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Clinical Trials/PACTR202206540830197
PACTR202206540830197
Other
Phase 3

PrEP My Way”: A Novel PrEP Delivery System to Meet the Needs of Young African Women

Massachusetts General Hospital Harvard Medical School0 sites100 target enrollmentMay 30, 2022

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Massachusetts General Hospital Harvard Medical School
Enrollment
100
Status
Other
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Massachusetts General Hospital Harvard Medical School

Eligibility Criteria

Inclusion Criteria

  • oYoung woman (age 16\-24 years); we will enroll emancipated minors (e.g., those who have been pregnant) per Kenyan national guidelines \[39] or 16\-17 year\-olds with parental consent
  • oInitiating PrEP (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV\-negative status, normal renal function, and lack of Hepatitis B infection)
  • oResidence in the Kisumu region (maximum of 20 km from our study offices at RCTP)
  • oPhone ownership
  • oAbility to understand KiSwahili, DhoLuo, and/or English

Exclusion Criteria

  • Inability to provide informed consent (e.g., intoxication, mental disability)

Outcomes

Primary Outcomes

Not specified

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