Following Longitudinal Outcomes To Understand, Report, Intervene And Sustain Health Of Infants, Children And Adolescents Who Are HIV-Exposed Uninfected (FLOURISH) Cohort Study

Overview

About this study

The purpose of this study is to evaluate short- and long-term health and development differences in outcomes and identify possible biological, social and structural mechanisms for differences between infants, children and adolescents who remain HIV-uninfected following in utero exposure to HIV, and where applicable, maternal antiretroviral (ARV) drugs, as well as ARV drugs as prophylaxis after birth compared to infants, children and adolescents born to women without HIV.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Caregiver:

  • Citizen of Botswana.
  • Legal guardian of child to be enrolled.
  • ≥ 18 years old.
  • Able to provide informed consent.
  • Must consent to allow HIV testing and counseling of child.
  • Must consent to allow female children ≥ 12 years old to undergo pregnancy testing.
  • Women recruited in pregnancy must be willing to undergo HIV testing and counseling if not known to be living with HIV.
  • Pregnant women must be 22-28 weeks gestation with a singleton pregnancy.
  • Women recruited in pregnancy must have the intent to breastfeed their infant.
  • For newly recruited adolescents1 for Aim 4, biological mother must be alive and willing to undergo HIV-testing and test negative for HIV.

Inclusion Criteria - Children/Adolescents:

  • < 18 years old
  • For CHEU ≥ 16 years, disclosure of maternal HIV status
  • Provision of assent if age and developmentally appropriate
  • Children ≥ 13 years old; willingness to consent to continued study participation if they reach 18 years of age while on study.
  • For children and adolescents providing written informed assent for study enrollment:
    • Must assent to HIV testing & counseling;
    • Must assent to pregnancy testing if female and ≥ 12 years old.

Exclusion Criteria - Caregiver:

  • Incarceration during any period of study, including at enrollment.
  • Non-pregnant biological mothers of a prospectively recruited adolescents testing positive for HIV during screening for study eligibility.
  • Women enrolled in pregnancy who do not experience a liveborn delivery.
  • Women enrolled in pregnancy who are lost to follow-up before delivery.

Exclusion Criteria - Children/Adolescents:

  • Child may not be HIV positive at time of enrollment.
  • Female adolescent cannot be pregnant at time of enrollment.
  • Incarceration during period of study.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Adam Cassidy, Ph.D., L.P.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

More information

Publications

Publications are currently not available
.
CLS-20598436

Mayo Clinic Footer