Status:
COMPLETED
The Kampala Women's Bone Study
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Conditions:
Bone Demineralization
Hypoestrogenism
Eligibility:
FEMALE
16-25 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to address critical safety questions with concurrent TDF-based PrEP and DMPA use. We hypothesize that young women using TDF-based PrEP and DMPA will have lower b...
Detailed Description
The proposed research will investigate the hypothesis that TDF-based PrEP and DMPA initiated concurrently by HIV-uninfected women will enhance each other's effects on bone metabolism. The investigator...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 16-25
- If age 16-17:
- qualification as an emancipated minor (due to past pregnancy, being married, having a child, or catering for their own livelihood) or a mature minor (due to having a sexually transmitted infection) or able to have a parent/guardian provide informed consent
- HIV-uninfected
- Initiated DMPA within the past 90 days or using condoms only for contraception
- Willing and able to provide written informed consent
- Not planning to get pregnant in the next 24 months
- Sexually active
- Planning to remain in the study area for the next 2 years
Exclusion
- Exclusion criteria:
- Currently enrolled in a biomedical HIV-1 prevention study
- Current or prior use of PrEP consecutively in the last 3 months
- Abnormal renal function (creatinine clearance \<60 min/ml)
- Hepatitis B infection
- Currently pregnant or breastfeeding
- Current DMPA use for longer than 90 days
- Use of implant, IUD, or oral contraceptives
- Past hysterectomy, oophorectomy, or tubal ligation
- Current or recent history of primary or secondary amenorrhea
- Taking medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs).
- Has any other condition that would preclude the ability to provide informed consent, make study participation unsafe, complicate the interpretation of study findings or otherwise interfere with achievement of the study objectives, in the investigator's discretion.
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03464266
Start Date
May 15 2018
End Date
December 21 2023
Last Update
June 17 2024
Active Locations (1)
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1
Infectious Disease Institute
Kampala, Uganda