Kuwa Free! - Live Free!

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: Indiana University; Moi Teaching and Referral Hospital; National Institute of Allergy and Infectious Diseases (NIAID); University of Nebraska
• Treatments: Cabotegravir; Etonogestrel; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate; Rilpivirine

Criteria

Inclusion Criteria (PK study):

• 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

Exclusion Criteria (PK study):

• 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.

Inclusion Criteria Aim 1b (qualitative PK study):

• 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

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 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

Exclusion Criteria (Hybrid trial):

• 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.

Inclusion Criteria Aim 2b (qualitative study):

• 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