607 
Preparing for Adolescent HIV Vaccine Trials: Will Adolescent Participants Experience Social Harms?
Daniella Mark*1, H Jaspan1,2, E Ryan Burrell1, P Mthimunye1, K Middelkoop1, N Soka1, R Wood1, and L G Bekker1
1Desmond Tutu HIV Ctr, Inst of Infectious Disease and Molecular Med, Univ of Cape Town, South Africa and 2Tygerberg Hosp, Cape Town, South Africa
Background: High infection rates make adolescents a target for HIV prevention
research. Preparations are underway globally for the initiation of HIV vaccine
trials in adolescents. The social harms and implementation risks in this age
group have been posited as a challenge to adolescent vaccine trials. Identifying
and preparing for these risks is an ethical imperative.
Methods: An
HIV vaccine trial preparatory study was conducted among adolescents from
a peri-urban community near Cape Town, South Africa, in which 100 adolescents, aged 14 to 17, were enrolled and interviewed 3-monthly
for 1 year. Social harms data were collected through interviewer-administered
surveys. Crude proportion comparisons for categorical variables were
made using the χ2 test (p <0.05) of independence to
detect trends across multiple levels. All tests were 2-sided.
Results: The
mean age of participants was 15 years and 70% were female. Retention was 85% at
12 months; 89% had disclosed their participation, but 5% were afraid someone
would find out they were participating; 67% reported 1 or more social harms
across the study, the mean number of social harms per participant being 1.72
(range 0 to 7). The most frequently reported social harm was being asked to
reveal HIV test results (64%). Other social harms reported were being thought
to be HIV+ (10%), negative statements made by others (7%), being
emotionally hurt (4%), and being forced to reveal HIV test results (3%). The
percentage of participants reporting social harms decreased significantly with
each visit (p <0.008). The mean number of social harms reported was
significantly more for females (1.9) than males (1.3) (p = 0.0424).
Conclusions:
Adolescents are likely to report large numbers of social harms in HIV vaccine
trials, most of which relate to their presumed or actual HIV status. Adolescent
trials should facilitate disclosure by offering counseling referral services to
those who become infected. Preparatory and adjunct community education should
focus on the HIV-negative criterion for trial participation as well as elimination
of stigma. Social harms reporting decreased with each visit, meaning that
social harms may influence retention. An alternative interpretation is that social
harms tend to resolve with time. Females report more social harms than males,
although this may be a function of reporting rather than experience.
|
