Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2017-11-17
2018-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Depo-Provera
Tenofovir Disoproxil Fumarate
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Depo-Provera
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Non-hormonal contraception
Tenofovir Disoproxil Fumarate
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Interventions
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Tenofovir Disoproxil Fumarate
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Depo-Provera
Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
Eligibility Criteria
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Inclusion Criteria
* HIV-positive
* Stable on antiretroviral regimen containing TDF for at least 2 weeks at time of enrollment.
* Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment.
* Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
* Willing and able to give signed informed consent.
Exclusion Criteria
* Currently breast feeding
* Symptomatic vaginal infection within 2 weeks prior to enrollment
* Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
* History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
* Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit
18 Years
35 Years
FEMALE
No
Sponsors
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MU-JHU CARE
OTHER
University of Minnesota
OTHER
Responsible Party
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Locations
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MU-JHU Care Ltd
Kampala, , Uganda
Countries
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References
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Nicol MR, Eneh P, Nakalega R, Kaiser T, Kabwigu S, Isingel E, Beksinska M, Sykes C, Fowler MG, Brown TT, Staley C, Kiweewa Matovu F. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis. Clin Infect Dis. 2020 Apr 10;70(8):1717-1724. doi: 10.1093/cid/ciz443.
Other Identifiers
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STUDY00000171
Identifier Type: -
Identifier Source: org_study_id
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