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NCT02357368 · ClinicalTrials.gov registry record · Phase 4
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
A Phase 4 study of HIV and Contraception, sponsored by Lisa Haddad.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
- 4
- Study locations
NCT02357368: Completed Phase 4 study of HIV and Contraception, sponsored by Lisa Haddad.
NCT02357368 is a Phase 4 study of HIV and Contraception that has completed, run by Lisa Haddad. The registered enrollment target is 59 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02357368, a Phase 4 study of HIV and Contraception, has completed, sponsored by Lisa Haddad.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Depot medroxyprogesterone acetate (DMPA)
- DEVICE Etonogestrel implant (Eng-Implant)
- DEVICE Levonorgestrel intrauterine device (Lng-IUD)
- DEVICE ParaGard® T 380A Intrauterine Copper Contraceptive
Study Locations (4)
Georgia
- Grady Health System - Atlanta
- The Ponce de Leon Center of the Grady Health System - Atlanta
- Emory Clinic - Atlanta
- Emory University Clinical Research Network - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 4 |
What the finished NCT02357368 record still lists
NCT02357368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 4 interventions - of which Depot medroxyprogesterone acetate (DMPA) is the first listed.
NCT02357368 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02357368 about?
NCT02357368 is a clinical study titled "Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk". 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 ...
What is the current status of trial NCT02357368?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2015-02. Estimated completion is 2019-10-23.
What conditions does trial NCT02357368 study?
This clinical trial studies the following conditions: HIV, Contraception.
What interventions are being tested in trial NCT02357368?
The interventions under investigation include: Depot medroxyprogesterone acetate (DMPA) (DRUG), Etonogestrel implant (Eng-Implant) (DEVICE), Levonorgestrel intrauterine device (Lng-IUD) (DEVICE), ParaGard® T 380A Intrauterine Copper Contraceptive (DEVICE).
Who is sponsoring clinical trial NCT02357368?
This trial is sponsored by Lisa Haddad, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02357368 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02357368's enrollment target sits among peer trials
59 205th of 303 higher than 99 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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