BridgeMD
New treatment option for HIV Infections
Official title Kuwa Free! - Live Free!
ClinicalTrials.gov ID: NCT05044962
What this study is testing
What is Cabotegravir/ Rilpivirine?
Cabotegravir/ Rilpivirine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 24, women only. Healthy volunteers may be eligible.
You may be able to join if
- (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,
You likely can't join if
- (PK study):
- Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and...
- 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,
See the full eligibility 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
- (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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Eldoret, Kenya, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 24 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eldoret, Kenya, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.