Kuwa Free! - Live Free!

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Sep 10, 2021

Keywords

ClinConnect Summary

The "Kuwa Free! - Live Free!" clinical trial is investigating new treatment options for young women aged 15 to 24 who are living with HIV and are already on medication that helps control the virus. The study aims to see how well a long-acting injectable medication works compared to the standard treatment. Researchers will gather information on how the body processes these medications and any potential challenges related to using them together. By learning from this trial, they hope to improve how these treatments are given to young women in Kenya.

To participate, you need to be a female between 15 and 24 years old, have confirmed that your HIV is well-controlled (meaning the virus is very low in your blood), and be willing to provide blood samples every few weeks. You should also be planning to use a specific type of birth control for the duration of the study. If you meet these criteria, you might be able to help in this important research while receiving care and support from the study team.

Gender

FEMALE

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