Evaluation of the national clinical sentinel surveillance system for sexually transmitted infections in South Africa: Analysis of provincial and district-level data.

BACKGROUND: Globally, >1 million new cases of curable sexually transmitted infections (STIs) are estimated to occur daily, an alarming rate that has prevailed for over a decade. Modelled STI prevalence estimates for South Africa (SA) are among the highest globally. Robust STI surveillance systems have implications for policy and planning, antimicrobial stewardship and prevention strategies, and are critical in stemming the tide of STIs. OBJECTIVES: To evaluate the STI clinical sentinel surveillance system (STI CSSS) in SA, to describe the population incidence of four designated STI syndromes in males and females ≥15 years, and to provide recommendations for strengthening the STI CSSS. METHODS: This was a retrospective analysis of the STI CSSS in SA. Distribution of the primary healthcare facilities designated as STI CSSS sites was described, taking into account provincial population distribution and headcount coverage of STI CSSS facilities. Reporting compliance was evaluated to determine completion of data reporting. Further analysis was undertaken for those provinces that had good reporting compliance over a 12-month period. Population-level and demographic STI syndrome incidence were estimated from CSSS data using case reports of male urethritis syndrome (MUS) as a proxy for data extrapolation. RESULTS: Reporting compliance exceeded 70% for seven of the nine provinces. STI syndromes with the highest incidence were MUS and vaginal discharge syndrome (VDS). The 20 - 24 years age group had the highest STI incidence, at least double the incidence estimated in the other two age groups. Overall STI incidence in females was higher than among males in all provinces, except Limpopo and Western Cape. The 15 - 19 years age group had the most prominent gender disparity, with the national STI incidence in females 70% higher than in males. District-level analysis revealed high regional STI incidence even in provinces with lower overall incidence. CONCLUSION: The STI CSSS is pivotal to epidemiological monitoring and proactive management of STIs, especially in view of the high HIV prevalence in SA. CSSS processes and facility selection should be reviewed and revised to be representative and responsive to the current STI needs of the country, with biennial analysis and reporting to support evidence-based policy development and targeted implementation.

Factors associated with partner notification intentions among symptomatic sexually transmitted infection service attendees in South Africa.

BACKGROUND: In South Africa (SA), a client-initiated partner notification (PN) approach is implemented for the management of sexual partners of patients presenting with sexually transmitted infections (STIs) or STI syndromes. OBJECTIVES: To explore the demographic, sexual behavioural and clinical characteristics associated with PN intentions among symptomatic STI service attendees at sentinel primary healthcare facilities in three SA provinces. METHODS: We analysed cross-sectional data obtained from 1 293 adults enrolled into STI aetiological surveillance during 2019 - 2020 in Gauteng, KwaZulu-Natal and Western Cape provinces. Self-reported sexual practices, PN intentions and clinical data were collected using nurse-administrated questionnaires. We assessed gender-stratified factors associated with the index case's willingness to notify their sexual partners of their STI syndrome diagnosis. Univariable and multivariable Poisson regression models with robust error variance were used to determine factors associated with gender-stratified PN intentions. RESULTS: The enrolled participants comprised 887 male (68.6%) and 406 female (31.4%) STI clients. Self-reported PN intentions were higher among women than men (83.5% v. 64.4%; p<0.001). Multivariable analyses revealed that casual sex partnerships during the preceding 3-month period and enrolment at the KwaZulu-Natal site were independent barriers to PN intent among male participants. For females, enrolment at the Gauteng site was independently associated with lower PN intentions, while presenting with genital ulcer syndrome was a motivator towards PN intent. The primary reasons cited for non-disclosure across both genders were casual sexual encounters, followed by geographically distant partnerships and fear of disclosure. CONCLUSION: We show that demographic and behavioural characteristics, as well as relationship dynamics, may influence the PN intentions of STI service attendees in SA. Alternative PN strategies should be considered, based on the reported barriers, to increase overall STI notification, strengthen partner management and ultimately reduce STI incidence.

Population-level risk factors for vertical transmission of HIV in the national prevention of mother-to-child transmission programme in South Africa: An ecological analysis.

BACKGROUND: Although South Africa has an overall mother-to-child transmission (MTCT) of HIV rate <5%, case rates remain high. OBJECTIVES: To identify population-level predictors of MTCT to inform targeted interventions to further reduce paediatric HIV incidence. METHODS: The study was an ecological analysis of routine laboratory HIV-related test data from a synthetic cohort of women of reproductive age living with HIV (WRLHIV), identified from the National Health Laboratory Service's Corporate Data Warehouse between 2016 and 2017. Criteria based on syphilis screening and timing of HIV-related tests were used to identify pregnant and non-pregnant WRLHIV. Pregnant WRLHIV were followed from cohort entry at the first antenatal care (fANC) visit, through delivery to exit at the latest viral load (VL) or 15 months post delivery. Follow-up for non-pregnant WRLHIV started at cohort entry on 1 January 2016 to exit at the latest VL or 31 December 2018. HIV VL tests performed at cohort entry, delivery and cohort exit described viraemia (VL ≥50 copies/mL) at subdistrict level. A negative binomial regression model determined the association between MTCT cases and the number of viraemic WRLHIV at different time points, controlling for number of WRLHIV aged <25 years at cohort entry and other routine HIV-related indicators at subdistrict level. RESULTS: Of 3 386 507 WRLHIV identified, 178 319 (5.3%) met criteria for pregnancy. Median (interquartile range (IQR)) proportions of women with fANC booking <20 weeks' gestation, maternal HIV seroprevalence during antenatal care (ANC) and antiretroviral therapy (ART) coverage during ANC were 68.2% (62.9 - 72.8), 31.5% (23.4 - 35.7) and 94.8% (89.7 - 97.8), respectively. Viraemia was consistently higher in pregnant v. non-pregnant WRLHIV at median proportions of 42.9% (38.3 - 59.3) v. 35.0% (25.9 - 49.0) at cohort entry (p<0.001) and 36.3% (25.0 - 48.4) v. 29.6% (21.0 - 42.6) at cohort exit (p<0.001). In total, 4 535 children aged <24 months tested HIV polymerase chain reaction-positive, representing a median subdistrict-level case rate of 1 372 (914 - 2 077) per 100 000 live births. Maternal viraemia postpartum, maternal HIV seroprevalence and ART coverage during ANC positively correlated with cases of MTCT, while higher proportions of women with fANC booking <20 weeks' gestation were associated with a decline in MTCT cases. CONCLUSIONS: Findings suggest that maternal viraemia postpartum, geographical areas with a higher burden of maternal HIV, women initiating ART late in pregnancy and/or incident maternal HIV during pregnancy are significant population-level predictors of MTCT in the national prevention of MTCT programme. Scale-up of HIV prevention services is required to lower maternal HIV prevalence, while expanded access to HIV testing will fast-track ART initiation among WRLHIV. Increased VL monitoring is critical to improve VL suppression rates for elimination of MTCT.

Recency of HIV infection, antiretroviral therapy use and viral loads among symptomatic sexually transmitted infection service attendees in South Africa.

BACKGROUND: Better integration of HIV and sexually transmitted infection (STI) prevention and treatment services is needed to accelerate progress towards the goal of zero new HIV infections. OBJECTIVES: To describe HIV positivity, antiretroviral therapy (ART) use, viral suppression and recency of HIV infection among symptomatic STI service attendees at two primary care clinics in South Africa. METHODS: In a cross-sectional study, male and female STI service attendees presenting with symptoms consistent with STI syndromes were enrolled following informed consent. An interviewer-administered questionnaire was completed and appropriate genital and blood specimens were collected for STI testing and HIV biomarker measurements including recency of infection and antiretroviral (ARV) drug levels. Descriptive statistics were used to describe enrolled attendees, and to determine the proportion of attendees who were HIV-positive, recently infected, taking ART and virally suppressed. HIV-positive attendees with detectable ARVs were considered to be on ART, while those with viral loads (VLs) ≤200 copies/mL were considered virally suppressed. RESULTS: Of 451 symptomatic attendees whose data were analysed, 93 (20.6%) were HIV-positive, with 15/93 (16.1%) being recently infected. Recent infection was independently associated with genital ulcer disease at presentation, especially ulcers with no detectable STI pathogens. Among the 78 (83.9%) with long-term infection, only 30 (38.5%) were on ART, with 23/30 (76.7%) virally suppressed. CONCLUSIONS: In a population at risk of HIV transmission, there was a high burden of recent infection and unsuppressed VLs. Incorporating pre-exposure prophylaxis, ART initiation and adherence support into STI services will be necessary for progress towards eliminating HIV transmission.

Recency of HIV infection, antiretroviral therapy use and viral loads among symptomatic sexually transmitted infection service attendees in South Africa

Background. Better integration of HIV and sexually transmitted infection (STI) prevention and treatment services is needed to accelerate progress towards the goal of zero new HIV infections. Objectives. To describe HIV positivity, antiretroviral therapy (ART) use, viral suppression and recency of HIV infection among symptomatic STI service attendees at two primary care clinics in South Africa. Methods. In a cross-sectional study, male and female STI service attendees presenting with symptoms consistent with STI syndromes were enrolled following informed consent. An interviewer-administered questionnaire was completed and appropriate genital and blood specimens were collected for STI testing and HIV biomarker measurements including recency of infection and antiretroviral (ARV) drug levels. Descriptive statistics were used to describe enrolled attendees, and to determine the proportion of attendees who were HIV-positive, recently infected, taking ART and virally suppressed. HIV-positive attendees with detectable ARVs were considered to be on ART, while those with viral loads (VLs) ≤200 copies/mL were considered virally suppressed. Results. Of 451 symptomatic attendees whose data were analysed, 93 (20.6%) were HIV-positive, with 15/93 (16.1%) being recently infected. Recent infection was independently associated with genital ulcer disease at presentation, especially ulcers with no detectable STI pathogens. Among the 78 (83.9%) with long-term infection, only 30 (38.5%) were on ART, with 23/30 (76.7%) virally suppressed. Conclusions. In a population at risk of HIV transmission, there was a high burden of recent infection and unsuppressed VLs. Incorporating pre-exposure prophylaxis, ART initiation and adherence support into STI services will be necessary for progress towards eliminating HIV transmission

Evaluating the performance of the GeneXpert HIV-1 qualitative assay as a consecutive test for a new early infant diagnosis algorithm in South Africa.

BACKGROUND: The proportion of HIV-exposed infants and young children infected with HIV in South Africa (SA) has declined markedly over the past decade as a result of the country's comprehensive prevention of mother-to-child transmission programme. This decrease has in turn reduced the positive predictive value (PPV) of diagnostic assays, necessitating review of early infant diagnosis (EID) algorithms to ensure improved accuracy. OBJECTIVES: To evaluate the performance of the GeneXpert HIV-1 qualitative assay (Xpert EID) as a consecutive test for infants with an 'HIV-detected' polymerase chain reaction screening test at birth. METHODS: We retrospectively analysed a longitudinal cohort of HIV-exposed infants on whom birth testing was performed, using whole-blood ethylenediaminetetra-acetic acid samples, from four tertiary sites in Gauteng Province between June 2014 and December 2019. Birth samples from all infants with a Cobas AmpliPrep/Cobas TaqMan HIV-1 Qualitative Test v2.0 (CAP/CTM v2.0) HIV-detected screening test, a concurrent Xpert EID test and a subsequent confirmatory CAP/CTM v2.0 test on a separate specimen were included. Performance of the Xpert EID in predicting final HIV status was determined as proportions with 95% confidence intervals (CIs). A comparison of indeterminate CAP/CTM v2.0 results, as per National Health Laboratory Service resulting practice, with discordant CAP/CTM v2.0 v. Xpert EID results was performed. RESULTS: Of 150 infants who met the inclusion criteria, 6 (3.9%) had an Xpert EID result discordant with final HIV status: 5 (3.3%) were false negatives and 1 (0.7%) was false positive. As a consecutive test, the Xpert EID yielded a sensitivity of 96.5% (95% CI 92 - 98.9), specificity of 85.7% (95% CI 42.1 - 99.6), PPV of 99.3% (95% CI 95.7 - 99.9), negative predictive value of 54.5% (95% CI 32.5 - 74.9) and overall accuracy of 96.1% (95% CI 91.5 - 98.5). Using discordant CAP/CTM v2.0/Xpert EID results as criteria to verify indeterminate results instead of current practice would have reduced the number of indeterminate screening results by 42.1%, from 18 (12.6%) to 11 (7.2%), without increasing the false-positive rate. CONCLUSIONS: Addition of the Xpert EID as a consecutive test for specimens with an HIV-detected PCR screening result has the potential to improve the PPV and reduce the indeterminate rate, thereby reducing diagnostic challenges and time to final status, in SA's EID programme.

Maternal HIV viral load testing during pregnancy and postpartum care in Gauteng Province, South Africa.

BACKGROUND: Pregnant and breastfeeding women living with HIV (WLHIV) are a target population for elimination of mother-to-child transmission of HIV (eMTCT). However, there are limited data on maternal virological responses during pregnancy and the postpartum period in South Africa (SA). OBJECTIVES: To review compliance of viral load (VL) testing with national guidelines and suppression rates during pregnancy and up to 9  months postpartum among WLHIV delivering in four tertiary hospitals in Gauteng Province, SA. METHODS: All women who had a point-of-care HIV VL test using Xpert HIV-1 VL (Cepheid, USA) at delivery in four tertiary obstetric units in Gauteng between June 2018 and February 2020 were included. HIV VL tests of eligible women performed up to 9 months before and after delivery were extracted from the National Health Laboratory Service's Corporate Data Warehouse. Proportions of women delivering who had antenatal and postpartum VL tests performed and their suppression rates were determined and expressed as percentages. RESULTS: Of 4 989 eligible WLHIV (median age 31.1 years), 917 (18.4%) had a VL performed during the antenatal period; of these, 335 (36.5%) had a VL ≥50 copies/mL and 165 (18.0%) a VL ≥1 000 copies/mL. At delivery, 1 911 women (38.3%) had a VL ≥50 copies/mL and 1 028 (20.6%) a VL ≥1 000 copies/mL. Among 627 women (12.6%) with a VL test postpartum, 234 (37.3%) had a VL ≥50 copies/mL and 93 (14.8%) a VL ≥1 000 copies/mL. Overall, having a VL test performed during the antenatal period was associated with viral suppression at delivery and receiving a VL test postpartum (p<0.001). Women with a VL ≥50 copies/mL at delivery were more likely to be younger and to remain virally unsuppressed postpartum (p<0.001) compared with women with a VL <50 copies/mL. CONCLUSIONS: Fewer than 5% of WLHIV with a VL at the time of delivery received VL monitoring during the antenatal and postpartum periods in accordance with national guidelines. More than 80% of WLHIV delivering had no evidence of VL monitoring during the antenatal period, and they were more likely than women who received monitoring during the antenatal period to be virally unsuppressed at delivery and to receive no VL monitoring postpartum. Women with a high VL at delivery were likely to remain virally unsuppressed postpartum. These results emphasise the need for closer monitoring of and rapid reaction to high maternal VLs during pregnancy, at delivery and postpartum for attainment of eMTCT.

Factors associated with repeat genital symptoms among sexually transmitted infection service attendees in South Africa, 2015 - 2016.

BACKGROUND: South African guidelines recommend a syndromic approach for the management of sexually transmitted infections (STIs), based on the presence of genital symptoms. However, the guidelines do not prescribe specific indications for microbiology testing for patients presenting with or without repeat genital symptoms. OBJECTIVES: To describe the prevalence of and factors associated with repeat genital symptoms among STI service attendees at primary care facilities. METHODS: This was a cross-sectional study at 7 STI primary care facilities participating in the aetiological surveillance of STIs between January 2015 and December 2016. Demographic and clinical information and appropriate genital specimens were collected from participants presenting with vaginal discharge syndrome (VDS), male urethral syndrome (MUS) and/or genital ulcer syndrome (GUS). Repeat genital symptoms were defined as self-reported history of the same STI-related genital symptoms in the preceding 12 months. Multivariable logistic regression identified factors associated with repeat genital symptoms. RESULTS: Of 1 822 eligible participants, 480 (30%) had repeat genital symptoms (25% and 75% in the preceding 3 months and 12 months, respectively). Of those with repeat genital symptoms, the median age was 28 (interquartile range (IQR) 24 - 32) years, and 54% were females. The most common aetiological agents among participants with VDS, MUS and GUS were bacterial vaginosis (n=132; 55%), Neisseria gonorrhoeae (n=172; 81%) and ulcers (n=67; 63%), respectively. One hundred and seven (20%) participants had no detectable common STI aetiology. In the multivariable analysis, repeat genital symptoms were associated with HIV co-infection (adjusted odds ratio (aOR) 1.43; 95% confidence interval (CI) 1.14 - 1.78), VDS diagnosis (aOR 1.39; 95% CI 1.10 - 1.76), self-reported condom use (aOR 1.56; 95% CI 1.20 - 2.03) and age 25 - 34 years (aOR 1.33; 95% CI 1.03 - 1.71). CONCLUSIONS: Our study found a high prevalence of repeat genital symptoms ‒ a significant proportion without STI aetiology. Identified factors of repeat genital symptoms highlight the need for improved integration of HIV and STI prevention and management. Further research is needed to determine the aetiology of repeat genital symptoms and the contribution of non-STI causes.

The demographic and clinical profiles of women presenting with vaginal discharge syndrome at primary care facilities in South Africa: Associations with age and implications for management.

BACKGROUND: Current South African guidelines for the management of vaginal discharge syndrome (VDS) do not recommend treatment for sexually transmitted infection (STI) pathogens for women aged ≥35 years whose partners do not have male urethritis syndrome. The guideline assumes that older women are unlikely to have an STI and that their partners do not have asymptomatic infections. OBJECTIVES: To describe the demographic, behavioural and clinical characteristics of women with VDS, comparing older women (≥35 years) with younger women, and to determine the performance of age alone as a criterion for predicting the presence of STI. METHODS: This was a cross-sectional study at seven primary healthcare centres taking part in the aetiological surveillance of STIs between January 2015 and December 2016. Eligible women presenting with VDS were enrolled and completed a nurse-administered questionnaire. Genital swabs and blood specimens were collected for laboratory testing. Data were entered into surveillance-specific databases and exported into Stata 14 for analysis. Descriptive statistics were used to compare demographic and clinical profiles of older with younger women. A receiver operator curve (ROC) was used to determine the age cut-off that would best differentiate between women who had infection with STI pathogens and those without. RESULTS: Of 757 women enrolled, 157 (20.7%) were aged ≥35 years. HIV positivity was 46.6%, and higher in older than younger women (54.9% v. 44.5%; p=0.02). Of those enrolled, 283 (37.4%) had bacterial vaginosis (BV) and/or Candida infection only, 232 (30.7%) had BV or Candida with STI pathogens detected, 98 (13%) were infected with STI pathogens only, and 144 (19.0%) did not have any detectable STI or non-STI causes. Although older women were less likely than younger women to have Neisseria gonorrhoeae, Chlamydia trachomatis or Mycoplasma genitalium infection (23.6% v. 38.2%; p<0.01), the burden in older women was not negligible. The area under the ROC for age was 57.5% (95% confidence interval 53.2 - 61.8%), which implies suboptimal performance. CONCLUSIONS: Although older women with VDS were less likely than younger women to have STIs, a significant proportion of them did have an infection with STI pathogens. Age alone was not a good criterion for discriminating between women with and without infection with STI pathogens. Other ways of improving the VDS algorithm performance are needed, as is better integration of HIV and STI prevention and treatment.

An intervention to optimise the delivery of integrated tuberculosis and HIV services at primary care clinics: results of the MERGE cluster randomised trial.

OBJECTIVES: To evaluate the effect of an intervention to optimize TB/HIV integration on patient outcomes. METHODS: Cluster randomised control trial at 18 primary care clinics in South Africa. The intervention was placement of a nurse (TB/HIV integration officer) to facilitate provision of integrated TB/HIV services, and a lay health worker (TB screening officer) to facilitate TB screening for 24 months. Primary outcomes were i) incidence of hospitalisation/death among individuals newly diagnosed with HIV, ii) incidence of hospitalisation/death among individuals newly diagnosed with TB and iii) proportion of HIV-positive individuals newly diagnosed with TB who were retained in HIV care 12 months after enrolment. RESULTS: Of 3328 individuals enrolled, 3024 were in the HIV cohort, 731 in TB cohort and 427 in TB-HIV cohort. For the HIV cohort, the hospitalisation/death rate was 12.5 per 100 person-years (py) (182/1459py) in the intervention arm vs. 10.4/100py (147/1408 py) in the control arms respectively (Relative Risk (RR) 1.17 [95% CI 0.92-1.49]).For the TB cohort, hospitalisation/ death rate was 17.1/100 py (67/ 392py) vs. 11.1 /100py (32/289py) in intervention and control arms respectively (RR 1.37 [95% CI 0.78-2.43]). For the TB-HIV cohort, retention in care at 12 months was 63.0% (213/338) and 55.9% (143/256) in intervention and control arms (RR 1.11 [95% 0.89-1.38]). CONCLUSIONS: The intervention as implemented failed to improve patient outcomes beyond levels at control clinics. Effective strategies are needed to achieve better TB/HIV service integration and improve TB and HIV outcomes in primary care clinics. TRIAL REGISTRATION: South African Register of Clinical Trials (registration number DOH-27-1011-3846).

Near-real-time tracking of gaps in prevention of mother-to-child transmission of HIV in three districts of KwaZulu-Natal Province, South Africa.

BACKGROUND: Identifying and addressing gaps in the prevention of mother-to-child transmission of HIV (PMTCT) is required if South Africa (SA) is to achieve targets for eliminating MTCT (eMTCT). Potential PMTCT gaps that increase MTCT risk include late maternal HIV diagnosis, lack of or delayed antiretroviral therapy (ART) during pregnancy and breastfeeding, and lack of effective prophylaxis for HIV-exposed infants. OBJECTIVES: To investigate, in near real time, PMTCT gaps among HIV-infected infants in three districts of KwaZulu-Natal Province, SA. METHODS: Between May and September 2016, PMTCT co-ordinators from eThekwini, uMgungundlovu and uMkhanyakude districts received daily email notification of all HIV polymerase chain reaction (PCR)-positive results. Co-ordinators reviewed facility records for each infant to identify gaps in PMTCT care, including maternal age, timing of maternal HIV diagnosis, maternal treatment history and maternal viral load (VL) monitoring. Data were submitted via the mobile phone SMS (text message) service using Rapid Pro technology and analysed in Stata 14. RESULTS: Data on PMTCT gaps were received for 367 (91.8%) of 400 infants with HIV PCR-positive results, within a median time of 12.5 days (interquartile range (IQR) 6 - 23). The median maternal age was 25 years (IQR 22 - 30), with 48 teenage mothers (15 - 19 years). The sample size was too small to determine whether there were significant differences in PMTCT gaps between the 48 teenage mothers and 293 older (20 - 34 years) mothers. Of the mothers, 220 (60.0%) were first diagnosed prior to conception or at their first antenatal care (ANC) visit, and 127 (34.6%) at or after delivery; 137 (37.3%) transmitted HIV to their infants despite receiving >12 weeks of ART. VL results were unavailable for 70.0% of women. Only 41 (17.5%) of women known to be HIV-positive during ANC had confirmed virological suppression. No statistically significant differences in PMTCT gaps were observed between districts, owing to small sample sizes in uMgungundlovu and uMkhanyakude. CONCLUSIONS: The findings highlight the need to improve services during ANC, in particular prioritising maternal VL monitoring. We intend to use improved technology to streamline data collection and reporting towards eMTCT.

The demographic and clinical profiles of women presenting with vaginal discharge syndrome at primary care facilities in South Africa: Associations with age and implications for management

Background. Current South African guidelines for the management of vaginal discharge syndrome (VDS) do not recommend treatment for sexually transmitted infection (STI) pathogens for women aged ≥35 years whose partners do not have male urethritis syndrome. The guideline assumes that older women are unlikely to have an STI and that their partners do not have asymptomatic infections.Objectives. To describe the demographic, behavioural and clinical characteristics of women with VDS, comparing older women (≥35 years) with younger women, and to determine the performance of age alone as a criterion for predicting the presence of STI.Methods. This was a cross-sectional study at seven primary healthcare centres taking part in the aetiological surveillance of STIs between January 2015 and December 2016. Eligible women presenting with VDS were enrolled and completed a nurse-administered questionnaire. Genital swabs and blood specimens were collected for laboratory testing. Data were entered into surveillance-specific databases and exported into Stata 14 for analysis. Descriptive statistics were used to compare demographic and clinical profiles of older with younger women. A receiver operator curve (ROC) was used to determine the age cut-off that would best differentiate between women who had infection with STI pathogens and those without.Results. Of 757 women enrolled, 157 (20.7%) were aged ≥35 years. HIV positivity was 46.6%, and higher in older than younger women (54.9% v. 44.5%; p=0.02). Of those enrolled, 283 (37.4%) had bacterial vaginosis (BV) and/or Candida infection only, 232 (30.7%) had BV or Candida with STI pathogens detected, 98 (13%) were infected with STI pathogens only, and 144 (19.0%) did not have any detectable STI or non-STI causes. Although older women were less likely than younger women to have Neisseria gonorrhoeae, Chlamydia trachomatis or Mycoplasma genitalium infection (23.6% v. 38.2%; p<0.01), the burden in older women was not negligible. The area under the ROC for age was 57.5% (95% confidence interval 53.2 - 61.8%), which implies suboptimal performance.Conclusions. Although older women with VDS were less likely than younger women to have STIs, a significant proportion of them did have an infection with STI pathogens. Age alone was not a good criterion for discriminating between women with and without infection with STI pathogens. Other ways of improving the VDS algorithm performance are needed, as is better integration of HIV and STI prevention and treatment

Near-real-time tracking of gaps in prevention of mother-to-child transmission of HIV in three districts of KwaZulu-Natal Province, South Africa

Background. Identifying and addressing gaps in the prevention of mother-to-child transmission of HIV (PMTCT) is required if South Africa (SA) is to achieve targets for eliminating MTCT (eMTCT). Potential PMTCT gaps that increase MTCT risk include late maternal HIV diagnosis, lack of or delayed antiretroviral therapy (ART) during pregnancy and breastfeeding, and lack of effective prophylaxis for HIV-exposed infants.Objectives. To investigate, in near real time, PMTCT gaps among HIV-infected infants in three districts of KwaZulu-Natal Province, SA.Methods. Between May and September 2016, PMTCT co-ordinators from eThekwini, uMgungundlovu and uMkhanyakude districts received daily email notification of all HIV polymerase chain reaction (PCR)-positive results. Co-ordinators reviewed facility records for each infant to identify gaps in PMTCT care, including maternal age, timing of maternal HIV diagnosis, maternal treatment history and maternal viral load (VL) monitoring. Data were submitted via the mobile phone SMS (text message) service using Rapid Pro technology and analysed in Stata 14.Results. Data on PMTCT gaps were received for 367 (91.8%) of 400 infants with HIV PCR-positive results, within a median time of 12.5 days (interquartile range (IQR) 6 - 23). The median maternal age was 25 years (IQR 22 - 30), with 48 teenage mothers (15 - 19 years). The sample size was too small to determine whether there were significant differences in PMTCT gaps between the 48 teenage mothers and 293 older (20 - 34 years) mothers. Of the mothers, 220 (60.0%) were first diagnosed prior to conception or at their first antenatal care (ANC) visit, and 127 (34.6%) at or after delivery; 137 (37.3%) transmitted HIV to their infants despite receiving >12 weeks of ART. VL results were unavailable for 70.0% of women. Only 41 (17.5%) of women known to be HIV-positive during ANC had confirmed virological suppression. No statistically significant differences in PMTCT gaps were observed between districts, owing to small sample sizes in uMgungundlovu and uMkhanyakude.Conclusions. The findings highlight the need to improve services during ANC, in particular prioritising maternal VL monitoring. We intend to use improved technology to streamline data collection and reporting towards eMTCT

A cluster randomised trial to evaluate the effect of optimising TB/HIV integration on patient level outcomes: the "merge" trial protocol.

INTRODUCTION: We describe the design of the MERGE trial, a cluster randomised trial, to evaluate the effect of an intervention to optimise TB/HIV service integration on mortality, morbidity and retention in care among newly-diagnosed HIV-positive patients and newly-diagnosed TB patients. DESIGN: Eighteen primary care clinics were randomised to either intervention or standard of care arms. The intervention comprised activities designed to optimise TB and HIV service integration and supported by two new staff cadres-a TB/HIV integration officer and a TB screening officer-for 24 months. A process evaluation to understand how the intervention was perceived and implemented at the clinics was conducted as part of the trial. Newly-diagnosed HIV-positive patients and newly-diagnosed TB patients were enrolled into the study and followed up through telephonic interviews and case note abstractions at six monthly intervals for up to 18 months in order to measure outcomes. The primary outcomes were incidence of hospitalisations or death among newly diagnosed TB patients, incidence of hospitalisation or death among newly diagnosed HIV-positive patients and retention in care among HIV-positive TB patients. Secondary outcomes of the study included measures of cost-effectiveness. DISCUSSION: Methodological challenges of the trial such as implementation of a complex multi-faceted health systems intervention, the measurement of integration at baseline and at the end of the study and an evolving standard of care with respect to TB and HIV are discussed. The trial will contribute to understanding whether TB/HIV service integration affects patient outcomes.

Isoniazid preventive therapy use among patients on antiretroviral therapy: a missed opportunity.

Isoniazid preventive therapy (IPT) with antiretroviral therapy (ART) reduces incident tuberculosis among patients infected with the human immunodeficiency virus. We describe IPT use among patients on ART at two primary care clinics in South Africa. Of 597 participants interviewed, 100 (16.8%) reported IPT use; 73.4% (365/497) with no reported IPT use were eligible for IPT. IPT use was associated with age <35 years (aOR 1.90, 95%CI 1.18-3.06), and receiving care at one clinic as opposed to the other (aOR 4.72, 95%CI 2.69-7.93). The high proportion of patients on ART eligible for IPT represents a missed opportunity for IPT scale-up.

Willingness to participate in trials and to be vaccinated with new tuberculosis vaccines in HIV-infected adults.

BACKGROUND: New tuberculosis (TB) vaccines are required to meet global targets for TB control. OBJECTIVES: To determine willingness to participate (WTP) in new TB vaccine trials, willingness to be vaccinated with a newly licensed TB vaccine and associated factors among human immunodeficiency virus (HIV) infected persons. SETTING: Two primary care clinics in South Africa. DESIGN: Cross-sectional study design. Participants were asked about WTP and willingness to be vaccinated. Demographic, clinical, knowledge of TB and perception of risk information were collected. Log binomial regression was used to determine associated factors. RESULTS: A total of 827 participants were included in the analysis: 80.4% female, 72.2% on antiretroviral therapy, median age 35 years (interquartile range [IQR] 29-42 years), CD4 count 523 cells/µl (IQR 427-659 cells/µl). WTP and willingness to be vaccinated were high, at 84.5% and 92.6%, respectively. WTP was associated with knowledge about TB (prevalence ratio [PR] 1.10, 95% confidence interval [CI] 1.03-1.17) and perception of risk (PR 1.07, 95%CI 1.01-1.13). Willingness to be vaccinated was associated with employment (PR 1.04, 95%CI 1.01-1.08) and perception of risk (PR 1.05, 95%CI 1.01-1.09). CONCLUSIONS: There was high WTP in TB vaccine trials and willingness to be vaccinated among HIV-infected patients with good TB knowledge and high perceived risk of contracting TB.

A pilot study to assess the immunologic and virologic efficacy of generic nevirapine, zidovudine and lamivudine in the treatment of HIV-1 infected women with pre-exposure to single dose nevirapine or short course zidovudine and their spouses in Chitungwiza, Zimbabwe.

OBJECTIVE: A pilot study to assess effectiveness of generic Nevirapine (NVP)+Zidovudine (AZT)+Lamivudine (3TC) as potent antiretroviral therapy (ART) in women exposed to either SD NVP or short course (SC) AZT through participation in prevention of mother-to-child transmission of HIV-1 (pMTCT) interventions, and their spouses. DESIGN: A pilot study of antiretroviral treatment of adults with AIDS. SETTING: Primary health care clinics; Seke North and St Mary's in Chitungwiza, Zimbabwe. SUBJECTS: Women with pre-exposure to SD NVP or SC AZT and their spouses with CD4 count < 200 cells/ INTERVENTIONS: Generic AZT/3TC twice daily plus NVP daily for the first 14 days and then twice a day thereafter, administered to the cohort. MAIN OUTCOME MEASURES: The baseline median CD4 count for women and men was 128.5 and 119.0 cells/ microL respectively. The geomean virus load was similar for the women and men. At weeks 16, 24 and 48, 82.8%, 85.1% and 73.8% had < 400 copies/ml of HIV RNA respectively. Only at 16 weeks, was the proportion of women (75.9%) with undetectable virus significantly lower than that for men (93.9%), p = 0.031. Median CD4 count for both men and women increased significantly, p < 0.001. There were no significant differences in virologic responses between the women with pre-exposure to SD NVP and SC AZT. The mean adherence for women and men was similar, > 98%. CONCLUSION: Women showed a significantly reduced response top ART relative to men only at 16. However, prior exposure to SD NVP for PMTCT was no more likely to negatively influence responses to ART than use of SC AZT.