Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation.

BACKGROUND: A rapid and affordable point-of-care test is a priority for Neisseria gonorrhoeae control. WHO and Foundation for Innovative New Diagnostics (FIND) have a target product profile for a non-molecular N gonorrhoeae rapid point-of-care test that requires a clinical sensitivity of greater than 80% and a specificity over 95% to be considered useful in syndromic management; test turnaround time should be 30 min or under, and the test should cost less than US$3. A novel lateral flow assay (LFA) was developed to achieve that profile. METHODS: In this cross-sectional study we evaluated the performance of the novel N gonorrhoeae lateral flow assay (NG-LFA) at the primary health-care level in South Africa. Male patients with urethral discharge syndrome and female patients with vaginal discharge syndrome were recruited from five primary health-care facilities in the Buffalo City Metropolitan Municipality health district of South Africa. First-void urine specimens and nurse-collected vaginal swabs were tested in-facility with the NG-LFA and Xpert CT/NG PCR assay. N gonorrhoeae multi-antigen sequence typing (NG-MAST) was performed on all LFA positive specimens. FINDINGS: Between March 7, and Sept 19, 2022, we enrolled 200 male patients with urethral discharge and 200 female patients with vaginal discharge. The median age of male patients was 24 years (IQR 21-31 years), and the median age of female patients was 25 years (IQR 21-32 years). In addition, 23 male patients and 12 female patients who presented at the facility with a partner notification slip were enrolled of whom one (4%) and five (42%) were symptomatic, respectively. NG-LFA and Xpert results were available for all participants. In urine specimens, NG-LFA sensitivity was 96·1% (Wilson 95% CI 91·2-98·3; 123 LFA-positive among 128 PCR-positive specimens) and 91·7% in vaginal swab specimens (78·2-97·1; 33 LFA-positive among 36 PCR-positive). The specificity was 97·2% in urine specimens (90·4-99·2; 70 LFA-negative among 72 PCR-negative) and 96·3% in vaginal specimens (92·2-98·3; 158 LFA-negative among 164 PCR-negative). In 156 LFA-positive specimens, NG-MAST showed 93 different sequence types. INTERPRETATION: The novel NG-LFA had excellent clinical sensitivity and specificity in symptomatic male and female patients. The test met the optimal requirement for sensitivity and the minimal requirement for specificity specified in the target product profile. NG-LFA could provide an important tool to optimise clinical management and reduce excess antibiotic use in settings without direct access to laboratory testing. FUNDING: Global Antimicrobial Resistance Innovation Fund (GAMRIF) via FIND and National Institutes of Health.

Implementation considerations for a point-of-care Neisseria gonorrhoeae rapid diagnostic test at primary healthcare level in South Africa: a qualitative study.

BACKGROUND: South Africa maintains an integrated health system where syndromic management of sexually transmitted infections (STI) is the standard of care. An estimated 2 million cases of Neisseria gonorrhoeae (N. gonorrhoeae) occur in South Africa every year. Point-of-care diagnostic tests (POCT) may address existing STI control limitations such as overtreatment and missed cases. Subsequently, a rapid lateral flow assay with fluorescence-based detection (NG-LFA) with a prototype reader was developed for N. gonorrhoeae detection showing excellent performance and high usability; however, a better understanding is needed for device implementation and integration into clinics. METHODS: A qualitative, time-series assessment using 66 in-depth interviews was conducted among 25 trained healthcare workers involved in the implementation of the NG-LFA. Findings were informed by the Normalization Process Theory (NPT) as per relevant contextual (strategic intentions, adaptive execution, and negotiation capacity) and procedural constructs (coherence, cognitive participation, collective action, reflexive monitoring) to examine device implementation within primary healthcare levels. Interviews were audio-recorded, transcribed, and then analyzed using a thematic approach guided by NPT to interpret results. RESULTS: Overall, healthcare workers agreed that STI POCT could guide better STI clinical decision-making, with consideration for clinic integration such as space constraints, patient flow, and workload. Perceived NG-LFA benefits included enhanced patient receptivity and STI knowledge. Further, healthcare workers reflected on the suitability of the NG-LFA given current limitations with integrated primary care. Recommendations included sufficient STI education, and appropriate departments for first points of entry for STI screening. CONCLUSIONS: The collective action and participation by healthcare workers in the implementation of the NG-LFA revealed adaptive execution within the current facility environment including team compositions, facility-staff receptivity, and STI management experiences. User experiences support future clinic service integration, highlighting the importance of further assessing patient-provider communication for STI care, organizational readiness, and identification of relevant departments for STI screening.

High study participation but diverging adherence levels: qualitatively unpacking PrEP use among adolescent girls and young women over two years in Eastern Cape, South Africa.

In Southern and Eastern Africa, initiation of daily oral pre-exposure prophylaxis (PrEP) for HIV prevention has been high among adolescent girls and young women (AGYW) offered PrEP. However, persistence and prevention-effective use of PrEP among this critical group continues to be a challenge. We conducted a qualitative sub-study of AGYW from the Community PrEP Study in Eastern Cape Province, South Africa who had high rates of pick up for monthly PrEP refills over two years, but differing levels of PrEP adherence based on tenofovir-diphosphate (TFV-DP) measurements in dried blood spots (DBS). Contrasting 22 AGYW with low versus high levels of TFV-DP in DBS, we qualitatively explored factors which influenced PrEP persistence vs. non-persistence, unique patterns of PrEP use (e.g., discarding or stockpiling), and participant recommendations for improving AGYW prevention-effective use of PrEP in the future. Results showed that PrEP misconceptions and mistrust among participants' social networks negatively influenced adherence. In comparison, supportive families and/or partners and personal trust that PrEP works positively influenced adherence. Those with low adherence described being motivated to come to the site for other study benefits (e.g., reimbursement money, snacks, sanitary pads) and discarding PrEP to avoid stigma associated with being seen with pills. Future PrEP implementation strategies should focus on involving families and partners in PrEP support for AGYW and minimizing PrEP stigma at a community level.Trial registration NCT03977181. Retrospectively registered on June 6, 2019.

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

INTRODUCTION: Adolescent girls and young women (AGYW) face barriers that jeopardize their prevention-effective use of daily oral pre-exposure prophylaxis (PrEP). We sought to understand factors that influence AGYW's prolonged breaks in PrEP use, and their decisions to re-initiate or discontinue using PrEP in the context of a community-based adherence support intervention. METHODS: In-depth interviews (IDIs) were conducted between December 2019 and April 2021 with purposively selected AGYW (aged 16-25) enrolled in the Community PrEP Study (CPS) in Buffalo City Metro Health District, Eastern Cape Province, South Africa. AGYW were offered monthly PrEP for 24 months at two community-based study sites. Interview guides were informed by the Information-Motivation-Behavioural Skills Model, and data were analysed using illustrative code reports and a case analysis. RESULTS: A total of 603 participants were enrolled and initiated on PrEP in the parent study. Fifty-three IDIs were conducted with 50 CPS participants. Findings revealed that external factors (e.g. local movement, school holidays and medication side-effects) and social conflicts (e.g. discretion and partner mistrust) directly influenced breaks in PrEP usage. A decrease in one's self-perception of HIV risk prolonged the duration of these "PrEP breaks." Once PrEP refill visits were missed, some AGYW delayed returning for refills out of fear of being scolded by study staff. The differences between those participants who eventually re-initiated PrEP and those who disengaged from PrEP use can be attributed to social support and encouragement, level of familiarity with PrEP, risk perceptions, self-initiated discussions with staff and diminishing side effects. CONCLUSIONS: Despite implementing a community-based PrEP delivery platform and behavioural intervention that included support for daily oral PrEP adherence and disclosure, participants struggled with consistent daily oral PrEP use. Unpredictable life events, including local movement and schooling schedules, in addition to being judged for their perceived behaviours, pose a challenge for consistent pill pick-up for AGYW and habit formation. Long-acting injectable PrEP may mitigate a number of these external barriers. Interventions that integrate long-term planning skills, how to navigate existing social judgements and how to access sources of social support may further improve habit formation for PrEP use, regardless of its formulation.

Usability of a novel lateral flow assay for the point-of-care detection of Neisseria gonorrhoeae: A qualitative time-series assessment among healthcare workers in South Africa.

Accurate and user-friendly rapid point-of-care diagnostic tests (POCT) are needed to optimize treatment of Neisseria gonorrhoeae, especially in low-resource settings where syndromic management is the standard of care for sexually transmitted infections. This study aimed to assess the acceptability and usability of a novel lateral flow assay and portable reader for the point-of-care detection of N. gonorrhoeae infection (NG-LFA). This mixed-methods study was conducted as part of a diagnostic performance and usability evaluation of a prototype NG-LFA for detection of N. gonorrhoeae in symptomatic men and women at primary healthcare facilities in the Buffalo City Metro, South Africa. The Standardized System Usability Scale (SUS) was administered, and in-depth interviews were conducted among healthcare professionals (HCPs) and fieldworkers (FWs) at pre-implementation, initial use and 3- and 6-month study implementation to assess user expectations, practical experience, and future implementation considerations for the NG-LFA. Data collection and analysis was guided by the Health Technology Adoption Framework, including new health technology attributes, learnability, satisfaction, and suitability. The framework was adapted to include perceived durability. A total of 21 HCPs and FWs were trained on the NG-LFA use. SUS scores showed good to excellent acceptability ranging from 78.8-90.6 mean scores between HCPs and FWs across study time points. All transcripts were coded using Dedoose and qualitative findings were organized by learnability, satisfaction, suitability, and durability domains. Usability themes are described for each time point. Initial insecurity dissipated and specimen processing dexterity with novel POCT technology was perfected over time especially amongst FWs through practical learning and easy-to-use instructions (learnability). Participants experienced both positive and negative test results, yielding perceived accuracy and minimal testing challenges overall (satisfaction). By 3- and 6-month use, both HCPs and FWs found the NG-LFA convenient to use in primary health care facilities often faced with space constraints and outlined perceived benefits for patients (suitability and durability). Findings show that the NG-LFA device is acceptable and usable even amongst paraprofessionals. High SUS scores and qualitative findings demonstrate high learnability, ease-of-use and suitability that provide valuable information for first-step scale-up requirements at primary healthcare level. Minor prototype adjustments would enhance robustness and durability aspects.

"I know why I am taking this pill": Young women navigation of disclosure and support for PrEP uptake and adherence in Eastern Cape Province, South Africa.

There is limited understanding of the dynamic interplay between adolescent girl's and young women's (AGYW) disclosure and social support for using oral pre-exposure prophylaxis (PrEP) and adherence. Towards this, we conducted interviews with 42 AGYW enrolled in The Community PrEP Study who exhibited either high or low blood concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots. Guided by Theories of Practice, interviews and analysis focused on AGYW perspectives and experiences with PrEP disclosure, support and adherence. AGYW with high TFV-DP blood concentrations described larger social support networks and disclosure events. In contrast, those with low TFV-DP blood concentrations described disclosing to fewer people, resulting in limited social support. Participants discussed partner support, however, this support was not described as consequential to adherence, irrespective of TFV-DP levels. Those with high levels of TFV-DP in their blood described the ability to navigate social scrutiny and changes in social support, while those with low levels of TFV-DP in their blood were more likely to question their own continued use of PrEP. To facilitate AGYW's prevention-effective use of PrEP, expanded skill-building for disclosure and resiliency against changes to social support should be examined as part of PrEP services.

Factors influencing adolescent girls and young women's uptake of community-based PrEP services following home-based HIV testing in Eastern Cape, South Africa: a qualitative study.

Home-based service delivery has been used to improve access to HIV testing and antiretroviral initiation across sub-Saharan Africa, but it has yet to be leveraged to improve pre-exposure prophylaxis (PrEP) uptake. We interviewed 37 adolescent girls and young women (AGYW) in Eastern Cape, South Africa to explore why they chose to initiate PrEP or not following home-based HIV testing and referral for PrEP, and what influenced time to PrEP initiation. Participants reported that home visits provided a source of trusted information and a way to involve family members in their PrEP initiation decisions, motivating some to start PrEP. AGYW who initiated PrEP were more likely to qualitatively perceive themselves to be at high risk for HIV compared with those who never initiated PrEP. Integrating home-based HIV testing with PrEP education and referral may be a valuable way to reduce familial barriers and boost PrEP uptake among AGYW in South Africa. Trial registration: NCT03977181. Retrospectively registered on June 6, 2019.

Employment preferences of healthcare workers in South Africa: Findings from a discrete choice experiment.

There is a maldistribution of human resources for health globally, with many Lower- and Middle-Income Countries experiencing significant shortages. We examined healthcare workers' job preferences in South Africa to identify factors which potentially influence employment decisions. A discrete choice experiment was conducted among 855 South African healthcare workers critical to its national HIV testing and treatment programs. Job characteristics included workload, workplace culture, availability of equipment, training opportunities, sector and facility type, location, salary and benefits. Main effects analysis was conducted using fixed effects logistic regression. Interaction effects identified divergence in preferences. Heavy workload (OR = 0.78; 95% C.I. 0.74-0.83), poor workplace culture (odds ratio 0.66; 95% C.I. 0.62-0.69), insufficient availability of equipment (OR = 0.67; 95% C.I. 0.63-0.70) and infrequent training opportunities (OR = 0.75; 95% C.I. 0.71-0.80) had large, significant effects on worker preferences. An increase in salary of 20% (OR = 1.29; 95% C.I. 1.16-1.44) had a positive effect on preferences, while a salary decrease of 20% (OR = 0.55; 95% C.I. 0.49-0.60) had a strong negative effect. Benefits packages had large positive effects on preferences: respondents were twice as likely to choose a job that included medical aid, pension and housing contributions worth 40% of salary (OR = 2.06; 95% C.I. 1.87-2.26), holding all else constant. Although salary was important across all cadres, benefits packages had larger effects on job preferences than equivalent salary increases. Improving working conditions is critical to attracting and retaining appropriate health cadres responsible for the country's HIV services, especially in the public sector and underserved, often rural, communities. Crucially, our evidence suggests that factors amenable to improvement such as workplace conditions and remuneration packages have a greater influence on healthcare workers employment decisions than employment sector or location.

Mother-to-child transmission of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in HIV-infected pregnant women in South Africa.

BACKGROUND: Sexually transmitted infections (STIs) can be transmitted from mother to neonate. We determined the frequency of mother-to-child transmission (MTCT) of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis to the newborn nasopharynx. METHODS: This study was nested in a cohort study of etiologic testing versus syndromic management for STIs among pregnant women living with human immunodeficiency virus in South Africa. Mothers were tested for STIs using the GeneXpert platform within 60 days after delivery. Nasopharyngeal swabs were obtained from newborns of mothers with a positive STI test; these were then tested by Xpert® on the same day based on the maternal STI diagnosis. RESULTS: We tested nasopharyngeal swabs from 85 STI-exposed newborns; 74 (87%) were tested within 2 weeks after birth (median five; range 2-12 days). MTCT frequency of any STI was 30/74 (41%); 43% (23/53) for C. trachomatis, 29% (2/7) for N. gonorrhoeae, and 24% (6/25) for T. vaginalis. Also, 4/11 (36%) swabs obtained between 14 and 60 days after delivery tested positive for STI. CONCLUSIONS: There was a high frequency of MTCT of STIs to the nasopharynx of newborns in our setting. The impact of nasopharyngeal colonization and the benefits of STI testing on newborn health remain to be determined.

"I got tested at home, the help came to me": acceptability and feasibility of home-based TB testing of household contacts using portable molecular diagnostics in South Africa.

OBJECTIVE: The effectiveness of household contact investigations is limited by low referral uptake for clinic-based TB testing by symptomatic household contacts. We qualitatively investigated the acceptability and perceived benefits of home-based TB testing using a portable GeneXpert-I instrument (GX-I) in an urban South African township. METHODS: In-depth interviews were conducted with household contacts tested and those that observed testing. Semi-structured interviews explored household contact's understanding of TB, perceptions of the GX-I device and testing procedures, confidentiality, willingness to refer others, and views on home- vs. clinic-based testing. Focus group discussions with home-based TB testing implementing staff assessed operational considerations for scale-up. Data were analysed using a constant comparison approach to qualitatively evaluate the acceptability and feasibility of home-based TB testing. RESULTS: Thirty in-depth interviews and two focus group discussions were conducted. Observing one's own sputum being tested resulted in an emergent trust in home-based TB testing, the GX-I device and one's test results. Home-based TB testing was considered convenient, helped to overcome apathy towards testing and mitigated barriers to clinic-based testing. Perceptions that home-based TB testing contributes to improved household and community health resulted in an emergent theme of alleviation of health insecurities. Operational concerns regarding inadvertent disclosure of one's diagnosis to household members and time spent in people's homes were identified. CONCLUSIONS: Home-based TB testing was acceptable and feasible. Individuals expressed belief in the machine by being able to witness the testing process. Though most themes mirrored qualitative studies of home-based HIV testing, the alleviation of health insecurities theme is unique to home-based TB testing. Future research must evaluate the impact of home-based TB testing on case finding yield, time-to-treatment initiation and household outcomes.

OBJECTIF: L'efficacité des enquêtes sur les contacts familiaux est limitée par le faible taux de respect de l'orientation pour le dépistage de la tuberculose (TB) en clinique par les contacts familiaux symptomatiques. Nous avons investigué qualitativement l'acceptabilité et les avantages perçus du dépistage de la TB à domicile à l'aide d'un dispositif portable GeneXpert-I (GX-I) dans une ville urbaine sud-africaine. MÉTHODES: Des entretiens approfondis ont été menés avec des contacts familiaux testés et ceux qui ont observé la pratique des tests. Des entretiens semi-structurés ont permis d'explorer la compréhension de la TB par les contacts familiaux, les perceptions sur le dispositif GX-I et les procédures de test, la confidentialité, la volonté de référer d'autres personnes et les opinions sur le dépistage à domicile ou en clinique. Des discussions de groupe focalisées avec le personnel chargé de la mise en œuvre du dépistage de la TB à domicile ont évalué les considérations opérationnelles pour le déploiement. Les données ont été analysées en utilisant une approche de comparaison constante pour évaluer qualitativement l'acceptabilité et la faisabilité du dépistage de la TB à domicile. RÉSULTATS: Trente entretiens approfondis et deux discussions de groupe ont été menés. L'observation de ses propres expectorations testées a conduit à une émergente de confiance dans le dépistage de la TB à domicile, le dispositif GX-I et les résultats des tests. Le dépistage de la TB à domicile était considéré comme pratique, aidait à surmonter l'apathie envers le dépistage et atténuait les obstacles au dépistage en clinique. La perception selon laquelle le dépistage de la TB à domicile contribue à l'amélioration de la santé des ménages et de la communauté a donné lieu à l'émergence du thème de la réduction des insécurités sanitaires. Des préoccupations opérationnelles concernant la divulgation par inadvertance de son diagnostic aux membres du ménage et le temps passé au domicile des personnes ont été identifiées. CONCLUSION: Le dépistage de la TB à domicile était acceptable et faisable. Les individus ont exprimé leur croyance en la machine en étant en mesure d'assister au processus de test. Bien que la plupart des thèmes reflètent des études qualitatives sur le dépistage du VIH à domicile, le thème de l'atténuation des insécurités sanitaires est unique au dépistage de la TB à domicile. Les recherches futures doivent évaluer l'impact du dépistage de la TB à domicile sur le rendement de la recherche des cas, le délai de mise en route du traitement et les résultats au sein des ménages.

The role of trust and health literacy in nurse-delivered point-of-care STI testing for pregnant women living with HIV, Tshwane District, South Africa.

BACKGROUND: Sexually transmitted infections (STIs) during pregnancy result in neonatal morbidity and mortality, and may increase mother-to-child-transmission of HIV. Yet the World Health Organization's current syndromic management guidelines for STIs leaves most pregnant women undiagnosed and untreated. Point-of-care (POC) diagnostic tests for STIs can drastically improve detection and treatment. Though acceptable and feasible, poor medication adherence and re-infection due to lack of partner treatment threaten the programmatic effectiveness of POC diagnostic programmes. METHODS: To engender patient-provider trust, and improve medication adherence and disclosure of STI status to sexual partners, we trained study nurses in compassionate care, good clinical practices and motivational interviewing. Using qualitative methods, we explored the role patient-provider communications may play in supporting treatment adherence and STI disclosure to sexual partners. Nurses were provided training in motivational interviewing, compassionate care and good clinical practices. Participants were interviewed using a semi-structured protocol, with domains including STI testing experience, patient-provider communication, and HIV and STI disclosure. Interviews were audio-recorded, transcribed and analyzed using a constant comparison approach. RESULTS: Twenty-eight participants treated for Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), and/or Neisseria gonorrhea (NG) were interviewed. Participants described strong communications and trusting relationships with nurses trained in patient-centered care training and implementing POC STI diagnostic testing. However, women described a delayed trust in treatment until their symptoms resolved. Women expressed a limited recall of their exact diagnosis, which impacted their ability to fully disclose their STI status to sexual partners. CONCLUSIONS: We recommend implementing patient health literacy programmes as part of POC services to support women in remembering and disclosing their specific STI diagnosis to sexual partners, which may facilitate partner treatment uptake and thus decrease the risk of re-infection.

Factors influencing sexually transmissible infection disclosure to male partners by HIV-positive pregnant women in Pretoria townships, South Africa: a qualitative study.

Background Sexually transmissible infections (STI) may increase the risk of mother-to-child transmission (MTCT) of HIV. However, diagnostic testing and targeted treatment of STI (STI-TT) during pregnancy is not standard care in South Africa. METHODS: A qualitative study was nested in a STI-TT intervention to investigate motivating and enabling factors associated with STI test results disclosure to sexual partners. A semi-structured interview protocol covered partner communication, HIV and STI disclosure, financial security and relationships dynamics. Interviews were conducted in participants' preferred language, audio-recorded, transcribed into English and analysed using a constant comparison approach. The study was conducted in two townships in Pretoria, South Africa. RESULTS: Twenty-eight HIV-positive pregnant women were interviewed. Based on the interviews, two disclosure experiences for women were identified - those with vulnerable experiences and those with self-enabling experiences within their partnerships. Vulnerable women discussed intimate partner violence (IPV) and fear of relationship dissolution as factors influencing their test result disclosure. Self-enabled women discussed their ability to talk with their partners about STI and HIV infections and the influence of multiple concurrent partnerships in the acquisition of HIV/STIs. Both groups of women were concerned about men's health behaviours, and all cited the health and development of their unborn child as a key motivator for test result disclosure. CONCLUSIONS: Improved counselling and support for pregnant women to disclose their STI test results to their partners may improve the impact of STI diagnostic testing during pregnancy by improving partner treatment uptake and thus reducing the risk of re-infection.

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.

Prevalence and Detection of Trichomonas vaginalis in HIV-Infected Pregnant Women.

BACKGROUND: Trichomonas vaginalis is a sexually transmitted infection associated with increased transmission of HIV and significant adverse birth outcomes; culture and polymerase chain reaction (PCR) are commonly used in diagnosis. METHODS: Consenting HIV-infected pregnant women were recruited from clinics in South Africa and screened for T. vaginalis using PCR. Polymerase chain reaction-positive women provided an additional sample for culture. We compared T. vaginalis detection between PCR and culture, and investigated how PCR cycle threshold (Ct) values differ among culture results. RESULTS: A total of 359 women were enrolled and 76 (20%) tested T. vaginalis PCR positive. Cultures were obtained from 61 of the PCR-positive women, and 38 (62%) were culture positive. The median baseline Ct of the PCR-positive/culture-positive group was 22.6 versus 38.0 among those who were PCR positive/culture negative (P < 0.001). Culture-positive cases had lower Ct values (higher DNA load); a Ct value less than 30 predicted positivity with a sensitivity of 97% and a specificity of 96%. CONCLUSIONS: Culture was positive in roughly half of PCR-positive cases. The culture-negative cases had significantly higher Ct values, indicating a lower concentration of T. vaginalis DNA. A Ct value of 30 provides a reliable threshold for predicting culture positivity. The clinical significance of culture-negative infections detected by PCR is still unclear.

High prevalence of asymptomatic sexually transmitted infections among human immunodeficiency virus-infected pregnant women in a low-income South African community.

There is a lack of evidence on the burden of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) among HIV-infected pregnant women in South Africa. We conducted a cross-sectional analysis of HIV-infected pregnant women in two healthcare facilities in a South African township to determine the prevalence of CT, NG and TV. HIV-infected pregnant women were recruited during the first antenatal care visit for their current pregnancy and requested to self-collect vulvovaginal swab specimens. Specimens were tested for CT, NG and TV using the Xpert® assay (Cepheid, Sunnyvale, CA). Of 247 tested for CT, NG and TV, 47.8% tested positive for at least one organism; CT = 36.8%, TV = 23.9%, NG = 6.9%. Forty three (17.4%) had multiple infections, of which 42 included CT as one of the infecting organisms. Of the 118 participants who tested positive for at least one sexually transmitted infection (STI), 23.7% reported STI-like symptoms. Among women who tested positive for CT, 29.7% reported symptoms while 47.1 and 27.1% of those who tested positive for NG and TV, respectively, reported symptoms. The high STI prevalence coupled with the low symptom prevalence among infected individuals justifies the use of diagnostic screening approaches rather than syndromic management of STIs in this setting.