The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
330
MU-JHU Care Limited
Kampala, Uganda
RECRUITINGChanges in bone mineral density
We will assess percent change in BMD among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Time frame: 2 years
Changes in trabeculae bone score (TBS)
We will assess percent change in TBS among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Time frame: 2 years
Changes in bone biomarkers
We will compare changes in bone turnover markers (CTX and P1NP) in B/F/TAF switchers with and without DMPA use
Time frame: 2 years
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