Abstract:
Self-report of sexual behavior among
adolescents is notoriously inconsistent, yet such
measures are commonly used as outcomes for human
immunodeficiency virus (HIV) prevention interven-
tion trials. There has been a growing interest in the use
of HIV and other sexually transmitted disease bio-
markers as more valid measures of intervention impact
in high HIV prevalence areas, particularly in sub-
Saharan Africa. We examine the challenges, benefits,
and feasibility of including HIV and herpes simplex
virus type 2 (HSV-2) biomarker data, with details
about different data collection and disclosure methods
from two adolescent prevention trials in Kenya and
Zimbabwe. In Kenya, whole blood samples were
collected using venipuncture; adult guardians were
present during biomarker procedures and test results
were disclosed to participants and their guardians. In
contrast, in Zimbabwe, samples were collected using finger pricks for dried blood spots (DBS); guardians
were not present during biomarker procedures, and
results were not disclosed to participants and/or their
guardians. In both countries, prevalence in the study
samples was low. Although the standard of care for
testing for HIV and other sexually transmitted infec-
tions includes disclosure in the presence of a guardian
for adolescents under age 18, we conclude that more
research about the risks and benefits of disclosure to
adolescents in the context of a clinical trial is needed.
Notably, current serological diagnosis for HSV-2 has a
low positive predictive value when prevalence is low,
resulting in an unacceptable proportion of false
positives and serious concerns about disclosing test
results to adolescents within a trial. We also conclude
that the DBS approach is more convenient and
efficient than venipuncture for field research, although
both approaches are feasible.
