High rates of sexual and reproductive health (SRH) harms and interrupted schooling are global challenges for adolescent girls, requiring effective interventions. We assessed the impact of menstrual cups (MCs) or cash transfers conditioned on school attendance (CCTs), or both, on SRH and schooling outcomes in western Kenya. In this cluster-randomised Cups or Cash for Girls (CCG) trial, adolescent girls in Forms two and three at 96 secondary schools in Siaya County (western Kenya) were randomised to receive either CCT, MC, combined CCT and MC, or control (1:1:1:1) for an average of 30 months. The CCT intervention comprised 1500KES (US$15 in 2016) via a cash card each school trimester. All four treatment groups received puberty and hygiene training. Assenting girls with parent or guardian consent who were post-menarche, not pregnant, area residents, not boarding, and had no disabilities precluding participation were eligible. Socio-behavioural risk factors and incidence of HIV and herpes simplex virus type 2 (HSV-2) were measured annually. School retainment and adverse events were monitored throughout. The primary outcome comprised a composite of incident HIV, HSV-2 and/or all-cause school dropout by school exit examination. The primary analysis was by intention-to-treat (ITT) using generalised linear mixed models, controlling for a priori selected baseline covariates. The trial is registered with ClinicalTrials.gov, NCT03051789. Between February 28, 2017 and June 30, 2021, 4137 girls (median age 17.1 [interquartile range (IQR): 16.3–18.0]) were enrolled and followed annually until completion of secondary school (median 2.5 years [IQR: 2.4–2.7]); 4106 (99.3%) contributed to the ITT analysis. No differences in the primary composite outcome between intervention and control groups were seen (MC: 18.2%, CCT: 22.1%, combined: 22.1%, control: 19.6%; adjusted risk ratio [aRR]: 0.97, 95% confidence interval 0.76–1.24; 1.14, 0.90–1.45; and 1.13, 0.90–1.43, respectively). Incident HSV-2 occurred in 8.6%, 13.3%, 14.8%, and 12% of the MC, CCT, combined and control groups, respectively (MC: RR: 0.67, 0.47–0.95, p = 0.027; aRR: 0.71, 0.50–1.01, p = 0.057; CCT: aRR: 1.02, 0.73–1.41, p = 0.92; combined aRR: 1.16, 0.85–2.58, p = 0.36). Incident HIV was low (MC: 1.2%, CCT: 1.5%, combined: 1.0%, and control: 1.4%; aRR: 0.88, 0.38–2.05, p = 0.77, aRR: 1.16, 0.51–2.62, p = 0.72, aRR: 0.80, 0.33–1.94, p = 0.62, respectively). No intervention decreased school dropout (MC: 11.2%, CCT: 12.4%, combined: 10.9%, control: 10.5%; aRR: 1.16, 0.86–1.57; 1.23, 0.91–1.65; and 1.06, 0.78–1.44, respectively). No related serious adverse events were seen. MCs, CCTs, or both, did not protect schoolgirls against a composite of deleterious harms. MCs appear protective against HSV-2. Studies of longer follow-up duration with objective measures of health impact are needed in this population. 10.13039/501100000276 Department of Health and Social Care , the 10.13039/501100020171 Foreign, Commonwealth & Development Office , the 10.13039/501100000265 Medical Research Council and 10.13039/100004440 Wellcome .

A point-of-care (POC) HIV drug resistance (HIV-DR) test is needed for low- and middle-income countries (LMICs). Oligonucleotide Ligation Assay (OLA)-Simple, designed as a near-POC HIV-DR test, was assessed for its overall usability in Kenya by technicians with and without molecular laboratory PCR experience. Further, its diagnostic accuracy was evaluated by PCR-experienced technicians utilizing 147 plasma samples with known Sanger sequence genotypes—based on seven major HIV-DR mutations of nucleotide and non-nucleoside reverse transcriptase inhibitors. Thirteen laboratory technicians were recruited, including five with prior PCR experience. Twelve technicians completed the training and attained OLA-Simple testing competency, ten of whom were able to perform the OLA-Simple test within 6 h. Technicians’ survey feedback indicated the user-friendliness of OLA-Simple, citing straightforward reagent reconstitution, concise instructions in prompts, and a shorter sample-to-result test time compared to standard genotyping assays. Of the 147 archived plasma samples tested, 132 (90%) yielded interpretable results. OLA-Simple assay demonstrated a sensitivity of 97.3% (95% CI 94.5, 98.9), a specificity of 97.2% (95% CI 95.5, 98.3), and a percent agreement of 97.1% (95% CI 95.9, 98.2) compared to Sanger sequencing. This evaluation found that OLA-Simple was user-friendly among intended end-users and performed well. LMIC HIV programs would benefit from strategizing on case-use scenarios for such near-POC HIV-DR assays to improve HIV outcomes.

HIV-1 genetic diversity may influence the selection of antiretroviral drug resistance mutations (DRMs); however, subtype-specific resistance patterns remain incompletely characterized in East Africa, where subtype A1 predominates. We examined the distribution of genotypic DRMs across HIV-1 subtypes among patients with advanced HIV disease failing NNRTI-based first-line therapy in western Kenya. In this cross-sectional molecular sub-analysis, 65 hospitalized individuals (≥15 years) with virological failure (HIV-1 RNA ≥1000 copies/mL) had a 1,084-bp pol gene fragment sequenced. Subtypes were assigned using REGA. DRMs were identified using the Stanford HIV Drug Resistance Database. Associations between subtype and specific mutations were evaluated using Fisher’s exact test. Subtype A1 dominated (70.8%), followed by D (13.8%), recombinants (9.2%), and A2 (6.2%). We detected dual-class resistance in 73.8% of participants. The most frequent mutations were M184V (64.6%) and K103N/S (60.0%). Subtype A1 sequences were less frequently observed to have K101E/H (8.7%, p=0.011) and Y181C/I/V (17.4%, p=0.027) than non-A1 subtypes. No significant associations were observed between subtype and NRTI mutations. These findings suggest possible subtype-associated differences in NNRTI resistance patterns that warrant validation in larger studies, underscoring the importance of continued molecular surveillance to guide resistance monitoring and optimize long-term treatment strategies in the era of integrase inhibitor–based therapy.