search cab la dynamic choice hiv prevention study extension

Conditions: HIV

Summary: the overall purpose of this search cab-la (cabotegravir injectable suspension) randomized extension study is to determine if adding the option of cab-la as a prevention choice using a person-centered dynamic choice hiv (human immunodeficiency virus) prevention model, with option to switch products over time, compared to the standard of care: 1) increases prevention coverage; 2) reduces hiv incident infection; and 3) increases prevention coverage during periods of self-assessed risk of hiv infection, in three settings in rural uganda and kenya. in addition, this study will describe implementation of a person-centered model for dynamic choice hiv prevention including cab-la, using the re-aim (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework among persons randomized to the intervention arm.

the search cab-la (cabotegravir injectable suspension) dynamic choice hiv prevention study is a randomized extension study of a person-centered dynamic choice hiv prevention model for delivering existing evidence-based biomedical prevention interventions vs. standard of care (soc). the study is conducted in 3 settings in rural western uganda and kenya: antenatal (anc) clinics, the outpatient department (primary care clinics), and in community settings. participants previously randomized to dynamic choice hiv prevention or soc are re-consented and remain in their initial randomized arm. during the extension, the dynamic choice hiv prevention intervention offers participants choices of biomedical prevention product (oral pre-exposure prophylaxis (prep), oral post-exposure prophylaxis (pep), or cabotegravir injectable suspension (cab-la) on an ongoing basis with the option to switch products over time based on participant preference and perceived risk. the primary endpoint is proportion of time that is covered by a biomedical prevention product over 48 weeks; secondary endpoints are: i) incident hiv infection over 48 weeks; and, ii) proportion of time during which a participant reports risk of hiv infection that is covered by a biomedical prevention product over 48 weeks. participants in the intervention arm only are reconsented at 48 weeks for implementation evaluation up to 96 weeks.

Eligibility criteria:
inclusion criteria: inclusion criteria for the extension include: 1. enrollment in a search sapphire dynamic prevention study (nct04810650) 2. hiv negative at start of extension 3. residing in study region additional inclusion criteria to access cab-la as a prevention option 1. not pregnant or breastfeeding at time of initial cab-la injection 2. participant weighs at least 35kg exclusion criteria: exclusion criteria to access cab-la as a prevention option: 1. participant has hepatitis b or chronic hepatitis c diagnosis 2. participant has alt \>=5x uln 3. participant has clinical history of liver cirrhosis or current clinical evidence of cirrhosis 4. previous hypersensitivity reaction to cabotegravir 5. receiving the following co-administered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase: i. anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin ii. antimycobacterials: rifampin, rifapentine 6. participants with a current or anticipated need for chronic systemic anticoagulation or a history of known or suspected bleeding disorder, including a history of prolonged bleeding, except for the use of anticoagulation for deep vein thrombosis (dvt) prophylaxis (e.g., postoperative dvt prophylaxis) or the use of low dose acetylsalicylic acid (≤325 mg).

Keywords: cabotegravir injectable suspension prep hiv treatment and prevention community health