Trial Outcomes & Findings for Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk (NCT NCT02357368)
NCT ID: NCT02357368
Last Updated: 2020-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
Week 1, Week 17
Results posted on
2020-11-18
Participant Flow
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.
Participant milestones
| Measure |
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
|
Etonogestrel Impant (Eng-Implant)
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
Participants receiving a standard Mirena intrauterine device (IUD) that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
14
|
8
|
|
Overall Study
COMPLETED
|
13
|
15
|
13
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
1
|
3
|
Reasons for withdrawal
| Measure |
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
|
Etonogestrel Impant (Eng-Implant)
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
Participants receiving a standard Mirena intrauterine device (IUD) that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
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
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.
Baseline characteristics by cohort
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 Participants
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
|
Etonogestrel Impant (Eng-Implant)
n=18 Participants
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 Participants
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
n=8 Participants
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=59 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
14 Participants
n=14 Participants
|
8 Participants
n=8 Participants
|
59 Participants
n=59 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=59 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 7.8 • n=19 Participants • 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.
|
27.7 years
STANDARD_DEVIATION 7.2 • n=18 Participants • 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.
|
31.1 years
STANDARD_DEVIATION 7.9 • n=14 Participants • 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.
|
—
|
31.0 years
STANDARD_DEVIATION 8.0 • n=51 Participants • 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.
|
|
Sex: Female, Male
Female
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
14 Participants
n=14 Participants
|
8 Participants
n=8 Participants
|
59 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=59 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=19 Participants • 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.
|
1 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
2 Participants
n=51 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=19 Participants • 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.
|
17 Participants
n=18 Participants • 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.
|
14 Participants
n=14 Participants • 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.
|
—
|
49 Participants
n=51 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants • 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.
|
0 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
0 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants • 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.
|
0 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
0 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=19 Participants • 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.
|
0 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
0 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants • 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.
|
0 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
0 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=19 Participants • 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.
|
15 Participants
n=18 Participants • 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.
|
7 Participants
n=14 Participants • 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.
|
—
|
40 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
White
|
1 Participants
n=19 Participants • 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.
|
2 Participants
n=18 Participants • 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.
|
7 Participants
n=14 Participants • 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.
|
—
|
10 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants • 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.
|
1 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
1 Participants
n=51 Participants • 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.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants • 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.
|
0 Participants
n=18 Participants • 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.
|
0 Participants
n=14 Participants • 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.
|
—
|
0 Participants
n=51 Participants • 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.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
14 Participants
n=14 Participants
|
8 Participants
n=8 Participants
|
59 Participants
n=59 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 17Following 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.
Outcome measures
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 Participants
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
|
Etonogestrel Impant (Eng-Implant)
n=18 Participants
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 Participants
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
n=8 Participants
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
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
|
22.8 percentage of HIV target immune cells
Standard Deviation 20.5
|
16.9 percentage of HIV target immune cells
Standard Deviation 16.4
|
22.4 percentage of HIV target immune cells
Standard Deviation 20.3
|
|
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
|
32.2 percentage of HIV target immune cells
Standard Deviation 21.1
|
23.3 percentage of HIV target immune cells
Standard Deviation 20.6
|
15.3 percentage of HIV target immune cells
Standard Deviation 8.1
|
|
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
|
3.9 percentage of HIV target immune cells
Standard Deviation 2.5
|
2.9 percentage of HIV target immune cells
Standard Deviation 1.7
|
8.3 percentage of HIV target immune cells
Standard Deviation 2.9
|
|
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
|
4.2 percentage of HIV target immune cells
Standard Deviation 2.7
|
2.6 percentage of HIV target immune cells
Standard Deviation 1.4
|
7.5 percentage of HIV target immune cells
Standard Deviation 1.6
|
|
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
|
48.7 percentage of HIV target immune cells
Standard Deviation 16.7
|
54.0 percentage of HIV target immune cells
Standard Deviation 20.5
|
63.4 percentage of HIV target immune cells
Standard Deviation 11.2
|
|
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
|
47.0 percentage of HIV target immune cells
Standard Deviation 16.3
|
48.8 percentage of HIV target immune cells
Standard Deviation 23.5
|
47.5 percentage of HIV target immune cells
Standard Deviation 22.7
|
|
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
|
67.4 percentage of HIV target immune cells
Standard Deviation 8.0
|
65.7 percentage of HIV target immune cells
Standard Deviation 9.4
|
73.3 percentage of HIV target immune cells
Standard Deviation 4.9
|
|
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
|
67.5 percentage of HIV target immune cells
Standard Deviation 9.4
|
63.4 percentage of HIV target immune cells
Standard Deviation 10.8
|
71.1 percentage of HIV target immune cells
Standard Deviation 13.7
|
PRIMARY outcome
Timeframe: Week 1, Week 17CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection.
Outcome measures
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 Participants
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
|
Etonogestrel Impant (Eng-Implant)
n=18 Participants
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 Participants
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
n=8 Participants
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
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
|
2.6 CD4/CD8
Standard Deviation 1.8
|
2.9 CD4/CD8
Standard Deviation 3.0
|
3.9 CD4/CD8
Standard Deviation 3.0
|
|
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
|
2.3 CD4/CD8
Standard Deviation 2.0
|
2.3 CD4/CD8
Standard Deviation 2.1
|
4.9 CD4/CD8
Standard Deviation 6.5
|
|
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
|
3.1 CD4/CD8
Standard Deviation 1.7
|
2.9 CD4/CD8
Standard Deviation 1.5
|
4.7 CD4/CD8
Standard Deviation 2.0
|
|
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
|
3.3 CD4/CD8
Standard Deviation 2.5
|
2.5 CD4/CD8
Standard Deviation 1.2
|
5.4 CD4/CD8
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Week 1, Week 17Population: 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.
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.
Outcome measures
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 Participants
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
|
Etonogestrel Impant (Eng-Implant)
n=18 Participants
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 Participants
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
n=8 Participants
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
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
|
36.9 percentage of T cell activation markers
Standard Deviation 17.6
|
32.6 percentage of T cell activation markers
Standard Deviation 11.6
|
23.2 percentage of T cell activation markers
Standard Deviation 22.4
|
|
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
|
17.6 percentage of T cell activation markers
Standard Deviation 10.1
|
17.0 percentage of T cell activation markers
Standard Deviation 9.0
|
25.2 percentage of T cell activation markers
Standard Deviation 10.4
|
|
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
|
17.6 percentage of T cell activation markers
Standard Deviation 8.4
|
17.2 percentage of T cell activation markers
Standard Deviation 7.0
|
36.3 percentage of T cell activation markers
Standard Deviation 25.0
|
|
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
|
26.9 percentage of T cell activation markers
Standard Deviation 22.8
|
15.4 percentage of T cell activation markers
Standard Deviation 10.4
|
8.7 percentage of T cell activation markers
Standard Deviation 6.1
|
|
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
|
2.3 percentage of T cell activation markers
Standard Deviation 0.9
|
3.6 percentage of T cell activation markers
Standard Deviation 6.2
|
2.5 percentage of T cell activation markers
Standard Deviation 1.6
|
|
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
|
64.5 percentage of T cell activation markers
Standard Deviation 26.9
|
66.2 percentage of T cell activation markers
Standard Deviation 18.4
|
12.7 percentage of T cell activation markers
Standard Deviation 13.9
|
|
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
|
61.6 percentage of T cell activation markers
Standard Deviation 14.7
|
70.8 percentage of T cell activation markers
Standard Deviation 18.9
|
42.4 percentage of T cell activation markers
Standard Deviation 29.4
|
|
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
|
26.0 percentage of T cell activation markers
Standard Deviation 12.8
|
28.2 percentage of T cell activation markers
Standard Deviation 10.6
|
18.6 percentage of T cell activation markers
Standard Deviation 12.6
|
|
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
|
29.6 percentage of T cell activation markers
Standard Deviation 12.1
|
31.7 percentage of T cell activation markers
Standard Deviation 9.7
|
30.9 percentage of T cell activation markers
Standard Deviation 20.3
|
|
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
|
41.3 percentage of T cell activation markers
Standard Deviation 24.8
|
28.2 percentage of T cell activation markers
Standard Deviation 16.3
|
20.1 percentage of T cell activation markers
Standard Deviation 12.9
|
|
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
|
41.7 percentage of T cell activation markers
Standard Deviation 14.8
|
44.0 percentage of T cell activation markers
Standard Deviation 15.4
|
45.5 percentage of T cell activation markers
Standard Deviation 21.4
|
|
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
|
17.8 percentage of T cell activation markers
Standard Deviation 13.8
|
11.4 percentage of T cell activation markers
Standard Deviation 6.9
|
21.1 percentage of T cell activation markers
Standard Deviation 19.1
|
|
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
|
3.0 percentage of T cell activation markers
Standard Deviation 1.5
|
3.3 percentage of T cell activation markers
Standard Deviation 2.1
|
3.4 percentage of T cell activation markers
Standard Deviation 1.4
|
|
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
|
25.5 percentage of T cell activation markers
Standard Deviation 17.9
|
17.6 percentage of T cell activation markers
Standard Deviation 11.9
|
26.5 percentage of T cell activation markers
Standard Deviation 18.7
|
|
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
|
22.6 percentage of T cell activation markers
Standard Deviation 7.4
|
28.3 percentage of T cell activation markers
Standard Deviation 10.1
|
16.5 percentage of T cell activation markers
Standard Deviation 9.9
|
|
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
|
21.6 percentage of T cell activation markers
Standard Deviation 7.6
|
25.5 percentage of T cell activation markers
Standard Deviation 11.6
|
10.1 percentage of T cell activation markers
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: Week 1, Week 17Population: 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.
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.
Outcome measures
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 Participants
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
|
Etonogestrel Impant (Eng-Implant)
n=18 Participants
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 Participants
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
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
|
2417.6 pg/mL
Standard Deviation 3667.7
|
1241.5 pg/mL
Standard Deviation 1088.5
|
—
|
|
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
|
4107.3 pg/mL
Standard Deviation 1455.4
|
204.4 pg/mL
Standard Deviation 83.4
|
—
|
|
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
|
2120.6 pg/mL
Standard Deviation 2569.5
|
184.7 pg/mL
Standard Deviation 251.0
|
—
|
|
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
|
144.1 pg/mL
Standard Deviation 235.9
|
65.1 pg/mL
Standard Deviation 78.5
|
—
|
|
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
|
583.4 pg/mL
Standard Deviation 1569.9
|
43.9 pg/mL
Standard Deviation 91.3
|
—
|
|
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 42.0
|
485.8 pg/mL
Standard Deviation 971.9
|
37.1 pg/mL
Standard Deviation 30.8
|
—
|
|
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
|
51.4 pg/mL
Standard Deviation 73.2
|
4.2 pg/mL
Standard Deviation 2.3
|
—
|
|
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
|
46.5 pg/mL
Standard Deviation 58.1
|
4.3 pg/mL
Standard Deviation 1.9
|
—
|
|
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
|
1640.2 pg/mL
Standard Deviation 2051.6
|
256.4 pg/mL
Standard Deviation 413.1
|
—
|
|
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
|
2551.1 pg/mL
Standard Deviation 2936.2
|
1100.2 pg/mL
Standard Deviation 1974.1
|
—
|
|
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
|
3954.3 pg/mL
Standard Deviation 1617.0
|
209.6 pg/mL
Standard Deviation 75.7
|
—
|
|
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
|
156.2 pg/mL
Standard Deviation 233.2
|
54.6 pg/mL
Standard Deviation 87.7
|
—
|
Adverse Events
Depot Medroxyprogesterone Acetate (DMPA)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Etonogestrel Impant (Eng-Implant)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levonorgestrel Intrauterine Device (Lng-IUD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ParaGard® T 380A Intrauterine Copper Contraceptive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Depot Medroxyprogesterone Acetate (DMPA)
n=19 participants at risk
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
|
Etonogestrel Impant (Eng-Implant)
n=18 participants at risk
Participants receiving a standard nexplanon rod implant that was placed at study Week 3 by a trained clinician
|
Levonorgestrel Intrauterine Device (Lng-IUD)
n=14 participants at risk
Participants receiving a standard Mirena IUD that was placed at study Week 3 by a trained clinician
|
ParaGard® T 380A Intrauterine Copper Contraceptive
n=8 participants at risk
Participants receiving a standard ParaGuard IUD that was placed at study week 3 by a trained clinician
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Extended spotting 7 days before start of menstrual cycle
|
5.3%
1/19 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/18 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/14 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/8 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
|
Reproductive system and breast disorders
Extended menstrual bleeding with blood clots
|
0.00%
0/19 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/18 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
7.1%
1/14 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/8 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
|
Reproductive system and breast disorders
Heavy irregular menstrual bleeding
|
0.00%
0/19 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/18 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
0.00%
0/14 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
12.5%
1/8 • Information on adverse events was collected from the time of giving consent to participate through Study Visit 4 (Week 17).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place