The Kampala Women's Bone Study

• Status: Active, not recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: Female

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 bone acquisition and altered bone metabolism. Bone mineral metabolism is in part regulated by the kidney, and we hypothesize that bone effects from concurrent PrEP and DMPA use will be driven by subclinical kidney injury, a known side effect of TDF, as well as DMPA-induced hypoestrogenism. To investigate our hypothesis, we will enroll a prospective cohort of approximately 500 HIV-uninfected women ages 16-25 years in Kampala, Uganda who have substantial HIV risk and are initiating DMPA or barrier method contraception. Over a 24-month period, we will offer TDF-based PrEP. We will use state-of-the-art radiologic, biochemical, and epidemiologic methods to test the hypothesis that concurrent TDF-based PrEP and DMPA use results in compounding adverse effects on bone health.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: Columbia University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Icahn School of Medicine at Mount Sinai; Makerere University; Makerere University-Johns Hopkins University Research Collaboration; MU-JHU CARE
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.