top of page

Charter PLUS

 

 

 

 

 

 

 

 

 

 

 

 

 

We are conducting the study to learn more about the physical and mental effects of infection with human immunodeficiency virus (HIV), aging, substance use and the possible effects of antiretroviral medications (ARVs). Participation in the study may or may not benefit you directly, but may result in new knowledge that may help others.

We plan to screen 600 individuals for this study, with the expectation that we will assess 500 participants.

 

                    

Inclusion criteria will be:

  1. Aged 18 years and older

  2. Possess the capacity to provide informed consent to assessment procedures. Individuals unable to provide consent will not be enrolled.

  3. Fall into one of these subgroups:

    1. Subgroup 1: Completion of a 12-year follow-up visit in the recently completed CHARTER Aging study.  Those who previously completed the LP or neuroimaging assessments will be prioritized.

    2. Subgroup 2: Diagnosed with HIV within the past 10 years and on suppressive ART.

    3. Subgroup 3: HIV negative participants. Absence of HIV will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant’s self-report, a confirmatory test (HIV RNA, antigen/antibody test, HIV RNA) will be performed. Participants must have at least one of the following:

      1. high risk sexual or drug use (NIDA priorities) activity141,

      2. use of pre-exposure prophylaxis (PrEP),

      3. history of a sexually transmitted infection (e.g., syphilis).

    4. Subgroup 4: Aged 50 years or older who have a family history of dementia, including Alzheimer’s Disease (AD) and AD-related disorders (ADRD).

 

Exclusion criteria:

  1. Severe dementia or disability that would not allow the participant to provide informed consent or complete the project’s assessments.

  2. Factors that would prevent participants from qualifying for one of the four subgroups.

    1. Demographics and risk behavior: Participants who fall into an age, education, sex, ethnicity, or HIV risk category (including substance use) that would cause their group (2, 3, or 4) to not match Subgroup 1.

    2. HIV disease: For Subgroup 2, HIV diagnosis greater than 10 years prior to enrollment, not taking ART, or not suppressed in plasma.

    3. Family History: For Subgroup 4, a lack of family history of dementia, including AD or AD-related disorders.

                    

Since neuroimaging and LP will be optional and MRI is only on a subset of participants, we will allow participation by participants who have a contraindication to one of these procedures, such as a coagulopathy for LP or metal implant for MRI. When a contraindication is present, participants will not be offered participation in these procedures. Regarding ensuring demographic and risk behavior comparability between subgroups, we discussed the best approach for accomplishing this at length and considered individual- and group-matching approaches. The most implementable approach across six, geographically distant sites is to track these characteristics at the CHARTER Plus CU as we enroll the cohort and, as the sample size grows, coordinate targeting of new participants with specific characteristics that will keep the groups balanced.

bottom of page