TITLE:
Strategies for Good Retention Rates in HIV Exposed Sero-Negatives (HESN) Individuals: Important Consideration for HIV Biomedical Prevention Trials in Nigeria
AUTHORS:
Evaezi Okpokoro, Sophia Osawe, Stephen Umaru, Lincoln Egbo, Felicia Okolo, Pam Datong, Alash’le Abimiku
KEYWORDS:
Retention, HIV Exposed Sero-Negative, Prevention Studies, Clinical Trials
JOURNAL NAME:
World Journal of AIDS,
Vol.8 No.4,
December
26,
2018
ABSTRACT: 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 study termination.
Furthermore, no or low level of formal education, (AOR 2.79; 95% CI 1.29 - 6.02, p = 0.06), being unemployed (AOR 1.96; 95% CI 1.18 - 3.29, p CI 1.16 - 2.91, p
Conclusion: Retention
rates decline especially during month 1 (visit 1) and month 15 (visit 7) mainly
due to participants’ inability to locate study participants and death of HIV+
partners of HESN enrollees. One unexpected finding from our study is that those
who were more consistent in their use of condom were more likely to stay in the
study. This is a possible indication of commitment or an incentive for giving
free condoms at study visits. This is encouraging for combined biomedical
prevention strategies where consistent condoms use is desired. On the other
hand, factors such as unemployment, poor formal education and never/occasional
condom use were predictors of study drop out. Retention strategies should
consider these barriers and predictors of drop out as exclusion criteria in
preparation for future HIV biomedical prevention trial.