The Kampala Women's Bone Study

• Register: ClinicalTrials.gov
• Last refreshed on: 20 March 2023
• Main ID: NCT03464266
• Date of registration: 25/02/2018
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: The Kampala Women's Bone Study
• Scientific title: Impact of Concurrent Initiation of DMPA Contraception and Tenofovir PrEP on Bone Loss in Young Women
• Date of first enrolment: May 15, 2018
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03464266
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Factorial Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Uganda

Contacts

• Name: Renee Heffron, PhD, MPH
• Affiliation: University of Washington

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 25 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Bone Microarchitecture

Bone Demineralization

Hypoestrogenism

Subclinical Kidney Injury

Intervention(s)

Other: Neither DMPA nor FTC/TDF

Combination Product: FTC/TDF and DMPA

Drug: FTC/TDF

Drug: DMPA

Primary Outcome(s)

The investigators will assess whether young women using TDF-based PrEP and DMPA concurrently attain lower peak bone mass over a 24-month relative to women using either agent singly or neither agent. [Time Frame: 24 months]

The investigators will assess whether young women using TDF-based PrEP and DMPA concurrently have evidence of disrupted microarchitecture, relative to women using either agent singly or neither agent. [Time Frame: 24 months]

Secondary Outcome(s)

The investigators will investigate whether young women concurrently using TDF-based PrEP and DMPA experience higher rates of bone turnover. [Time Frame: Change from Baseline at 24 months]

The investigators will investigate whether young women concurrently using TDF-based PrEP and DMPA experience higher rates of subclinical kidney injury. [Time Frame: Change from Baseline at 24 months]

The investigators will investigate whether young women concurrently using TDF-based PrEP and DMPA experience higher rates of hypoestrogenism. [Time Frame: Change from Baseline at 24 months]

Using mediation analysis, the investigators will identify the degree to which the pathways through subclinical kidney injury and hypoestrogenism account for changes in bone density among women concurrently using TDF-based PrEP and DMPA [Time Frame: 24 months]

Secondary ID(s)

STUDY00001451

R01HD089843

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Columbia University

Icahn School of Medicine at Mount Sinai

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Makerere University

MU-JHU CARE