BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study
NCT ID: NCT03916328
Last Updated: 2023-04-07
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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UNKNOWN
PHASE4
330 participants
INTERVENTIONAL
2019-12-03
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DMPA+ and TDF+
HIV-infected women on DMPA, and TDF containing ART.
TDF/3TC/EFV or DTG or NVP
A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
DMPA
Two thirds of the women will be on DMPA for contraception.
DMPA+ and B/F/TAF+
HIV-infected women on DMPA, and B/F/TAF.
B/F/TAF
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
DMPA
Two thirds of the women will be on DMPA for contraception.
DMPA- and B/F/TAF+
HIV-infected women on non hormonal contraception, and B/F/TAF.
B/F/TAF
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
Interventions
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B/F/TAF
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
TDF/3TC/EFV or DTG or NVP
A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
DMPA
Two thirds of the women will be on DMPA for contraception.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide written informed consent to be screened for and to take part in the study.
* Able and willing to provide adequate locator information, as defined in site SOPs
* Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
* Per participant report, plans to stay in the study catchment area in the next 24 months
* Per participant report, willing to continue using similar contraceptive method as in the BONE: CARE study.
Exclusion Criteria
* Intentions to get pregnant in the next two years
* History of active tuberculosis
* Pathologic bone fracture not related to trauma (ever)
* Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
* Is taking the following medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs, etc.).
20 Years
40 Years
FEMALE
No
Sponsors
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MU-JHU CARE
OTHER
Responsible Party
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Flavia Kiweewa Matovu
Study Principal Investigator
Principal Investigators
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Flavia Kiweewa Matovu, MBChB, MSc
Role: PRINCIPAL_INVESTIGATOR
MU-JHU CARE
Locations
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MU-JHU Care Limited
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CO-EU-380-5327
Identifier Type: -
Identifier Source: org_study_id
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