HIV Pre-exposure Prophylaxis (PrEP) Care in Belgium: A mixed-methods Study on PrEP Users' Experiences and Service Delivery Preferences.

In Belgium, HIV pre-exposure prophylaxis (PrEP) services are mainly provided through specialised HIV clinics. To optimise PrEP uptake and retention in care, we require insights into users' perspectives on PrEP care. We aimed to elicit experiences with, and preferences for, PrEP service delivery among PrEP users in Belgium, including willingness to involve their family physician (FP) in PrEP care. We adopted a sequential mixed-methods design. We used a web-based longitudinal study among 326 PrEP users that consisted of two questionnaires at six-month intervals, and complemented this with 21 semi-structured interviews (September 2020-January 2022). We conducted descriptive analyses and logistic regression to examine factors associated with willingness to involve their FP in PrEP care. Interviews were analysed using thematic analysis. Survey respondents reported high satisfaction with care received in HIV clinics [median score 9 (IQR 8-10), 10='very satisfied']. Interviews revealed the importance of regular HIV/STI screening, and the expertise and stigma-free environment of HIV clinics. Yet, they also contextualised service delivery barriers reported in the questionnaire, including the burden of cost and challenges integrating PrEP visits into their private and professional lives. Although 63.8% (n = 208/326) of baseline respondents preferred attending an HIV clinic for PrEP follow-up, 51.9% (n = 108/208) of participants in the follow-up questionnaire reported to be willing to have their FP involved in PrEP care. Participants reporting trust in FPs' PrEP and sexual health expertise, or who didn't feel judged by their FP, were more likely to be willing to involve them in PrEP care. Therefore, we recommend a differentiated PrEP service delivery approach, including involving FPs, to make PrEP care more client-centred.

Opportunities for improved indicator-based HIV testing in the hospital setting: a structural equation model analysis.

Indicator condition (IC)-guided HIV testing, i.e., testing when diagnosing a condition associated with HIV, is a feasible and cost-effective testing strategy to identify undiagnosed individuals. Assessing determinants for IC-guided testing may identify opportunities for improvement. A survey study based on the Theory of Planned Behaviour (TPB) was conducted among 163 hospital physicians from five specialties in Amsterdam, the Netherlands. Structural equation models were used to determine the association between the TPB domains (i.e., attitude, belief, norms, self-efficacy and behavioural control) and (1) the intention to test as a mediator for HIV testing behaviour (intentional model) and (2) actual HIV testing behaviour (direct model). Both models accounted for the effect of guideline recommendations. Behaviour scored lower than intention on a five-point scale (mean score of 2.8, SD = 1.6 versus 3.8, SD = 1.1; p<0.0001). The direct model had a better fit than the intentional model based on fit statistics. Discrepancies between the determinants most important for intention versus those for behaviour led to the following recommendations: interventions to improve IC-guided testing in hospitals should primarily focus on implementation of guideline recommendations, followed by improving physicians' attitude towards IC-guided HIV testing and self-efficacy, as these were the most important correlates of actual HIV testing behaviour.

Patterns of PrEP and condom use among PrEP users in Belgium: a web-based longitudinal study.

BACKGROUND: Tailoring pre-exposure prophylaxis (PrEP) service delivery is key to scaling-up PrEP uptake. Optimal implementation of tailored services requires, among other things, insights into patterns of PrEP use, sexual behaviours and condom use over time. METHODS: Between September 2020 and January 2022, we conducted a web-based, longitudinal study among PrEP users in Belgium. In three questionnaire rounds every six-months, we assessed PrEP and condom use, and sex with steady, casual and anonymous partners in the preceding three months. Based on the patterns of PrEP use in the preceding three months, we identified distinct PrEP use categories. We investigated differences in baseline socio-demographics and sexual behaviours by PrEP use category using Fisher's exact and one-way ANOVA tests. Patterns in PrEP and condom use over time were examined using descriptive analyses and visualised in alluvial diagrams. RESULTS: In total, 326 participants completed the baseline questionnaire, and 173 completed all three questionnaires. We identified five distinct PrEP use categories: daily (≥ 90 pills), almost daily (75-89 pills), long period (> 7 consecutive days and < 75 pills) with or without additional short period use, short period (1-7 consecutive days and < 75 pills) and no PrEP use (0 pills). During the study, percentages of individuals in each PrEP use category varied, but did not change significantly over time. At baseline, daily and almost daily users were more likely to report five or more casual sex partners, ten or more anonymous sex partners and anal sex on a weekly basis with casual or anonymous partners compared to those using PrEP for long or short periods. Up to 12.6% (n = 16/127) of participants reporting anal sex with casual or anonymous partners, indicated always using condoms and PrEP with these partners. One in three (n = 23/69) participants who reported anal sex with steady partners had condomless anal sex and did not use PrEP with these partners; with casual or anonymous partners less than 3% reported this. CONCLUSIONS: Our findings show that there is little variation in PrEP use over time and that PrEP use was associated with sexual behaviours, which could be taken into account when designing tailored PrEP care.

Offering a choice of daily and event-driven preexposure prophylaxis for men who have sex with men in the Netherlands: a cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of a preexposure prophylaxis (PrEP) programme offering a choice of daily and event-driven PrEP for men who have sex with men (MSM) in the Netherlands. METHODS: We used an agent-based transmission model and an economic model to simulate a programme offering only daily PrEP and a programme offering daily and event-driven PrEP. Use of PrEP medication and preference for daily versus event-driven PrEP were estimated from the Amsterdam PrEP Demonstration Project (AMPrEP). We calculated costs, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICER), over 2018-2027. An ICER less than €20 000 per QALY gained was considered cost-effective. RESULTS: Using AMPrEP data, we estimated that 27% of PrEP users chose event-driven PrEP with a median of 12 pills per month; daily PrEP users used a median of 30 pills per month. With PrEP, 3740 HIV infections were averted and 1482 QALYs were gained over 2018-2027, compared to the scenario without PrEP. The probability of the PrEP programme being cost-effective (compared to not having a PrEP programme) increased from 91% with daily PrEP to 94% with a choice of daily and event-driven PrEP. The probability of being cost-saving increased from 42% with only daily PrEP to 48% with choice of daily and event-driven PrEP. CONCLUSIONS: A daily PrEP programme for MSM would be cost-effective. Providing a choice of daily and event-driven PrEP can result in savings and is more likely to be cost-effective and cost-saving, compared to a programme offering only daily PrEP.

Preexposure prophylaxis for men who have sex with men in the Netherlands: impact on HIV and Neisseria gonorrhoeae transmission and cost-effectiveness.

OBJECTIVES: To assess the impact of a preexposure prophylaxis (PrEP) programme for high-risk men who have sex with men (MSM), which includes gonorrhoea testing and treatment, on the transmission of HIV and Neisseria among MSM in the Netherlands and the cost-effectiveness of such programme with and without risk compensation (in the form of reduced condom use). METHODS: We developed a stochastic agent-based transmission model of HIV and gonorrhoea. We simulated a capped (max 2.5% of MSM) and uncapped (5.5% of MSM in 2018 declining to 3% in 2027) daily PrEP programme for high-risk MSM, with 3-monthly HIV and gonorrhoea testing, with and without risk compensation. Epidemiological outcomes were calculated from the transmission model and used in an economic model to calculate costs, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICER), over 2018-2027, taking a healthcare payer perspective. RESULTS: Without risk compensation, PrEP can lead to a reduction of 61 or 49% in the total number of new HIV infections in 2018-2027, if the programme is uncapped or capped to 2.5% of MSM, respectively. With risk compensation, this reduction can be 63 or 46% in the uncapped and capped programmes, respectively. In all scenarios, gonorrhoea prevalence decreased after introducing PrEP. Without risk compensation, 92% of simulations were cost-effective (of which 52% cost-saving). With risk compensation, 73% of simulations were cost-effective (of which 23% was cost-saving). CONCLUSION: A nationwide PrEP programme for high-risk MSM can result in substantial reductions in HIV and gonorrhoea transmission and be cost-effective, even with risk compensation.

Change in sexual risk behaviour after 6 months of pre-exposure prophylaxis use: results from the Amsterdam pre-exposure prophylaxis demonstration project.

OBJECTIVE: HIV pre-exposure prophylaxis (PrEP) use may lead to higher STI incidence via behavioural risk compensation. We examined changes in sexual behaviour between baseline and 6 months after PrEP initiation among MSM and transgender women (TGW). DESIGN: Prospective, open-label demonstration study at a large sexually transmitted infection (STI) clinic in Amsterdam, the Netherlands. METHODS: Participants answered questions about sexual behaviour in the preceding 3 months, including number of anal sex partners and frequency of anal sex with and without condom by partner type and were tested for STI. Sexual behaviour at baseline was compared with 6 months after PrEP initiation using Wilcoxon signed rank tests. Logistic regression was used to identify factors associated with an increase in receptive condomless anal sex acts (rCASa) with casual partners. RESULTS: Data were available for 328 (99%) MSM and 2 (1%) TGW. The number of receptive and insertive condomless anal sex acts (CASa) increased (baseline: median 11, interquartile range 4-23; 6 months: median 14, interquartile range 6-26, P < 0.001), whereas the number of anal sex partners (P = 0.2) and anal sex acts (P = 0.8) remained unchanged. Prevalence of STI was stable. Older age, prior engagement in chemsex, recent use of postexposure prophylaxis and choosing a daily PrEP regimen at baseline were associated with an increase in rCASa with casual partners. CONCLUSION: Over the first 6 months after initiation of PrEP, an increase in insertive and receptive CASa with casual partners was observed. Long-term follow-up data are needed and STI incidence needs to be closely monitored.

Predicting the extinction of HIV-2 in rural Guinea-Bissau.

OBJECTIVE: This article predicts the future epidemiology of HIV-2 in Caió, a rural region of Guinea Bissau; and investigates whether HIV-2, which has halved in prevalence between 1990 and 2007 and is now almost absent in young adults in Caió, can persist as an infection of the elderly. DESIGN: A mathematical model of the spread of HIV-2 was tailored to the epidemic in Caió, a village in Guinea-Bissau. METHODS: An age-stratified difference equation model of HIV-2 transmission was fitted to age-stratified HIV-2 incidence and prevalence data from surveys conducted in Caió in 1990, 1997 and 2007. A stochastic version of the same model was used to make projections. RESULTS: HIV-2 infection is predicted to continue to rapidly decline in Caió such that new infections will cease and prevalence will reach low levels (e.g. below 0.1%) within a few decades. HIV-2 is not predicted to persist in the elderly. CONCLUSION: HIV-2 is predicted go extinct in Caió during the second half of this century.

The importance of partnership factors and individual factors associated with absent or inconsistent condom use in heterosexuals: a cross-sectional study.

OBJECTIVES: Decisions to use condoms are made within partnerships. We examined the associations between inconsistent or no condom use and individual and partnership characteristics. We also examined the relative importance of individual versus partnership factors. METHODS: Cross-sectional study of heterosexual individuals enrolled from the sexually transmitted infections (STI) outpatient clinic in Amsterdam, the Netherlands, from May to August 2010. Participants completed a questionnaire about sexual behaviour with the last four partners in the preceding year. Participant and partnership factors associated with inconsistent or no condom use in steady and casual partnerships were identified. RESULTS: 2144 individuals were included, reporting 6401 partnerships; 54.7% were female, the median age was 25 (IQR 22-30) years and 79.9% were Dutch. Inconsistent or no condom use occurred in 86.1% of 2387 steady partnerships and in 66.5% of 4014 casual partnerships. There was statistical evidence of associations between inconsistent condom use in steady partnerships and ethnic concordance, longer duration, higher number of sex acts, practising anal sex, and sex-related drug use. In casual partnerships, associations were found with having an older partner, ethnic concordance, longer duration, higher number of sex acts, anal sex, sex-related drug use, ongoing partnerships and concurrency. In multivariable models, partnership factors explained 50.9% of the variance in steady partnerships and 70.1% in casual partnerships compared with 10.5% and 15.4% respectively for individual factors. CONCLUSIONS: Among heterosexual STI clinic attendees in Amsterdam, partnership factors are more important factors related with inconsistent condom use than characteristics of the individual.

The effects of female sex, viral genotype, and IL28B genotype on spontaneous clearance of acute hepatitis C virus infection.

UNLABELLED: Although 20%-40% of persons with acute hepatitis C virus (HCV) infection demonstrate spontaneous clearance, the time course and factors associated with clearance remain poorly understood. We investigated the time to spontaneous clearance and predictors among participants with acute HCV using Cox proportional hazards analyses. Data for this analysis were drawn from an international collaboration of nine prospective cohorts evaluating outcomes after acute HCV infection. Among 632 participants with acute HCV, 35% were female, 82% were Caucasian, 49% had interleukin-28 (IL28)B CC genotype (rs12979860), 96% had injected drugs ever, 47% were infected with HCV genotype 1, and 7% had human immunodeficiency virus (HIV) coinfection. Twenty-eight percent were HCV antibody negative/RNA positive at the time of acute HCV detection (early acute HCV). During follow-up, spontaneous clearance occurred in 173 of 632, and at 1 year after infection, 25% (95% confidence interval [CI]: 21, 29) had cleared virus. Among those with clearance, the median time to clearance was 16.5 weeks (IQR: 10.5, 33.4), with 34%, 67%, and 83% demonstrating clearance at 3, 6, and 12 months. Adjusting for age, factors independently associated with time to spontaneous clearance included female sex (adjusted hazards ratio [AHR]: 2.16; 95% CI: 1.48, 3.18), IL28B CC genotype (versus CT/TT; AHR, 2.26; 95% CI: 1.52, 3.34), and HCV genotype 1 (versus non-genotype 1; AHR: 1.56; 95% CI: 1.06, 2.30). The effect of IL28B genotype and HCV genotype on spontaneous clearance was greater among females, compared to males. CONCLUSIONS: Female sex, favorable IL28B genotype, and HCV genotype 1 are independent predictors of spontaneous clearance. Further research is required to elucidate the observed sex-based differences in HCV control.

Adherence to tuberculosis treatment, sputum smear conversion and mortality: a retrospective cohort study in 48 Rwandan clinics.

BACKGROUND: Adherence to treatment and sputum smear conversion after 2 months of treatment are thought to be important for successful outcome of tuberculosis (TB) treatment. METHODS: Retrospective cohort study of new adult TB patients diagnosed in the first quarter of 2007 at 48 clinics in Rwanda. Data were abstracted from TB registers and individual treatment charts. Logistic regression analysis was done to examine associations between baseline demographic and clinical factors and three outcomes adherence, sputum smear conversion at two months, and death. RESULTS: Out of 725 eligible patients the treatment chart was retrieved for 581 (80%). Fifty-six (10%) of these patients took <90% of doses (defined as poor adherence). Baseline demographic characteristics were not associated with adherence to TB treatment, but adherence was lower among HIV patients not taking antiretroviral therapy (ART); p = 0.03). Sputum smear results around 2 months after start of treatment were available for 220 of 311 initially sputum-smear-positive pulmonary TB (PTB+) patients (71%); 175 (80%) had achieved sputum smear conversion. In multivariable analysis, baseline sputum smear grade (odds ratio [OR] = 2.7, 95% Confidence interval [CI] 1.1-6.6 comparing smear 3+ against 1+) and HIV infection (OR 3.0, 95%CI 1.3-6.7) were independent predictors for non-conversion at 2 months. Sixty-nine of 574 patients (12%) with known TB treatment outcomes had died. Besides other known determinants, poor adherence had an independent, strong effect on mortality (OR 3.4, 95%CI 1.4-7.8). CONCLUSION: HIV infection is an important independent predictor of failure of sputum smear conversion at 2 months among PTB+ patients. Poor adherence to TB treatment is an important independent determinant of mortality.

Frequency and predictors for late start of antiretroviral therapy in primary care clinics, Kampala, Uganda.

BACKGROUND: Access to antiretroviral treatment (ART) has improved greatly in many parts of the world, including Uganda, yet, many patients delay to start ART even when registered within the HIV services. We assessed, in a routine ambulatory care setting, what proportion of patients start ART late and the associated factors. METHODS: We conducted a cross-sectional study from a cohort of adult, HIV-infected, ART-naive patients seeking care at 3 primary care centers in Kampala, Uganda. ART eligibility at the time was World Health Organization clinical stage 4 or CD4 <200 cells/µL. We defined late start of ART as starting ART at CD4 count <100 cells/µL and analyzed associated factors using multivariable logistic regression. RESULTS: Between May 2008 and August 2009, 326 adults were studied. Two hundred eighteen (67%) were women; the median age was 34 years (range, 18-71). The median CD4 count was 132 cells/µL (range, 1-505). Thirty-one patients (10%) were in World Health Organization stage 4. One hundred twenty-three patients (37.7%) were initiated on ART with CD4 cells <100 cells/µL. Being male [adjusted OR (aOR): 2.4; 95% confidence interval: 1.3 to 4.2, P = 0.002] and having no employment (aOR: 1.9; 95% confidence interval: 1.2 to 3.3, P = 0.012) were associated with late start of ART. Being older, being married, and showing signs of alcohol dependence were associated with an earlier start of ART. CONCLUSIONS: A considerable proportion of patients started ART at very low CD4 counts. Male and unemployed patients were more likely and married people and those aged 40 years or older were less likely to start ART late.

Influence of HLA class I and HLA-KIR compound genotypes on HIV-2 infection and markers of disease progression in a Manjako community in West Africa.

Overall, the time to AIDS after HIV-2 infection is longer than with HIV-1, and many individuals infected with HIV-2 virus remain healthy throughout their lives. Multiple HLA and KIR gene products have been implicated in the control of HIV-1, but the effect of variation at these loci on HIV-2 disease is unknown. We show here for the first time that HLA-B*1503 is associated significantly with poor prognosis after HIV-2 infection and that HLA-B*0801 is associated with susceptibility to infection. Interestingly, previous data indicate that HLA-B*1503 is associated with low viral loads in HIV-1 clade B infection but has no significant effect on viral load in clade C infection. In general, alleles strongly associated with HIV-1 disease showed no effect in HIV-2 disease. These data emphasize the unique nature of the effects of HLA and HLA/KIR combinations on HIV-2 immune responses relative to HIV-1, which could be related to their distinct clinical course.

Cause of death among people with retroviral infection in rural Guinea-Bissau.

HIV-2 and HTLV-1 infection are both associated with increased mortality, but the causes of death are not well known. Relatives of 84 deceased persons from a rural part of Guinea-Bissau were interviewed using a standardised verbal autopsy questionnaire in the context of a large longitudinal community cohort study. The results were reviewed by two doctors to conclude cause of death. A cause of death was agreed upon for 49/84 subjects. Nineteen of these 49 were infected with HIV-2 alone and 7 with both HIV-2 and HTLV-1. Among these, the main causes of death were pulmonary tuberculosis (n = 5), AIDS (n = 5), cerebrovascular accident (n = 5), sepsis (n = 3) and hepatocellular carcinoma (n = 2). Death associated with traditional HIV-related causes were implicated in 13/26 (50%) of those with HIV-2.

Low HIV testing rates among tuberculosis patients in Kampala, Uganda.

BACKGROUND: HIV testing among tuberculosis patients is critical in improving morbidity and mortality as those found to be HIV positive will be offered a continuum of care including ART if indicated. We conducted a cross-sectional study in three Kampala City primary care clinics: to assess the level of HIV test uptake among newly diagnosed pulmonary tuberculosis (PTB) patients; to assess patient and health worker factors associated with HIV test uptake; and to determine factors associated with HIV test uptake at the primary care clinics METHODS: Adult patients who had been diagnosed with smear-positive PTB at a primary care clinic or at the referral hospital and who were being treated at any of the three clinics were interviewed. Associations between having taken the test as the main outcome and explanatory variables were assessed by multivariate logistic regression. RESULTS: Between April and October 2007, 112 adults were included in the study. An HIV test had been offered to 74 (66%). Of the 112 patients, 61 (82%) had accepted the test; 45 (74%) had eventually been tested; and 32 (29%) had received their test results.Patients who were <25 yeas old, female or unemployed, or had reported no previous HIV testing, were more likely to have been tested. The strongest predictor of having been tested was if patients had been diagnosed at the referral hospital compared to the city clinic (adjusted OR 24.2; 95% CI 6.7-87.7; p < 0.001). This primarily reflected an "opt-out" (uptake 94%) versus an "opt-in" (uptake 53%) testing policy. CONCLUSIONS: The overall HIV test uptake was surprisingly low at 40%. The HIV test uptake was significantly higher among TB patients who were identified at hospital, among females and in the unemployed.

Two distinct epidemics: the rise of HIV-1 and decline of HIV-2 infection between 1990 and 2007 in rural Guinea-Bissau.

OBJECTIVES: To assess changes in HIV incidence and prevalence in Caió, a rural area of Guinea-Bissau, between 1990 and 2007. DESIGN: Three cross-sectional community surveys. METHODS: In 1990, 1997, and 2007, surveys were conducted among adults. The prevalence of HIV-1 and of HIV-2 was estimated for each survey, and incidence rates were calculated for the first (1990-1997) and second period (1997-2007). RESULTS: The HIV-1 incidence was approximately 4.5/1000 person-years in the two periods, whereas the HIV-2 incidence decreased from 4.7 (95% confidence interval 3.6-6.2) in the first to 2.0 (95% confidence interval 1.4-3.0) per 1000 person-years in the second period (P < 0.001). HIV-1 prevalence rose from 0.5% in 1990 to 3.6% in 2007, and HIV-2 prevalence decreased from 8.3% in 1990 to 4.7% in 2007. HIV-1 prevalence was less than 2% in 15 to 24 year olds in all surveys and was highest (7.2%) in 2007 among 45 to 54 year olds. The HIV-2 prevalence was fivefold higher in older subjects (> or =45 yr) compared with those less than 45 years in both sexes in 2007. CONCLUSIONS: HIV-1 incidence is stable, and its prevalence is increasing, whereas HIV-2 incidence and prevalence are both declining. In contrast with what has been observed in other sub-Saharan countries, HIV-1 prevalence is lower in younger age groups than older age groups.

The neurology of HTLV-1 infection.

HTLV-1 is a significant global health problem but remains largely confined to endemic areas and risk groups. However, increasing migration may mean that the virus will be encountered more frequently in areas traditionally thought of as virtually free of HTLV-1. In this review we discuss the epidemiology, transmission, clinical features, diagnosis and treatment of HTLV-1, focussing specifically on the neurological manifestations. We highlight the circumstances in which HTLV-1 should be suspected and outline the current understanding of HTLV-1-associated myelopathy and other neurological presentations.

Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings.

The immune reconstitution inflammatory syndrome (IRIS) has emerged as an important early complication of antiretroviral therapy (ART) in resource-limited settings, especially in patients with tuberculosis. However, there are no consensus case definitions for IRIS or tuberculosis-associated IRIS. Moreover, previously proposed case definitions are not readily applicable in settings where laboratory resources are limited. As a result, existing studies on tuberculosis-associated IRIS have used a variety of non-standardised general case definitions. To rectify this problem, around 100 researchers, including microbiologists, immunologists, clinicians, epidemiologists, clinical trialists, and public-health specialists from 16 countries met in Kampala, Uganda, in November, 2006. At this meeting, consensus case definitions for paradoxical tuberculosis-associated IRIS, ART-associated tuberculosis, and unmasking tuberculosis-associated IRIS were derived, which can be used in high-income and resource-limited settings. It is envisaged that these definitions could be used by clinicians and researchers in a variety of settings to promote standardisation and comparability of data.

Immunological predictors of survival in HIV type 2-infected rural villagers in Guinea-Bissau.

We investigated the association between beta2-microglobulin, neopterin, serum levels of soluble urokinase-type plasminogen activator receptor (suPAR), CD4 count, and plasma viremia with survival in 133 HIV-2-infected villagers and 160 controls living in rural Guinea-Bissau. Subjects were recruited in 1991 and visited at home every 3-6 months until 1998. Median beta2-microglobulin, neopterin, and suPAR were significantly higher and CD4% significantly lower among HIV-2-infected individuals than controls. Thirty-one HIV-2-infected individuals died and 7 were lost to follow-up. beta2-Microglobulin, CD4%, and plasma viral load were associated independently with survival in multivariate analyses. Neopterin and suPAR did not reach statistical significance. These findings suggest that immune activation is central to the pathogenesis of HIV. They also have important implications for resource-poor settings where CD4 count and plasma viral load are unaffordable.

Bacterial vaginosis, vaginal flora patterns and vaginal hygiene practices in patients presenting with vaginal discharge syndrome in The Gambia, West Africa.

BACKGROUND: Bacterial vaginosis (BV) - a syndrome characterised by a shift in vaginal flora - appears to be particularly common in sub-Saharan Africa, but little is known of the pattern of vaginal flora associated with BV in Africa. We conducted a study aimed at determining the prevalence of BV and patterns of BV-associated vaginal micro-flora among women with vaginal discharge syndrome (VDS) in The Gambia, West Africa. METHODS: We enrolled 227 women with VDS from a large genito-urinary medicine clinic in Fajara, The Gambia. BV was diagnosed by the Nugent's score and Amsel's clinical criteria. Vaginal swabs were collected for T vaginalis and vaginal flora microscopy, and for Lactobacillus spp, aerobic organisms, Candida spp and BV-associated bacteria (Gardnerella vaginalis, anaerobic bacteria, and Mycoplasma spp) cultures; and cervical swabs were collected for N gonorrhoeae culture and C trachomatis PCR. Sera were tested for HIV-1 and HIV-2 antibodies. Sexual health history including details on sexual hygiene were obtained by standardised questionnaire. RESULTS: BV prevalence was 47.6% by Nugent's score and 30.8% by Amsel's clinical criteria. Lactobacillus spp were isolated in 37.8% of women, and 70% of the isolates were hydrogen-peroxide (H202)-producing strains. Prevalence of BV-associated bacteria were: G vaginalis 44.4%; Bacteroides 16.7%; Prevotella 15.2%; Peptostretococcus 1.5%; Mobiluncus 0%; other anaerobes 3.1%; and Mycoplasma hominis 21.4%. BV was positively associated with isolation of G vaginalis (odds-ratio [OR] 19.42, 95%CI 7.91 - 47.6) and anaerobes (P = 0.001 [OR] could not be calculated), but not with M hominis. BV was negatively associated with presence of Lactobacillus (OR 0.07, 95%CI 0.03 - 0.15), and H2O2-producing lactobacilli (OR 0.12, 95% CI 0.05 - 0.28). Presence of H2O2-producing lactobacilli was associated with significantly lower prevalence of G vaginalis, anaerobes and C trachomatis. HIV prevalence was 12.8%. Overall, there was no association between BV and HIV, and among micro-organisms associated with BV, only Bacteroides spp. and Prevotella spp. were associated with HIV. BV or vaginal flora patterns were not associated with any of the factors relating to sexual hygiene practices (vaginal douching, menstrual hygiene, female genital cutting). CONCLUSION: In this population, BV prevalence was higher than in corresponding populations in industrialised countries, but the pattern of vaginal micro-flora associated with BV was similar. BV or vaginal flora patterns were not associated with HIV nor with any of the vaginal hygiene characteristics.