HIV/AIDS
Conditions
Interventions
Sponsors
Univesity of Washington
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Kenya
Contacts
Public ContactEdwin Were
Moi University
Outcome results
None listed