NCT05044962Toboroz
Kuwa Free! - Live Free!
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 700 (tervezett)
- Első benyújtás
- 2021. aug. 26.
- Kezdés
- 2021. nov. 26.
- Elsődleges befejezés
- 2027. márc. 31.
- Fő szponzor
- University of Alabama at Birmingham
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT05044962
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 700
- 2021. nov. 26. és az elsődleges befejezés (2027. márc. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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,
- 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,
- 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
- Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,
Más betegség
- 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).
- 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).
Laborértékek
- Serum ALT\>5x ULN at the time of screening,
- Serum creatinine \>2.5x ULN at the time of screening.
- Serum ALT\>5x ULN at the time of screening,
- Serum creatinine \>2.5x ULN at the time of screening.
Egyéb
- Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- Be obese (BMI≥30),
- 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,
Kiket keres a vizsgálat
- 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
- 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
- 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
- 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
Életkor a regiszterben: 15 év – 24 év · Nem: csak nők · Egészséges önkénteseket is fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH) Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Eldoret | Kenya | Toboroz |
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