The burden and viral diversity of HIV in Nigeria makes it suitable to evaluate biomedical prevention strategies including HIV vaccines. We document baseline clinical characteristics of a cohort of HIV Exposed Sero-Neg...The burden and viral diversity of HIV in Nigeria makes it suitable to evaluate biomedical prevention strategies including HIV vaccines. We document baseline clinical characteristics of a cohort of HIV Exposed Sero-Negative (HESN) partners to highlight background morbidities that might impact the interpretation of research findings especially in low income countries where “normal control” is based on physical appearance and self-reporting. We established a 2-year prospective cohort of HESN, and obtained, at baseline medical history, general physical examination findings and safety laboratory tests results. Among 534 participants with a mean age of 37 ± 9 years, the commonest symptoms were headache (25.5%) and fever (20%), which occurred more among females. Also, 13% reported a history of urethral/vaginal discharge and genital ulcer. High blood pressure (HBP) (i.e. blood pressure ≥ 140/90 mmhg) was a major abnormal examination finding, which occurred more among males (53.2% vs 26.2%, p < 0.01). More female participants had abnormal laboratory results with 31% having low hemoglobin concentration (<12 g/dl, p = 0.021);30% with elevated alanine transaminase level (p = 0.019) and 28% with abnormal blood urea nitrogen level (p = 0.093). HBP and abnormal safety laboratory are significant findings among so called “normal population” that could affect interpretation of research findings of HIV biomedical prevention studies in Nigeria.展开更多
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 associa...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 < 0.01) and inconsistent use of condoms (AOR 1.83;95% 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.展开更多
文摘The burden and viral diversity of HIV in Nigeria makes it suitable to evaluate biomedical prevention strategies including HIV vaccines. We document baseline clinical characteristics of a cohort of HIV Exposed Sero-Negative (HESN) partners to highlight background morbidities that might impact the interpretation of research findings especially in low income countries where “normal control” is based on physical appearance and self-reporting. We established a 2-year prospective cohort of HESN, and obtained, at baseline medical history, general physical examination findings and safety laboratory tests results. Among 534 participants with a mean age of 37 ± 9 years, the commonest symptoms were headache (25.5%) and fever (20%), which occurred more among females. Also, 13% reported a history of urethral/vaginal discharge and genital ulcer. High blood pressure (HBP) (i.e. blood pressure ≥ 140/90 mmhg) was a major abnormal examination finding, which occurred more among males (53.2% vs 26.2%, p < 0.01). More female participants had abnormal laboratory results with 31% having low hemoglobin concentration (<12 g/dl, p = 0.021);30% with elevated alanine transaminase level (p = 0.019) and 28% with abnormal blood urea nitrogen level (p = 0.093). HBP and abnormal safety laboratory are significant findings among so called “normal population” that could affect interpretation of research findings of HIV biomedical prevention studies in Nigeria.
文摘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 < 0.01) and inconsistent use of condoms (AOR 1.83;95% 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.
