Kuwa Free! - Live Free!
Recruiting · NCT05044962 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
Cabotegravir/ RilpivirineEtonogestrel (ETG) implantIntramuscular depo-medroxyprogesterone acetate (IM DMPA)LevonorgestrelNNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens
What this trial is about
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.
Who can take part
Age range
15 Years to 24 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH) - Eldoret, Kenya, Kenya