CTN 277: CARMA endo study

About The Study

The purpose of this observational study is to assess the prevalence of various endocrine, metabolic and reproductive abnormalities in HIV-positive and HIV-negative women and female youth in the CARMA-2 (also referred to by the team as ‘CORE’) cohort, and to determine possible links between abnormalities and accelerated cellular aging in women/girls (associated with markers of aging such as shorter LTL [telomere length] and/or mtDNA alterations).

The larger CARMA cohort study started in 2008 and will continue until 2018. It involves more than one thousand participants, including HIV-positive women (both pregnant and not), their children (both HIV-positive and HIV-exposed uninfected), as well as a control group of HIV-negative women who share socio-demographic characteristics. The researchers are seeking to determine whether women and female youth living with HIV have an increased risk of hormonal, metabolic and reproductive abnormality, and whether this correlates to aging at the cellular level.

About The Disease

There is mounting evidence of endocrine, metabolic and reproductive abnormalities (endocrinopathy) in HIV-positive individuals. These abnormalities increase with age, and links between several of these abnormalities and telomeres (TL) have been suggested. In addition, antiretroviral therapy (ART), which is commonly used to treat HIV, can affect molecular and cellular aging through a variety of mechanisms.

While there is a lack of gender-specific data on the impact of HIV and ART on women and female youth, a review published in June 2012 highlights the importance of studying HIV-positive women and their response to ART given their delayed entry to care, higher rates of adverse effects and therapy discontinuation, and poorer outcomes including comorbidities.

Study Approach

Women and female youth (at least 12 years of age) already enrolled in the CARMA cohort, as well as new participants (both HIV-positive and HIV-negative), will be asked to participate in the study. After informed consent has been obtained, standard CARMA data collection will occur. Participants will fill out a questionnaire pertaining to personal and family history of endocrine/metabolic or reproductive dysfunction, as well as medications, procedures or diseases affecting the normal functioning of any of these. Detailed questions regarding menstrual cycles and reproductive histories will also be included. Saliva will be collected by participants in order to assess late-evening and early-morning salivary cortisol levels. A maximum of twenty ml of blood will be collected as per usual CARMA research sample procedures.