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Objective: To assess the safety of dextrin sulphate (DS) gel compared to placebo gel in terms of local and systemic adverse events, and to determine the acceptability of dextrin sulphate gel., Design: A 4-week randomized trial of DS intra-vaginal gel, partially blinded, with placebo and observation control arms. Participants were randomized to use DS gel twice daily, placebo gel twice daily, DS gel pre-sex, or into an observation only arm., Methods: Sexually active women were recruited from post natal and HIV clinics at Nsambya Hospital, Kampala, Uganda. Screening, enrollment and follow-up visits took place every 1 or 2 weeks over an 8-week period and consisted of questionnaire interviews, colposcopy examinations, sexually transmitted infection screen and routine laboratory testing., Results: Out of a total of 172 women screened, 109 were randomized to use DS gel twice daily (65 women), placebo gel twice daily (15 women), DS gel pre-sex (nine women) or into an observation only arm (20 women). Two individuals had abnormal colposcopy findings in the DS twice daily gel use arm. Vaginal bleeding was reported as frequently by participants in the active gel arm as by participants in the placebo and observation only arms. No clinically significant difference was observed between arms in terms of vaginal flora, Candida, haemoglobin, white cell count, platelets, thrombin time, activated partial thromboplastin time, creatinine and aspartate aminotransferase results after 4 weeks of gel use. DS gel appeared to be acceptable to over 95% of the users., Conclusions: Results show a satisfactory safety and acceptability profile of dextrin sulphate gel.

Background: Adults with dual tuberculosis (TB) and HIV infection have a poor outcome. Studies in West Africa suggest that cotrimoxazole prophylaxis may reduce this mortality., Objective: To evaluate the effectiveness of cotrimoxazole in reducing mortality in adults with active TB, irrespective of HIV status, in a high prevalence setting., Design: Cohort study using historical controls., Methods: Adults treated for TB between 1998 and 2000 were traced and vital status at 6 months ascertained (2004: control group). All adults starting treatment for TB between June 2001 and June 2002 were offered cotrimoxazole prophylaxis 960 mg once daily for 6 months during TB treatment irrespective of HIV status (1321: intervention group). Mortality, adverse reactions and adherence were compared between intervention and control groups., Results: HIV seroprevalence in patients with TB at the start of the intervention was estimated to be 78%. Mortality at 6 months was 29% lower in the group given cotrimoxazole than in the control group. The number needed to treat to prevent one death during the period of TB treatment was 24. The benefit was seen across all types of TB but was only evident in new patients; patients being retreated had similar outcomes in both groups. Adverse events were infrequent and minor, with only two participants having treatment stopped for this reason., Conclusion: Cotrimoxazole prophylaxis for all adults with TB, irrespective of HIV status, in an area of high HIV seroprevalence may be a feasible, safe and effective way to reduce mortality for the duration of treatment.

Background: The AIDS epidemic is now more than a decade old and direct evidence of mortality impact has become measurable, as indicated by an increasing number of publications presenting empirical data from less developed countries., Methods: This review focuses on the evidence of mortality impact among adults and children in community studies. The majority of these studies are located in Africa, particularly eastern Africa, where the AIDS epidemic is conjectured to be older than in other less developed countries., Results: Community studies show a two- to threefold increase in total adult mortality with an even larger increase in mortality among young adults in communities with adult HIV prevalence levels below 10%. Mortality amongst HIV-infected adults ranges from 5 to 11% per year, and more than half of all adult deaths can be attributed to HIV. HIV-infected women die at an earlier age than men and thereby lose significantly more productive years of life. Follow-up studies of incident cases are few, but population-based data indicate that the median survival time is substantially longer than originally thought on the basis of mortality amongst HIV-infected commercial sex workers. Tuberculosis incidence is on the increase, but evidence of additional impact on mortality is hitherto limited. Infant and early child mortality among children of HIV-infected mothers is two to five times higher than among children of HIV-negative mothers in follow-up studies of maternity-based and community samples., Conclusion: There is now empirical evidence of the mortality impact of HIV/AIDS from several community studies. The large increase in adult mortality and moderate increase in child mortality lead to dramatic falls in life expectancy. For instance, in a rural area of Uganda, which has an HIV prevalence of 8%, life expectancy has dropped from just under 60 years to 42.5 years.

Objective: To study the association between change of residence and HIV-1 serostatus in a rural Ugandan population., Design: A longitudinal cohort study., Methods: As part of the annual surveillance of a population cohort of approximately 10,000 individuals in a rural subcounty of southwest Uganda, information has been collected for all adults on change of residence over a 3-year period and its association with HIV-1 serostatus. Sera were collected by a medical team during home visits. Antibody testing was performed at the Uganda Virus Research Institute using two independent enzyme immunoassay systems and Western blot when appropriate., Results: At the fourth survey-round, age and sex-standardized seroprevalence rates were 7.9% overall; the rate was 5.5% for 2,129 adults who had not changed address since the first survey, 8.2% for 336 who moved within the village, 12.4% for 128 who moved to a neighbouring village, 11.5% for 1,130 who had left the area and 16.3% for 541 who had joined the study area during the previous 3 years (P << 0.001, 4 degrees of freedom). We also observed an inverse relationship between years lived at the present house at the time of the first survey and both seroprevalence and subsequent seroincidence rates. The reported numbers of lifetime sexual partners were higher in those who changed residence., Conclusion: Change of residence is strongly associated with an increased risk of HIV-1 infection in this rural population and is likely to be the result of more risky sexual behaviour among those who move. These findings have important implications for the design of AIDS control programmes and intervention studies.

Objective: To study in depth sexual history and sexual behaviour variables as risk factors for HIV-1 infection in a rural Ugandan population., Methods: Following a socioeconomic and serological survey of a rural population in Masaka District, south-west Uganda, 233 randomly selected HIV-1-positive cases and 233 negative controls matched on age and village of residence, were invited in October 1990 to participate in a case-control study. A total of 132 cases and 161 controls attended for in-depth investigation including an interview about sexual behaviour., Results: The factor most strongly associated with increased risk of infection was a greater number of lifetime sexual partners, with odds ratios (OR) of 2.1 and 4.9 for those reporting 4-10 and 11 or more partners, respectively, compared with those reporting less than four partners. Having only one sexual partner did not provide complete protection, a total of seven (one male, six female) subjects reporting only one sexual partner were HIV-1-positive. Other significant factors were a history of genital ulcers [OR, 2.9; 95% confidence intervals (CI), 1.0-9.1) and not being a Muslim (OR, 5.4; 95% CI, 1.8-16.5) suggesting a possible protective effect of circumcision. There was a suggestion that those who married within the last 7 years (OR, 2.4; 95% CI, 0.9-6.1) and men exposed to menstrual blood (OR, 5.7; 95% CI, 0.7-49.8) were at an increased risk of HIV-1 infection., Conclusions: These results confirm the predominant role of sexual behaviour in the HIV-1 epidemic. Of particular concern is the observation of HIV-1 infection among those reporting only one partner. Where HIV-1 infection is widely distributed in the general population, risk reduction strategies should, in addition to the promotion of partner reduction, place strong emphasis on safe-sex techniques.

Objective: To determine the incidence of HIV-1 infection and HIV-1-associated mortality in a rural Ugandan population., Design: A prospective cohort study., Methods: A cohort consisting of the population (de jure census 9820) of a cluster of 15 villages in Masaka District, south-west Uganda was enrolled between 1989 and 1990 through a demographic and medical survey. The HIV-1 seroprevalence rate was 4.8% for all ages combined and 8.2% for those aged 13 years or more. The survey was repeated after 1 year., Results: The 1-year HIV-1 incidence rate among adults was 1% [9.2 per 1000 person-years of observation; 95% confidence interval (CI), 5.5-12.9). A total of 84 deaths were observed. In adults, half of all deaths (31 out of 60) were in HIV-1-seropositive individuals. The age-adjusted overall mortality rate ratio for HIV-positive adults compared with HIV-negatives was 20.8 (95% CI, 12.0-35.7). In the 13-44 age group the corresponding rate ratios for men, women and both sexes combined were 16.3, 108.9 and 58.7, respectively. The HIV-attributable mortality fractions, i.e., the proportion of deaths that would have been avoided in the absence of HIV, were 44, 50 and 89% for adult men, adult women and adults aged 25-34 years (both sexes combined), respectively. The 1-year progression to death among HIV-1-seropositive adults was 10.3%., Conclusion: These results demonstrate the profound impact that the HIV-1 epidemic has on adult mortality in a rural area of Uganda where the HIV-1 prevalence and incidence rates in adults are 8 and 1%, respectively.

Objective: To determine sociodemographic risk factors associated with HIV-1 infection in a rural Ugandan population., Design: A population-based survey., Methods: All adult residents (aged > or = 13 years) in a cluster of 15 neighbouring villages of the Masaka District of south-west Uganda were invited to participate in a sociodemographic and serological survey. Questions relating to sexual behaviour were asked separately in an accompanying case-control study. Socioeconomic data and an unambiguous HIV-1 serostatus were obtained by house-to-house survey for 3809 (72%) of the adult population. The association between serostatus and the following variables were analysed: age, sex, marital status, tribe, religion, education, occupational group, place and frequency of travel and recent history of sexually transmitted disease., Results: Women aged 13-21 years were at a much higher risk than men of the same age [odds ratio (OR), 8.6; 95% confidence interval (CI), 3.0-24.5]. Married people aged < 25 years were twice as likely to be infected as those who were not currently married (OR, 2.3; 95% CI, 1.5-3.7). In contrast, in those aged > or = 25 years, women were at a lower risk than men (OR, 0.72; 95% CI, 0.52-0.98) as were those who were currently married compared with those who were not (OR, 0.47; 95% CI, 0.34-0.64). In both age groups those with a history of a recent genital ulcer were approximately three times more likely to be infected. Muslims had lower risks than non-Muslims (OR, 0.58 for both age groups)., Conclusions: The people most at risk of HIV-1 infection in this rural Ugandan population are young married women who had, presumably, commenced sexual activity recently.

Objectives: The AIDS epidemic in sub-Saharan Africa affects whole communities, adding to the already high burden of morbidity. Reports of AIDS cases are usually from hospital attenders, often diagnosed using the World Health Organization (WHO) clinical case definition. Little is known about the extent of HIV-associated morbidity in the general population. The objectives of this study were to describe the prevalence of (1) markers of general morbidity and (2) the criteria of the WHO clinical case definition for AIDS and (3) to determine the association between these markers and HIV-1 serostatus in a rural Ugandan community., Methods: A survey was conducted among the adult population (aged > or = 13 years) of 15 neighbouring villages in Masaka District, south-west Uganda. The survey included medical history, physical examination and testing for HIV-1 antibodies., Results: The HIV-1 seroprevalence among 4175 out of 5278 (79%) eligible adults was 8.2%. Current health problems were reported by 57.6% of adults, with increased rates in HIV-1-positive subjects, women and older people. Five of the 10 most common complaints showed significant associations with HIV-1 status, as did reported genital ulcer and vaginal discharge. The crude HIV-1 attributable disease burden in the population was 1.2% for current illness, 4.3% for previous serious illness and 9.9% for illness leading to hospital admission. Overall, 11 (3.3%) of the HIV-1-positive and nine (0.2%) of the HIV-1-negative subjects had AIDS as defined by the clinical case definition. The positive and negative predictive values and specificity were 55.0, 92.0%, and 99.8%, respectively., Conclusions: Against a background of high general morbidity, we observed a relatively small population attribution of HIV-1-associated morbidity. The results indicate that the clinical AIDS case definition may provide a useful tool for population surveys.

Objective: To evaluate an algorithm using two enzyme immunoassays (EIA) for anti-HIV-1 antibodies in a rural African population and to assess alternative simplified algorithms., Methods: Sera obtained from 7895 individuals in a rural population survey were tested using an algorithm based on two different EIA systems: Recombigen HIV-1 EIA and Wellcozyme HIV-1 Recombinant. Alternative algorithms were assessed using negative or confirmed positive sera., Results: None of the 227 sera classified as unequivocably negative by the two assays were positive by Western blot. Of 192 sera unequivocably positive by both assays, four were seronegative by Western blot. The possibility of technical error cannot be ruled out in three of these. One of the alternative algorithms assessed classified all borderline or discordant assay results as negative had a specificity of 100% and a sensitivity of 98.4%. The cost of this algorithm is one-third that of the conventional algorithm., Conclusions: Our evaluation suggests that high specificity and sensitivity can be obtained without using Western blot and at a considerable reduction in cost.