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Kuwa Free! - Live Free!

RecruitingNA

Sponsor: University of Alabama at Birmingham

Conditions: HIV Infections, Contraception, Drug-drug Interaction

Interventions: Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA), Levonorgestrel, NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens

Countries: Kenya

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 overview

Sex: FEMALE

Age: 15 Years to 24 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Eldoret, Kenya, Kenya