Developing an mHealth program to improve HIV care continuum outcomes among young Black gay and bisexual men.

BACKGROUND: Young Black gay and bisexual men (YBGBM) in the United States face significant disparities in HIV care outcomes. Mobile health (mHealth) interventions have shown promise with improving outcomes for YBGBM across the HIV care continuum. METHODS: We developed an mHealth application using human-centered design (HCD) from 2019-2021 in collaboration with YBGBM living with HIV and with HIV service providers. Our HCD process began with six focus groups with 50 YBGBM and interviews with 12 providers. These insights were used to inform rapid prototyping, which involved iterative testing and refining of program features and content, with 31 YBGBM and 12 providers. We then collected user feedback via an online survey with 200 YBGBM nationwide and usability testing of a functional prototype with 21 YBGBM. RESULTS: Focus groups and interviews illuminated challenges faced by YBGBM living with HIV, including coping with an HIV diagnosis, stigma, need for social support, and a dearth of suitable information sources. YBGBM desired a holistic approach that could meet the needs of those newly diagnosed as well as those who have been living with HIV for many years. Program preferences included video-based content where users could learn from peers and experts, a range of topics, a community of people living with HIV, and tools to support their health and well-being. Providers expressed enthusiasm for an mHealth program to improve HIV care outcomes and help them serve clients. Rapid prototyping resulted in a list of content topics, resources, video characteristics, community features, and mHealth tools to support adherence, retention, goal setting, and laboratory results tracking, as well as tools to help organization staff to support clients. Online survey and usability testing confirmed the feasibility, acceptability, and usability of the content, tools, and features. CONCLUSIONS: This study demonstrates the potential of a video-based mHealth program to address the unique needs of YBGBM living with HIV, offering support and comprehensive information through a user-friendly interface and videos of peers living with HIV and of experts. The HCD approach allowed for continuous improvements to the concept to maximize cultural appropriateness, utility, and potential effectiveness for both YBGBM and HIV service organizations.

Feasibility and acceptability of sexually transmitted infection screening during antenatal care of women in Dhaka, Bangladesh.

BACKGROUND: Sexually transmitted infections (STIs) are a major public health concern worldwide. Untreated STIs may have serious sequelae, particularly in pregnant women. The objective of this study was to assess the feasibility and acceptability of screening and treating common STIs in women during pregnancy in Bangladesh. METHODS: Women were enrolled from four maternity clinics/hospitals serving the lower-middle class population in Dhaka, Bangladesh. The participants were interviewed, and vaginal swab samples were collected by clinical staff. Specimens were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and high-risk Human Papilloma Viruses (HPVs) using GeneXpert (Cepheid, Sunnyvale, California). Women were informed of their test results and were provided treatment for curable infections. A test of cure was performed. RESULTS: Out of 1157 pregnant women approached, 1000 (86.4%) participated. Ninety-one percent women learned of their test results on the same day of testing. Out of the 996 valid results, 7 (0.7%) tested positive for Chlamydia trachomatis and 1 (0.1%) for Trichomonas vaginalis. There were no gonorrhoea cases. Out of the 971 women with valid results for high-risk HPVs, 46 (4.7%) tested positive. CONCLUSIONS: Screening women for STIs during antenatal care was highly feasible and well-accepted in Bangladesh. While the prevalence of common curable STIs was very low, hrHPV infection prevalence was moderately high. Our findings support period monitoring of STIs and continued prevention efforts for cervical cancer in Bangladesh.

Clinical Performance of Cas13a-based Point-of-Care Lateral Flow Assay for Detecting Neisseria gonorrhoeae.

Background: Diagnosis of Neisseria (N.) gonorrhoeae is dependent on nucleic acid amplification testing (NAAT), which is not available in resource-limited settings where the prevalence of infection is highest. Recent advances in molecular diagnostics leveraging the high specificity of CRISPR enzymes can permit field-deployable, point-of-care lateral flow assays. We previously reported on the development and in vitro performance of a lateral flow assay for detecting N. gonorrhoeae. Here we aimed to pair that assay with point-of-care DNA extraction techniques and assess the performance on clinical urine specimens. Methods: We collected an additional urine specimen among individuals enrolling in an ongoing clinical trial at the Massachusetts General Hospital Sexual Health Clinic who presented with symptoms of urethritis or cervicitis (urethral or vaginal discharge, dysuria, or dyspareunia). We then assessed thermal, detergent, and combination DNA extraction conditions, varying the duration of heat at 95°C and concentration of Triton X. We assessed the efficacy of the various DNA extraction methods by quantitative polymerase chain reaction (qPCR). Once an extraction method was selected, we incubated samples for 90 minutes to permit isothermal recombinase polymerase amplification. We then assessed the performance of lateral flow Cas13a-based detection using our previously designed porA probe and primer system for N. gonorrhoeae detection, comparing lateral flow results with NAAT results from clinical care. Results: We assessed DNA extraction conditions on 3 clinical urine specimens. There was no consistent significant difference in copies per microliter of DNA obtained using more or less heat. On average, we noted that 0.02% triton combined with 5 minutes of heating to 95°C resulted in the highest DNA yield, however, 0.02% triton alone resulted in a quantity of DNA that was above the previously determined analytic sensitivity of the assay. Given that detergent-based extraction is more easily deployable, we selected that as our method for extraction. We treated 23 clinical specimens with 0.02% triton, which we added to the Cas13a detection system. We ran all lateral flow detections in duplicate. The Cas13a-based assay detected 8 of 8 (100%) positive specimens, and 0 of 15 negative specimens. Conclusion: Using point-of-care DNA extraction, isothermal amplification, and Cas13a-based detection, our point-of-care lateral flow N. gonorrhoeae assay correctly identified 23 clinical urine specimens as either positive or negative. Further evaluation of this assay among larger samples and more diverse sample types is warranted.

Managing treatment failure in Neisseria gonorrhoeae infection: current guidelines and future directions.

Due to the continued emergence of resistance to extended-spectrum cephalosporin antibiotics, clinicians are increasingly more likely to encounter cases of Neisseria gonorrhoeae treatment failure. The current international treatment guidelines offer few regimens for cases of N gonorrhoeae infection that do not respond to first-line therapy, and there are many complexities that should be considered with such regimens; these include regional variations in resistance to alternative agents, access to different antibiotics, and penetration of those antibiotics within different tissues. Further, such regimens do not account for the challenges of treating pharyngeal infections; many patients who have not responded to treatment with extended-spectrum cephalosporin antibiotics to date have had pharyngeal involvement. In addition, pharyngeal infections play a pivotal role in the emergence and spread of antimicrobial resistance in N gonorrhoeae and are more difficult to treat than urogenital infections because of the unfavourable pharmacokinetics of cephalosporins in pharyngeal tissues. Here, we summarise the current guidelines, provide additional approaches and considerations for clinicians, and highlight knowledge gaps that should be addressed to ensure appropriate therapy in cases of treatment failure.

Proyecto Facil: Using the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) as a Diagnostic Tool to Improve Access to Human Immunodeficiency Virus Pre-Exposure Prophylaxis (PrEP) via Telemedicine.

Following the underutilization of pre-exposure prophylaxis (PrEP) among Latinx men who have sex with men (MSM) and transgender women in Southern California and the growing use of the delivery of PrEP through telemedicine, the California Department of Public Health implemented a telemedicine component to their already existing assistance program. We used the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify and characterize factors inhibiting the successful implementation of the telemedicine program through in-depth, online stakeholder interviews and online community focus groups with Latinx MSM and trans women in southern California. Obstacles reported by stakeholders were complicated enrollment process, preference for in-person care, more appealing private sector models of PrEP, while community members reported low awareness of the program, fear of complications due to immigration status, challenges to fulfill enrollment requirements. Findings can used for the future improvement of the ongoing program, as well as other similar PrEP telemedicine programs.

Evaluating Chlamydia trachomatis and Neisseria gonorrhoeae screening and treatment among asymptomatic pregnant women to prevent preterm birth and low birthweight in Gaborone, Botswana: A secondary analysis from a non-randomised, cluster-controlled trial.

OBJECTIVE: To evaluate the impact of screening and treating asymptomatic pregnant women for Chlamydia (C.) trachomatis and Neisseria (N.) gonorrhoeae infections on the frequency of preterm birth or low birthweight infants in Botswana. DESIGN: Non-randomised, cluster-controlled trial. SETTING: Four antenatal care clinics in Gaborone, Botswana. POPULATION: Pregnant women aged ≥15 years, attending a first antenatal care visit, ≤27 weeks of gestation and without urogenital symptoms were eligible. METHODS: Participants in the intervention clinics received screening (GeneXpert®, Cepheid) during pregnancy and at the postnatal visit. Participants in the standard-of-care clinics received screening at the postnatal visit only. We used multivariable logistic regression and post-estimation predictive margins analysis. Post-hoc analysis was conducted among sub-samples stratified by parity. MAIN OUTCOME MEASURES: Preterm birth (<37 weeks of gestation) and low birthweight (<2500 g). RESULTS: After controlling for parity, hypertension, antenatal care visits and clinic site, the predicted prevalence of preterm birth or low birthweight was lower in the intervention arm (11%) compared with the standard-of-care arm (16%) (adjusted odds ratio [aOR] 0.59; 95% confidence interval [CI] 0.28-1.24). In post-hoc analysis, the intervention was more effective than the standard-of-care (aOR 0.20; 95% CI 0.07-0.64) among nulliparous participants. CONCLUSION: A C. trachomatis and N. gonorrhoeae infection screening and treatment intervention among asymptomatic pregnant women may have reduced preterm birth or low birthweight outcomes, but results were not statistically significant. Post-hoc analysis found that the intervention reduced adverse outcomes among nulliparous participants.

Use of Expedited Partner Therapy for Pregnant Women Treated for Sexually Transmitted Infections in Gaborone, Botswana.

BACKGROUND: Partner notification and treatment for sexually transmitted infections are critical to prevent reinfection and reduce transmission. However, partner treatment rates are low globally. Expedited partner therapy (EPT), in which the patient delivers treatment directly to their partner, may result in more partners treated. We assessed partner notification and treatment outcomes among pregnant women in Gaborone, Botswana, including EPT intent, uptake, and effectiveness. METHODS: The Maduo study was a cluster-controlled trial evaluating the effect of antenatal Chlamydia trachomatis and Neisseria gonorrhoeae infection screening in pregnant women. The intervention arm received screening at first antenatal care (ANC), third-trimester, and postnatal care visits. The standard-of-care arm received screening postnatally. Participants screening positive were given options for partner treatment: contact slips, in-clinic treatment, or EPT. Self-reported partner notification and treatment outcomes were assessed at test-of-cure visit. RESULTS: Of 51 women who screened positive for C. trachomatis / N. gonorrhoeae at first ANC and returned for test of cure, 100% reported notifying their partner and 48 (94.1%) reported their partner received treatment. At third trimester 100% (n = 5), reported partners were treated. Before testing, EPT intent was lower than EPT uptake at all time points (first ANC: 17.9% vs. 80.4%; third-trimester: 57.1% vs. 71.4%; postnatal care: 0% vs. 80.0%). Partner treatment success was 100% among EPT users compared with 70% among nonusers ( P = 0.006). CONCLUSIONS: Partner notification and treatment success was high in this population. Despite low pretest intent to use EPT, uptake was high and associated with greater partner treatment success. Our findings suggest that EPT may be a successful partner treatment strategy to pursue in low- and middle-income countries.

HIV Infection Modifies the Role of Prior Treponema pallidum Infection in the Clinical Presentation of Early Syphilis Among Adult Patients From Sexually Transmitted Infection Clinics in Peru.

BACKGROUND: We aimed to compare the clinical presentations (symptomatic vs. asymptomatic) with prior Treponema pallidum infection status (first infection vs. reinfection) among people with early syphilis. METHODS: We used data from PICASSO, a cohort study in Peru that enrolled people with active syphilis from May 2019 to August 2021. Study participants had early syphilis and a prior syphilis serological test result within the prior 12 months to determine prior T. pallidum infection status. We calculated prevalence ratios (PRs) of symptomatic clinical presentation (primary or secondary syphilis) by prior T. pallidum infection status, stratified by HIV infection status. In addition, we explored the association of prior T. pallidum infection status and lesion presentation, stratified by primary and secondary syphilis cases, using the Fisher exact test. RESULTS: We include 84 T. pallidum reinfection cases and 61 first infection cases. We found increased frequency of symptomatic clinical presentation among first-infection cases (39% vs. 20%; PR, 1.94; P = 0.014). This association was stronger among persons living without HIV infection (38% vs. 7%; adjusted PR, 6.63; P = 0.001) in comparison to those living with HIV infection (45% vs. 34%; adjusted PR, 1.38; P = 0.458). Among secondary syphilis cases, more participants from the reinfection group reported that their lesions improved 1 week after treatment (100% vs. 29%, P = 0.045) compared with those with a first infection. Among the primary syphilis cases, all participants reported that their lesions improved 1 week after treatment. CONCLUSIONS: Prior syphilis was associated with a decreased prevalence of symptomatic reinfection, especially among persons not living with HIV infection.

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.

Filling in the Gaps: Updates on Doxycycline Prophylaxis for Bacterial Sexually Transmitted Infections.

Over the past two decades, cases of sexually transmitted infections (STIs) due to syphilis, gonorrhea, and chlamydia have been rising in the United States, disproportionately among gay, bisexual, and other men who have sex with men (MSM), as well as racial and ethnic minorities of all genders. In this review, we address updates about the evidence on doxycycline post-exposure prophylaxis (doxy-PEP) for prevention of bacterial STIs, including efficacy, safety, antimicrobial resistance (AMR), acceptability, modeling population impact, and evolving guidelines for use. Equitable implementation of doxy-PEP will require evaluation of who is offered and initiates it, understanding patterns of use and longer-term STI incidence and AMR, provider training, and tailored community education.

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.