Sexually Transmitted Infections
● BMJ
Preprints posted in the last 30 days, ranked by how well they match Sexually Transmitted Infections's content profile, based on 23 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit.
Mittelstaedt, R.; Helekal, D.; Kline, M. C.; Oliveira Roster, K. I.; Robbins, G. K.; Ard, K. L.; Grad, Y.
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Background: Doxycycline post-exposure prophylaxis (doxy-PEP) reduces the incidence of bacterial sexually transmitted infections (STIs) among men who have sex with men and transgender women (MSMTW), but it may select for antimicrobial resistance (AMR). AMR development will depend in part how doxy-PEP changes rates of antibiotic use. Methods: We conducted a retrospective electronic medical record review of antibiotic prescriptions received by patients at the Massachusetts General Hospital Sexual Health Clinic from January 1, 2023, to December 27, 2025. Using a Bayesian negative binomial regression, we assessed the direct, indirect, and combined effects of doxy-PEP implementation on antibiotic prescription rates among doxy-PEP-eligible MSMTW who were receiving HIV pre-exposure prophylaxis. Results: Controlling for direct effects, the cohort's total antibiotic prescription rate decreased by 10% (0.90, 95% CI 0.87 - 0.94) for every 100 doxy-PEP starts. Doxy-PEP users were prescribed antibiotics at double the rate predicted in the absence of doxy-PEP implementation, and, controlling for indirect effects, received 3.40 (95% CI 2.95 - 3.91) times the antibiotic prescriptions of patients not using doxy-PEP. Doxy-PEP non-users were prescribed antibiotics at less than half the rate predicted in the absence of doxy-PEP. The full cohort's overall antibiotic prescription rate increased by 1.4 times after doxy-PEP implementation. Conclusions: Individuals who are taking doxy-PEP have higher antibiotic prescription rates, increasing selection for antibiotic-resistant bacteria in these individuals. However, doxy-PEP-driven decreases in the overall incidence of bacterial STIs have the potential to decrease selective pressure for resistant organisms in those not using doxy-PEP.
Landray, I.; Carpenter, J.; Free, C.
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Background Preventing sexually transmitted re-infections brings health benefits and can be significantly less costly than treating their sequelae. Safetxt is a potential novel digital intervention developed to promote safer sexual behaviours. However, a recent randomised controlled trial of safetxt found no effect on reinfection at 1 year (OR 1.13, 95%CI: 0.98-1.31). We investigated if safetxt's effect was mediated through sexually risky behaviours. Methods We used data from 6248 young people with STIs from 92 UK sexual health clinics. The direct and indirect effects of safetxt on reinfection were estimated using the counterfactual approach. Condom use at last sexual encounter, number of sexual partners and STI testing were assessed as mediators. These were analysed singly and together, using regression models and a formal weighting approach. The assumptions of each approach were considered and tested. Analyses were repeated in the subgroup showing the most promising effect of safetxt: men who have sex with men or with men and women (MSM/MSMW). Results No evidence was found for the total, indirect or direct effects differing from the null. Despite not being significant, for MSM/MSMW, some of safetxt's effect on reducing reinfection was identified as being offset through its effect on number of sexual partners. Conclusions There was no evidence that safetxt's effect on reinfection was mediated through changes in sexually risky behaviours. Adaptations to specifically target these behaviours are unlikely to improve safetxt's overall effect. However, improving safetxt's effect on the number of sexual partners a participant has may improve its effect for MSM/MSMW.
van Stokkom, H.; Dekker, L. P.; Pastoor, H.; Enthoven, C.
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BACKGROUND: Sexual pleasure is integral to sexual health, offering important physical and mental benefits. Yet, sex education programs often neglect pleasure, focusing instead on preventing sexual risk behaviors (SRBs), which young adults are particularly vulnerable to. AIM: This study investigates the association between SRBs and sexual pleasure in young adults and whether sex assigned at birth moderates this relationship. METHODS: Embedded within the Generation R cohort, 1010 young adults completed an online questionnaire assessing sexual pleasure using the six subscales of the Amsterdam Sexual Pleasure Inventory (ASPI 1.0), Arousal Enjoyment, Enjoyment-Related Self-Efficacy, Enjoyment-Related Self-Worth, Interaction Enjoyment, Bonding Enjoyment, and Sexual Experience Enjoyment, and various SRBs including sexual debut <15 years, six or more lifetime partners, frequent unprotected sex, and substance use during sex. Multiple linear regression analyses were performed for each SRB and sexual pleasure subscale, adjusting for demographics, self-esteem, relationship status, socioeconomic status, and psychopathology, with additional stratification by sex assigned at birth. OUTCOMES: The primary outcome measure is sexual pleasure, measured across six domains, examined in relation to SRBs. RESULTS: Fully adjusted regression analyses showed that engaging in SRB was positively associated with several dimensions of sexual pleasure. All SRBs were associated with higher Enjoyment-Related Self-Efficacy (ERSE) scores (p<0.002). Early sexual debut was additionally linked to higher Interaction Enjoyment scores, while having six or more lifetime partners was associated with increased Enjoyment-Related Self-Worth and Sexual Experience Enjoyment scores (p<0.002). Some associations, particularly involving ERSE, were only significant among males. Individuals without partnered sexual experience reported lower sexual pleasure scores. CLINICAL IMPLICATIONS: Incorporating sexual pleasure into sex education could promote a more balanced, realistic understanding of sexuality among young adults, emphasizing both enjoyment and responsible sexual decision-making. STRENGHTS & LIMITATIONS: Key strengths of this study are the use of the multidimensional Amsterdam Sexual Pleasure Inventory (ASPI 1.0) and the large population-based cohort study design, enabling a nuanced and generalizable analysis. This study is limited by potential selection and reporting bias, the cross-sectional design, residual confounding, and the absence of universally agreed-upon thresholds for defining SRBs. CONCLUSION: These findings suggest there is a positive association between engagement in SRB and sexual pleasure, possibly reflecting greater overall sexual experience. The stronger associations observed among males might reflect gendered differences in the role of self-esteem and societal expectations.
Barbosu, C. M.; Manciuc, C. D.; Dye, T.
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HIV/AIDS remains a major global public health challenge, and disparities in HIV testing persist. In 2024, an estimated 87% of people living with HIV were aware of their status, with lower testing coverage among children aged 0-14 years (63%), and among men (84%) compared with women (92%). Romania initiated its national AIDS program in 1995 and quickly progressed in addressing the epidemic; however, HIV testing remains largely concentrated in specialized services, with late diagnosis, missed testing opportunities, and stigma continuing to limit timely identification and linkage to care. This study aimed to understand better HIV testing/screening practices among clinicians in eastern Romania and to identify gaps that could be addressed through medical education. We conducted an analytical cross-sectional study among healthcare providers in the eastern region of Romania to assess whether HIV testing is routinely offered to patients, explore gaps in clinical judgment and perceived responsibility, and identify factors that facilitate HIV testing. A 17-question anonymous survey was distributed via WhatsApp to clinician groups between August 1 and September 30, 2023. Respondents included physicians (71.9%), nurses (28.1%), and other healthcare professionals, working in infectious diseases (36.0%), internal medicine (22.3%), primary care (13.7%), and other specialties, such as obstetrics-gynecology and pediatrics (18.0%). Only 38.1% of respondents reported routinely screening all patients aged 18 years and older for HIV, while 61.9% did not offer regular HIV testing. The most cited reasons for not screening were the perception that HIV testing was not their responsibility and that their department did not require testing (18.1% each). Clinicians working in settings with established policies on HIV confidentiality, non-discrimination, testing, and post-exposure prophylaxis were more likely to offer routine testing. Universal HIV screening remains uncommon among clinicians in eastern Romania. Supportive institutional policies appear to facilitate routine testing and may reduce missed opportunities for early diagnosis. Normalizing HIV testing as part of routine clinical care, in line with the Romanian National Health Strategy 2022-2030, is crucial for enhancing early detection and strengthening prevention efforts through coordinated action among clinicians, public institutions, and civil society.
Willemstein, I. J. M.; Prins, M.; Heijne, J. C. M.; Davidovich, U.; Schim van der Loeff, M. F.; Chaname Pinedo, L.; Akwiwu, E. U.; van Benthem, B.; Hoornenborg, E.; Jongen, V. W.
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Background Clinical trials demonstrated high efficacy of daily and event-driven oral pre-exposure prophylaxis (PrEP) in HIV prevention. Event-driven PrEP involves taking two tablets before and two times one tablet after sexual contact (2-1-1/on-demand). While both are implemented in Dutch clinical practice, evaluating real-world effectiveness requires large-scale data from routine clinical care. This study compared HIV incidence between daily and event-driven PrEP in the Netherlands. Methods We used surveillance data from the Dutch national PrEP program (August 1, 2019-December 31, 2025). Individuals [≥]16 years with [≥]1 follow-up consultation after PrEP initiation were included; PrEP regimen since last visit was recorded at each visit. Person-time was modeled as time-varying based on the regimen reported at each consultation. HIV incidence rates were calculated per 100 person-years and Cox proportional hazards models estimated hazard ratios between regimens for HIV acquisition, adjusted for sociodemographics, sexual behavior, and history of sexually transmissible infections. Findings 16,469 individuals (15,843 men who have sex with men, 579 transgender and gender diverse persons, 45 women and two men who have sex with women) initiated PrEP and had [≥]1 follow-up visit (median follow-up 2.0 years (IQR=0.8-4.0)). Median age was 33 years (IQR=27-44). 49 PrEP users were diagnosed with HIV over 41,092 person-years (IR=0.12/100 py;95%CI=0.09-0.16), of whom 42 event-driven users (IR=0.20/100 py;95%CI=0.15-0.27) and seven daily PrEP users (IR=0.04/100 py;95%CI=0.02-0.07). In multivariable Cox regression, event-driven PrEP use was associated with a higher hazard of HIV acquisition (aHR=7.0;95%CI=3.0-16.4). Interpretation Despite overall low HIV incidence, the incidence rate in the Dutch national PrEP program was seven-fold higher during event-driven PrEP use compared to daily, which may be due to lower adherence. These findings denotes that, in real-world settings, improved person-centered counseling is needed for individuals interested in, or using event-driven PrEP. Research should identify domains and preferred methods of support. Funding None for this study.
Bola-Oyebamiji, S.; Awowole, I. O.; Adeyemo, S. C.; Oyeniran, A. O.; Bamkefa, T. A.; Olatunji, B. Y.; Adekanle, D. A.; Olabode, E. D.
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Background Women living with Human Immunodeficiency Virus (WLHIV) are at high risk of cervical cancer. While Human Papilloma Virus Deoxyribonucleic acid (HPV DNA) testing is the standard of care, its cost limits widespread use in resource-limited settings, therefore visual inspection with acetic acid (VIA) remains the primary screening method. This study therefore evaluated the diagnostic accuracy of VIA compared to HPV DNA testing for cervical cancer screening among WLHIV in Nigeria. Methods This cross-sectional analytical study was conducted between November 2022 and November 2024 in Osogbo, Nigeria among 300 WLHIV on antiretroviral therapy aged 25-49 years underwent cervical cancer screening using VIA and HPV DNA testing (Ampfire HPV test kits, ATILA Biosystems(R) USA). All 309 participants underwent colposcopy and biopsy regardless of their screening results, with histological examination serving as the gold standard. Data were analyzed using Stata, with diagnostic performance measures calculated using histology as the gold standard. Results The mean age of participants was 42.6 {+/-} 6.4 years. Thirty-six of 309 women (11.7%) were VIA-positive, while 91 (29.4%) were HPV-positive. Histology confirmed CIN2+ in 22 participants (7.1%). HPV testing demonstrated significantly higher sensitivity than VIA for detecting CIN2+ (91.2%, 95% CI: 76.3-98.1 vs. 44.1%, 95% CI: 26.7-62.6; p<0.001) and higher negative predictive value (98.9%, 95% CI: 96.3-99.8 vs. 92.0%, 95% CI: 88.0-95.0; p<0.001). However, VIA showed higher specificity (91.7%, 95% CI: 87.8-94.7 vs. 83.3%, 95% CI: 78.4-87.6; p=0.003). The agreement between the two tests was fair (kappa = 0.20, p<0.001). Both HPV positivity (adjusted OR: 42.1, 95% CI: 9.5-186.2; p<0.001) and VIA positivity (adjusted OR: 6.9, 95% CI: 2.6-18.4; p<0.001) were independently associated with CIN2+. Conclusion HPV DNA testing demonstrated superior sensitivity and negative predictive value compared to VIA for detecting CIN2+ among WLHIV, while VIA showed higher specificity. Keywords: Cervical cancer screening, visual inspection with acetic acid, Human Papilloma Virus Women living with HIV, Nigeria
McGowan, M.; Maswera, R.; Chisvo, L.; Moorhouse, L.; Dzamatira, F.; Mandizvidza, P.; Tsenesa, B.; Otambo, W.; Inghels, M.; Harling, G.; Mee, P.; Baernighausen, T.; Gregson, S.; Nyamukapa, C.; Tanser, F.; Skovdal, M.
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Introduction: HIV testing and pre-exposure prophylaxis (PrEP) are efficacious HIV prevention strategies, but uptake remains low among Sub-Saharan African men. Peer-delivered approaches may improve engagement. We developed an intervention combining peer-delivered oral HIV self-testing (HIVST) with incentivized peer referral to HIV services and an SMS-based HIV risk assessment among men in eastern Zimbabwe (IMPERATIVE Trial: NCT06370923). We co-adapted the intervention through iterative prototyping (IP) to enhance its acceptability, feasibility, and potential effectiveness. Methods: From November 2023 to June 2024, we implemented a novel IP framework to refine and test the intervention. Four primary distributors (PDs) were trained to deliver HIVSTs to three peers and refer them to clinic services. Peers could become secondary distributors (SDs), obtain HIVSTs from community hubs and distribute them further. Qualitative data were collected alongside intervention testing to adapt the intervention over two iterations. Activities included three forum theatre workshops, one community advisory board meeting, 25 in-depth interviews, four focus group discussions, and eight observational reports involving men, implementers, stakeholders, and advisory board members. Additionally, 20 men completed baseline and one-week follow-up surveys. Quantitative data were analysed descriptively; qualitative data were analysed using thematic analysis. Results: During testing, HIVST uptake was 100% among PDs, 90% among PD-recruited peers, and 63% among SD-recruited peers. Among self-testers, 50% sought confirmatory testing and about one-quarter initiated PrEP (PDs 25%, PD-recruited peers 30%, SD-recruited peers 25%). Participants viewed the intervention positively and anticipated increased HIV testing and PrEP initiation. Four areas for refinement were identified: recruitment, information dissemination, incentives, and socio-cultural factors. Participant recommendations were adopted before randomised controlled trial testing. Conclusion: Peer-delivered HIVST with referral to HIV services shows promise for engaging Zimbabwean men. The IP framework incorporating participant recommendations enhanced intervention design and delivery within the IMPERATIVE trial. This methodology may inform future intervention development in similar settings.
Gigi, R. M.; Mdingi, M. M.; Jung, H.; Braunack-Mayer, L.; Mensah, E.; Rossel, J.-B.; Babalola, C. M.; Muzny, C. M.; Taylor, C. M.; Medina-Marino, A.; Klausner, J. D.; van de Wijgert, J. H.; Peters, R. P.; Low, N.
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Background: Sexually transmitted infections (STIs) and vaginal dysbiosis during pregnancy are associated with adverse pregnancy outcomes. Mycoplasma genitalium is the most recent STI implicated but evidence remains limited. The objectives of this study were to investigate 1) the association between M. genitalium infection during pregnancy and gestational age at delivery, preterm birth, miscarriage or stillbirth, and low birth weight and 2) the interaction with vaginal dysbiosis. Methods: We conducted a prospective cohort study in East London, South Africa. We enrolled pregnant women at gestational age <27 weeks, confirmed by ultrasound. We tested vaginal samples using nucleic acid amplification tests for M. genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, other genital mycoplasmas and Candida spp. We defined vaginal dysbiosis using Gram-stain criteria as a Nugent score 4-10. We used quantile regression to compare the outcome in women with and without M. genitalium across the gestational age distribution, adjusting for prespecified sociodemographic and clinical characteristics and co-occurring organisms. Results: From April 1, 2021 to August 29, 2023, we enrolled 603 women, followed up 584 and obtained pregnancy outcomes for 560 (93%). Median age was 28 years (interquartile range, IQR 24, 33) and 27% of women were living with HIV. M. genitalium was detected in 44/584 (8%, 95% CI 6, 10%) and vaginal dysbiosis in 375/584 (64%) of women. Median gestational age at delivery was 39 weeks +0 days (IQR 37+4, 40+1) in women with and 39 weeks +0 days (37+4, 40+0) in those without M. genitalium. In multivariable models, associations were not observed for any adverse birth outcomes. There was no interaction between M. genitalium and vaginal dysbiosis. Discussion: M. genitalium in pregnancy was not associated with earlier gestational age at delivery or with other adverse birth outcomes. These findings do not support routine testing and treatment for M. genitalium in pregnancy.
Banda, C.; Bourdin, S.; Singogo, E.; Kudowa, E.; Chagomerana, M.; Chapola, J.; Jones, H.; Hartney, T.; Edwards, J. K.; Jahn, A.; Kawalazira, G.; Kamgwira, Y.; Platt, L.; Rice, B.; Hargreaves, J. R.; Hosseinipour, M. C.; Weir, S. S.
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Precision targeting is essential for maximising impact and cost-effectiveness of interventions at this stage of the HIV response in Malawi. We aimed to measure gaps in access to and use of condoms, HIV testing, pre-exposure prophylaxis (PrEP) and voluntary medical male circumcision among HIV-negative individuals at public health facilities and social venues (bars, rest houses and liquor stores) in Blantyre, Malawi. We analysed cross-sectional data from 2,227 HIV-negative patients at government clinics and 1,634 patrons at social venues recruited in the Clinic vs Venue (CLOVE) study between January and March 2022. We estimated gaps in access to and use of condoms, HIV testing, PrEP and circumcision. Estimates were stratified by risk group, defined as reporting transactional sex, having multiple sex partners in the past 4 weeks, being female aged 15 to 24, or being male aged 30 and above. Access and use were based on self-reports. Overall, 30% of clinic and 60% of venue participants reported higher risk. Among men, we found a gap between access to condoms and condom use at last sex (76.7% vs 29.8% among clinic men; 75.4% vs 36.7% among venue men). Among women, the gap between access and use of condoms was 65.9% vs 18.0% at clinics and 79.9% vs 46.0% in the venues. Approximately 80-85% of participants reported knowing where to get an HIV test in Blantyre but less than half reported testing in the past 6 months. Use of PrEP was low (~2%). Comparable proportions of men who paid for sex and those with multiple partners (~77%) reported being circumcised, but this was lower among those aged 30 years or older (~57%). Despite expanded HIV prevention services in Blantyre, gaps remain in the uptake of prevention services among people reachable at public health facilities and social venues. Use of PrEP was particularly low across all groups. Condom and testing use remained suboptimal despite high reported access. Targeted efforts are needed to address barriers to uptake, particularly for PrEP among high-risk venue-based populations.
Brazier, E.; Kludze, M.; Maruri, F.; Niyongabo, A.; Kreniske, P.; Duda, S. N.; Nash, D.
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Introduction After U.S. foreign assistance was frozen in January 2025, empirical data on the status of the HIV response has been limited. To better understand the ongoing impacts of changes in U.S. foreign assistance, we launched an open survey to assess disruptions in HIV-related care among clinics and programs in low- and middle-income countries (LMICs). Methods Conducted from August to December 2025, the survey explored U.S. foreign assistance-related disruptions in HIV service delivery, medication availability, laboratory services and clinic operations; whether disruptions were fully resolved at the survey timepoint; and the introduction of clinic mitigation strategies. Data on other impacts of U.S. funding changes were explored through an open-ended question. A convergent mixed-methods design, involving parallel quantitative and qualitative analyses and merging of findings from each, was used to examine the impacts of U.S. funding freezes on HIV-related care. Results We received 158 responses from 38 LMICs, including 30 countries supported by the U.S. President's Emergency Fund for AIDS Relief (PEPFAR) at the beginning of 2025 (n=123 responses) and eight non-PEPFAR countries (n=35 responses). Respondents represented health centers (25%), hospitals (31%), dedicated HIV clinics and drop-in centers (39%), and multi-site programs (4%), with a majority (59%) in the non-governmental/private sector. Overall, 81% reported disruptions in at least one HIV-related service since January 2025 because of changes in U.S. foreign assistance, with most also reporting disruptions in medication availability, laboratory services, and clinic operations. The largest reported disruptions were in the areas of pre-exposure prophylaxis (67%) and HIV testing (63%), along with patient tracing (67%), adherence support (63%) and services to key populations (64%). Disruptions were more prevalent in PEPFAR-supported countries and were more likely to be "not fully resolved" by time of survey completion. Qualitative data highlighted the impact of U.S. foreign assistance disruptions on the erosion of client trust in the health system and strains on staff morale. Conclusions Substantial and sustained disruptions in HIV prevention and care reported by diverse clinics in LMICs reinforce concerns that recent funding shifts could reverse progress in ending the HIV epidemic, particularly for vulnerable and key populations.
Chimpandule, T.; Tweya, H.; Goeke, L.; Masina, T.; Macheso, S.; Low, N.; Jahn, A.; Imai-Eaton, J. W. W.
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Background: In 2019, WHO recommended three consecutive reactive serological test results for HIV diagnosis to reduce false-positive diagnoses. Malawi changed from a two-test to a three-test strategy in 2022 as HIV test positivity declined. We assessed diagnostic performance, implementation fidelity, and costs. Methods: We analysed national HIV testing data from Nov 1, 2022, to Oct 31, 2025. Using observed three-test classifications as the reference standard, we reconstructed classifications under the two-test strategy. We estimated positive predictive value (PPV), implementation fidelity, potential false-positive diagnoses prevented, incremental costs, and time to offset testing costs through avoided antiretroviral therapy expenditure. Results: Among 9,885,599 encounters eligible for implementation-fidelity analysis, 99.98% followed a valid three-test pathway. The diagnostic-performance analysis included 9,862,908 encounters, of which 171,351 (1.7%) were classified HIV-positive and 9,138 (0.09%) were inconclusive. Under the two-test strategy, 1,209 inconclusive encounters with a T1+/T2+/T3- sequence would have been classified as HIV-positive. Retesting and reference-laboratory data indicated that 82.5% of these would subsequently be classified as HIV-negative, corresponding to 997 false-positive diagnoses prevented (10.3 per 100 000 three-test non-positive encounters; 95% CI 9.7-10.9). Retesting within 1-2 weeks was associated with the highest odds of potential false-positive classification (adjusted OR 39.37, 95% CrI 30.63-50.61). The incremental cost was US$471 per false-positive diagnosis averted and was offset within 7.30 years. Conclusions: Malawi's transition to a three-test HIV testing strategy prevented false-positive diagnoses and unnecessary antiretroviral therapy at modest cost, supporting broader adoption of WHO guidance in similar settings. Funding: Gates Foundation.
Waterfield, T.; Taylor Miller, P.; McDowell, C.; Agus, A.; Murphy, L.; Sanders, C.; Kearney, A.; Sherrett, F.; Wyche, J.; Hartshorn, S.; Bandi, S.; Blackwood, B.; Williams, N.; Roland, D.; Ferris, K.; Marshall, A.; Clarke, M.; Sutcliffe, A.; Woolfall, K.
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Background Obtaining uncontaminated urine samples from children can be difficult. Clean catch urine (CCU) is non-invasive but may be slow and lead to a contaminated sample, whereas transurethral bladder catheterisation (TUBC) and suprapubic aspiration (SPA) are invasive. We assessed the feasibility of randomising children to a definitive trial. Methods FROG was a multicentre, randomised feasibility trial with a mixed-methods perspectives study, health-economic analysis and stakeholder consensus meeting. Children under 16 years requiring urine testing for suspected urinary tract infection (UTI) who could not provide a midstream sample were eligible for the feasibility trial. Parents, children and healthcare professionals were eligible for the perspectives study and consensus meeting. Results Of 703 children screened, 170 were offered the study and 99 were recruited. Overall, 64/170 (37.6%) consented to randomisation, exceeding the feasibility threshold (33%); 32 were allocated to CCU and 32 to TUBC. The allocated method was received by 46/64 (71.9%); delays, unsuccessful collection and distress contributed to non-receipt. Among participants with available cultures, contamination occurred in 2/12 (16.7%) allocated CCU and 0/6 allocated TUBC. No participants consented to randomisation involving SPA. The perspectives study included 14 parent interviews, 89 parent questionnaires and 28 staff across 5 focus groups and 1 interview. CCU and TUBC were considered acceptable, although participants balanced speed and accuracy against pain and distress. SPA availability and acceptability were limited. A total of 19 stakeholders attended the consensus meeting; 94% supported recruiting children aged under 18 months and 100% supported comparing CCU with TUBC, without SPA. Accuracy was the highest-ranked outcome. Conclusions A definitive trial comparing CCU-first with TUBC-first in children aged under 18 months is feasible. Its primary outcomes should reflect diagnostic accuracy and clinical consequences of contamination, with successful collection, collection time, pain and distress assessed as key secondary outcomes.
Ikabongo, I.; Macha, S.; Vwalika, B.; Kaonga, P.; Masumo, M. m.; Halwiindi, H.; Kunka, E.; Hazemba, A. N.
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Background: Unintended adolescent pregnancies remain a public health challenge in Zambia, where LARC use is low despite their effectiveness. Barriers such as stigma, misconceptions, and limited access persist. Previous studies conducted in Lusaka district did not explore the challenges faced by adolescents in trying to access and use LARCs. Understanding these challenges is crucial for developing targeted interventions to promote safe and effective contraception practices. This study examined factors influencing adolescent knowledge, willingness, and uptake of LARCs in public health facilities in Lusaka. Methods: A cross-sectional study was conducted between November 2024 and March 2025 among adolescent girls aged 15-19 years in five first-level hospitals in Lusaka, Zambia, using structured questionnaires to obtain quantitative data1. LARC use was measured as a binary outcome, with multiple regression identifying associated factors. Results: There were 400 participants in total, of whom 48% (181/376) had ever used a LARC. In the adjusted model, age was significantly associated with LARC use (AOR = 1.27, 95% CI: 1.11-1.77; p < 0.001). Adolescents who were willing to delay pregnancy had markedly higher odds of using LARCs (AOR = 7.46, 95% CI: 1.42-39.06; p = 0.017). Knowledge of LARCs remained a strong independent predictor, more than doubling the likelihood of uptake (AOR = 2.69, 95% CI: 1.12-6.46; p = 0.027). Having children was also significantly associated with higher LARC use (AOR = 2.62, 95% CI: 1.11-6.23; p = 0.029), while participants with unknown HIV status had lower odds of LARC use (AOR = 0.31, 95% CI: 0.10-0.97; p = 0.044). In addition, adolescents residing in Chipata had substantially higher odds of LARC uptake compared to those in Kanyama (AOR = 317.93, 95% CI: 35.01-2887.2; p < 0.001). Conclusions: The findings indicate that age, knowledge of LARCs, reproductive experience (having children), and willingness to delay pregnancy were significantly associated with higher odds of LARC uptake, and almost half of the participants had already used a LARC method. Although higher education showed an upward trend, it was not statistically significant in the adjusted model. Limited awareness and variability in service delivery across clinics highlight the need for strengthened counseling and reliable access to LARCs. As this study focused only on adolescents already attending Family Planning Clinics, further research is needed to assess LARC availability, accessibility, and quality of counseling across different settings in Zambia.
Chiaborelli, M.; Nayame, L.; Hamoonga, T. E.; Mweemba, O.; Kopeka, M.; Hampanda, K.; Amstutz, A.
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Adolescent girls and young women in Zambia face barriers to accessing HIV and sexual and reproductive health services. We conducted a cross-sectional survey among 846 female students at a university in Zambia to assess acceptability of receiving these services in hair salons and explore whether HIV acquisition risk influenced acceptability of HIV services. Acceptability varied by service, ranging from 25% to 50%. Higher HIV acquisition risk may increase the acceptability for HIV services. Hair salons may be a promising community-based, demedicalized setting for delivering selected HIV and sexual and reproductive health services to HIV at-risk female students.
Smith, E.; Babalola, C. M.; Medina-Marino, A.; Mdingi, M. M.; Mukomana, F.; Low, N.; Obse, A.; Peters, R. P. H.; Cleary, S.; Sinanovic, E.
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Background: Curable sexually transmitted infections (STIs) are associated with adverse birth outcomes, yet little cost-effectiveness evidence guides antenatal STI screening policy in high-burden settings. We conducted a cost-effectiveness and cost-utility analysis of the Philani Ndiphile trial in South Africa, comparing One-Time and Two-Time antenatal screening for C. trachomatis, N. gonorrhoeae, and T. vaginalis with standard syndromic management. Methods: A decision-analytic model from the provider perspective simulated costs and outcomes for pregnant women and infants. Costs included diagnostics, treatment, and neonatal hospitalisation for a primary composite outcome of preterm birth and/or low birthweight and its components (secondary trial outcomes). Modelled outcomes included incremental cost (US$) per composite (preterm birth and/or low birthweight) case, per component case and per disability-adjusted life year (DALY) averted. The analysis captured infant outcomes in the first year. Univariate and probabilistic sensitivity analyses were conducted to assess parameter uncertainty and robustness of results. Results: Screening for C. trachomatis, N. gonorrhoeae, and T. vaginalis twice during pregnancy was not cost-effective for preventing the primary composite outcome, nor for preventing low birthweight alone. However, two-time screening was cost-saving for preventing preterm birth alone, averting more DALYs and thereby yielding better health outcomes while reducing healthcare costs compared with syndromic management. One-time screening was not cost-effective for preventing any outcome. Conclusions: Repeat antenatal screening for C. trachomatis, N. gonorrhoeae, and T. vaginalis has the potential to prevent preterm births while reducing healthcare costs in high-burden settings. These findings support further research to confirm the clinical effectiveness of repeat screening and to evaluate longer-term health and economic impacts.
Emesu, G. K.; Najjuma, S.; Tiikabulamu, P.; Mukose, A. D.; Kagaayi, J.
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Abstract Background: HIV self-testing (HIVST) has been promoted as a strategy to reach individuals who do not access facility-based testing. However, evidence on whether HIVST leads to more frequent testing among women of reproductive age in Uganda remains limited. This study evaluated the impact of HIV self-testing on recent HIV testing among women using nationally representative data. Methods: Data were drawn from the 2022 Uganda Demographic and Health Survey (UDHS), including 6,438 women aged 15-49 years. The primary outcome was recent HIV testing, defined as having tested for HIV within the 12 months preceding the survey. The treatment variable was ever having used HIV self-testing. Propensity score matching (PSM) with 1:1 nearest neighbour matching (caliper = 0.05) was used to balance observed covariates including parity, media exposure, education, residence, wealth quintile, health insurance, and age group. The average treatment effect on the treated (ATT) was estimated. Results: Among 6,438 women, 23.87% (1,537) reported ever using HIV self-testing. Recent HIV testing was observed in 67.4% of HIVST users compared to 47.4% of non-users (unmatched difference = 20%). After matching, HIVST use increased the likelihood of recent testing by 15.6 percent (ATT = 15.6%; SE = 0.052; t = 2.99). Covariate balance was achieved post-matching, with mean bias reduced from 20.5% to 0.7%, and the B statistic falling from 50.4% to 2.5% (below the 25% threshold). All standardized differences were substantially reduced, with education showing perfect balance (100% reduction) and wealth showing 97.6% reduction. Conclusion: HIV self-testing significantly increases recent HIV testing among women of reproductive age in Uganda. Expanding access to HIVST, particularly for women with lower education, those in poorer wealth quintiles, and those without media exposure, could improve testing frequency and support progress toward the UNAIDS 95-95-95 targets.
Mata-Robles, S.; Khalaf, K.; Kelley, J.; Chauhan, A.; Balian, L.; Linnes, J. C.; Rodriguez, N. M.
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Point-of-care Hepatitis C Virus (HCV) RNA assays reduce diagnostic turnaround time but depend on benchtop instrumentation and continuous electricity, limiting their deployment in the harm reduction and community settings where confirmatory testing is most needed, as people who use drugs (PWUD) carry a disproportionate share of the HCV burden in the United States. This is a systemic problem in diagnostic development, where decision-making and design requirements overlook point-of-use stakeholders. Closing the gap requires integrating real-world constraints throughout design rather than validating against user needs once a product already exists. Here, we apply a human-centered design (HCD) approach to inform rigorous, stakeholder-derived design requirements, implementation considerations, and early value proposition for a novel point-of-need HCV RNA test intended for deployment in harm reduction and community settings in Indiana. To determine design specifications grounded in real-world context, our objectives were (1) identifying and characterizing context-specific experiences and barriers to HCV testing among higher-risk populations; (2) assessing the perceived benefits and acceptability of the proposed test within real-world settings across direct and indirect user groups; and (3) translating the user needs and contextual constraints into design requirements and implementation considerations that support the test's clinical, operational, and user-centered value. We conducted 18 semi-structured interviews with frontline staff and HCV testing/treatment pipeline experts (n=11) and people who get tested (n=7) across harm reduction organizations, syringe service programs, and community testing settings, analyzed using Rapid Qualitative Analysis guided by the PARRQA framework. Stakeholders responded positively to a single-encounter point-of-need RNA test, and implementation considerations, including funding restrictions, staffing structures, and diverse deployment settings, directly shaped design requirements spanning turnaround time, sample type and volume, portability, result output, target operator, and ease of use. Benchmarking these stakeholder-derived specifications against the FIND Dx HCV target product profile (TPP) showed that stakeholder input confirmed, modified, or extended several TPP criteria and introduced requirements the TPP does not address. Together, these objectives constitute an upstream, evidence-driven design process that translates contextual and stakeholder knowledge into actionable engineering requirements, highlighting the need for diverse stakeholder engagement at all stages of the design process for closing the translation gap between laboratory-validated diagnostic tools and effective point-of-need deployment.
Naidu, L.; Tlhaku, K.; Govender, K.; Sookrajh, Y.; Moodley, P.; van der Molen, J.; Samsunder, N.; Lewis, L.; Gandhi, M.; Drain, P. K.; Butler, C. C.; Hayward, G.; Garrett, N.; Dorward, J.
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Background Urine tenofovir (uTFV) and dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations respectively estimate short- and medium-term adherence to tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART). We evaluated the accuracy of a point-of-care uTFV assay, and associations between uTFV/TFV-DP, and viral load (VL) and retention outcomes within a South African community ART programme. Methods We measured uTFV and DBS TFV-DP concentrations using liquid chromatography-tandem mass spectrometry (LC-MS/MS). We calculated sensitivity and specificity of the point-of-care uTFV assay at the manufacturer-recommended threshold of [≥]1,500 ng/mL compared to LC-MS/MS. We assessed associations of the point-of-care uTFV assay, and DBS TFV-DP concentrations with concurrent viraemia, and with retention-in-care by 16 weeks post-enrolment. Results Of 196 adults median age was 44 years, 127 (64.8%) were female, and 191 (97.4%) were receiving TDF. 185 (94.4%) had detectable point-of-care uTFV, which had high sensitivity (99.5%, 95% CI 96.5-100%) and moderate specificity (76.9%, 95% CI 46.0-93.8%) for detecting uTFV [≥]1,500 ng/mL. Two participants had concurrent viraemia [≥]1,000 copies/mL; of these 50.0% (95% CI 9.4-90.5) had undetectable point-of-care uTFV, and 100% (95% CI 19.7-100) had low TFV-DP <483 fmol/punch. Among participants without viraemia 97.4% (95% CI 93.6-99.0) had detectable uTFV, and 98.1% (95.3-99.6) had high TFV-DP [≥]483 fmol/punch. Point-of-care uTFV and DBS TFV-DP were not associated with retention-in-care. Conclusions The point-of-care uTFV assay demonstrated high sensitivity and moderate specificity to detect uTFV. Over 95% of people without viraemia had detectable point-of-care uTFV or high DBS TFV-DP levels respectively, but these were not associated with 16-week retention-in-care.
Farida, H.; Hapsari, R.; Lestari, E. S.; Farhanah, N.; Roberts, A. P.; Graf, F. E.; Dacombe, R. E.; Moore, M. E.; Lewis, J. M.
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Background Carbapenem-resistant bacteria are a major global public health threat, classified as critical priority pathogens by the WHO. In Indonesia, despite a national antimicrobial resistance control programme established by the Ministry of Health in 2015, resistance rates continue to rise, including increasing carbapenem resistance among clinically important bacteria. Strengthening approaches to directly interrupt transmission is essential, yet transmission pathways remain poorly understood with limited research and policy guidance within the Indonesian context. Methods and analysis The INTERCEPT study is a UK-Indonesia multidisciplinary collaboration aiming to identify transmission routes of carbapenem-resistant bacteria across healthcare and community settings, and the mechanisms of resistance gene transfer between bacteria and mobile genetic elementss. We will conduct genomic surveillance of hospital inpatients, healthcare workers, hospital environments, and surrounding communities, including wastewater systems, combined with genomic analyses and mathematical transmission modelling. A cohort of patients with bloodstream infections will be recruited to evaluate resistant bacteria, treatment practices, and clinical outcomes. Qualitative research will explore behavioural and system-level factors influencing transmission and intervention implementation. Findings will inform stakeholder workshops to co-design context-specific interventions, with pilot intervention over 9 months with pre- and post-intervention assessment to guide scalable strategies to reduce AMR transmission. Discussion The INTERCEPT study addresses carbapenem resistance in Indonesia using an integrated approach combining microbiological surveillance, genomics, modelling, and qualitative methods. Strengths include cross-sectoral analysis (patients, workers, environment) and participatory intervention design. Limitations include geographic scope restricted to Central Java, Indonesia.
Kakai, D.; Twinamasiko, N.; Kigozi, E.; Namutale, R.; Mutesi, B. A.; Bagaya, J.; Akinyi, L.; Kajumbula, H.; Nakubulwa, S.
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Abstract Background: Vaginal steaming has gained popularity among women for reasons known best to them. However, the effects of vaginal steaming on vaginal lactobacilli levels remain poorly understood and understudied. This study investigated the prevalence, assessed differences in the presence of bacterial vaginosis (BV) among women who practiced vaginal steaming and those who do not and determined the factors associated with vaginal steaming among women attending Mulago Sexually Transmitted Infections (STI) clinic in Uganda. Methods: This study utilized a cross-sectional design to enroll 181 women aged 18 to 49 years who were systematically sampled at Mulago STI clinic. Interviews were conducted to obtain the demographic characteristics of the participants. Vaginal swabbing and Gram staining were done to attain lactobacilli counts by microscopy which were categorized using the Nugent score. Data were analyzed using Stata. The potential confounding effects of other variables on the relation between vaginal steaming and the presence of bacterial vaginosis as well as factors associated with vaginal steaming were assessed using modified Poisson regression. Results: Prevalence of vaginal steaming was 40.3%, (95% confidence interval (CI) 33.0% - 48.0%). There were 41.1% women who practiced vaginal steaming occasionally, 53.4% who used hot water having herbs and 78.1% who practiced vaginal steaming for medical reasons. There was no difference in the presence of bacterial vaginosis when women who practiced vaginal steaming were compared to those who did not (p-value = 0.286). Factors that were significantly associated with vaginal steaming included having experienced vaginal issues (aPR = 0.07, 95% CI 0.01 - 0.12, p value = < 0.001) and contraceptive use (aPR= 0.52, 95% CI 0.37 - 0.72, p value = 0.001). Conclusions: About 2 in every 5 women at Mulago STI clinic reported to have indulged in vaginal steaming. There was no difference in the presence of bacterial vaginosis when women who practiced vaginal steaming were compared to those who did not. Having experienced vaginal issues and contraceptive use were significantly associated with vaginal steaming among women at Mulago STI clinic, Uganda. The Ministry of Health of Uganda should establish targeted screening and treatment for bacterial vaginosis alongside other sexually transmitted infections.