HIV/AIDS
Conditions
Interventions
7 DOT doses per week
2 DOT doses per week
4 DOT doses per week
7 DOT doses per week pregnant
Sponsors
University of Washington
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria for the pregnant cohort -Age =18 and =30 years -HIV uninfected -Has an active smart phone -Normal renal function (GFR >60ml/min) -Hepatitis B surface Ag negative -High risk for HIV -Pregnant at 13-26 weeks of gestation -Willing to use DOT and come to clinic daily for DOT PrEP for 8 weeks -Willing to have home visits/video streaming if clinic visit not feasible Inclusion criteria for the non- pregnant cohort -Age =18 and =30 years -HIV uninfected -Has an active smart phone -Normal renal function (GFR >60ml/min) -Hepatitis B surface Ag negative -Low risk for HIV -Not pregnant or breastfeeding -Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP -Willing to have home visits/video streaming if clinic visit not feasible
Exclusion criteria
Exclusion criteria: Exclusion criteria for pregnant women -Inability to give informed consent -HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician -Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively. -Current or past use of PrEP (pre-exposure prophylaxis) -Not willing to have home visit -Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias -Fetus has a known or suspected major congenital anomaly defined by fetal ultrasound. Exclusion criteria for non-pregnant women -Inability to give informed consent -HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician -Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively. -Current or past use of PrEP (pre-exposure prophylaxis) -pregnancy/plan to become pregnant in the next 6 months/unwillingness to use birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Benchmark concentrations of TFV-DP in DBS and PBMCs, and the dosing frequency (i.e., doses per week) required to generate them. The goal is to quantify the effects of dose on steady state TFV-DP in DBS and PBMC based on an incomplete block design. We will use the observed week 8 concentrations for the dose-proportionality model. Week 8 is approximately 90% of steady state (3.3 * 17-day half-life = 8 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Examine models to predict non-daily adherence based on TFV/FTC and TFV-DP in DBS. We will first consider a saturated model allowing a separate mean for each dose/adherence group. The results will then be compared to a reduced model with a class variable indicating non-daily dosing groups” or 100% dosing (that is, the effect of “non-daily dosing” adherence does not differ by dose groups). | — |
Countries
Kenya
Contacts
Public ContactNina Ouko
study lead clinician
Outcome results
None listed