Kuwa Free! - Live Free!
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202108805211718
- Lead Sponsor
- nivesity of Washington
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 700
Inclusion Criteria (PK study):
•Female sex,
•HIV-positive (for PK groups #1-4 and hybrid trial) or HIV-uninfected (for PK group #5 only),
•Age 15-24 years at the time of enrollment,
•Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening,
•Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,
•Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,
•Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period
•Able to consent or assent (with parental consent) for study participation in English or Kiswahili
Inclusion Criteria (Hybrid trial):
•Female sex,
•HIV-positive,
•Age 15-24 years at the time of enrollment,
•Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening,
•Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,
•Able to consent or assent (with parental consent) for study participation in English or Kiswahili
Exclusion Criteria (PK study):
•Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
•Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,
•Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
•Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,
•Current or planned concomitant use of other hormonal contraceptives,
•Be obese (BMI=30),
•Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
•Serum ALT>5x ULN at the time of screening,
•Serum creatinine >2.5x ULN at the time of screening.
Exclusion Criteria (Hybrid trial):
•Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
•Currently pregnant or intends to become pregnant or breastfeeding within the next one year,
•Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
•Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,
•Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
•Serum ALT>5x ULN at the time of screening,
•Serum creatinine >2.5x ULN at the time of screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method These geometric means will be compared to HIV-negative groups recruited in this study (for the DMPA comparator) or from the PARVI study (for the implants comparator), ;The proportion of participants with viral suppression ( via HIV viral load <40 copies/ mL) in the intervention vs. control arms
- Secondary Outcome Measures
Name Time Method Adherence and persistence to ART For secondary outcomes of adherence and persistence to ART over the preceding month prior to the VL evaluation and persistence/average MPR since study enrollment.<br>;Time to LA contraceptive uptake, or incident use, among participants who are not already using a LA contraceptive method at enrollment and wish to delay pregnancy.