Kuwa Free! - Live Free!
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
University of Alabama at Birmingham
700 participants
Nov 26, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria20
- 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
Exclusion Criteria16
- 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,
- 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.
- 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 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.
Interventions
For initial injection participants will be given CABENUVA 600-mg/900-mg Kit: (single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir , single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirin). For subsequent injections participants will be given CABENUVA 400-mg/600-mg Kit: (single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir, single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine) CABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709
Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm
DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide
Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05044962