Bone Health in Older Ugandan Women with and without HIV

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Project Summary/Abstract The Johns Hopkins University-Uganda Clinical Trial Unit (JHU-CTU) has been at the forefront of clinical trial research as part of the DAIDS funded HIV network studies with a goal of developing effective and safe interventions for both HIV prevention and treatment in resource limited settings. For this cycle (2020-2027), the JHU-CTU with its two Ugandan research sites, aims to evaluate new antiretroviral treatment and prevention regimens, novel delivery systems and/or novel immune-based therapy for prevention among at risk women and adolescents; and for treatment of HIV-infected pregnant women, adolescents and children. The CTU aims also address prevention and treatment of HIV coinfections including TB and HBV; and studies of vaccines for emerging infections. As a further aim, the JHU-CTU continues its commitment to mentor and develop international investigators to become leaders in conducting HIV research. This administrative supplement falls within the JHU Uganda CTU aim addressing the safety, (short and long term) of ARVs used for both HIV prevention and treatment in resource-limited settings such as Uganda. As ARVs may have different safety profiles in differing racial/ethnic groups, it is important to use appropriate normal values to assess ARV safety across diverse populations; and if there are differences in safety profile by sex, age and race/ethnicity. Tenofovir-based ART (TDF-AFT) for example is known to be associated with decreased bone mineral density (BMD) during the first year of treatment. However, little is known on later effects of lifetime TDF-ART in international populations including among post-menopausal women and if they are at increased risk for osteoporosis and bone fracture compared to older HIV negative women. And BMD “normal values” for older HIV negative African women are not available. Thus, for this administrative supplement, the JHU CTU MU-JHU clinical research site (CRS) aims to assess and compare (BMD) and body composition among older women with HIV on lifetime ART, to BMD results among HIV negative Ugandan women of similar age. MU-JHU will recruit 236 women (both HIV infected and HIV negative) age 40-60+ years from the AFRICOS cohort in Kayunga, Uganda to perform DXA imaging scans and bone health lab studies. Data from this cross-sectional analysis will be used to: (1) compare BMD in Ugandan women living with HIV and HIV-uninfected women, (2) examine body composition (i.e., visceral adiposity and BMI) in these two groups, and (3) analyze the distribution of BMD for comparison to standard population-based cohorts. This study will collect valuable normative data on BMD and safety data on fracture risk among older women of African origin, including those living in the U.S.