Kuwa Free! - Live Free!

A vizsgálat adatai

Ki végzi

University of Alabama at Birmingham

Azonosító

NCT05044962

A regiszteradat frissítve

2026. április 13.

Eredeti leírás

The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.A teljes eredeti leírásKevesebb

Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives

The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.

Bevonási feltételek: Female sex,; HIV-positive (for PK groups #1-4) 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 enrollment,; 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; Participating in PK study for study participants,; Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,; Able to consent for study participation in English or Kiswahili; 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 enrollment,; 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; Participating in hybrid trial study for study participants,; Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,; Able to consent for study participation in English or Kiswahili.

Kizáró feltételek: Already be on ART that concurrently contains combinations of non-nucleoside 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,; 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,; Already be on ART that concurrently contains combinations of non-nucleoside 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; 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); 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; Serum ALT>5x ULN at the time of screening,; Serum creatinine >2.5x ULN at the time of screening; Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,; Be obese (BMI≥30),; 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,.

ClinicalTrials.gov NCT05044962