Zeitschrift für AIDS und klinische Forschung

Understanding potential users' preferences for new HIV prevention options is an important component in designing effective roll-out and uptake plans. We surveyed opinions of 164 opinion leaders, health workers and key population representatives in five regions in Kenya to examine their preferences, concerns, perceived benefits and recommendations on Pre-exposure prophylaxes (PrEP) and potential HIV microbicides and vaccines. Data was captured via questionnaires and focus group discussions. We coded emerging themes in the data then extracted representative quotes. Cost, accessibility and efficacy were key determinants of acceptability and demand across prevention modalities. Myths, misconceptions, product associated stigma and anticipated societal resistance were identified as potential barriers to uptake, though the specifics of these varied from product to product. Vaccines elicited specific fears related to product-induced HIV infection and infertility. There was a strong preference for injectable over oral delivery of vaccines. There was also the perception that vaccines were more 'socially acceptable' and carried less stigma and concern around disinhibition than the other products. For microbicides, most groups favored the self-administered gel over ring or film because of individual's ability to control when to stop in case of side effect; however, health care providers showed a preference for the ring. Respondents expressed concern over potential sideeffects and the stigmatization of product users. With PrEP, there was a difference of opinion on the preferred mode of administration, with health care providers and MSM preferring oral PrEP and other respondents opting for longlasting injectable. Perceived benefit of PrEP was its demonstrated ability to protect against HIV. The primary concern associated with PrEP was safety and side effects. These included anxieties about the risk of taking drugs when one was not sick. Product design needs to proactively take into account community preferences and provide options that fit individual preferences as well as socio-cultural contexts.

Background: Adequate HIV/AIDS knowledge and positive attitude towards People Living with HIV/AIDS (PLWHA) are very important and vanguards in averting and ending the epidemics. This study was aimed at assessing predictors of HIV/AIDS knowledge and acceptance attitude towards PLWHA among young women aged 15-24 of Nigeria and Democratic Republic of Congo (DRC). Methods: This was a cross-sectional study which used 2013 Nigeria and 2013-2014 DRC demographic health survey data, with a sample size of 14,619 in Nigeria and 7661 for DRC. SPSS Version 22 was employed to analyze chi-square tests and multivariate logistic regression. P-values of 0.05 were set up to show the statistical significance. Results: Awareness of the young women of Nigeria (91.1%) and DRC (90.6%) was universal. HIV/AIDS knowledge (33.6% Vs 9.8% respectively) and acceptance attitude towards PLWHA (28.4% vs. 3.2%, respectively) was low. Multivariate logistic regression model showed that age, residence, education, religion, marital status and wealth index were significant associates with HIV/AIDS knowledge. Similarly, age, education, religion, marital status, wealth index and HIV/AIDS knowledge showed significant associations with acceptance attitude towards PLWHA. After controlling the confounding variables, higher HIV/AIDS knowledge (OR 1.09, 95% C.I 1.01-1.17) and acceptance attitude towards PLWHA women (OR2.54, 95% C.I 2.17-2.98) was observed among young women in Nigeria than in DRC. Conclusion: Increased HIV/AIDS awareness was observed. However the level knowledge on HIV/AIDS and positive attitude towards PLWHA was very low. Hence educational intervention programs to increase the knowledge of the young women on the epidemic are highly needed.

Background: There has not been a systematic analysis of factors affecting ethics and regulatory timelines of HIV Vaccine trials and epidemiologic studies in Eastern and Southern Africa. We analyzed regulatory and ethics approval timelines and associated factors for HIV vaccine clinical trials and epidemiologic studies in Kenya, Uganda, Rwanda, South Africa and Zambia using data collected from seven Clinical Research Centers (CRCs) from 2001 to 2015. Methodology: Staff responsible for regulatory issues at CRCs provided archived data on ethical and regulatory review time-frames which were then validated with the sponsor central database. A semi structured questionnaires was administered to establish qualitative information on perceived factors affecting efficiency of approval processes and potential solutions. Quantitative data analysis was conducted using Excel. Qualitative data were analyzed using an open coding to analyze and elicit general themes. Findings: Data on submission for 23 clinical trials and 51 epidemiological study protocols were analyzed. Across all seven CRCs it took on average of 178 and 108 days to obtain full authorization to commence clinical trials and epidemiological studies, respectively. These timelines are shorter than the average found in other disease fields in Africa but seem longer than approval timelines in the USA and the EU that are estimated at 15-45 days and 43-75 days, respectively. We found that countries with sequential, rather than parallel, submission procedures had longer review timelines. Clinical trial approval timelines that were longer than 200 days were associated with amendment submissions prior to initial approval and with investigational products that required institutional biosafety committee reviews. Lengthier approval timelines were also associated with epidemiological studies with more invasive procedures. Conclusion: Strategies to further shorten timelines will need to focus on adoption of parallel approval processes; increase frequency of ethical review meetings and capacity strengthening of ethical review institutions.

Aim: We assessed liver stiffness measurement (LSM) for the prediction of mortality and decompensation in HIVinfected patients with compensated liver cirrhosis. Method: A prospective cohort study of HIV-infected patients with confirmed liver cirrhosis from 9 hospitals in Spain. LSM was undertaken for each patient; clinical events were collected prospectively after the baseline visit, and patients were followed until death or the censoring date. We used univariate/multivariate Cox proportional hazard models to evaluate the utility of LSM for predicting the first hepatic decompensation or overall mortality. The sensitivity (SEN), specificity (SPE), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+) and negative likelihood ratio (LR-) were calculated. The LSM cutoff was selected using ROC curves. Results: We included 102 patients with compensated liver cirrhosis; median [interquartile, (IQR)] follow-up was 36 (21-46) months, median (IQR) CD4+ cell count was 415 cells/μL (307-624) and 94% were receiving antiretroviral therapy. The median (IQR) LSM was 17 kPa (11.7-26). Nineteen events were recorded during follow-up. Multivariate analysis showed that time to hepatic decompensation was associated with CD4+ <200 cells/μL (HR, 26; 95% CI, 1.8- 377; p<0.02) and LSM ≥ 25 kPa (HR, 7.2; 95% CI, 1.1-47; p=0.04) and that time to overall mortality was associated with LSM ≥ 25 kPa (HR, 14.3; 95% CI, 1.5-138; p=0.02). The predictive values for decompensation (LSM ≥ 25 kPa) were as follows: SEN, 67%; SPE, 78%; NPV, 96%; PPV, 23%; LR+, 3; LR-, 0.4. The predictive values for overall mortality with this LSM cutoff were as follows: SEN, 86%; SPE, 79%; NPV, 99%; PPV, 23%; LR+, 4; LR-, 0.2. Conclusion: Our data suggest that LSM is an accurate method for the prediction of mortality and decompensation in HIV-infected patients with liver cirrhosis.

Background: Concomitant use of antiretroviral therapy (ART) and hormonal contraceptives should be safe for women while maintaining medication efficacy without causing significant immunological or metabolic changes. However, the metabolic effect of the concomitant use of etonogestrel (ENG)-releasing implant and commonly used ARTs is not known. Objective: To evaluate the effect of coadministration of ENG-releasing implant and ARTs containing lopinavir/ ritonavir or efavirenz on the metabolic parameters of women living with human immunodeficiency virus (HIV) infection/ acquired immune deficiency syndrome (AIDS). Methods: This is an open, prospective, non-randomized exploratory study. Forty-five women who sought to receive the ENG contraceptive implant were selected, including 15 non-ART users, 15 zidovudine/lamivudine (AZT/3TC)+lopinavir/ritonavir users and 15 AZT/3TC+efavirenz users for at least 3 months. Clinical and metabolic parameters were assessed before, during and 24 weeks after implant insertion. Results: At 24 weeks after ENG implant insertion, the group without ART showed a 4.7% increase in albumin level (p=0.03), a 6.2% decrease in total cholesterol level (p=0.03) and a 5.6% increase in alkaline phosphatase level (p<0.01), whereas the lopinavir/ritonavir group showed a 12.5% increase in aspartate aminotransferase (p=0.03). The efavirenz group showed a 12.9% decrease in low-density lipoprotein (p=0.03). The other results showed no significant changes during the 24 week study. The observed changes remained within the normal values for the parameters. Conclusion: Co-administration of ENG implant with ARTs containing lopinavir/ritonavir or efavirenz is not associated with clinically relevant metabolic changes in women living with HIV infection/AIDS, after a 6 month followup period.

Toxoplasmosis is a disease caused by an obligate intracellular protozoan Toxoplasma gondii. In immunocompetent adults, infection can occur subclinically, or with lymphadenitis. In HIV-infected individuals with severe immune suppression, Toxoplasma gondii can cause severe disease with invasion of the gray and white matter of the brain, the retina, the lungs, the heart and the skeletal muscles. Toxoplasmosis is the most common opportunistic infection of the central nervous system in patients with acquired immunodeficiency syndrome (AIDS). The clinical presentation of cerebral toxoplasmosis in the majority of these patients includes headaches, focal neurological deficits, and seizures. In this article, we report two cases with different presentation of cerebral toxoplasmosis in the setting of an HIV infection.

Background: The purpose of this study was to evaluate care rendered to HIV positive women during the first six weeks of postpartum. Quantitative, descriptive, cross sectional and analytic study was conducted to investigate postnatal care services provided to HIV positive mothers. Methods: Data collection was done using structured questionnaires. A total of 372 respondents participated in the study. Descriptive data analysis was used; Epi info version 3.5.1 software was used for data entering and analysis. Results: The results of the study highlighted that the quality of immediate postnatal care (PNC) was com-promised: only 44.9% (n=167) had their temperature measured, 26.6% (n=99) had their pulse rate measured, about half 53.2% (n=198) were physically assessed following childbirth. Whereas, all the health facilities (100%) had the basic equipment for the provision of quality immediate PNC. Conclusion: The study reveals compromised PNC services provided to HIV positive mothers during the immediate postpartum. It had also documented gaps in the delivery of quality PNC to this special group. Recommendations: The researchers recommend that the Sexual Reproductive Health Programme within the MoH conduct training needs assessment and skills audit in collaboration with partners, midwifery schools and regulatory bodies to provide evidence-based in-service training and/or specialised trainings in PNC to ensure that a competent midwifery workforce is maintained.

Aim: To inform three cases with declining of CD4 T-cell with unknown reasons. Method: The report on clusters of disease cases. 3 patients were treated at the National Hospital for Tropical Diseases in Ha Noi, in the period from 30/04/2013 to 05/13/2013. Three of them had evidence of the counts decline of CD4 T-cell, but the causes were not identified. Results and conclusion: Three male patients aged from 23 to 40 were engaged in gold mining. All three patients had no history of any special and hospitalized because of fever, cough, difficult breathing from a few days to 2 months. Physical examination and test results showed lung disease with respiratory failure, weakness, oral fungus. T-CD4 of two patients declined, but the results of HIV were negative. Although all of them were treated with intensive, as well as antibiotics, antifungal drugs but the treatment have not resulted. These are the issues that need to be studied further.

Objective: The Government of Uganda recommends the serial HIV rapid testing algorithm where weakly reactive results on any of the three: Determine, Statpak and Unigold are interpreted as positive. We assessed the proportion of weak positive (WP) rapid results against confirmed results. Methods: We generated cross tabulations using Stata 3.0 to compare the WP rapid test results on each kit in the algorithm against final results on EIA/PCR to assess the proportion of samples confirmed to be HIV negative on ELISA and/or qualitative DNA PCR. We also generated Positive Predictive Values (PPV) to find the proportion of results that were true positives. Results: A total of 231 weak positive (WP) results were selected. 71 were WP on Determine HIV1/2, 149 on Statpak and 11 on Unigold. We found that 35.2% of the WP results on Determine were confirmed Negative by EIA/PCR test with a Positive Predictive Value (PPV) of 64.8%, 80.5% of WP on Statpak were confirmed negative with a PPV of 19.5% while 63.6% of the WP on Unigold were confirmed negative with a PPV of 36.4%. When using the National serial rapid HIV testing algorithm, WP on both Determine and Statpak are scored as positive. However, we found that out of the 11 WP on both Determine and Statpak for screening and confirmatory tests respectively, 45.5% returned a final negative result with a PPV of 54.5%. Conclusion: Since point of care results are interpreted following manufacturer’s instructions, a substantial proportion that would have been scored as positive end up with Negative results. WP screening results whether using parallel or serial testing algorithm, need to be confirmed by EIA or PCR before results are finalized. This calls for a reevaluation of the national algorithm that considers WP scores instead of what is instated in the kit insert.

Background: Youth are the future, and investing in the youth of today means a brighter future for the entire world. Nowhere is this truer than in Africa, where changing demographics are creating a unique opportunity to harness the potential of young people to accelerate development. Swaziland, with a large and growing youth population and a declining birth rate, is on the cusp of a critical demographic transition. Methods: The HIV and Sexual Reproductive Health Status of Young People in Swaziland analysis were prepared in stages: desk review and analysis, consultations/interview meetings with key stakeholders, data analysis and compilation of the report. Results and discussion: Early sexual debut, high adolescent fertility rate, unmet need for family planning, and on-going problems with sexual and gender based violence (GBV) are some of the key issues faced by young people in terms of reproductive health in Swaziland. Adolescent fertility did decline slightly from 89/1000 to 87/1000 between 2010 and 2014. HIV prevalence is much higher in young women than young men across all age groups, and marked increases in prevalence become apparent throughout the 20s for both sexes. Approximately 1 in 4 females in Swaziland experienced physical violence as a child and 9% of the youth aged 18-24 experienced coerced sexual intercourse before they turned eighteen. Conclusion: There seems to be some improvement in sexuality education and behaviour change interventions. There is gradual increase in age at sexual debut and in the proportion of adolescents reporting to be abstaining from sexual activity. This suggests that some interventions may have dissuaded some adolescents from sexual intercourse. Recommendations: A minimum standard for health facilities to be considered youth-friendly should be put in place, and all facilities should be assessed against the standard as well as linkages between schools, communities and health facilities should prioritized.

Background and objectives: Human immunodeficiency virus (HIV) infection is a global healthcare problem. Low CD4 cells count, an index of immunosuppression, is associated with escalating activity and progression of HIV infection. The factors which influence low CD4 cells count have not been completely identified nor are they evaluated in routine clinical practice. The aim of this study was to determine the prevalence of low CD4 cells count and to evaluate the factors which might influence immunosuppression in treatment-naïve HIV subjects in Southeast Nigeria. Methodology: This was a cross-sectional study involving treatment-naïve HIV subjects. Anthropometric and demographic data were obtained and CD4 cells count and other relevant investigations performed. The data were compared between those who have low CD4 cells count, defined, here, as CD4 <200 cells/ml, and those with CD4 ≥ 200 cells/ml. Potential risk factors of low CD4 cells count were determined. Results: The mean age of the subjects was 39+11 years. Females were made up 283 (72.0%) and males 110 (28.0%). The median value of the CD4 cells count was 391. Low CD4 cells count was prevalent in 49 (12.5%) of the subjects. There was significant association between CD4 cells count and body mass index (df=2, p=0.017), as well as serum low density lipoprotein cholesterol (df=1, p=0.027) and anemia (df=3, p=0.025). Significant, but poor, correlation was observed between CD4 cells count and 24 h urine protein (r=-0.117, p=0.023), creatinine clearance (r=-0.122, p=0.018), as well as hemoglobin (r=0.224, p<0.001). Creatinine clearance was a predictor of low CD4 cells count, p=0.001. Conclusion: The prevalence of low CD4 cells count was high in this study. Abnormal weight, dyslipidemia and proteinuric renal damage were common among treatment-naïve subjects who have low CD4 cells count.