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POWER STUDY

Evaluation of open-label Pre exposure prophylaxis (PrEP) delivery amongKenyan women

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202003507062297
Enrollment
1000
Registered
2020-03-19
Start date
2018-06-08
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

ANC clinic
Family planning clinics
Standard PrEP as per the guideline

Sponsors

University of Washington
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: For HIV uninfected women - Age 16-25 o 16 and 17 year olds, where permissible by national regulations and local IRB approval - Able and willing to provide written informed consent - Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months) - HIV uninfected based on negative HIV rapid tests, on the date of enrollment

Exclusion criteria

Exclusion criteria: Not within the required age range Not willing to provide informed consent Not sexually active HIV infected

Design outcomes

Primary

MeasureTime frame
The primary goal of this project is to demonstrate feasibility of delivery of open-label PrEP to young women using three different delivery platforms. Thus, the principal justification for the sample size is inclusion of a sufficient number of HIV negative young women to indicate implementation feasibility, in a way that would inform normative guidance and public health recommendations. Importantly, in this way, the justification for the sample size is different than that of a comparative study (e.g., a randomized, placebo-controlled trial) ;Determine the persistence and patterns of PrEP use as they relate to contraceptive use, pregnancy and sexual exposure, and timing and reasons for PrEP discontinuation;Demonstrate PrEP delivery models for young women in family planning setting in Kisumu; HIV incidence in relationship to PrEP use, and HIV drug resistance among seroconverters on PrEP

Secondary

MeasureTime frame
Cost, and cost-effectiveness of PrEP when delivered in public health clinics.

Countries

Kenya

Contacts

Public ContactPeter Mwangi Mugo

Pharmacist

pmugo@kemri-wellcome.org0730162000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026