Metabolomic profiling of preterm birth in pregnant women living with HIV.

BACKGROUND: Preterm birth is a leading cause of death in children under the age of five. The risk of preterm birth is increased by maternal HIV infection as well as by certain antiretroviral regimens, leading to a disproportionate burden on low- and medium-income settings where HIV is most prevalent. Despite decades of research, the mechanisms underlying spontaneous preterm birth, particularly in resource limited areas with high HIV infection rates, are still poorly understood and accurate prediction and therapeutic intervention remain elusive. OBJECTIVES: Metabolomics was utilized to identify profiles of preterm birth among pregnant women living with HIV on two different antiretroviral therapy (ART) regimens. METHODS: This pilot study comprised 100 mother-infant dyads prior to antiretroviral initiation, on zidovudine monotherapy or on protease inhibitor-based antiretroviral therapy. Pregnancies that resulted in preterm births were matched 1:1 with controls by gestational age at time of sample collection. Maternal plasma and blood spots at 23-35 weeks gestation and infant dried blood spots at birth, were assayed using an untargeted metabolomics method. Linear regression and random forests classification models were used to identify shared and treatment-specific markers of preterm birth. RESULTS: Classification models for preterm birth achieved accuracies of 95.5%, 95.7%, and 80.7% in the untreated, zidovudine monotherapy, and protease inhibitor-based treatment groups, respectively. Urate, methionine sulfone, cortisone, and 17α-hydroxypregnanolone glucuronide were identified as shared markers of preterm birth. Other compounds including hippurate and N-acetyl-1-methylhistidine were found to be significantly altered in a treatment-specific context. CONCLUSION: This study identified previously known as well as novel metabolomic features of preterm birth in pregnant women living with HIV. Validation of these models in a larger, independent cohort is necessary to ascertain whether they can be utilized to predict preterm birth during a stage of gestation that allows for therapeutic intervention or more effective resource allocation.

New Guinea highland wild dogs are the original New Guinea singing dogs.

New Guinea singing dogs (NGSD) are identifiable by their namesake vocalizations, which are unlike any other canid population. Their novel behaviors and potential singular origin during dog domestication make them an attractive, but elusive, subject for evolutionary and conservation study. Although once plentiful on the island of New Guinea (NG), they were presumed to currently exist only in captivity. This conclusion was based on the lack of sightings in the lowlands of the island and the concurrent expansion of European- and Asian-derived dogs. We have analyzed the first nuclear genomes from a canid population discovered during a recent expedition to the highlands of NG. The extreme altitude (>4,000 m) of the highland wild dogs' (HWD) observed range and confirmed vocalizations indicate their potential to be a wild NGSD population. Comparison of single-nucleotide polymorphism genotypes shows strong similarity between HWD and the homogeneous captive NGSD, with the HWD showing significantly higher genetic diversity. Admixture analyses and estimation of shared haplotypes with phylogenetically diverse populations also indicates the HWD is a novel population within the distinct evolutionary lineage of Oceanic canids. Taken together, these data indicate the HWD possesses a distinct potential to aid in the conservation of NGSD both in the wild and under human care.

Postnatal clubs for integrated postnatal care in Johannesburg, South Africa: a qualitative assessment of implementation.

BACKGROUND: South Africa has reported challenges in retaining women in Prevention of Mother-to-Child Transmission of HIV (PMTCT) programs postnatally. Due to the success of PMTCT in the antenatal period, proportionally more infant transmissions now occur after delivery. The Médecins sans Frontières (MSF) Postnatal Club (PNC) model allows for integrated postnatal care and support. Anova Health Institute implemented the model in primary health facilities in Johannesburg as part of a planned national scale-up. We aimed to assess the implementation of these PNCs. METHODS: We used the RE-AIM (Reach, Adoption, Implementation, Maintenance) framework to assess implementation success and explore factors influencing implementation. In-depth interviews were conducted with 15 PNC staff, both clinicians and lay counsellors, using convenience sampling, from 12 facilities in Johannesburg. Data were analysed thematically using the RE-AIM framework. RESULTS: PNC were perceived to have many benefits for postnatal clients and their infants: providers reported reduced waiting times, reduced number of clinic visits and that PNC provided clients with a space to form cohesive group dynamics thereby contributing to retention and adherence to antiretroviral therapy. However, it was found that lacking resources (e.g., space, medical equipment, staff) negatively impacted reach, implementation and sustainability. At times the PNC model was altered to accommodate the availability of resources (e.g., counselling mothers individually). Additionally, providers expressed concerns about lack of stakeholder adoption and emphasized the importance of involving facility leadership for successful integration of the model into routine primary healthcare. CONCLUSION: Our study found incomplete implementation of PNC in most of the participating facilities attributed to lack of resources and stakeholder buy-in. This underscores the need for increased support at management level to ensure sustainability. Effective collaboration between all stakeholders would allow better use of existing resources. Further studies are needed to evaluate whether all components of the model need to be implemented fully to ensure optimal outcomes, and to identify implementation strategies to facilitate scale-up.

Single-Dose Azithromycin for Genital Lymphogranuloma Venereum Biovar Chlamydia trachomatis Infection in HIV-Infected Women in South Africa: An Observational Study.

ABSTRACT: We conducted an observational study of lymphogranuloma venereum (LGV) biovar Chlamydia trachomatis infection in HIV-infected women in South Africa. The LGV biovar was detected in vaginal specimens of 17 (20%) of 85 women with C. trachomatis infection; 29% were symptomatic. All cases were negative for the LGV biovar after single-dose azithromycin.

Increases in HIV status disclosure and sexual communication between South African men who have sex with men and their partners following use of HIV self-testing kits.

Availability of HIV self-testing may increase HIV testing frequency among men who have sex with men (MSM). It is unclear, however, if self-testing may impact HIV-related sexual behaviors among MSM, including HIV status disclosure and condom use. We conducted a mixed methods analysis of changes in HIV-related behaviors after HIV self-testing introduction, using data from 110 MSM participating in a feasibility and acceptability study of HIV self-testing in Mpumalanga Province, South Africa. We found increased HIV status disclosure from study participants to sexual partners after HIV self-testing introduction, from 61.8% at baseline to 75.5% at 6-month follow-up (p = 0.04), but decreased condom use with female partners (p = 0.03). Qualitative interviews reveal that some participants used test results to inform condom use. Distribution of self-testing kits can improve mutual disclosure, but should be accompanied by information stressing that the tests may not detect early HIV infections or other sexually transmitted infections.

High rate of loss to follow-up and virological non-suppression in HIV-infected children on antiretroviral therapy highlights the need to improve quality of care in South Africa.

Provision of high-quality care and ensuring retention of children on antiretroviral therapy (ART) are essential to reduce human immunodeficiency virus (HIV)-associated morbidity and mortality. Virological non-suppression (≥1000 viral copies/ml) is an indication of suboptimal HIV care and support. This retrospective cohort study included ART-naïve children who initiated first-line ART between July 2015 and August 2017 in Johannesburg and rural Mopani district. Of 2739 children started on ART, 29.5% (807/2739) were lost to care at the point of analysis in August 2018. Among retained children, overall virological non-suppression was 30.2% (469/1554). Virological non-suppression was associated with higher loss to care 30.3% (229/755) compared with suppressed children (9.7%, 136/1399, P < 0.001). Receiving treatment in Mopani was associated with virological non-suppression in children under 5 years (adjusted odds ratio (aOR) 1.7 (95% confidence interval (CI) 1.1-2.4), 5-9 years (aOR 1.8 (1.1-3.0)) and 10-14 years (aOR 1.9 (1.2-2.8)). Virological non-suppression was associated with lower CD4 count in children 5-9 years (aOR 2.1 (1.1-4.1)) and 10-14 years (aOR 2.1 (1.2-3.8)). Additional factors included a shorter time on ART (<5 years aOR 1.8-3.7 (1.3-8.2)), and male gender (5-9 years, aOR1.5 (1.01-2.3)), and receiving cotrimoxazole prophylaxis (10-14 years aOR 2.0 (1.2-3.6)). In conclusion, virological non-suppression is a factor of subsequent programme loss in both regions, and factors affecting the quality of care need to be addressed to achieve the third UNAIDS 90 in paediatric HIV.

Antiretroviral Adherence, Elevated Viral Load, and Drug Resistance Mutations in Human Immunodeficiency Virus-infected Women Initiating Treatment in Pregnancy: A Nested Case-control Study.

BACKGROUND: Elevated viral load (VL) early after antiretroviral therapy (ART) initiation appears frequently in pregnant and postpartum women living with human immunodeficiency virus; however the relative contributions of pre-ART drug resistance mutations (DRMs) vs nonadherence in the etiology of elevated VL are unknown. METHODS: Within a cohort of women initiating ART during pregnancy in Cape Town, South Africa, we compared women with elevated VL after initial suppression (cases, n = 80) incidence-density matched to women who maintained suppression over time (controls, n = 87). Groups were compared on pre-ART DRMs and detection of antiretrovirals in stored plasma. RESULTS: The prevalence of pre-ART DRMs was 10% in cases and 5% in controls (adjusted odds ratio [aOR], 1.53 [95% confidence interval {CI}, .4-5.9]); all mutations were to nonnucleoside reverse transcriptase inhibitors. At the time of elevated VL, 19% of cases had antiretrovirals detected in plasma, compared with 87% of controls who were suppressed at a matched time point (aOR, 131.43 [95% CI, 32.8-527.4]). Based on these findings, we estimate that <10% of all elevated VL in the cohort may be attributable to pre-ART DRMs vs >90% attributable to ART nonadherence. CONCLUSIONS: DRMs account for a small proportion of all elevated VL among women occurring in the 12 months after ART initiation during pregnancy in this setting, with nonadherence appearing to drive most episodes of elevated VL. Alongside the drive for access to more robust antiretroviral agents in resource-limited settings, there is an ongoing need for effective strategies to support ART adherence in this patient population.

Antimicrobial Resistance of Neisseria gonorrhoeae Isolates from High-Risk Men in Johannesburg, South Africa.

Neisseria gonorrhoeae antimicrobial drug resistance has emerged worldwide; however, the situation in sub-Saharan Africa is not well documented. We investigated the molecular epidemiology and occurrence of antimicrobial resistance in Neisseria gonorrhoeae infections in two core transmission groups of men in Johannesburg, South Africa. We recruited men who have sex with men (MSM) presenting with urethral discharge and men with recurrent episodes of urethral discharge. Molecular testing and culture for N. gonorrhoeae were performed, followed by antimicrobial susceptibility testing. Whole-genome sequencing (WGS) was used to identify resistance-conferring mutations and to determine the genetic relatedness of the isolates. In all, 51 men were recruited; 42 (82%) had N. gonorrhoeae infections. Most gonococcal isolates were resistant to ciprofloxacin (78%) and tetracycline (74%); 33% were penicillin resistant. All gonococcal isolates were susceptible to cephalosporins and spectinomycin. Azithromycin resistance was observed in 4 (15%) isolates (epidemiological cutoff), all with mutations in the mtrR promoter region. Most of the isolates (19/27) harbored the gonococcal genetic island, which is associated with antimicrobial resistance. WGS revealed a diverse epidemic with mostly novel NG-STAR (70%) and NG-MAST (70%) sequence types. Thus, we demonstrate a high prevalence of antimicrobial resistance in Neisseria gonorrhoeae strains obtained from high-risk men in South Africa. The introduction of diagnostics and scale-up of surveillance are warranted to prevent the emergence of multidrug-resistant infections.

Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.

BACKGROUND: We describe enrollment and accrual challenges in the "Promoting Maternal and Infant Survival Everywhere" (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study. METHODS: PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment. The PROMISE breastfeeding protocol (1077BF) used a sequential randomization design with up to three randomizations (Antepartum, Postpartum, and Maternal Health). The PROMISE formula-feeding protocol (1077FF) had two randomizations (Antepartum and Maternal Health). Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization. RESULTS: The study was conducted at 14 sites in seven countries and opened to enrollment in April 2011. A total of 3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed were randomized in the Antepartum component. A total of 204 Late Presenters were registered during labor or after delivery. Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected). The successful overall enrollment and final primary study analyses results were attributed to substantial preparation before the study opened, collaboration among all stakeholders, close study monitoring during implementation and the flexibility to change and streamline the protocol. CONCLUSIONS: Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials.

Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention.

BACKGROUND: Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking. METHODS: We randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine plus a 1-to-2-week postpartum "tail" of tenofovir and emtricitabine (zidovudine alone); zidovudine, lamivudine, and lopinavir-ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir-ritonavir (tenofovir-based ART). The primary outcomes were HIV transmission at 1 week of age in the infant and maternal and infant safety. RESULTS: The median CD4 count was 530 cells per cubic millimeter among 3490 primarily black African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, -1.3 percentage points; repeated confidence interval, -2.1 to -0.4). However, the rate of maternal grade 2 to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P=0.008), and the rate of grade 2 to 4 abnormal blood chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%, P=0.03). Adverse events did not differ significantly between the ART groups (P>0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART than with zidovudine alone (23.0% vs. 12.0%, P<0.001) and was more frequent with tenofovir-based ART than with zidovudine alone (16.9% vs. 8.9%, P=0.004); preterm delivery before 37 weeks was more frequent with zidovudine-based ART than with zidovudine alone (20.5% vs. 13.1%, P<0.001). Tenofovir-based ART was associated with higher rates than zidovudine-based ART of very preterm delivery before 34 weeks (6.0% vs. 2.6%, P=0.04) and early infant death (4.4% vs. 0.6%, P=0.001), but there were no significant differences between tenofovir-based ART and zidovudine alone (P=0.10 and P=0.43). The rate of HIV-free survival was highest among infants whose mothers received zidovudine-based ART. CONCLUSIONS: Antenatal ART resulted in significantly lower rates of early HIV transmission than zidovudine alone but a higher risk of adverse maternal and neonatal outcomes. (Funded by the National Institutes of Health; PROMISE ClinicalTrials.gov numbers, NCT01061151 and NCT01253538 .).

Provision of Sexually Transmitted Infection Services in a Mobile Clinic Reveals High Unmet Need in Remote Areas of South Africa: A Cross-sectional Study.

BACKGROUND: The burden of sexually transmitted infections (STIs) in areas of sub-Saharan Africa with poor access to health care services is not well documented. In remote areas of South Africa, we investigated the prevalence of STIs and approaches to providing STI services through a mobile clinic. METHODS: We recruited 251 adult women visiting a mobile clinic that normally provides general health education and screening services, but not STI care. Clinical and sexual history was obtained and vaginal specimens were tested for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium infection and for Candida albicans and bacterial vaginosis. RESULTS: Laboratory test was positive for 133 (53%) of 251 women for at least 1 STI: C. trachomatis was observed in 52 (21%) women, N. gonorrhoeae in 39 (16%) women, T. vaginalis in 81 (32%) women and M. genitalium in 21 (8%) women. Eighty-one (32%) women met the criteria for vaginal discharge syndrome, of which 58% (47/81) would have been treated accurately. Among asymptomatic women 84 (49%) of 170 were diagnosed with an STI but untreated under the syndromic approach. We could not identify factors associated with asymptomatic STI infection. CONCLUSIONS: There is a high unmet need for STI care in rural South African settings with poor access to health care services. Provision of STI services in a mobile clinic using the syndromic management approach provides a useful approach, but would have to be enhanced by targeted diagnostics to successfully address the burden of infection.

High Rate of Repeat Sexually Transmitted Diseases Among Men Who Have Sex With Men in South Africa: A Prospective Cohort Study.

We observed a high rate of incident sexually transmitted diseases within 55 days (median) of follow-up (78% retention) among symptomatic men who have sex with men (n = 78) in South Africa (188 per 100 person-years; 95% confidence interval, 1.2-2.7); 16 newly acquired and 10 with persistent positivity. This highlights the need to strengthen prevention efforts, whereas introduction of diagnostics is urgently warranted.

Community-based strategies to identify the unmet need for care of individuals with sexually transmitted infection-associated symptoms in rural South Africa.

OBJECTIVES: To determine the unmet need for care and barriers for consulting sexually transmitted infection (STI) services at six primary healthcare (PHC) facilities in rural South Africa. METHODS: Cross-sectional study using three community-based strategies to mobilise adult individuals with STI-associated symptoms to access care. Participants were mobilised through clinic posters and referral by community healthcare workers (CHWs) and traditional leaders after training. Men with male urethritis syndrome and women with vaginal discharge syndrome were mobilised to visit participating PHC facilities on two designated days when an expert team visited the facility. Questionnaires were completed and HIV rapid tests offered. The minimal unmet need for care of individuals with STI-associated symptoms was calculated by dividing the number of cases over the adult catchment population of each PHC facility. RESULTS: We successfully mobilised 177 symptomatic individuals: 134 (76%) women and 43 (24%) men. The estimated minimal unmet need for STI care was 1:364 (95% CI 1:350-1:380) individuals in this region; the rate was higher in village than township facilities, and among women. Mobilisation through clinic posters (57%) and by CHWs (23%) was most successful. Three-quarters of individuals (132/177) reported symptoms that had been present for >30 days; 49% (87/177) had symptoms >6 months. In addition, we identified 14 individuals with untreated HIV infection amounting to a 7% HIV testing yield. Lack of awareness of symptoms (34%), and disappointment in care due to persistent (23%) or recurrent (15%) symptoms after previous treatment, or disappointment with health services in general during previous visit(s) for any reason (10%) was the most common reasons for not consulting health care. CONCLUSIONS: We demonstrate a high unmet need for care of individuals with STI-associated symptoms in rural South Africa that requires urgent attention. A multidisciplinary approach that creates service demand through community awareness and information provision by healthcare workers combined with strengthening the quality of STI services is required to improve reproductive health and prevent complications of untreated STIs in this population.

OBJECTIFS: Déterminer les besoins non satisfaits en matière de soins et les obstacles à la consultation des services pour IST dans six établissements de soins de santé primaires (SSP) en milieu rural en Afrique du Sud. MÉTHODES: Etude transversale utilisant trois stratégies communautaires pour mobiliser les individus adultes présentant des symptômes associés aux IST afin qu'ils puissent accéder aux soins. Les participants ont été mobilisés à travers des affiches dans les cliniques et sur recommandation des agents de santé communautaires (ASC) et des chefs traditionnels après une formation. Les hommes atteints du syndrome d'urétrite masculin et les femmes atteintes du syndrome de pertes vaginales ont été mobilisés à visiter les établissements de SSP participants, au cours de deux jours choisis lorsqu'une équipe d'experts était présente dans l'établissement. Des questionnaires ont été remplis et des tests de dépistage rapides du VIH ont été proposés. Le besoin minimal non satisfait de soins pour les personnes présentant des symptômes associés aux IST a été calculé en divisant le nombre de cas par la population adulte de la zone de chaque établissement de SSP. RÉSULTATS: Nous avons réussi à mobiliser 177 personnes symptomatiques: 134 (76%) femmes et 43 (24%) hommes. Le besoin minimal non satisfait en matière de soins IST était de 1:364 (IC95%: 1:350 - 1:380) individus dans cette région; le taux était plus élevé dans les villages que dans les installations des bidonvilles et chez les femmes. La mobilisation par le biais d'affiches de cliniques (57%) et par les ASC (23%) a eu le plus de succès. Les trois quarts des personnes (132/177) ont signalé des symptômes présents depuis >30 jours; 49% (87/177) présentaient des symptômes > 6 mois. En outre, nous avons identifié 14 personnes présentant une infection par le VIH, non traitée, ce qui représente un rendement de dépistage du VIH de 7%. Le manque de prise de conscience des symptômes (34%) et la déception avec les soins en raison de symptômes persistants (23%) ou récurrents (15%) après un traitement précédent, ou la déception avec les services de santé en général lors de visites précédentes pour une raison quelconque (10 %) étaient les raisons les plus courantes de ne pas consulter les soins de santé. CONCLUSIONS: Dans les zones rurales d'Afrique du Sud, nous démontrons un besoin élevé de soins non satisfaits pour les personnes présentant des symptômes associés aux IST et nécessitant une attention urgente. Une approche multidisciplinaire qui crée une demande de services par le biais de la sensibilisation de la communauté et de la fourniture d'informations par les agents de santé, associée au renforcement de la qualité des services IST, est nécessaire pour améliorer la santé reproductive et prévenir les complications des IST non traitées dans cette population.

'My Tablets are on Top of the Fridge': The Roles of Relationship Desire and Medical Mistrust in ART Adherence for HIV-Positive MSM and Transgender Women Living in Rural South Africa.

Given the high HIV prevalence for men who have sex with men (MSM) and transgender women in South Africa, there is limited understanding of social determinants that influence antiretroviral treatment (ART) adherence. Although universal testing and treatment (UTT) is available, ART adherence remains suboptimal. We conducted focus groups with MSM and transgender women in order to understand factors influencing their ART adherence in Mpumalanga, South Africa. All focus groups were audio-recorded, transcribed and translated for analysis using a constant comparison approach, guided by the concept of Therapeutic Citizenship. We found there is medical mistrust of ART based on differing interpretations of HIV cure that may influence treatment adherence behaviors within social networks, and relationship desire had a significant influence on optimal ART adherence. Our findings suggest that clinics must provide interventions that integrate HIV disclosure and relationship skill-building to support optimal ART adherence for MSM and transgender women under UTT.

Comparison of an in-house real-time duplex PCR assay with commercial HOLOGIC® APTIMA assays for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis in urine and extra-genital specimens.

BACKGROUND: Extra-genital Neisseria gonorrhoeae and Chlamydia trachomatis infections are mostly asymptomatic, and important reservoir sites of infection as they often go undetected and may be more difficult to eradicate with recommended therapeutic regimens. Commercial nucleic acid amplification tests (NAATs) have not received regulatory approval for the detection of N. gonorrhoeae and C. trachomatis in extra-genital specimens. The HOLOGIC® APTIMA Combo2 assay for N. gonorrhoeae and C. trachomatis has performed well in evaluations using extra-genital specimens. METHODS: We assessed the performance of an in-house real-time duplex PCR assay for the detection of N. gonorrhoeae and C. trachomatis in urine and extra-genital specimens using the HOLOGIC® APTIMA assays as gold standard comparators. Urine, oropharyngeal and ano-rectal specimens were collected from each of 200 men-who-have-sex-with-men (MSM) between December 2011 and July 2012. RESULTS: For N. gonorrhoeae detection, the in-house PCR assay showed 98.5-100% correlation agreement with the APTIMA assays, depending on specimen type. Sensitivity for N. gonorrhoeae detection was 82.4% for ano-rectal specimens, 83.3% for oropharyngeal specimens, and 85.7% for urine; and specificity was 100% with all specimen types. The positive predictive value (PPV) for N. gonorrhoeae detection was 100% and the negative predictive value (NPV) varied with sample type, ranging from 98.5-99.5%. For C. trachomatis detection, correlation between the assays was 100% for all specimen types. The sensitivity, specificity, PPV and NPV of the in-house PCR assay was 100% for C. trachomatis detection, irrespective of specimen type. CONCLUSION: The in-house duplex real-time PCR assay showed acceptable performance characteristics in comparison with the APTIMA® assays for the detection of extra-genital N. gonorrhoeae and C. trachomatis.

The role of health and advocacy organisations in assisting female sex workers to gain access to health care in South Africa.

BACKGROUND: Globally, female sex workers (FSWs) are considered a key population group due to the high HIV prevalence. Studies show that there are various factors in some contexts that render FSWs marginalised, which limits their access to sexual reproductive health (SRH) services. Access to SRH services are particularly challenging in countries where sex work is criminalised such as is the case in South Africa. Evidently, there are alternative ways in which FSWs in this context receive non-stigmatising SRH care through non-governmental organisations. The aim of this study was to understand the functioning of these non-governmental health care services as well as to document the experiences of FSWs utilising these services. METHODS: Eleven focus group discussions were held with 91 FSWs. In addition, 21 in-depth individual interviews with researchers, stakeholders and FSWs were conducted. Interview guides were utilised for data collection. Informed consent was obtained from all participants. Data were analysed thematically. RESULTS: The FSWs expressed challenges related to SRH care access at public health facilities. The majority felt that they could not consult for SRH-related services because of stigma. The non-governmental health and advocacy organisations providing SRH services to FSWs through their mobile facilities utilising the peer approach, have done so in a way that promotes trust between FSWs and mobile health care providers. FSWs have access to tailored services, prevention materials as well as health information. This has resulted in the normalising of HIV testing as well as SRH seeking behaviours. CONCLUSION: This study has established that health and advocacy organisations have attempted to fill the gap in responding to SRH care needs of FSWs amidst intersecting vulnerabilities. FSWs' engagement with these organisations has encouraged their willingness to test for HIV. However, it is important to note that these organisations operate in urban areas, thus FSWs operating outside these areas are most likely exposed to compounding health risks and lack access to tailored services.

Integration of postpartum healthcare services for HIV-infected women and their infants in South Africa: A randomised controlled trial.

BACKGROUND: As the number of HIV-infected women initiating lifelong antiretroviral therapy (ART) during pregnancy increases globally, concerns have emerged regarding low levels of retention in HIV services and suboptimal adherence to ART during the postpartum period. We examined the impact of integrating postpartum ART for HIV+ mothers alongside infant follow-up within maternal and child health (MCH) services in Cape Town, South Africa. METHODS AND FINDINGS: We conducted a randomised trial among HIV+ postpartum women aged ≥18 years who initiated ART during pregnancy in the local antenatal care clinic and were breastfeeding when screened before 6 weeks postpartum. We compared an integrated postnatal service among mothers and their infants (the MCH-ART intervention) to the local standard of care (control)-immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to separate routine infant follow-up. Evaluation data were collected through medical records and trial measurement visits scheduled and located separately from healthcare services involved in either arm. The primary trial outcome was a composite endpoint of women's retention in ART care and viral suppression (VS) (viral load < 50 copies/ml) at 12 months postpartum; secondary outcomes included duration of any and exclusive breastfeeding, mother-to-child HIV transmission, and infant mortality. Between 5 June 2013 and 10 December 2014, a total of 471 mother-infant pairs were enrolled and randomised (mean age, 28.6 years; 18% nulliparous; 57% newly diagnosed with HIV in pregnancy; median duration of ART use at randomisation, 18 weeks). Among 411 women (87%) with primary endpoint data available, 77% of women (n = 155) randomised to the MCH-ART intervention achieved the primary composite outcome of retention in ART services with VS at 12 months postpartum, compared to 56% of women (n = 117) randomised to the control arm (absolute risk difference, 0.21; 95% CI: 0.12-0.30; p < 0.001). The findings for improved retention in care and VS among women in the MCH-ART intervention arm were consistent across subgroups of participants according to demographic and clinical characteristics. The median durations of any breastfeeding and exclusive breastfeeding were longer in women randomised to the intervention versus control arm (6.9 versus 3.0 months, p = 0.006, and 3.0 versus 1.4 months, p < 0.001, respectively). For the infants, overall HIV-free survival through 12 months of age was 97%: mother-to-child HIV transmission was 1.2% overall (n = 4 and n = 1 transmissions in the intervention and control arms, respectively), and infant mortality was 1.9% (n = 6 and n = 3 deaths in the intervention and control arms, respectively), and these outcomes were similar by trial arm. Interpretation of these findings should be qualified by the location of this study in a single urban area as well as the self-reported nature of breastfeeding outcomes. CONCLUSIONS: In this study, we found that integrating ART services into the MCH platform during the postnatal period was a simple and effective intervention, and this should be considered for improving maternal and child outcomes in the context of HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT01933477.

Sexual Behaviors of Human Immunodeficiency Virus-Infected Pregnant Women and Factors Associated With Sexually Transmitted Infection in South Africa.

BACKGROUND: Sexual behaviors in human immunodeficiency virus (HIV)-infected pregnant women in South Africa are not well understood. METHODS: Human immunodeficiency virus-infected pregnant women were recruited into a prospective cohort at first antenatal care visit. Sociodemographic information and self-collected vulvovaginal swab samples were collected from participants. Vulvovaginal swab samples were tested for Chlamydia trachomatis, Neisseria gonorrhoea, and Trichomonas vaginalis using GeneXpert. We investigated sexual behaviors, alcohol use, factors associated with condomless sex during pregnancy, and prevalent sexually transmitted infection (STI) among our cohort. We report descriptive, univariate and multivariable logistic regression results of sexual behaviors and alcohol use, factors associated with condomless sex at last sex, and having any STI during pregnancy adjusting for a priori confounders. RESULTS: We recruited and enrolled 430 HIV-infected pregnant women. Median age was 30 years; median gestational age was 20 weeks. Eighty-nine percent of women reported sex during pregnancy. At last sex, 68% reported condomless sex; 18% reported having more than 1 sex partner in the past 12 months. Adjusting for age, income and relationship status, condom use at last sex was associated with prior knowledge of HIV status (adjusted odds ratio [aOR], 2.46; 95% confidence interval [CI], 1.54-3.92) and being in a concordant HIV-positive (aOR, 3.17; 95% CI, 1.84-5.50), or serodiscordant relationship (aOR, 6.50; 95% CI, 3.59-11.80). The prevalence of any STI was 41% (95% CI, 36%-45%). Adjusting for mothers' age and employment, odds of having an STI increased if the woman reported alcohol use during pregnancy (aOR, 1.96; 95% CI, 1.06-3.64) or if the father of the child was a non-cohabiting or casual partner (aOR, 1.42; 95% CI, 0.97-2.03). CONCLUSIONS: Almost all HIV-infected pregnant women were sexually active during pregnancy and most women reported condomless sex at last sex. Condom use was associated with knowledge of serostatus and/or partner's serostatus before first antenatal care visit. Factors associated with having STIs included: alcohol use during pregnancy and father of child being a non-cohabiting partner.

Understanding health worker data use in a South African antiretroviral therapy register.

OBJECTIVE: To evaluate how electronic data management systems affect data use practices in antiretroviral therapy (ART) programs within local health districts, and individual health facilities. METHODS: We used a data quality audit to establish a baseline of the quality of data in the electronic register alongside in-depth interviews with health workers and managers, to understand perceptions of data quality, data use by facility staff and challenges affecting data use. RESULTS: The findings provide a four-level continuum of data use that can be applied to other settings and recommendations for optimising facility-level data use. CONCLUSION: By defining four levels of data use our findings suggest the potential to encourage a structured process of moving from passive data use, to more active and engaged data use, where data could be used to anticipate patient behaviour and link that behaviour to differentiated care plans.