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OBJECTIVE: To devise a flowchart suitable for assessing risk of trichomoniasis, chlamydia and gonorrhoea in an adolescent population, not all of whom will be sexually experienced or currently in a relationship. METHODS: The data used to derive the flowchart were generated from cross-sectional microbiological surveys of girls aged 14-19 years in Port Harcourt, Nigeria. The flowchart screened on the basis of: (i) sexual experience; (ii) recent sexual activity; (iii) a positive urine leukocyte esterase (LE) test; and (iv) among LE negatives, a history of malodorous/pruritic discharge. FINDINGS: Using this flowchart, we found that 26.2% of all adolescents screened would receive treatment for cervicitis and vaginitis. Chlamydial, gonococcal, and trichomonal infections were correctly diagnosed in 37.5%, 66.7%, and 50 % of the cases, respectively. CONCLUSION: Although the flowchart is more suitable for an adolescent population than the vaginal discharge algorithm used in syndromic management protocols, it still lacks precision and needs adapting to local settings.

Abstract Background Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria. Methods We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses. Results A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study. Conclusion Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial. Trial Registration The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770

Background: This study aimed to evaluate the gap between guidelines and local clinical practice for diagnosis and treatment of uncomplicated and severe malaria, the patient characteristics, diagnostic approach, treatment, and compliance to standard guideline recommendations., Methods: This was a multicentre, observational study conducted between October 2020 and March 2021 in which patients of all ages with symptoms suggestive of malaria and who visited a healthcare facility were prospectively enrolled in six countries in sub-Saharan Africa (The Democratic Republic of the Congo, Mozambique, Nigeria, Rwanda, The United Republic of Tanzania, and Zambia)., Results: Of 1001 enrolled patients, 735 (73.4%) patients had confirmed malaria (based on overall judgment by investigator) at baseline (uncomplicated malaria: 598 [81.4%] and severe malaria: 137 [18.6%]). Of the confirmed malaria patients, 533 (72.5%) were administered a malaria rapid diagnostic test. The median age of patients was 11 years (range: 2 weeks-91 years) with more patients coming from rural (44.9%) than urban (30.6%) or suburban areas (24.5%). At the community level, 57.8% of patients sought advice or received treatment for malaria and 56.9% of patients took one or more drugs for their illness before coming to the study site. In terms of early access to care, 44.1% of patients came to the study site for initial visit ≥ 48 h after symptom onset. In patients with uncomplicated malaria, the most prescribed treatments were artemisinin-based combination therapy (ACT; n = 564 [94.3%]), primarily using artemether-lumefantrine (82.3%), in line with the World Health Organization (WHO) treatment guidelines. In addition, these patients received antipyretics (85.6%) and antibiotics (42.0%). However, in those with severe malaria, only 66 (48.2%) patients received parenteral treatment followed by oral ACT as per WHO guidelines, whereas 62 (45.3%) received parenteral treatment only. After receiving ambulatory care, 88.6% of patients with uncomplicated malaria were discharged and 83.2% of patients with severe malaria were discharged after hospitalization. One patient with uncomplicated malaria having multiple co-morbidities and three patients with severe malaria died., Conclusions: The findings of this study suggest that the prescribed treatment in most patients with uncomplicated malaria, but not of those with severe malaria, was in alignment with the WHO recommended guidelines., (© 2023. The Author(s).)

Background: Poor retention can reduce study power and thwart randomization, possibly resulting in biased estimates of effect. Some HIV prevention trials conducted in developing countries have been challenged by high loss to follow-up. Identifying factors associated with non-retention could lead to recruitment of women more likely to remain in the trial, potentially yielding greater efficiency and validity., Methods: We summarized retention rates and, using Cox regression, evaluated factors associated with non-retention in four trials of two candidate vaginal microbicides (1% C31G or SAVVY® and 6% cellulose sulfate or CS) conducted in multiple sub-Saharan African countries. We defined retention as completion of the trial, including those with an HIV outcome. Non-retention comprised participants randomized to a study arm who were either lost to follow-up or discontinued prior to infection with HIV., Results: 7,367 women were enrolled and randomized in the four trials; 7,086 are included in this analysis. 1,514 (21.4%) participants were either lost to follow-up or had early discontinuation. In the final Cox model, the following baseline factors were associated with non-retention: younger age (hazard ratio [HR] = 0.95); less education (HR = 0.97); condom use at last sex (HR = 1.18); larger number of sex acts in a typical week (HR = 1.01); and baseline candidiasis or bacterial vaginosis (HR = 1.12)., Conclusions: Younger and less educated women were more difficult to retain in these microbicide trials. But these same traits may be associated with higher HIV infection rates. Enhanced retention methods focused on those at highest risk of non-retention and possibly infection will optimize study efficiency and validity., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Since the discovery of acquired immunodeficiency syndrome (AIDS), many studies demonstrated that intestinal parasites were frequently associated with pictures of severe diarrhoea in patients with HIV., Objectives: To determine the prevalence of Cryptosporidiosis among HIV-infected persons in the Niger Delta of Nigeria., Method: Faecal samples from One hundred and five HIV/AIDS infected subjects made up of 48 males and 57 females aged 18-54 years, mean age and CD4 count of 36.14 +/- 8.46 years and 320 +/- 140 cells/microl respectively were evaluated for Cryptosporidiosis using the Modified Ziehl-Neelsen staining method., Results: Of the one hundred and five faecal samples examined, 3 (2.9%) were positive for cryptosporidium oocyst. Prevalence was significantly higher among females 2/57 (3.5%) compared to males 1/48 (2.1%), among subjects with diarrhoea 3(11.5%) and among subjects with CD4 lymphocyte count < 200 cells/microl (p < 0.01). CD4 count of subjects positive for cryptosporidium oocyst was significantly lower (150 +/- 50 cells/microl). The mean CD4 count of subjects with diarrhoea was significantly lower (mean 180 cells/microl) compared to those without diarrhoea (360 cells/microl)., Conclusion: Our study indicates that the prevalence of intestinal colonization due to Cryptosporidium is significantly higher among HIV-infected persons presenting with diarrhoea and low CD4 lymphocyte count of < 200cells/microl and re-emphasizes the need to incorporate routine faecal parasitological examination (FPE) in the follow up management of patients with HIV/AIDS. This is likely to optimise treatments in these patients by eradicating opportunistic pathogens and improve the quality of life of these patients.

Background: Lower-than-expected incidence of HIV undermines sample size calculations and compromises the power of a HIV prevention trial. We evaluated the effectiveness of interim monitoring of HIV infection rates and on-going modification of recruitment strategies to enroll women at higher risk of HIV in the Cellulose Sulfate Phase III study in Nigeria., Methods: We analyzed prevalence and incidence of HIV and other sexually transmitted infections, demographic and sexual behavior characteristics aggregated over the treatment groups on a quarterly basis. The site investigators were advised on their recruitment strategies based on the findings of the interim analyses., Results: A total of 3619 women were screened and 1644 enrolled at the Ikeja and Apapa clinics in Lagos, and at the Central and Peripheral clinics in Port Harcourt. Twelve months after study initiation, the overall incidence of HIV was less than one-third of the pre-study assumption, with rates of HIV that varied substantially between clinics. Due to the low prevalence and incidence rates of HIV, it was decided to close the Ikeja clinic in Lagos and to find new catchment areas in Port Harcourt. This strategy was associated with an almost two-fold increase in observed HIV incidence during the second year of the study., Conclusion: Given the difficulties in estimating HIV incidence, a close monitoring of HIV prevalence and incidence rates during a trial is warranted. The on-going modification of recruitment strategies based on the regular analysis of HIV rates appeared to be an efficient method for targeting populations at greatest risk of HIV infection and increasing study power in the Nigeria trial., Trial Registration: The trial was registered with the ClinicalTrials.gov registry under #NCT00120770 http://clinicaltrials.gov/ct2/show/NCT00120770.

Background: This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection., Methods: This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1:1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events., Results: The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10) than on placebo (13), a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3-1.8; p = 0.56). Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5-1.1; p = 0.19 for the combined STI outcome). Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported., Conclusions: Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV., Trial Registration: ClinicalTrials.gov NCT00120770.

Giemsa-stained blood films from 1018 consecutively recruited blood donors was examined quantitatively for plasmodium species to determine the prevalence of transfusion-transmissible malaria among blood donors. The overall prevalence rate was 104 (10.2%). Infection rate was highest among donors aged 10-19 years (16.7%) and was significantly higher among commercially remunerated donors (17.8%) compared with family replacement donors (4.8%) (chi(2) = 45.19; P < 0.001). Pre-donation mean haemoglobin value was significantly lower among malaria-parasitized donors and commercial donors (12.3+/-0.30 and 12.63+/-0.57 g/dL) compared with non-parasitized and family replacement donors (13.5+/-1.01 and 13.9+/-0.96 g/dL) (chi(2) = 143.88; P = 0.001) and (chi(2) = 392.7; P = 0.001), respectively. This study confirms a high prevalence of transfusion-transmissible malaria among blood donors and lays bare the need to routinely treat transfusion recipient with anti-malaria as a prophylactic measure.

Background: Diabetic foot ulcer and/or gangrene is a common cause of morbidity and mortality in Nigeria. The lesions are usually infected and early treatment of the infection will reduce the associated problems. The study was carried out to determine the common bacteriological flora of diabetic foot ulcers in Port Harcourt. The antimicrobial sensitivity pattern of the isolates was determined to enhance possible empirical treatment., Methods: Deep wound swabs were collected from 60 consecutive diabetic patients admitted with foot ulcers and/or gangrene into the medical wards of the University of Port Harcourt Teaching Hospital from January 2001 to April 2002. The bacteriological isolation and antimicrobial sensitivity tests of the isolates was carried out by standard microbiological methods., Results: Aerobes and anaerobes constituted 95.4% and 4.6% of the total bacterial isolates respectively. Staphylococcus aureus was the commonest bacterial isolate; it was cultured from 32 (56.1%) of infected patients and constituted 24.4% of the total isolate. The mean bacterial isolate per patient infected was 2.3. The aerobic isolates showed significant sensitivity to ciprofloxacin (78.4%), pefloxacine (71.2%), ceftazidime (73.6%) and cefuroxime (69.6%). All the anaerobic isolates were sensitive to metronidazole and clindamycin., Conclusion: Infections of diabetic foot ulcers are usually polymicrobial. From the in vitro antimicrobial susceptibility pattern of the bacterial isolates, diabetic patients presenting with foot ulcers and/or gangrene could be commenced empirically on a combination of clindamycin or metronidazole and either a fluoroquinolone (ciprofloxacin or pefloxacine) or a second or third generation cephalosporin (e.g. cefuroxime or ceftazidime).

Few studies from developing countries have investigated reproductive tract infections or other indicators of sexual health among unmarried adolescent girls in rural areas. We have obtained baseline demographic, clinical, and microbiological data on reproductive tract infections and induced abortion in girls in a rural area of southeast Nigeria, in order to assess the need for health care for adolescents. 868 females attended for interview and examination: 458 aged 20 and above and 410 aged 12-19, the latter representing 93.4%of the adolescent population. 43.6% of those < 17 and 80.1% aged 17-19 years were sexually active and at least 24.1% had undergone an induced abortion; only 5.3% had ever used a modern contraceptive. Vaginal discharge was reported by 82.4%, though few sought treatment. 94.1% of sexually active adolescents and 97.6% of sexually active women 20 years old or over were gynaecologically examined and screened for reproductive tract infections. Of those aged less than 17, 19.8% had symptomatic candida and 11.1% trichomonas infections. Among those aged 17-19 years, chlamydia was detected in 10.5%, and symptomatic candidosis in 25.6%; this was the group most likely to have any infection (43.8%). 42.1% of sexually active adolescents had experienced either an abortion or a sexually transmitted disease. Syphilis was the only infection for which the incidence clearly increased with age. Health-care services for adolescents in this community are needed and should include sex education, contraceptive provision (especially barrier methods), and access to treatment for reproductive tract infections. Investments in health for this age group will have an effect on subsequent reproductive health.