About The Study

CTNPT 046 aims to understand the fertility desires and intentions of youth living with HIV since childhood (YLHSC), as well as the impact of chronic HIV on fertility. Both of these have important implications for clinical care and policies around accessing assisted reproductive technologies.

Background

With advances in antiretroviral therapy (ART) over the years, YLHSC are reaching their reproductive years and may be thinking about starting a family. However, little is known about their fertility potential, desire, and intentions.

While markers of fertility, such as sperm motility and anti-Müllerian hormone levels (AMH; an indicator of the total number of eggs left in the ovaries), are reduced for people who acquired HIV in adulthood, they remain understudied in YLHSC. This is noteworthy because this group has undergone reproductive development following years of exposure to a chronic viral infection, inflammation, and different therapies, all of which have the potential to impact reproductive health. Furthermore, it is important to understand the fertility desires and intentions of YLSCS to understand the significance of any findings related to impaired fertility.

Study Approach

AIM 1

The CTNPT 046 team will enrol 100 YLHSC (50 females and 50 males) and 50 age-matched females not living with HIV. They will collect data on demographics, substance use, HIV control and complications (i.e., CD4 counts, viral suppression, and previous opportunistic infections), and ART history through self-reporting questionnaires and clinical records. They will also collect information on reproductive history, including previous pregnancies (females), fathering pregnancies (males), past infertility (inability to conceive after two years of unprotected sex), and past genital infections that increase risk of infertility. Where possible, blood samples and data will be collected from existing CTN study databases (CARMA, EPIC 4, and BCC3), for which many participants have already agreed to continuously participate in future research. If that’s not possible, data will be obtained through clinical review. In addition, the team will conduct blood and semen tests to measure specific fertility characteristics.

The information collected will be analyzed to measure markers of fertility potential and explore the relationships with HIV parameters (peak HIV viral load, years with suppressed HIV viral load [if available], and specific ART regimens).

AIM 2

The second aim of the CTNPT 046 involves the revision and validation of an existing survey of fertility desires and intentions among people living with HIV. The updated survey will be used to understand the specific desires and intentions of YLHSC. The survey has already been reviewed by a community co-investigator, a young male YLHSC, and five clinical experts, and has undergone validation by a focus group of YLHSC.

Eligibility Requirements

Inclusion Criteria

AIM 1 and 2

Males

  1. Cis-gender male
  2. Aged ≥19 years
  3. Able to communicate in English or have an interpreter available to them throughout the study
  4. HIV acquisition prior to age 10
  5. Able to understand and provide consent
  6. Able to provide study specimens

Females

  1. Cis-gender female
  2. Aged ≥16 years
  3. HIV acquisition prior to age 10
  4. Able to communicate in English or have an interpreter available to them throughout the study
  5. Able to understand and provide consent
  6. Aged-matched females not living with HIV and aged ≥16 years will also be recruited as controls through CTN 335: the BCC3 study
AIM 2

Transgender, males and females

  1. Female participants aged ≥16 years, male and transgender participants aged ≥19 years
  2. HIV acquisition prior to age 10
  3. Able to communicate in English or have an interpreter available to them throughout the study
  4. Able to understand and provide consent

Not Allowed

AIM 1 and 2

Males

  1. Known causes of infertility (i.e., varicocele, previous testicular surgery, or cancer)
  2. Self-reported genital tract infection in the past three months or urine positive for chlamydia or gonorrhoea (may participate >3 months after a genital tract infection)

Females

  1. Self-reported primary amenorrhea

Additional Information

If you would like to take part in this study or want more information, please contact Amber Campbell, Branka Vulesevic, or Logan Kennedy. Their contact details can be found below in the ‘Participating Sites’ section.

Principal Investigators

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Participating Sites

Here’s where this study is being conducted.