation 20.3 |
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.
Time frame: Week 1, Week 17
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depot Medroxyprogesterone Acetate (DMPA) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio PBMC Week 17 | 2.6 CD4/CD8 | Standard Deviation 1.3 |
| Depot Medroxyprogesterone Acetate (DMPA) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio CVL Week 17 | 2.6 CD4/CD8 | Standard Deviation 2.7 |
| Depot Medroxyprogesterone Acetate (DMPA) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 4.3 CD4/CD8 | Standard Deviation 8.8 |
| Depot Medroxyprogesterone Acetate (DMPA) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1 | 2.4 CD4/CD8 | Standard Deviation 2.5 |
| Etonogestrel Impant (Eng-Implant) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio CVL Week 17 | 2.3 CD4/CD8 | Standard Deviation 2 |
| Etonogestrel Impant (Eng-Implant) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1 | 2.6 CD4/CD8 | Standard Deviation 1.8 |
| Etonogestrel Impant (Eng-Implant) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio PBMC Week 17 | 3.3 CD4/CD8 | Standard Deviation 2.5 |
| Etonogestrel Impant (Eng-Implant) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 3.1 CD4/CD8 | Standard Deviation 1.7 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1 | 2.9 CD4/CD8 | Standard Deviation 3 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio CVL Week 17 | 2.3 CD4/CD8 | Standard Deviation 2.1 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio PBMC Week 17 | 2.5 CD4/CD8 | Standard Deviation 1.2 |
| Levonorgestrel Intrauterine Device (Lng-IUD) | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 2.9 CD4/CD8 | Standard Deviation 1.5 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1 | 3.9 CD4/CD8 | Standard Deviation 3 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1 | 4.7 CD4/CD8 | Standard Deviation 2 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio CVL Week 17 | 4.9 CD4/CD8 | Standard Deviation 6.5 |
| ParaGard® T 380A Intrauterine Copper Contraceptive | Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood | CD4/CD8 Ratio PBMC Week 17 | 5.4 CD4/CD8 | Standard Deviation 2.1 |