Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566430
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
PrEP My Way A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PrEP My Way A Hybrid Type 1 Clinical Effectiveness-implementation Trial to Promote PrEP Persistence Among Young Kenyan Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation followed by peer-delivered kits for HIV self-testing PrEP refills vaginal swabs for gonorrhea and chlamydia self-sampling pregnancy tests and contraception refills if desired Based on Social Cognitive Theory the overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health
Preliminary testing of PrEP My Way in Kisumu Kenya found it to be highly feasible and acceptable but PrEP use as an oral medication was lower than expected Now that newer PrEP formulations are becoming available the team is adding choice of PrEP formulation ie oral tenofoviremtricitabine injectable cabotegravir-long acting CAB-LA or dapivirine ring as well as choice of adherence support from peers eg SMS short message service routine check-ins andor WhatsApp groups to the intervention The study team will then test the effectiveness of the augmented PrEP My Way intervention with and without testing for gonorrhea and chlamydia due to cost concerns on PrEP persistence in women with ongoing HIV prevention needs ie self-reported desire for PrEP self-reported HIV risk condomless sex andor multiple sexual partners The team will also track implementation service and client metrics per Proctors framework and determine cost-effectiveness of the intervention
Preliminary testing of PrEP My Way in Kisumu Kenya found it to be highly feasible and acceptable but PrEP use as an oral medication was lower than expected Now that newer PrEP formulations are becoming available the team is adding choice of PrEP formulation ie oral tenofoviremtricitabine injectable cabotegravir-long acting CAB-LA or dapivirine ring as well as choice of adherence support from peers eg SMS short message service routine check-ins andor WhatsApp groups to the intervention The study team will then test the effectiveness of the augmented PrEP My Way intervention with and without testing for gonorrhea and chlamydia due to cost concerns on PrEP persistence in women with ongoing HIV prevention needs ie self-reported desire for PrEP self-reported HIV risk condomless sex andor multiple sexual partners The team will also track implementation service and client metrics per Proctors framework and determine cost-effectiveness of the intervention
Detailed Description:
1 Augment PrEP My Way to include choice of PrEP formulation CAB-LA dapivirine ring or oral FTC TDF and adherence support With a Kenyan design firm the study team will conduct 28 individual interviews and 2 workshops with young women young men as sexual partners caregivers nurses and community health workers to adapt the kit product guides and delivery systems The study team will use a nurse-delivered model for injections per Kenya regulations and a peer-delivered model for ringsoral PrEP The Kenya National AIDSSTI Control Program will review the design to optimize potential uptake and sustainability in routine care
2 Conduct a type 1 effectiveness-implementation trial of PrEP My Way The study team will enroll 432 women age 16-24 in Kisumu Kenya and randomize them 111 to the full intervention vs the intervention without STI testing ie to assess marginal impact of the most costly kit component beyond PrEP vs enhanced standard of care Women in the intervention will choose bimonthly CAB-LA or quarterly ringoral delivery The primary outcome will be PrEP persistence by recorded injection CAB-LA or drug levels ringoral at 9 months in women with ongoing HIV prevention needs ie self-reported desire for PrEP self-reported HIV risk condomless sex andor multiple sexual partners Secondaryadditional outcomes will be persistence and adherence at other time points and with alternative definitions of HIV prevention needs STI sexually transmitted infection testing and family planning use Investigators will also track implementation service and client metrics per Proctors framework
3 Determine cost and cost-effectiveness of PrEP My Way Analysts will conduct micro-costing analyses through time and motion studies and use published cost data internal reports and supply-chain data to determine the cost of delivering each PrEP formulation and support option and the marginal cost of STI testing The team will also estimate the incremental cost-effectiveness ratio in terms of cost per woman with PrEP persistence
2 Conduct a type 1 effectiveness-implementation trial of PrEP My Way The study team will enroll 432 women age 16-24 in Kisumu Kenya and randomize them 111 to the full intervention vs the intervention without STI testing ie to assess marginal impact of the most costly kit component beyond PrEP vs enhanced standard of care Women in the intervention will choose bimonthly CAB-LA or quarterly ringoral delivery The primary outcome will be PrEP persistence by recorded injection CAB-LA or drug levels ringoral at 9 months in women with ongoing HIV prevention needs ie self-reported desire for PrEP self-reported HIV risk condomless sex andor multiple sexual partners Secondaryadditional outcomes will be persistence and adherence at other time points and with alternative definitions of HIV prevention needs STI sexually transmitted infection testing and family planning use Investigators will also track implementation service and client metrics per Proctors framework
3 Determine cost and cost-effectiveness of PrEP My Way Analysts will conduct micro-costing analyses through time and motion studies and use published cost data internal reports and supply-chain data to determine the cost of delivering each PrEP formulation and support option and the marginal cost of STI testing The team will also estimate the incremental cost-effectiveness ratio in terms of cost per woman with PrEP persistence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None