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High plasma HIV-1 RNA concentrations are associated with increased risk of HIV-1 transmission. Initiation of antiretroviral therapy (ART) reduces plasma HIV-1 concentrations. We aimed to assess the effect of ART use by patients infected with HIV-1 on risk of transmission to their uninfected partners. Participants in our prospective cohort analysis were from a randomised placebo-controlled trial that enrolled heterosexual African adults who were seropositive for both HIV-1 and herpes simplex virus type 2, and their HIV-1 seronegative partners. At enrolment, HIV-1 infected participants had CD4 counts of 250 cells per μL or greater and did not meet national guidelines for ART initiation; during 24 months of follow-up, CD4 counts were measured every 6 months and ART was initiated in accordance with national guidelines. Uninfected partners were tested for HIV-1 every 3 months. The primary outcome was genetically-linked HIV-1 transmission within the study partnership. We assessed rates of HIV-1 transmission by ART status of infected participants. 3381 couples were eligible for analysis. 349 (10%) participants with HIV-1 initiated ART during the study, at a median CD4 cell count of 198 (IQR 161–265) cells per μL. Only one of 103 genetically-linked HIV-1 transmissions was from an infected participant who had started ART, corresponding to transmission rates of 0·37 (95% CI 0·09–2·04) per 100 person-years in those who had initiated treatment and 2·24 (1·84–2·72) per 100 person-years in those who had not—a 92% reduction (adjusted incidence rate ratio 0·08, 95% CI 0·00–0·57, p=0·004). In participants not on ART, the highest HIV-1 transmission rate (8·79 per 100 person-years) was from those with CD4 cell counts lower than 200 cells per μL. In couples in whom the untreated HIV-1 infected partner had a CD4 cell count greater than 200 cells per μL, 66 (70%) of 94 transmissions occurred when plasma HIV-1 concentrations exceeded 50 000 copies per mL. Low CD4 cell counts and high plasma HIV-1 concentrations might guide use of ART to achieve an HIV-1 prevention benefit. Provision of ART to HIV-1 infected patients could be an effective strategy to achieve population-level reductions in HIV-1 transmission. Bill & Melinda Gates Foundation; US National Institutes of Health.

Abstract STUDY QUESTION What are the direct costs of assisted reproductive technology (ART), and how affordable is it for patients in low- and middle-income countries (LMICS)? SUMMARY ANSWER Direct medical costs paid by patients for infertility treatment are significantly higher than annual average income and GDP per capita, pointing to unaffordability and the risk of catastrophic expenditure for those in need. WHAT IS KNOWN ALREADY Infertility treatment is largely inaccessible to many people in LMICs. Our analysis shows that no study in LMICs has previously compared ART medical costs across countries in international dollar terms (US$PPP) or correlated the medical costs with economic indicators, financing mechanisms, and policy regulations. Previous systematic reviews on costs have been limited to high-income countries while those in LMICs have only focussed on descriptive analyses of these costs. STUDY DESIGN, SIZE, DURATION Guided by the preferred reporting items for systematic reviews and meta-analyses (PRISMA), we searched PubMed, Web of Science, Cumulative Index of Nursing and Allied Health Literature, EconLit, PsycINFO, Latin American & Caribbean Health Sciences Literature, and grey literature for studies published in all languages from LMICs between 2001 and 2020. PARTICIPANTS/MATERIALS, SETTING, METHODS The primary outcome of interest was direct medical costs paid by patients for one ART cycle. To gauge ART affordability, direct medical costs were correlated with the GDP per capita or average income of respective countries. ART regulations and public financing mechanisms were analyzed to provide information on the healthcare contexts in the countries. The quality of included studies was assessed using the Integrated Quality Criteria for Review of Multiple Study designs. MAIN RESULTS AND THE ROLE OF CHANCE Of the 4062 studies identified, 26 studies from 17 countries met the inclusion criteria. There were wide disparities across countries in the direct medical costs paid by patients for ART ranging from USD2109 to USD18 592. Relative ART costs and GDP per capita showed a negative correlation, with the costs in Africa and South-East Asia being on average up to 200% of the GDP per capita. Lower relative costs in the Americas and the Eastern Mediterranean regions were associated with the presence of ART regulations and government financing mechanisms. LIMITATIONS, REASONS FOR CAUTION Several included studies were not primarily designed to examine the cost of ART and thus lacked comprehensive details of the costs. However, a sensitivity analysis showed that exclusion of studies with below the minimum quality score did not change the conclusions on the outcome of interest. WIDER IMPLICATIONS OF THE FINDINGS Governments in LMICs should devise appropriate ART regulatory policies and implement effective mechanisms for public financing of fertility care to improve equity in access. The findings of this review should inform advocacy for ART regulatory frameworks in LMICs and the integration of infertility treatment as an essential service under universal health coverage. STUDY FUNDING/COMPETING INTEREST(S) This work received funding from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO). The authors declare no competing interests. TRIAL REGISTRATION NUMBER This review is registered with PROSPERO, CRD42020199312.

Quantifying sexually transmitted infection (STI) prevalence and incidence is important for planning interventions and advocating for resources. The World Health Organization (WHO) periodically estimates global and regional prevalence and incidence of four curable STIs: chlamydia, gonorrhoea, trichomoniasis and syphilis. WHO's 2012 estimates were based upon literature reviews of prevalence data from 2005 through 2012 among general populations for genitourinary infection with chlamydia, gonorrhoea, and trichomoniasis, and nationally reported data on syphilis seroprevalence among antenatal care attendees. Data were standardized for laboratory test type, geography, age, and high risk subpopulations, and combined using a Bayesian meta-analytic approach. Regional incidence estimates were generated from prevalence estimates by adjusting for average duration of infection. In 2012, among women aged 15-49 years, the estimated global prevalence of chlamydia was 4.2% (95% uncertainty interval (UI): 3.7-4.7%), gonorrhoea 0.8% (0.6-1.0%), trichomoniasis 5.0% (4.0-6.4%), and syphilis 0.5% (0.4-0.6%); among men, estimated chlamydia prevalence was 2.7% (2.0-3.6%), gonorrhoea 0.6% (0.4-0.9%), trichomoniasis 0.6% (0.4-0.8%), and syphilis 0.48% (0.3-0.7%). These figures correspond to an estimated 131 million new cases of chlamydia (100-166 million), 78 million of gonorrhoea (53-110 million), 143 million of trichomoniasis (98-202 million), and 6 million of syphilis (4-8 million). Prevalence and incidence estimates varied by region and sex. Estimates of the global prevalence and incidence of chlamydia, gonorrhoea, trichomoniasis, and syphilis in adult women and men remain high, with nearly one million new infections with curable STI each day. The estimates highlight the urgent need for the public health community to ensure that well-recognized effective interventions for STI prevention, screening, diagnosis, and treatment are made more widely available. Improved estimation methods are needed to allow use of more varied data and generation of estimates at the national level.

Infertility affects one in six people globally, with similar prevalence rates across high-income and low- and middle-income countries. Technological advancements, particularly in Assisted Reproductive Technology (ART), have improved fertility treatment options. Although access to ART is presumed to be better in high-income countries (HICs), economic factors and eligibility restrictions could still impact effective utilization in these settings. Informed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P), this protocol outlines the methodological and analytical approaches to examine the ART costs paid by patients in HICs and the correlation with economic indicators and ART regulatory frameworks. Following the PRISMA approach, we will search for articles indexed in PubMed, EMBASE, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Web of Science, PsycINFO, and Latin American & Caribbean Health Sciences Literature (LILACS). Grey literature from relevant organizations' virtual databases will also be searched. The review will encompass studies published between 2001 and 2024, with the primary outcome being ART direct medical and direct non-medical costs, while secondary outcomes shall include ART financing arrangements. The review will synthesize ART costs, adjusting them to USD Purchasing Power Parity for cross-country comparison, and correlate findings with GNI per capita and ART financing policies. The Integrated Quality Criteria for Review of Multiple Study Designs (ICROMS) tool will be utilized to evaluate the quality of the included studies. We will conduct a meta-analysis if the studies provide sufficient cost-effect size estimates. The review findings will contribute to our understanding of the potential financial burden faced by (disadvantaged) individuals in HICs due to ART costs. Additionally, the review shall highlight the implications that ART financing policies have in enhancing access and affordability, offering valuable insights for healthcare planning and policy formulation. The results will be disseminated through a peer-reviewed journal article and relevant international conferences. Systematic review registration: PROSPERO number: CRD42023487655.

Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting. A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055) and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml) (HR 0.41; 95% CI 0.21-0.81; p = 0.01) compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7) or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0) compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution. Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.

Our study aimed to assess adult women's knowledge of human papillomavirus (HPV) and cervical cancer, and characterize their attitudes towards potential screening and prevention strategies. Women were participants of an HIV-discordant couples cohort in Nairobi, Kenya. An interviewer-administered questionnaire was used to obtain information on sociodemographic status, and sexual and medical history at baseline and on knowledge and attitudes towards Pap smears, self-sampling, and HPV vaccination at study exit. Only 14% of the 409 women (67% HIV-positive; median age 29 years) had ever had a Pap smear prior to study enrollment and very few women had ever heard of HPV (18%). Although most women knew that Pap smears detect cervical cancer (69%), very few knew that routine Pap screening is the main way to prevent ICC (18%). Most women reported a high level of cultural acceptability for Pap smear screening and a low level of physical discomfort during Pap smear collection. In addition, over 80% of women reported that they would feel comfortable using a self-sampling device (82%) and would prefer at-home sample collection (84%). Nearly all women (94%) reported willingness to be vaccinated to prevent cervical cancer if offered at no or low cost. These findings highlight the need to educate women on routine use of Pap smears in the prevention of cervical cancer and demonstrate that vaccination and self-sampling would be acceptable modalities for cervical cancer prevention and screening.

Background. Knowledge of factors that affect per-act infectivity of human immunodeficiency virus type 1 (HIV-1) is important for designing HIV-1 prevention interventions and for the mathematical modeling of the spread of HIV-1. Methods. We analyzed data from a prospective study of African HIV-1-serodiscordant couples. We assessed transmissions for linkage within the study partnership, based on HIV-1 sequencing. The primary exposure measure was the HIV-1-seropositive partners' reports of number of sex acts and condom use with their study partner. Results. Of 3297 couples experiencing 86 linked HIV-1 transmissions, the unadjusted per-act risks of unprotected male-to-female (MTF) and female-to-male (FTM) transmission were 0.0019 (95% confidence interval [CI], .0010-.0037) and 0.0010 (95% CI, .00060-.0017), respectively. After adjusting for plasma HIV-1 RNA of the HIV-1-infected partner and herpes simplex virus type 2 serostatus and age of the HIV-1-uninfected partner, we calculated the relative risk (RR) for MTF versus FTM transmission to be 1.03 (P = .93). Each log₁₀ increase in plasma HIV-1 RNA increased the per-act risk of transmission by 2.9-fold (95% CI, 2.2-3.8). Self-reported condom use reduced the per-act risk by 78% (RR = 0.22 [95% CI, .11-.42]). Conclusions. Modifiable risk factors for HIV-1 transmission were plasma HIV-1 RNA level and condom use, and, in HIV-1-uninfected partners, herpes simplex virus 2 infection, genital ulcers, Trichomonas vaginalis, vaginitis or cervicitis, and male circumcision.

One in six people of reproductive age experience infertility in their lifetime. Infertility can have significant impacts on mental health. Psychological distress is a broad term encompassing emotional suffering and mental health discomfort that can include symptoms of anxiety and depression but is not limited to these conditions. We investigated the prevalence of symptoms of depression, anxiety, and psychological distress and their associated risk factors among women of reproductive age with delayed conception. A total of 1530 women were recruited from community settings in Northern India. Quantitative data were collected using a 4-item Patient Health Questionnaire-4 (PHQ-4) which is an ultra-brief self-report questionnaire consisting of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (generalized anxiety depression-2). Data were collected between July 2020 and August 2021. Descriptive analysis was conducted to summarise the characteristics and prevalence of symptoms of depression, anxiety, and psychological distress. Logistic regression was used to identify risk factors for psychological distress. We obtained responses from all 1,530 women using these scales. Over half (54.31%) of participants had psychological distress, of whom 38.10% were experiencing mild distress, 10.59% moderate distress, and 5.62% severe distress. Additionally,16.07% of participants reported symptoms of anxiety and 20% reported symptoms of depression. Factors associated with psychological distress were: (i) a higher total number of children that women intended to have in their lifetime, (ii) longer duration of trying to get pregnant (> 18 months), (iii) continuous effort trying to achieve pregnancy, (iv) women's perception that conception is taking long, (v) social isolation, (vi) being emotionally or verbally abused by husband and family members, and (vii) having other co-morbidities such as hypertension, irregular menstrual cycles, irregular bleeding between regular cycles, abnormal vaginal discharge or pain during sex. This study demonstrates the high mental health burden faced by women with delayed conception in low- to mid-socioeconomic neighbourhoods of North India including high levels of anxiety and depression. To better support individuals and couples achieve their reproductive goals, we advocate for the integration of psychosocial interventions to improve mental health outcomes and promote the well-being of those facing delays in achieving pregnancy. Specifically, addressing social isolation, fostering supportive networks, combating violence towards women, and incorporating fertility counselling and group-based psychosocial interventions within community and healthcare settings are needed to alleviate mental health symptoms among women who have difficulties in conceiving. However, the successful implementation of these recommendations may be challenged by the availability of the state's healthcare resources, necessitating tailored strategies with contextual adaptations.

Experiences of delayed conception and infertility have been reported among women. However, the concept of intersectionality is rarely utilised in studies of infertility, and it is particularly uncommon in research from low- and middle- income countries. What are the lived experiences of women with delayed conception in low to -middle income neighbourhoods of Delhi, India? This was a qualitative study (n = 35) that recruited women who had failed to conceive after 18 months of regular unprotected sexual intercourse. Data were collected between February and July 2021. Data were collected through focus group discussions in low income to middle income neighbourhoods of Delhi, India. Analysis identified themes related to intersecting axes of inequality. The results showed that gender intersected with economics, masculinity, patriarchal norms and class to influence the experiences of women. The intersection of gender, economics and patriarchal norms compromised women's agency to be active generators of family income, and this dynamic was exacerbated by patrilocal residence. In addition, masculinity contributed to stigmatisation and blaming of women, due to the inaccurate perception that men did not contribute to a couple's infertility. The intersection of gender and social class in medical settings created barriers to women's access to medical information. Findings from this study provide representative examples of the variety of axes of inequality that shape women's experiences in the study setting. Although these findings may not be generalisable to all women who are experiencing delayed conception, they highlight a need for improved awareness and education on infertility, as well as a need to ensure the availability and accessibility of fertility care for couples in need.

Human immunodeficiency virus (HIV) is a chronic infection that can be managed by antiretroviral treatment (ART). However, periods of suboptimal viral suppression during lifelong ART can select for HIV drug resistant (DR) variants. Transmission of drug resistant virus can lessen or abrogate ART efficacy. Therefore, testing of individuals for drug resistance prior to initiation of treatment is recommended to ensure effective ART. Sensitive and inexpensive HIV genotyping methods are needed in low-resource settings where most HIV infections occur. The oligonucleotide ligation assay (OLA) is a sensitive point mutation assay for detection of drug resistance mutations in HIV pol. The current OLA involves four main steps from sample to analysis: (1) lysis and/or nucleic acid extraction, (2) amplification of HIV RNA or DNA, (3) ligation of oligonucleotide probes designed to detect single nucleotide mutations that confer HIV drug resistance, and (4) analysis via oligonucleotide surface capture, denaturation, and detection (CDD). The relative complexity of these steps has limited its adoption in resource-limited laboratories. Here we describe a simplification of the 2.5-hour plate-format CDD to a 45-minute paper-format CDD that eliminates the need for a plate reader. Analysis of mutations at four HIV-1 DR codons (K103N, Y181C, M184V, and G190A) in 26 blood specimens showed a strong correlation of the ratios of mutant signal to total signal between the paper CDD and the plate CDD. The assay described makes the OLA easier to perform in low resource laboratories.