Browsing by Author "Levin, Jonathan"
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Item Barriers to starting ART and how they can be overcome: individual and operational factors associated with early and late start of treatment(Tropical medicine & international health, 2010) Parkes-Ratanshi, Rosalind; Bufumbo, Leonard; Nyanzi-Wakholi, Barbara; Levin, Jonathan; Grosskurth, Heiner; Lalloo, David G.; Kamali, AnatoliDespite expanding access to antiretroviral therapy (ART) in Sub-Saharan Africa, there are few data on patients’ perceptions about starting ART to explore issues affecting decisions to start ART in eligible individuals during the ART roll out. Methods We studied patterns of ART uptake for 957 participants in a trial of cryptococcal disease prevention and performed a qualitative cross-sectional study about issues affecting decisions to start ART in this cohort. In-depth interviews (IDIs) were conducted with 48 participants who started ART after variable time on the trial. results Time to starting ART from trial enrolment decreased during the ART roll out (Median 83 days to 68 days). Multiple factors causing delay to ART were reported; awaiting home visit by service provider (P = 0.025), domestic issues (P = 0.028), moving from area (P £ 0.001) and fear of side effects (P = 0.013) were statistically significant. In the IDIs, fear of side effects was the strongest factor for delay and observation of health improvement in others on ART was the strongest inducement to start. Information from patients already taking ART was the most valued source of information. Conclusions This study provided novel information about factors encouraging people to start ART early; positive beliefs about ART were the most important. Whilst side effects of ART must not be downplayed, programmes should provide information in a balanced way to prevent unnecessary fear of starting ART. Those already receiving ART were found to be good advocates and should be utilised by ART programmes to educate others.Item A Cluster-Randomised Trial to Compare Home-Based with Health Facility- Based Antiretroviral Treatment in Uganda: Study Design and Baseline Findings(Bentham Science Publishers Ltd., 2007) Amuron, Barbara; Coutinho, Alex; Grosskurth, Heiner; Nabiryo, Christine; Birungi, Josephine; Namara, Geoffrey; Levin, Jonathan; Smith, Peter G.; Jaffar, ShabbarThe scale-up of antiretroviral therapy is progressing rapidly in Africa but with a limited evidence-base. We re- port the baseline results from a large pragmatic cluster-randomised trial comparing different strategies of ART delivery. The trial is integrated in normal health service delivery. 1453 subjects were recruited into the study. Significantly more women (71%) than men (29%) were recruited. The WHO HIV clinical stage at presentation did not differ significantly between men and women: 58% and 53% respectively were at WHO stage III or IV (p=0.9). Median CD4 counts (IQR) x 10 6 cells/l were 98 (28, 160) among men and 111 (36, 166) among women. Sixty-four percent of women and 61% men had plasma viral load 100,000 copies. Baseline characteris- tics did not change over time. Considerably fewer men than women presented for treatment.Item Decreasing trends of bacteraemia among HIV-infected Ugandan adults: incidence, aetiology, clinical outcomes and effect of antiretroviral therapy in a semi-urban setting (2000–2008)(Tropical Medicine & International Health, 2011) Zawedde Muyanja, Stella; Larke, Natasha; Rutebarika, Diana; Kaddu, Ismael; Nakubulwa, Susan; Levin, Jonathan; Grosskurth, Heiner; Miiro, GeorgeTo investigate the effect of antiretroviral therapy on trends of incidence, aetiology and clinical outcomes of bacteraemia among HIV-infected Ugandans in a semi-urban setting. methods A cohort of HIV-1-infected Ugandans aged 15 or older was followed from 2000 to 2008. Clinical, haematological and immunological measurements were taken at 6-monthly visits. Additionally, patients reported to outpatient clinics whenever they were ill. Patients with elevated axillary temperature above 37.4 C consistently triggered clinical assessment (with mandatory blood cultures) and empirical management protocol. Daily cotrimoxazole prophylaxis and highly active antiretroviral therapy (HAART) were introduced stepwise to eligible patients in August 2000 and February 2003, respectively. We compared the rates of bacteraemia across five calendar periods using random-effects Poisson regression for the effect of HAART at the population level. results A total of 246 bacteraemia episodes (including multiple episodes) were documented among 188 individuals (crude incidence: 42.4 events per 1000 person-years; 95% CI: 35.0, 51.4). The most common species isolated was Streptococcus pneumoniae. After adjustment for current age, clinical characteristics at enrolment (CD4+ T-cell counts and WHO stage) and time since enrolment, the incidence of bacteraemia dropped significantly when HAART was widely available compared with the period when treatment was not available (adjusted hazard ratio: 0.17; 95% CI: 0.09, 0.35). No poor health outcomes (death or lack of clinical response to antibiotics) after bacteraemia occurred after complete access to HAART. conclusions HAART availability in a resource-poor setting substantially reduced the trends of bacteraemia among HIV-infected adults. This may further impact on future morbidity and healthcare costs of HIV-infected people.Item Effect of isoniazid preventive therapy on immune responses to mycobacterium tuberculosis: an open label randomised, controlled, exploratory study(BMC infectious diseases, 2015) Andia Biraro, Irene; Egesa, Moses; Kimuda, Simon; Smith, Steven G.; Toulza, Frederic; Levin, Jonathan; Joloba, Moses; Katamba, Achilles; Cose, Stephen; Hazel M., Dockrell; Elliott, Alison M.With the renewed emphasis to implement isoniazid preventive therapy (IPT) in Sub-Saharan Africa, we investigated the effect of IPT on immunological profiles among household contacts with latent tuberculosis. Methods: Household contacts of confirmed tuberculosis patients were tested for latent tuberculosis using the QuantiFERON®-TB Gold In-Tube (QFN) assay and tuberculin skin test (TST). HIV negative contacts aged above 5 years, positive to both QFN and TST, were randomly assigned to IPT and monthly visits or monthly visits only. QFN culture supernatants from enrolment and six months’ follow-up were analysed for M.tb-specific Th1, Th2, Th17, and regulatory cytokines by Luminex assay, and for M.tb-specific IgG antibody concentrations by ELISA. Effects of IPT were assessed as the net cytokine and antibody production at the end of six months. Results: Sixteen percent of contacts investigated (47/291) were randomised to IPT (n = 24) or no IPT (n = 23). After adjusting for baseline cytokine or antibody responses, and for presence of a BCG scar, IPT (compared to no IPT) resulted in a relative decline in M.tb-specific production of IFN gamma (adjusted mean difference at the end of six months (bootstrap 95 % confidence interval (CI), p-value) -1488.6 pg/ml ((−2682.5, −294.8), p = 0.01), and IL- 2 (−213.1 pg/ml (−419.2, −7.0), p = 0.04). A similar decline was found in anti-CFP-10 antibody levels (adjusted geometric mean ratio (bootstrap 95 % CI), p-value) 0.58 ((0.35, 0.98), p = 0.04). We found no effect on M.tb-specific Th2 or regulatory or Th17 cytokine responses, or on antibody concentrations to PPD and ESAT-6. Conclusions: IPT led to a decrease in Th1 cytokine production, and also in the anti CFP-10 antibody concentration. This could be secondary to a reduction in mycobacterial burden or as a possible direct effect of isoniazid induced T cell apoptosis, and may have implications for protective immunity following IPT in tuberculosis-endemic countries.Item Effectiveness of the standard WHO recommended retreatment regimen (Category II) for tuberculosis in Kampala, Uganda(PLoS medicine, 2011) Jones-López, Edward C.; Ayakaka, Irene; Levin, Jonathan; Reilly, Nancy; Mumbowa, Francis; Dryden-Peterson, Scott; Nyakoojo, Grace; Fennelly, Kevin; Temple, Beth; Nakubulwa, Susan; Joloba, Moses L.; Okwera, Alphonse; Eisenach, Kathleen D.; McNerney, Ruth; Elliott, Alison M.; Ellner, Jerrold J.; Smith, Peter G.; Mugerwa, Roy D.Each year, 10%–20% of patients with tuberculosis (TB) in low- and middle-income countries present with previously treated TB and are empirically started on a World Health Organization (WHO)-recommended standardized retreatment regimen. The effectiveness of this retreatment regimen has not been systematically evaluated. Methods and Findings: From July 2003 to January 2007, we enrolled smear-positive, pulmonary TB patients into a prospective cohort to study treatment outcomes and mortality during and after treatment with the standardized retreatment regimen. Median time of follow-up was 21 months (interquartile range 12–33 months). A total of 29/148 (20%) HIV-uninfected and 37/140 (26%) HIV-infected patients had an unsuccessful treatment outcome. In a multiple logistic regression analysis to adjust for confounding, factors associated with an unsuccessful treatment outcome were poor adherence (adjusted odds ratio [aOR] associated with missing half or more of scheduled doses 2.39; 95% confidence interval (CI) 1.10–5.22), HIV infection (2.16; 1.01–4.61), age (aOR for 10-year increase 1.59; 1.13–2.25), and duration of TB symptoms (aOR for 1-month increase 1.12; 1.04–1.20). All patients with multidrug-resistant TB had an unsuccessful treatment outcome. HIV-infected individuals were more likely to die than HIV-uninfected individuals (p,0.0001). Multidrug-resistant TB at enrolment was the only common risk factor for death during follow-up for both HIV-infected (adjusted hazard ratio [aHR] 17.9; 6.0–53.4) and HIV-uninfected (14.7; 4.1–52.2) individuals. Other risk factors for death during follow-up among HIVinfected patients were CD4,50 cells/ml and no antiretroviral treatment (aHR 7.4, compared to patients with CD4$200; 3.0– 18.8) and Karnofsky score ,70 (2.1; 1.1–4.1); and among HIV-uninfected patients were poor adherence (missing half or more of doses) (3.5; 1.1–10.6) and duration of TB symptoms (aHR for a 1-month increase 1.9; 1.0–3.5). Conclusions: The recommended regimen for retreatment TB in Uganda yields an unacceptable proportion of unsuccessful outcomes. There is a need to evaluate new treatment strategies in these patients.Item Good adherence to HAART and improved survival in a community HIV/AIDS treatment and care programme: the experience of The AIDS Support Organization (TASO), Kampala, Uganda(BMC health services research, 2008) Abaasa, Andrew M.; Todd, Jim; Ekoru, Kenneth; Kalyango, Joan N.; Levin, Jonathan; Odeke, Emmanuel; Karamagi, Charles A. S.Poor adherence to highly active antiretroviral therapy (HAART) may result in treatment failure and death. Most reports of the effect of adherence to HAART on mortality come from studies where special efforts are made to provide HAART under ideal conditions. However, there are few reports of the impact of non-adherence to HAART on mortality from community HIV/AIDS treatment and care programmes in developing countries. We therefore conducted a study to assess the effect of adherence to HAART on survival in The AIDS Support Organization (TASO) community HAART programme in Kampala, Uganda. Methods: The study was a retrospective cohort of 897 patients who initiated HAART at TASO clinic, Kampala, between May 2004 and December 2006. A total of 7,856 adherence assessments were performed on the data. Adherence was assessed using a combination of self-report and pill count methods. Patients who took ≤ 95% of their regimens were classified as non-adherent. The data was stratified at a CD4 count of 50 cells/mm3. Kaplan Meier curves and Cox proportional hazards regression models were used in the analysis. Results: A total of 701 (78.2%) patients had a mean adherence to ART of > 95%. The crude death rate was 12.2 deaths per 100 patient-years, with a rate of 42.5 deaths per 100 patient-years for non-adherent patients and 6.1 deaths per 100 patient-years for adherent patients. Non-adherence to ART was significantly associated with mortality. Patients with a CD4 count of less than 50 cells/mm3 had a higher mortality (HR = 4.3; 95% CI: 2.22– 5.56) compared to patients with a CD4 count equal to or greater than 50 cells/mm3 (HR = 2.4; 95% CI: 1.79–2.38). Conclusion: Our study showed that good adherence and improved survival are feasible in community HIV/AIDS programmes such as that of TASO, Uganda. However, there is need to support community HAART programmes to overcome the challenges of funding to provide sustainable supplies particularly of antiretroviral drugs; provision of high quality clinical and laboratory support; and achieving a balance between expansion and quality of services. Measures for the early identification and treatment of HIV infected people including home-based VCT and HAART should be strengthened.Item Impact of Co-Infections and BCG Immunisation on Immune Responses among Household Contacts of Tuberculosis Patients in a Ugandan Cohort(PLoS ONE, 2014) Biraro, Irene A.; Egesa, Moses; Toulza, Frederic; Levin, Jonathan; Cose, Stephen; Joloba, Moses; Smith, Steven; Dockrell, Hazel M.; Katamba, Achilles; Elliott, Alison M.Tuberculosis incidence in resource poor countries remains high. We hypothesized that immune modulating co-infections such as helminths, malaria, and HIV increase susceptibility to latent tuberculosis infection (LTBI), thereby contributing to maintaining the tuberculosis epidemic. Methods: Adults with sputum-positive tuberculosis (index cases) and their eligible household contacts (HHCs) were recruited to a cohort study between May 2011 and January 2012. HHCs were investigated for helminths, malaria, and HIV at enrolment. HHCs were tested using the QuantiFERON-TB Gold In-Tube (QFN) assay at enrolment and six months later. Overnight whole blood culture supernatants from baseline QFN assays were analyzed for cytokine responses using an 11- plex Luminex assay. Associations between outcomes (LTBI or cytokine responses) and exposures (co-infections and other risk factors) were examined using multivariable logistic and linear regression models. Results: We enrolled 101 index cases and 291 HHCs. Among HHCs, baseline prevalence of helminths was 9% (25/291), malaria 16% (47/291), HIV 6% (16/291), and LTBI 65% (179/277). Adjusting for other risk factors and household clustering, there was no association between LTBI and any co-infection at baseline or at six months: adjusted odds ratio (95% confidence interval (CI); p-value) at baseline for any helminth, 1.01 (0.39–2.66; 0.96); hookworm, 2.81 (0.56–14.14; 0.20); malaria, 1.06 (0.48–2.35; 0.87); HIV, 0.74 (0.22–2.47; 0.63). HHCs with LTBI had elevated cytokine responses to tuberculosis antigens but co-infections had little effect on cytokine responses. Exploring other risk factors, Th1 cytokines among LTBIpositive HHCs with BCG scars were greatly reduced compared to those without scars: (adjusted geometric mean ratio) IFNc 0.20 (0.09–0.42), ,0.0001; IL-2 0.34 (0.20–0.59), ,0.0001; and TNFa 0.36 (0.16–0.79), 0.01. Conclusions: We found no evidence that co-infections increase the risk of LTBI, or influence the cytokine response profile among those with LTBI. Prior BCG exposure may reduce Th1 cytokine responses in LTBI.Item Model-Based Small Area Estimation Methods and Precise District-Level HIV Prevalence Estimates in Uganda(PloS one, 2021) Ouma, Joseph; Jeffery, Caroline; Awor, Colletar Anna; Muruta, Allan; Musinguzi, Joshua; Wanyenze, Rhoda K.; Biraro, Sam; Levin, Jonathan; Valadez, Joseph J.Model-based small area estimation methods can help generate parameter estimates at the district level, where planned population survey sample sizes are not large enough to support direct estimates of HIV prevalence with adequate precision. We computed district-level HIV prevalence estimates and their 95% confidence intervals for districts in Uganda.Our analysis used direct survey and model-based estimation methods, including Fay-Herriot (area-level) and Battese-Harter-Fuller (unit-level) small area models. We used regression analysis to assess for consistency in estimating HIV prevalence. We use a ratio analysis of the mean square error and the coefficient of variation of the estimates to evaluate precision. The models were applied to Uganda Population-Based HIV Impact Assessment 2016/2017 data with auxiliary information from the 2016 Lot Quality Assurance Sampling survey and antenatal care data from district health information system datasets for unit-level and area-level models, respectively.Estimates from the model-based and the direct survey methods were similar. However, direct survey estimates were unstable compared with the model-based estimates. Area-level model estimates were more stable than unit-level model estimates. The correlation between unit-level and direct survey estimates was (β1 = 0.66, r2 = 0.862), and correlation between area-level model and direct survey estimates was (β1 = 0.44, r2 = 0.698). The error associated with the estimates decreased by 37.5% and 33.1% for the unit-level and area-level models, respectively, compared to the direct survey estimates.Although the unit-level model estimates were less precise than the area-level model estimates, they were highly correlated with the direct survey estimates and had less standard error associated with estimates than the area-level model. Unit-level models provide more accurate and reliable data to support local decision-making when unit-level auxiliary information is available.Item Mycobacterium Tuberculosis Infection is Associated with Increased B Cell Responses to Unrelated Pathogens(Scientific reports, 2020) Kimuda, Simon G.; Andia‑Biraro, Irene; Sebina, Ismail; Egesa, Moses; Nalwoga, Angela; Smith, Steven G.; Bagaya, Bernard S.; Levin, Jonathan; Elliott, Alison M.; Cose, StephenAntigens from Mycobacterium tuberculosis (M.tb), have been shown to stimulate human B cell responses to unrelated recall antigens in vitro. However, it is not known whether natural M.tb infection or whether vaccination with, Mycobacterium bovis BCG, has a similar efect. This study investigated the efects of M.tb infection and BCG vaccination on B cell responses to heterologous pathogen recall antigens. Antibodies against several bacterial and viral pathogens were quantifed by ELISA in 68 uninfected controls, 62 individuals with latent TB infection (LTBI) and 107 active pulmonary TB (APTB) cases, and 24 recently BCG-vaccinated adolescents and naive controls. Antibody avidity was investigated using surface plasmon resonance and B cell ELISPOTs were used to measure plasmablast and memory B cell responses (MBC) in APTB cases and healthy donor controls. APTB was associated with higher levels of antibodies to respiratory syncytial virus and measles virus, compared to uninfected controls. BCG vaccination did not alter levels of antibodies against heterologous pathogens. Tetanus toxoid (TT)-specifc antibody avidity was increased in APTB cases in comparison to uninfected individuals and the ratio of TT-specifc plasmablasts to MBCs in the APTB cases was 7:1. M.tb infection is associated with increased antibody responses to heterologous pathogens in human subjects.Item Participation in Clinical Research Could Modify Background Risk for Trial Outcome Measures(AIDS Research and Human Retroviruses, 2014) Abaasa, Andrew M.; Asiki, Gershim; Levin, Jonathan; Bahemuka, Ubaldo; Ruzagira, Eugene; Kibengo, Freddie M.; Mulondo, Jerry; Ndibazza, Juliet; Price, Matthew A.; Fast, Pat; Kamali, AnatoliData on HIV incidence and retention are needed to inform study design of efficacy trials. However, the selection criteria and interventions during an actual clinical trial could reduce HIV incidence and thus affect the statistical power. We investigated the effect of inclusion and participation in a simulated vaccine efficacy trial (SiVET) on HIV and pregnancy incidence in a fisherfolk cohort in SW Uganda.Item Rate and Amplification of Drug Resistance among Previously-Treated Patients with Tuberculosis in Kampala, Uganda(Clinical infectious diseases, 2008) Temple, Beth; Ayakaka, Irene; Ogwang, Sam; Nabanjja, Helen; Kayes, Susan; Nakubulwa, Susan; Worodria, William; Levin, Jonathan; Joloba, Moses; Okwera, Alphonse; Eisenach, Kathleen D.; McNerney, Ruth; Elliott, Alison M.; Smith, Peter G.; Mugerwa, Roy D.; Ellner, Jerrold J.; Jones-Lopez, Edward C.Drug-resistant Mycobacterium tuberculosis has emerged as a global threat. In resource-constrained settings, patients with a history of tuberculosis (TB) treatment may have drug-resistant disease and may experience poor outcomes. There is a need to measure the extent of and risk factors for drug resistance in such patients. Methods. From July 2003 through November 2006, we enrolled 410 previously treated patients with TB in Kampala, Uganda. We measured the prevalence of resistance to first- and second-line drugs and analyzed risk factors associated with baseline and acquired drug resistance. Results. The prevalence of multidrug-resistant TB was 12.7% (95% confidence interval [95% CI], 9.6%–16.3%). Resistance to second-line drugs was low. Factors associated with multidrug-resistant TB at enrollment included a history of treatment failure (odds ratio, 23.6; 95% CI, 7.7–72.4), multiple previous TB episodes (odds ratio, 15.6; 95% CI, 5.0–49.1), and cavities present on chest radiograph (odds ratio, 5.9; 95% CI, 1.2–29.5). Among a cohort of 250 patients, 5.2% (95% CI, 2.8%–8.7%) were infected with M. tuberculosis that developed additional drug resistance. Amplification of drug resistance was associated with existing drug resistance at baseline (P ! .01) and delayed sputum culture conversion (P ! .01). Conclusions. The burden of drug resistance in previously treated patients with TB in Uganda is sizeable, and the risk of generating additional drug resistance is significant. There is an urgent need to improve the treatment for such patients in low-income countries.Item Treatment Outcomes of New Tuberculosis Patients Hospitalized in Kampala, Uganda: A Prospective Cohort Study(PLoS ONE, 2014) Kirenga, Bruce J.; Levin, Jonathan; Ayakaka, Irene; Worodria, William; Reilly, Nancy; Mumbowa, Francis; Nabanjja, Helen; Nyakoojo, Grace; Fennelly, Kevin; Nakubulwa, Susan; Joloba, Moses; Okwera, Alphonse; Eisenach, Kathleen D.; McNerney, Ruth; Elliott, Alison M.; Mugerwa, Roy D.; Smith, Peter G.; Ellner, Jerrold J.; Jones-Lopez, Edward C.In most resource limited settings, new tuberculosis (TB) patients are usually treated as outpatients. We sought to investigate the reasons for hospitalisation and the predictors of poor treatment outcomes and mortality in a cohort of hospitalized new TB patients in Kampala, Uganda Methods and findings: Ninety-six new TB patients hospitalised between 2003 and 2006 were enrolled and followed for two years. Thirty two were HIV-uninfected and 64 were HIV-infected. Among the HIV-uninfected, the commonest reasons for hospitalization were low Karnofsky score (47%) and need for diagnostic evaluation (25%). HIV-infected patients were commonly hospitalized due to low Karnofsky score (72%), concurrent illness (16%) and diagnostic evaluation (14%). Eleven HIV uninfected patients died (mortality rate 19.7 per 100 person-years) while 41 deaths occurred among the HIV-infected patients (mortality rate 46.9 per 100 person years). In all patients an unsuccessful treatment outcome (treatment failure, death during the treatment period or an unknown outcome) was associated with duration of TB symptoms, with the odds of an unsuccessful outcome decreasing with increasing duration. Among HIV-infected patients, an unsuccessful treatment outcome was also associated with male sex (P = 0.004) and age (P = 0.034). Low Karnofsky score (aHR = 8.93, 95% CI 1.88 – 42.40, P = 0.001) was the only factor significantly associated with mortality among the HIV-uninfected. Mortality among the HIV-infected was associated with the composite variable of CD4 and ART use, with patients with baseline CD4 below 200 cells/mL who were not on ART at a greater risk of death than those who were on ART, and low Karnofsky score (aHR = 2.02, 95% CI 1.02 – 4.01, P = 0.045). Conclusion: Poor health status is a common cause of hospitalisation for new TB patients. Mortality in this study was very high and associated with advanced HIV Disease and no use of ART.Item War related sexual violence and it’s medical and psychological consequences as seen in Kitgum, Northern Uganda: A cross-sectional study(BMC International Health and Human Rights 2, 2010) Kinyanda, Eugene; Musisi, Seggane; Biryabarema, Christine; Ezati, Isaac; Oboke, Henry; Ochieng, Ruth Ojiambo-; Oguttu, Juliet Were; Levin, Jonathan; Grosskurth, Heiner; Walugembe, JamesBackground: Despite the recent adoption of the UN resolution 1820 (2008) which calls for the cessation of war related sexual violence against civilians in conflict zones, Africa continues to see some of the worst cases of war related sexual violence including the mass sexual abuse of entire rural communities particularly in the Great Lakes region. In addition to calling for a complete halt to this abuse, there is a need for the systematic study of the reproductive, surgical and psychological effects of war related sexual violence in the African socio-cultural setting. This paper examines the specific long term health consequences of war related sexual violence among rural women living in two internally displaced person’s camps in Kitgum district in war affected Northern Uganda who accessed the services of an Isis-Women’s International Cross Cultural Exchange (Isis-WICCE) medical intervention. Methods: The study employed a purposive cross-sectional study design where 813 respondents were subjected to a structured interview as part of a screening procedure for an emergency medical intervention to identify respondents who required psychological, gynaecological and surgical treatment. Results: Over a quarter (28.6%) of the women (n = 573) reported having suffered at least one form of war related sexual violence. About three quarters of the respondents had ‘at least one gynaecological complaint’ (72.4%) and ‘at least one surgical complaint’ (75.6%), while 69.4% had significant psychological distress scores (scores greater than or equal to 6 on the WHO SRQ-20). The factors that were significantly associated with war related sexual violence were the age group of less than or equal to 44 years, being Catholic, having suffered other war related physical trauma, and having ‘at least one gynaecological complaint’. The specific gynaecological complaints significantly associated with war related sexual violence were infertility, chronic lower abdominal pain, abnormal vaginal bleeding, and sexual dysfunction. In a multivariable analysis the age group of less than or equal to 44 years, being Catholic and having ‘at least one gynaecological complaint’ remained significantly associated with war related sexual violence. Conclusion: The results from this study demonstrate that war related sexual violence is independently associated with the later development of specific gynaecological complaints.Item Willingness to participate in preventive HIV vaccine trials in a community-based cohort in South Western Uganda(Tropical medicine & international health, 2009) Ruzagira, Eugene; Wandiembe, Symon; Bufumbo, Leonard; Levin, Jonathan; Price, Matthew A.; Grosskurth, Heiner; Kamali, AnatoliTo assess willingness to participate in HIV vaccine trials and possible barriers to participation. methods Questionnaire survey of participants completing a 2-year community-based HIV Vaccine Preparedness Study, followed by cross sectional analysis of data. results 95% of participants were willing to participate in a trial with similar attributes to the Vaccine Preparedness Study. Certain hypothetical trial attributes significantly reduced willingness to participate: The requirement to delay pregnancy (for females) had the largest effect, reducing willingness to participate from 97% to 23% (P < 0.0001). Larger blood draws had the second largest effect: 95–55% (P < 0.0001). The possibility of receiving either candidate vaccine or placebo had the third largest effect: 95–73% (P < 0.0001). Monthly study visits had the fourth largest effect: 95–92% (P < 0.0001). Trial duration longer than 2 years had the least effect: 95–93% (P = 0.0025). Combined attributes reduced willingness to participate from 95% to 43% (McNemar’s v2 = 521.00; P < 0.0001) overall and 97–11% (McNemar’s v2 = 531.00; P < 0.0001) for female participants. Physical harm concerns (adjusted OR = 34.9; 95% CI, 10.4–118) and a low risk behaviour index (adjusted OR = 0.09; 95% CI, 0.01–0.73) were associated with unwillingness to participate. conclusions We found a high level of willingness to participate in HIV vaccine trials in this population. However, certain HIV vaccine trial requirements were associated with reduced willingness to participate. Community as well as individual concerns will have to be carefully addressed in planned HIV vaccine trials.