[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442713":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":66,"centralContacts":76,"locations":82,"responsibleParty":99,"collaborators":102,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":49,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":49,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":85,"whyStopped":49,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,15,20,25,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 1a (PK study group 1)","EXPERIMENTAL","Initiating injectable cabotegravir\u002Frilpivirine (LA ART) and DMPA",[13,14],"Drug: Cabotegravir\u002F Rilpivirine","Drug: Intramuscular depo-medroxyprogesterone acetate (IM DMPA)",{"label":16,"type":10,"description":17,"interventionNames":18},"Aim 1a (PK study group 2)","Initiating injectable cabotegravir\u002Frilpivirine (LA ART) and and etonogestrel implant",[13,19],"Drug: Etonogestrel (ETG) implant",{"label":21,"type":10,"description":22,"interventionNames":23},"Aim 1a (PK study group 3)","Initiating injectable cabotegravir\u002Frilpivirine (LA ART) and levonorgestrel implant.",[13,24],"Drug: Levonorgestrel",{"label":26,"type":27,"description":28,"interventionNames":29},"Aim 1a (PK study group 4)","ACTIVE_COMPARATOR","Receiving injectable cabotegravir\u002F rilpivirine (LA ART) and not using any hormonal contraceptive method (e.g. copper IUD)",[13],{"label":31,"type":27,"description":32,"interventionNames":33},"Aim 1a (PK study group 5)","AGYW without HIV and not exposed to antiretrovirals (e.g., for PrEP) initiating DMPA",[14],{"label":35,"type":10,"description":36,"interventionNames":37},"Aim 2a (Hybrid trial intervention group)","AGYW with viral suppression on their current ART regimen to switch to cabotegravir\u002F rilpivirine.",[13],{"label":39,"type":27,"description":40,"interventionNames":41},"Aim 2a (Hybrid trial comparator group)","AGYW with viral suppression to continue their oral ART regimen.",[42],"Drug: NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens",[44,50,54,58,62],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Cabotegravir\u002F Rilpivirine","For initial injection participants will be given CABENUVA 600-mg\u002F900-mg Kit: (single-dose vial of 600 mg\u002F3 mL (200 mg\u002FmL) cabotegravir , single-dose vial of 900 mg\u002F3 mL (300 mg\u002FmL) rilpivirin).\n\nFor subsequent injections participants will be given CABENUVA 400-mg\u002F600-mg Kit: (single-dose vial of 400 mg\u002F2 mL (200 mg\u002FmL) cabotegravir, single-dose vial of 600 mg\u002F2 mL (300 mg\u002FmL) rilpivirine)\n\nCABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709",[9,16,21,26,35],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Etonogestrel (ETG) implant","Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm",[16],{"type":45,"name":55,"description":56,"armGroupLabels":57,"otherNames":49},"Intramuscular depo-medroxyprogesterone acetate (IM DMPA)","DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)\u002Fml IMI) is the most commonly used injectable contraceptive worldwide",[9,31],{"type":45,"name":59,"description":60,"armGroupLabels":61,"otherNames":49},"Levonorgestrel","Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm",[21],{"type":45,"name":63,"description":64,"armGroupLabels":65,"otherNames":49},"NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens","ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir",[39],[67,70,73],{"name":68,"affiliation":5,"role":69},"Rena Patel, MD, MPH, MPhil","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":72,"role":69},"Edwin Were","Moi Teaching and Referral Hospital",{"name":74,"affiliation":75,"role":69},"Edith Apondi","MTRH Adolescent Rafiki Clinic and Pediatric Program at AMPATH",[77],{"name":78,"role":79,"phone":80,"phoneExt":49,"email":81},"Rena Patel, MD, MPH","CONTACT","205.934.8145","renapatel@uabmc.edu",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":49,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Academic Model Providing Access to Healthcare (AMPATH) Moi Teaching And Referral Hospital (MTRH)","RECRUITING","Eldoret","Kenya","KE",{"type":90,"coordinates":91},"Point",[92,93],35.26993,0.52036,{"lat":93,"lon":92},[96],{"name":97,"role":79,"phone":49,"phoneExt":49,"email":98},"Eunice Kaguiri","pipscoordinatoreldoret@gmail.com",{"type":69,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Rena Patel","Principal Investigator",[103,104,106,108],{"name":72,"class":6},{"name":105,"class":6},"Indiana University",{"name":107,"class":6},"University of Nebraska",{"name":109,"class":110},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100442713","kuwa-free---live-free-100442713",false,"NCT05044962","Kuwa Free! - Live Free!","Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives","Inclusion Criteria (PK study):\n\n* Female sex,\n* HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,\n* Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (PK study):\n\n* 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\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,\n* Current or planned concomitant use of other hormonal contraceptives,\n* Be obese (BMI≥30),\n* 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\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 1b (qualitative PK study):\n\n* Participating in PK study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili\n\nInclusion Criteria (Hybrid trial):\n\n* Female sex,\n* HIV-positive,\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (Hybrid trial):\n\n* 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\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next one year,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,\n* 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\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 2b (qualitative study):\n\n* Participating in hybrid trial study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili",true,"FEMALE","15 Years","24 Years",{"count":123,"type":124},700,"ESTIMATED","INTERVENTIONAL",[127],"NA","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\u002Frilpivirine 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.",[130,131,132],"HIV Infections","Contraception","Drug-drug Interaction",[87,134,135,136,137,138],"Adolescent girls and young women","HIV adherence","Long-acting antiretroviral therapy","Injectable cabotegravir","Injectable rilpivirine","2026-04-08",{"date":141,"type":142},"2026-04-13","ACTUAL",{"date":144,"type":142},"2021-11-26",{"date":146,"type":124},"2027-03-31",{"name":5,"class":6},1]