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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMPA+ and TDF+ | Active Comparator | HIV-infected women on DMPA, and TDF containing ART. |
|
| DMPA+ and B/F/TAF+ | Experimental | HIV-infected women on DMPA, and B/F/TAF. |
|
| DMPA- and B/F/TAF+ | Experimental | HIV-infected women on non hormonal contraception, and B/F/TAF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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 | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
20 - 40 year old HIV-infected non pregnant women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Mbanza, MA | Contact | +256414541044 | jmbanza@mujhu.org | |
| Flavia Matovu Kiweewa, MBChB, MSc. | Contact | +256414541044 | fmatovu@mujhu.org |
| Name | Affiliation | Role |
|---|---|---|
| Flavia Kiweewa Matovu, MBChB, MSc | MU-JHU CARE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MU-JHU Care Limited | Recruiting | Kampala | +256 | Uganda |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| C562325 | dolutegravir |
| D019829 | Nevirapine |
| C050795 | N,N-dimethyl-4-anisidine |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008525 | Medroxyprogesterone |
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|
| TDF/3TC/EFV or DTG or NVP | Drug | A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART. |
|
| DMPA | Other | Two thirds of the women will be on DMPA for contraception. |
|
|
| D006908 |
| Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |