Strategies for Good Retention Rates in HIV Exposed Sero-Negatives (HESN) Individuals: Important Consideration for HIV Biomedical Prevention Trials in Nigeria
Background: Retention
in clinical trials is critical for the accumulation of data over time and
retaining enough power for comprehensive analysis. We document for the first
time the retention rates and factors associated with retention among a cohort
of HIV exposed seronegative (HESN) person in a discordant relationship.
Understanding these factors will provide valuable cues for maintaining high
retention rates in future HIV biomedical prevention studies in this cohort. Aim: We aimed to document retention rates and associated factors relevant in
conducting future HIV prevention studies using a cohort of HIV exposed
sero-negative individuals. Method: We conducted a prospective cohort
study to enroll HESN persons in discordant relationship based on established
inclusion criteria that includes: Established sero-discordance with at least 3
months in the relationship; above 18 years and willingness to be followed up.
Relevant ethical approvals were obtained. Following informed consent at
enrollment, standardized questionnaires on risk behavior and factors that may
affect retention were administered at enrollment and during the 2 years follow-up.
This was spread over 10 follow-up visits to mimic phase a 2b HIV vaccine
clinical trial follow up and duration. In addition, clinical examinations were
done and samples collected for safety lab during the follow up visits.
Estimation of CD4 and viral load was also done for the HIV+ partners of HESN
study participants. Results: Six hundred and sixty HESN persons were
screened and 534 (81%) enrolled (i.e. month 0) and followed up. There was a decline in
retention from 96% at month 1 (visit 1) to 78% at month 24 (Visit 10). Sharpest
drop out from the study occurred at month 1 (20%) and month 15 (14%) follow-up
visits. Inability to reach study participants, unwillingness of study
participants to continue study, and mortality of the HIV+ partners of HESN
participants were the commonest reasons for participant
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