The trade-off between accuracy and accessibility of syphilis screening assays.

The availability of rapid and sensitive methods to diagnose syphilis facilitates screening of pregnant women, which is one of the most cost-effective health interventions available. We have evaluated two screening methods in Tanzania: an enzyme immunoassay (EIA), and a point-of-care test (POCT). We evaluated the performance of each test against the Treponema pallidum particle agglutination assay (TPPA) as the reference method, and the accessibility of testing in a rural district of Tanzania. The POCT was performed in the clinic on whole blood, while the other assays were performed on plasma in the laboratory. Samples were also tested by the rapid plasma Reagin (RPR) test. With TPPA as reference assay, the sensitivity and specificity of EIA were 95.3% and 97.8%, and of the POCT were 59.6% and 99.4% respectively. The sensitivity of the POCT and EIA for active syphilis cases (TPPA positive and RPR titer ≥ 1/8) were 82% and 100% respectively. Only 15% of antenatal clinic attenders in this district visited a health facility with a laboratory capable of performing the EIA. Although it is less sensitive than EIA, its greater accessibility, and the fact that treatment can be given on the same day, means that the use of POCT would result in a higher proportion of women with syphilis receiving treatment than with the EIA in this district of Tanzania

HIV Infection among Young People in Northwest Tanzania: The Role of Biological, Behavioural and Socio-Demographic Risk Factors.

BACKGROUND: Young people are at high risk of HIV and developing appropriate prevention programmes requires an understanding of the risk factors for HIV in this age group. We investigated factors associated with HIV among participants aged 15-30 years in a 2007-8 cross-sectional survey nested within a community-randomised trial of the MEMA kwa Vijana intervention in 20 rural communities in northwest Tanzania. METHODS: We analysed data for 7259(53%) males and 6476(47%) females. Using a proximate-determinant conceptual framework and conditional logistic regression, we obtained sex-specific Odds Ratios (ORs) for the association of HIV infection with socio-demographic, knowledge, behavioural and biological factors. RESULTS: HSV-2 infection was strongly associated with HIV infection (females: adjOR 4.4, 95%CI 3.2-6.1; males: adjOR 4.2, 95%CI 2.8-6.2). Several socio-demographic factors (such as age, marital status and mobility), behavioural factors (condom use, number and type of sexual partnerships) and biological factors (blood transfusion, lifetime pregnancies, genital ulcers, Neisseria gonorrhoeae) were also associated with HIV infection. Among females, lifetime sexual partners (linear trend, p<0.001), ≥2 partners in the past year (adjOR 2.0, 95%CI 1.4-2.8), ≥2 new partners in the past year (adjOR 1.9 95%CI 1.2, 3.3) and concurrent partners in the past year (adjOR 1.6 95%CI 1.1, 2.4) were all associated with HIV infection. CONCLUSIONS: Efforts must be intensified to find effective interventions to reduce HSV-2. Effective behavioural interventions focusing on reducing the number of sexual partnerships and risk behaviour within partnerships are also needed. An increase in risky sexual behaviour may occur following marriage dissolution or when a young woman travels outside of her community and interventions addressing the needs of these subgroups of vulnerable women may be important. TRIAL REGISTRATION: ClinicalTrial.gov NCT00248469

Technologies, strategies and approaches for testing populations at risk of sexually transmitted infections: a systematic review protocol to inform prevention and control in EU/EEA countries.

OBJECTIVES: This protocol outlines a systematic review methodology, aiming to assess the recent evidence-base for the impact of testing strategies and approaches on access to testing, testing coverage, and linkage to care for populations at risk for specific curable sexually transmitted infections (STIs) (chlamydia, gonorrhoea, syphilis, trichomoniasis, and Mycoplasma genitalium infections). DATA SOURCES: These include MEDLINE, Embase, PsycINFO, Global Health, Cochrane Database, Epistemonikos, CINAHL Plus, and Web of Science Core Collection. REVIEW METHODS: Papers reporting primary data from 1 January 2012 onwards will be included. Titles, abstracts, and full texts will be reviewed for inclusion, and data will be extracted using a pre-specified and piloted data extraction form, by two independent reviewers. Experts in the field will be contacted and interviewed for further information about ongoing or unpublished studies. A narrative synthesis of the findings will be conducted. DISCUSSION: Outcomes of this study will inform policy makers, national and international programme coordinators, public health and clinical experts, and civil society organisations involved in STI prevention and control in EU/EEA countries and elsewhere. The review will provide a direction for future researchers and programmers seeking to improve STI testing services among key populations at high risk for STIs. SYSTEMATIC REVIEW REGISTRATION: In accordance with guidelines outlined in the PRISMA-P methodology, this protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 30 January 2019: CRD42019118261

Impact of malaria and helminth infections on immunogenicity of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Tanzania.

BACKGROUND: Endemic malaria and helminth infections in sub-Saharan Africa can act as immunological modulators and impact responses to standard immunizations. We conducted a cohort study to measure the influence of malaria and helminth infections on the immunogenicity of the bivalent HPV-16/18 vaccine. METHODS: We evaluated the association between malaria and helminth infections, and HPV-16/18 antibody responses among 298 Tanzanian females aged 10-25 years enrolled in a randomized controlled trial of the HPV-16/18 vaccine. Malaria parasitaemia was diagnosed by examination of blood smears, and helminth infections were diagnosed by examination of urine and stool samples, respectively. Geometric mean antibody titres (GMT) against HPV-16/18 antibodies were measured by enzyme-linked immunosorbent assay. RESULTS: Parasitic infections were common; one-third (30.4%) of participants had a helminth infection and 10.2% had malaria parasitaemia. Overall, the vaccine induced high HPV-16/18 GMTs, and there was no evidence of a reduction in HPV-16 or HPV-18 GMT at Month 7 or Month 12 follow-up visits among participants with helminths or malaria. There was some evidence that participants with malaria had increased GMTs compared to those without malaria. CONCLUSIONS: The data show high HPV immunogenicity regardless of the presence of malaria and helminth infections. The mechanism and significance for the increase in GMT in those with malaria is unknown

The Vaginal Microbiota Among Adolescent Girls in Tanzania Around the Time of Sexual Debut.

The aetiology of bacterial vaginosis (BV) is not well-understood, and prevalence appears to be higher among women living in sub-Saharan Africa. A recent conceptual model implicates three main bacteria (Gardnerella vaginalis; Atopobium vaginae; and Prevotella bivia), sexual activity, sialidase activity, and biofilm formation in the pathogenesis of BV. We describe the vaginal microbiota, presence of the putative sialidase A gene of G. vaginalis, and biofilm among 386 adolescent girls aged 17 and 18 years in a cross-sectional study in Mwanza, Tanzania around the time of expected sexual debut. Vaginal swabs were collected and tested by quantitative polymerase chain reaction (qPCR) for five Lactobacillus species, G. vaginalis, A. vaginae, P. bivia, the sialidase A gene of G. vaginalis, and by fluorescence in situ hybridisation (FISH) for evidence of G. vaginalis and A. vaginae biofilm. We conducted a risk factor analysis of G. vaginalis, A. vaginae and P. bivia, and explored the associations between biofilm, the presence of the sialidase A gene, and non-optimal vaginal microbiota (Nugent 4-7). L. crispatus and L. iners were detected in 69 and 82% of girls, respectively. The prevalence of L. crispatus was higher than previously reported in earlier studies among East and Southern African women. G. vaginalis, A. vaginae, P. bivia were independently associated with reported penile-vaginal sex. Samples with all three BV-associated bacteria made up the highest proportion of samples with Nugent-BV compared to samples with each bacterium alone or together in pairs. Of the 238 girls with G. vaginalis, 63% had the sialidase A gene detected, though there was no difference by reported sexual activity (p = 0.197). Of the 191 girls with results for sialidase A gene and FISH, there was strong evidence for an increased presence of sialidase A gene among those with evidence of a biofilm (p < 0.001). There was a strong association between biofilm and non-optimal microbiota (aOR67.00; 95% CI 26.72-190.53). These results support several of the steps outlined in the conceptual model, although the role of sexual activity is less clear. We recommend longitudinal studies to better understand changes in vaginal microbiota and biofilm formation around the time of sexual debut

Long-term biological and behavioural impact of an adolescent sexual health intervention in Tanzania: follow-up survey of the community-based MEMA kwa Vijana Trial.

BACKGROUND: The ability of specific behaviour-change interventions to reduce HIV infection in young people remains questionable. Since January 1999, an adolescent sexual and reproductive health (SRH) intervention has been implemented in ten randomly chosen intervention communities in rural Tanzania, within a community randomised trial (see below; NCT00248469). The intervention consisted of teacher-led, peer-assisted in-school education, youth-friendly health services, community activities, and youth condom promotion and distribution. Process evaluation in 1999-2002 showed high intervention quality and coverage. A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 (HSV-2) seroprevalence but found substantial improvements in SRH knowledge, reported attitudes, and some reported sexual behaviours. It was postulated that the impact on "upstream" knowledge, attitude, and reported behaviour outcomes seen at the 3-year follow-up would, in the longer term, lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes. A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention) tested this hypothesis. METHODS AND FINDINGS: This is a cross-sectional survey (June 2007 through July 2008) of 13,814 young people aged 15-30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial (1999-2002). Prevalences of the primary outcomes HIV and HSV-2 were 1.8% and 25.9% in males and 4.0% and 41.4% in females, respectively. The intervention did not significantly reduce risk of HIV (males adjusted prevalence ratio [aPR] 0.91, 95%CI 0.50-1.65; females aPR 1.07, 95%CI 0.68-1.67) or HSV-2 (males aPR 0.94, 95%CI 0.77-1.15; females aPR 0.96, 95%CI 0.87-1.06). The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime (aPR 0.87, 95%CI 0.78-0.97) and an increase in reported condom use at last sex with a non-regular partner among females (aPR 1.34, 95%CI 1.07-1.69). There was a clear and consistent beneficial impact on knowledge, but no significant impact on reported attitudes to sexual risk, reported pregnancies, or other reported sexual behaviours. The study population was likely to have been, on average, at lower risk of HIV and other sexually transmitted infections compared to other rural populations, as only youth who had reached year five of primary school were eligible. CONCLUSIONS: SRH knowledge can be improved and retained long-term, but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence. Youth interventions integrated within intensive, community-wide risk reduction programmes may be more successful and should be evaluated. TRIAL REGISTRATION: ClinicalTrials.gov NCT0024846

HPV prevalence around the time of sexual debut in adolescent girls in Tanzania.

OBJECTIVES: Cervical cancer is the leading cause of cancer-related mortality among women in sub-Saharan Africa (SSA). Data on human papillomavirus (HPV) epidemiology in adolescent girls in SSA are essential to inform HPV vaccine policy recommendations for cervical cancer prevention. We assessed the burden of HPV infection, and risk factors for infection, among adolescent girls around the time of sexual debut. METHODS: Cross-sectional study of secondary school girls aged 17-18 years in Tanzania. Consenting participants provided samples for HPV and STI testing. Vaginal swabs were tested for 37 HPV genotypes by Roche Linear Array. Logistic regression was used to identify factors associated with HPV infection. Y chromosome was tested as a marker of recent condomless sex. RESULTS: 163/385 girls (42.3%) reported previous penetrative sex. HPV was detected in 125/385 (32.5%) girls, including 84/163 (51.5%) girls reporting previous sex and 41/222 (18.5%) reporting no previous sex. High-risk (HR) genotypes were detected in 70/125 (56.0%) girls with HPV infection. The most common HR genotype was HPV-16 (15/385; 3.9%). The prevalence of other HR HPV vaccine genotypes was between 0.8% and 3.1%. Among 186 girls who reported no previous sex, were negative for Y chromosome, and had no STI, 32 (17%) had detectable HPV. Lactobacillus sp and bacterial vaginosis-associated bacteria were negatively and positively associated, respectively, with HPV. CONCLUSIONS: HPV prevalence among adolescent girls around the time of sexual debut was high. However, prevalence of most vaccine genotypes was low, indicating that extending the age range of HPV vaccination in this region may be cost-effective

Results from a cross-sectional sexual and reproductive health study among school girls in Tanzania: high prevalence of bacterial vaginosis.

OBJECTIVES: Bacterial vaginosis (BV) increases women's susceptibility to sexually transmitted infections (STIs) and HIV and may partly explain the high incidence of STI/HIV among girls and young women in East and southern Africa. The objectives of this study were to investigate the association between BV and sexual debut, to investigate other potential risk factors of BV and to estimate associations between BV and STIs. METHODS: Secondary school girls in Mwanza, aged 17 and 18 years, were invited to join a cross-sectional study. Consenting participants were interviewed and samples were obtained for STI and BV testing. Factors associated with prevalent BV were analysed using multivariable logistic regression. Y-chromosome was tested as a biomarker for unprotected penile-vaginal sex. RESULTS: Of the 386 girls who were enrolled, 163 (42%) reported having ever had penile-vaginal sex. Ninety-five (25%) girls had BV. The prevalence of BV was 33% and 19% among girls who reported or did not report having ever had penile-vaginal sex, respectively. BV was weakly associated with having ever had one sex partner (adjusted odds ratio (aOR) 1.59;95% CI 0.93 to 2.71) and strongly associated with two or more partners (aOR = 3.67; 95% CI 1.75 to 7.72), receptive oral sex (aOR 6.38; 95% CI 1.22 to 33.4) and having prevalent human papillomavirus infection (aOR = 1.73; 95% CI 1.02 to 2.95). Of the 223 girls who reported no penile-vaginal sex, 12 (5%) tested positive for an STI and 7 (3%) tested positive for Y-chromosome. Reclassifying these positive participants as having ever had sex did not change the key results. CONCLUSIONS: Tanzanian girls attending school had a high prevalence of BV. Increasing number of sex partner was associated with BV; however, 19% of girls who reported no penile-vaginal sex had BV. This suggests that penile-vaginal sexual exposure may not be a prerequisite for BV. There was evidence of under-reporting of sexual debut

Facial cleanliness indicators by time of day: results of a cross-sectional trachoma prevalence survey in Senegal.

BACKGROUND: The World Health Organization-recommended strategy for trachoma elimination as a public health problem is known by the acronym "SAFE", where "F" stands for facial cleanliness to reduce transmission of ocular Chlamydia trachomatis infection. Accurately and reliably measuring facial cleanliness is problematic. Various indicators for measuring an unclean face exist, however, the accuracy and reliability of these indicators is questionable and their relationship to face washing practices is poorly described. METHODS: Clean face indicator (ocular or nasal discharge, flies on the face, and dirt on the face), trachoma clinical sign, and ocular C. trachomatis infection data were collected for 1613 children aged 0-9 years in 12 Senegalese villages as part of a cross-sectional trachoma prevalence study. Time of examination was recorded to the nearest half hour. A risk factor questionnaire containing Water, Sanitation and Hygiene (WASH) questions was administered to heads of compounds (households that shared a common doorway) and households (those who shared a common cooking pot). RESULTS: WASH access and use were high, with 1457/1613 (90.3%) children living in households with access to a primary water source within 30 min. Despite it being reported that 1610/1613 (99.8%) children had their face washed at awakening, > 75% (37/47) of children had at least one unclean face indicator at the first examination time-slot of the day. The proportion of children with facial cleanliness indicators differed depending on the time the child was examined. Dirt on the face was more common, and ocular discharge less common, in children examined after 11:00 h than in children examined at 10:30 h and 11:00 h. CONCLUSIONS: Given the high reported WASH access and use, the proportion of children with an unclean face indicator should have been low at the beginning of the day. This was not observed, explained either by: the facial indicators not being reliable measures of face washing; eye discharge, nose discharge or dirt rapidly re-accumulated after face washing in children in this population at the time of fieldwork; and/or responder bias to the risk factor questionnaire. A high proportion of children had unclean face indicators throughout the day, with certain indicators varying by time of day. A reliable, standardised, practical measure of face washing is needed, that reflects hygiene behaviour rather than environmental or cultural factors

Data for: "Immune activation in the female genital tract: Expression profiles of soluble proteins in women at high risk for HIV infection"

An anonymised dataset containing details of a sub-study of 100 HIV-negative women in 2009. This sub-study was part of a microbicide feasibility study in North-West Tanzania that was carried out between 2008-2010. It contains information on sexual behaviour, vaginal practices, current contraception, STI symptoms, as well as results of a clinical and colposcopic examinatio