Back
 WJA  Vol.5 No.4 , December 2015
Baseline Clinical Profile of a “Normal Popu-lation” of HIV Exposed Sero-Negative (HESN) Partners May Impact HIV Biomedical Prevention Studies Negatively
Abstract: 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.
Cite this paper: Datong, P. , Okpokoro, E. , Osawe, S. , Datiri, R. , Choji, G. , Okolo, F. , Abimiku, R. , Mamman, I. and Abimiku, A. (2015) Baseline Clinical Profile of a “Normal Popu-lation” of HIV Exposed Sero-Negative (HESN) Partners May Impact HIV Biomedical Prevention Studies Negatively. World Journal of AIDS, 5, 299-307. doi: 10.4236/wja.2015.54032.
References

[1]   NACA (2011) Fact Sheet: Update on the HIV/AIDS Epidemic and Response in Nigeria. NACA, Boston.

[2]   Cohen, M.S., et al. (2011) Prevention of HIV-1 Infection with Early Antiretroviral Therapy. New England Journal of Medicine, 365, 493-505.
http://dx.doi.org/10.1056/NEJMoa1105243

[3]   Vermund, S.H. (2013) Treatment as Prevention for HIV in China. Lancet, 382, 1159-1161.
http://dx.doi.org/10.1016/S0140-6736(12)62005-4

[4]   Reynolds, S.J., et al. (2011) HIV-1 Transmission among HIV-1 Discordant Couples before and after the Introduction of Antiretroviral Therapy. AIDS, 25, 473-477.
http://dx.doi.org/10.1097/QAD.0b013e3283437c2b

[5]   Huachun, Z., et al. (2012) Condom Use in China: Prevalence, Policies, Issues and Barriers. Sexual Health, 9, 27-33.
http://dx.doi.org/10.1071/SH11021

[6]   Baeten, J.M., et al. (2012) Antiretroviral Pre-Exposure Prophylaxis for HIV-1 Prevention among Heterosexual African Men and Women. New England Journal of Medicine, 367, 399-410.
http://dx.doi.org/10.1056/NEJMoa1108524

[7]   Rerks-Ngam, S., Pitisuttithum, P. and Nitayaphan, S. (2009) Vaccination with ALVAC and AIDSvax to Prevent HIV-1 Infection in Thailand. New England Journal of Medicine, 361, 2209-2220.
http://dx.doi.org/10.1056/NEJMoa0908492

[8]   Abimiku, A.G., et al. (1994) Subgroup G HIV Type 1 Isolates from Nigeria. Research and Human Retroviruses. Research and Human Retroviruses, 10, 1581-1583.
http://dx.doi.org/10.1089/aid.1994.10.1581

[9]   WHO (2012) Guidance on Couples HIV Testing and Counselling Including Antiretroviral Therapy for Treatment and Prevention in Serodiscordant Couples. Recommendations for a Public Health Approach, World Health Organization, Geneva.

[10]   Omosa-Manyonyi, G.S., et al. (2011) Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya. PLoS ONE, 6, e14580.
http://dx.doi.org/10.1371/journal.pone.0014580

[11]   Altman, D. and Doré, C. (1990) Randomisation and Baseline Comparisons in Clinical Trials. The Lancet, 335, 149-153.
http://dx.doi.org/10.1016/0140-6736(90)90014-V

[12]   Peduzzi, P., Henderson, W., Hartigan, P. and Lavori, P. (2002) Analysis of Randomized Controlled Trials. Epidemioloic Reviews, 24, 26-38.

[13]   UT Health (2008) Clinical Trials Resource Center. Clinical Trials Glossary 2008.
https://www.uth.edu/ctrc/participants/glossary.htm

[14]   Miri-Dashe, T., Osawe, S., Tokdung, M., et al. (2014) Comprehensive Reference Ranges for Hematology and Clinical Chemistry Laboratory Parameters Derived from Normal Nigerian Adults. PLoS ONE, 9, e93919.
http://dx.doi.org/10.1371/journal.pone.0093919

[15]   Burgess, D.C., Gebski, V.J. and Keech, A.C. (2003) Baseline Data in Clinical Trials. Medical Journal of Australia, 179, 105-107.

[16]   Akani, C.I., Erhabor, O., Opurum, H., et al. (2005) HIV Sero-Discordance among Nigerian Couples: Challenges and Controversies. Nigeria Medical Practitioner, 48, 62-66.

[17]   Ruzagira, E., Wandiembe, S., Abaasa, A., et al. (2011) Prevalence and Incidence of HIV in a Rural Community-Based HIV Vaccine Preparedness Cohort in Masaka, Uganda. PLoS ONE, 6, e20684.
http://dx.doi.org/10.1371/journal.pone.0020684

[18]   Ige, K. and Nwachukwu, C. (2008) Health Care Seeking Behaviour among Market Traders in Ibarapa Central Local Government, Nigeria. The Internet Journal of Health, 9.
http://ispub.com/IJGG/5/2/5831

[19]   Agbogidi, J. and Azodo, C. (2009) Experiences of the Elderly Utilizing Healthcare Services in Edo State. The Internet Journal of Geriatrics and Gerontology, 5.
http://ispub.com/IJH/9/2/9674

[20]   Gyoh, S. (2011) Doctors and the Truth. African Health, 34, 5.

[21]   Sekoni, A.O., Odukoya, O.O., Onajole, A.T. and Odeyemi, K.A. (2013) Sexually Transmitted Infections: Prevalence, Knowledge and Treatment Practices among Female Sex Workers in a Cosmopolitan City in Nigeria. African Journal of Reproductive Health, 17, 94-102.

[22]   Baltazar, R.M., et al. (2005) Prevalence of Sexually Transmitted Infections and Associated Risk Factors among Female Commercial Sex Workers in Cuantha, Morclos. Ginecología y Obstetricia de México, 73, 36-47.

[23]   Balogun, M.O. and Owoaje, E.T. (2007) Work Conditions and Health Problems of Female Traders in Ibadan, Nigeria. African Journal of Medicine and Medical Sciences, 36, 57-63.

[24]   Okechukwu, S.O., Okpechi, I., Chukwuonye, I.I., et al. (2012) Blood Pressure, Prevalence of Hypertension and Hypertension Related Complications in Nigerian Africans: A Review. World Journal of Cardiology, 4, 327-340.
http://dx.doi.org/10.4330/wjc.v4.i12.327

[25]   Pirraglia, P.A., Bishop, D., Herman, D.S., et al. (2005) Caregiver Burden and Depression among Informal Caregivers of HIV-Infected Individuals. Journal of General Internal Medicine, 20, 510-514.
http://dx.doi.org/10.1111/j.1525-1497.2005.0073.x

[26]   Player, M.S. and Peterson, L.E. (2011) Anxiety Disorders, Hypertension, and Cardiovascular Risk: A Review. International Journal of Psychiatry in Medicine, 41, 365-377.
http://dx.doi.org/10.2190/PM.41.4.f

[27]   Damulak, O. and Damen, J. (2012) Diagnostic Outcome of Bone Marrow Aspiration in a New Centre in Nigeria. Global Advanced Journal of Medicine and Medical Sciences, 1, 166-171.

[28]   Chen, S.C., Yeh, J.J., Chang, M.H., et al. (2010) Gender Difference of Alanine Aminotransferase Elevation May Be Associated with Higher Hemoglobin Levels among Male Adolescents. PLoS ONE, 5, e13269.
http://dx.doi.org/10.1371/journal.pone.0013269

[29]   Song, H.R., Yun, K.E. and Park, H.S. (2008) Relation between Alanine Aminotransferase Concentrations and Visceral fat Accumulation among Nondiabetic Overweight Korean Women. The American Journal of Clinical Nutrition, 88, 16-21.

 
 
Top