Improving HIV prevention among heterosexual men seeking sexually transmitted infection services in Malawi: Protocol for a Type I effectiveness-implementation hybrid randomized controlled trial of systems navigator–delivered integrated prevention package (HPTN 112-NJIRA Study)

Background: Preexposure prophylaxis (PrEP) remains one of the most efficacious interventions for preventing HIV, but its effectiveness is often limited by poor persistence. Although regional efforts have primarily focused on young women and men who have sex with men, heterosexual men in East and Southern Africa represent a crucial group to engage and retain in PrEP care—both to improve health outcomes for men and to interrupt HIV transmission chains. Men seeking sexually transmitted infection (STI) services are particularly vulnerable to HIV acquisition, yet only a few interventions have tested strategies for engaging and retaining these men in PrEP services. Systems navigation, which addresses barriers to health care access and enhances comfort in clinical settings, may offer a promising approach to improving persistent PrEP use among heterosexual men. Objective: This study will assess the effect of a peer-delivered systems navigator–facilitated HIV prevention package on PrEP persistence at 26 weeks among heterosexual men seeking STI clinical services in Lilongwe, Malawi. It will also evaluate the acceptability of the intervention and barriers to implementation among key stakeholders. Insights will inform the feasibility of a future randomized controlled trial. Methods: In this single-site pilot type I effectiveness-implementation hybrid randomized controlled trial, 200 heterosexual men seeking STI services and initiated on PrEP in Lilongwe, Malawi, will be randomized (1:2) to standard-of-care PrEP services or systems navigator–assisted PrEP care (intervention). Participants will be followed every 13 weeks for at least 26 and up to 52 weeks. PrEP use and engagement in care will be assessed through medical record review and intraerythrocytic tenofovir diphosphate measurement, using objective biomedical analyses via dried blood spot. Primary effectiveness and implementation outcomes include 26-week PrEP persistence (adapted to accommodate daily oral, event-driven oral, or injectable PrEP) and acceptability, respectively. Additional implementation outcomes include feasibility and cost. Exploratory objectives characterize preferences for PrEP modalities, perceived and experienced stigma, and the influence of gender norms on PrEP persistence. All clinical services, including the provision of PrEP and PrEP safety monitoring, are being conducted by the Malawi Ministry of Health. Results: HPTN (HIV Prevention Trials Network) 112 was funded in November 2023. Study recruitment began in April 2024 and closed in November 2024. As of February 3, 2025, the study has enrolled 199 participants, with follow-up expected through June 2025. No interim analyses were planned; data analysis for primary end points is expected in the summer of 2025. Conclusions: Improving PrEP use outcomes among heterosexual men in East and Southern Africa is critical to interrupting HIV transmission. This study offers unique insights into a low-resource, potentially scalable intervention, focusing on a group of men at particularly high risk of HIV acquisition—those with recent STIs. The hybrid RCT design addresses clinically relevant effectiveness questions and explores key determinants that will inform future multisite implementation trials

Optimized intranasal delivery of segesterone acetate progestin to the brain using nanoemulsions and microemulsions

Segesterone acetate (SA) is a selective and potent progesterone receptor agonist with potential application in the treatment of neurological diseases, such as multiple sclerosis and stroke. In this study, a microemulsion (ME) and three nanoemulsions (NEs) with a target SA concentration of 0.48 mg/g were developed for intranasal administration and extensively characterized regarding their physicochemical properties, stability, antimicrobial activity, and safety (in primary cortical cells, Hen’s Egg Test, MucilAir™ model and in rats). Plasma and brain SA levels were measured 30 and 60 min after intranasal administration in male rats. The ME and the different NEs exhibited a droplet mean diameter of approximately 20 nm and 100 nm, respectively, with a low polydispersity index (≤ 0.1). Depending on their composition, they had neutral, positive, or negative zeta potentials and varying viscosities. The NEs exhibited good chemical and physical stability for 150–180 days at 4 °C, while the ME required a reduction in initial SA concentration to avoid drug precipitation. The NEs also demonstrated antimicrobial activity, although not ensuring effective antimicrobial preservation. The ME was the least cytotoxic of the formulations in vitro. No significant impairment of olfactory function or histopathological evidence of toxicity was observed in rats following single or repeated administrations of the ME and neutral NE at doses up to 40 µg/kg of SA. After a single intranasal administration of 40 µg/kg, SA brain concentrations exceeded 4 ng/g at 30 min, with no significant differences observed among the different formulation strategies. Notably, the ME led to a higher brain-to-plasma ratio (~ 7) at 30 min and thereby is a promising strategy to increase brain targeting

What about well-being? Measuring what we really care about in sexual and reproductive health

The well-being of individuals and communities is increasingly recognized as a core objective of economic and global development policies and programs. However, existing measures of well-being neglect sexual and reproductive experiences, which are core dimensions of people\u27s lives. While there has been increasing attention to the concept of sexual well-being, measures of sexual and reproductive health are predominantly deficit-based and ignore whether people are having positive experiences. To consider the development of a measure of sexual and reproductive well-being, a multidisciplinary and geographically diverse group of experts was convened. Outcomes of this meeting included endorsement of a draft definition of sexual and reproductive well-being, demonstrated enthusiasm and commitment to the development of a measure capturing this construct, and delineation of core considerations in the measure development process. These included considering the diversity of normative and political contexts around sexuality and reproduction, and the critical nature of meaningful community engagement when developing this measure. A pathway for measuring development was defined, with the goal of creating a concise measure assessing people\u27s holistic experiences of sexuality and reproduction that can draw attention to and monitor the extent to which people are having the sexual and reproductive lives they wish to have

Communities started the end of the HIV epidemic: Experiences with and recommendations for conducting community-engaged HIV implementation research

Communities of people living with or impacted by HIV have been at the forefront of HIV research, from identifying the health priorities to advocating for the development and implementation of interventions that benefit affected populations and individuals. Community engagement is considered fundamental for successful implementation of science projects. However, researchers have acknowledged the limited guidance on community engagement for implementation science research. Some recommendations have been made for community engagement in implementation sciences, but conducting HIV implementation research must consider the unique challenges of addressing the stigma and disenfranchisement of the populations affected. Despite the specific difficulties for community-engaged implementation science research, there are successful experiences and lessons learned that could support future fruitful experiences. This publication aims to share recommendations for community-engaged HIV implementation research based on the expertise of community–academic partnerships. These recommendations include the perspectives of academic and community partners. Community engagement in HIV implementation research will be needed beyond ending the epidemic. The future of community engagement in research may lay in embracing the constant change and securing the mechanisms to respond to it

Building a rights-based approach to nutrition for women and children: Harnessing the potential of women’s groups and rights-based organizations in South Asia

Women face numerous gender-based barriers that hinder their access to resources, nutritious foods, nutrition services, and maternity entitlements. Evidence shows that certain types of women’s groups can improve women’s access to resources and social capital and in some approaches also improve health and nutrition outcomes. Women’s rights-based organizations in South Asia have a longstanding tradition of collective action toward gender equality. Women’s rights-based organizations work in areas such as microfinance, livelihoods, women’s rights, health, and combating violence against women. In this perspective article, we explore how women’s groups and rights-based organizations can leverage their collective strength to advance nutrition outcomes for women and children. We identify seven pathways implemented through women’s groups toward improving nutrition outcomes. These pathways include (i) income generation, (ii) agriculture, (iii) health and nutrition behavior change communication and participatory learning and action, (iv) advocating for rights to better health and social services, (v) food access, (vi) cash transfers, and (vii) strengthening service delivery and fostering convergence with health systems. We also note that women’s groups have the potential to implement integrated interventions through combined food-systems-rights pathways. Investing in this area can support transforming nutrition policy from a service delivery model to a rights-based approach

A prodrug strategy for sustained release of lactic acid from silicone elastomer vaginal rings

Lactic acid is the most abundant organic weak acid in the healthy human vagina and plays a pivotal role in maintaining an acidic vaginal environment protective against exogenous bacteria and viruses. However, in dysbiotic or non-optimal vaginal environments, significantly decreased concentrations of lactobacilli result in reduced lactic acid production, increased vaginal pH, and enhanced risk of sexually transmitted infections (including human immunodeficiency virus), and bacterial vaginosis. Various gel-based products are marketed to administer lactic acid vaginally for the treatment of bacterial vaginosis and non-hormonal contraception, and there is interest in developing vaginal ring products for sustained/controlled release of lactic acid. However, lactic acid is not compatible with the most common addition-cure type of silicone elastomer used to manufacture vaginal rings; the carboxylic acid group inhibits the hydrosilylation reaction used to cure the elastomer system. Here, we report that DL-lactide—a racemic mixture of (R,R)-D-lactide and (S,S)-L-lactide, in which the dilactide molecules are cyclic lactones derived from esterification of two molecules of lactic acid—can be successfully incorporated into and released from addition-cure medical grade silicone elastomer vaginal rings. Following release of lactide from the rings into an aqueous medium, the lactide molecule rapidly hydrolyses to produce only lactic acid. We demonstrate that lactic acid (i) is formed f release of lactide from the rings; (ii) inhibits sperm motility, (iii) inhibits replication of HIV-1 and HSV-2, and (iv) is active against Gardnerella vaginalis (one of the causative organisms responsible for bacterial vaginosis) but not lactobacillus (associated with optimal human vaginal health). The results support the inclusion of lactide as a lactic acid prodrug in next-generation multipurpose contraceptive silicone elastomer vaginal rings

The social life of the Abriendo Oportunidades® Program in Guatemala: Three decades of enabling community and civic spaces for Indigenous girls and women

Since 2004, Abriendo Oportunidades® (Opening Opportunities, AO) has emerged as a gender transformative social program to support Indigenous girls and young women in Guatemala’s post-war context. Following an evidence-based, community-anchored approach, AO began as a program and has evolved into a social movement. AO has continuously demonstrated its impact in reducing girls’ exposure to gender-based violence and pioneered alternative education through utilizing mentors as tutors. Over time, AO has successfully reached more than 25,000 Indigenous girls and adolescents across 500+ rural Guatemala communities and built a pathway of professional opportunities for the young women who lead the program. AO is a living example of Population Council’s stewardship in Guatemala and the Mesoamerica region, as this work has left a meaningful footprint in Belize, the Dominican Republic, Honduras, and Mexico. This brief is part of the Abriendo Oportunidades® Legacy Series, celebrating and highlighting 20 years of impactful program implementation

Schooling and intimate partner violence: Retrospective analysis of India’s \u3ci\u3eSarva Shiksha Abhiyan\u3c/i\u3e using quasi-experimental techniques

Background: Almost one-third of ever-married women in India experience physical, psychological or sexual violence by their husbands or partners. In this study, we examined the associations of universal primary education with long-term intimate partner violence (IPV) rates and attitudes condoning IPV among women in India. Methods: We used data from the National Family Health Survey 2019–2021 and compared women who were eligible for Sarva Shiksha Abhiyan (SSA)—a national programme of universal primary schooling implemented in 2001—with women who were older and not eligible for SSA. We employed a quasi-experimental method of propensity score matching and fixed effects regression analyses, accounting for a rich set of background socioeconomic and demographic characteristics as covariates. Results: Intervention group women who were originally eligible for SSA in 2001 (4 years below the primary to secondary transition age of 14 years) were 16%–31% less likely to justify IPV or experience emotional violence than control group women who were not eligible for the programme (4 years above the age cut-off). There were no statistically significant associations between SSA eligibility and the rates of physical IPV experienced by women. The results were robust to a series of sensitivity analyses and alternate model specifications. Conclusions: Our findings indicate that universal access to primary schooling may play an important role in reducing IPV and improving gender equality in India and similar low-income and middle-income countries

Growing the Abriendo Oportunidades® Ecosystem: Sowing seeds of change within government systems

Population Council-Guatemala (PC-Guatemala) is supporting and shaping a movement led by young Indigenous leaders to expand inclusive education and civic participation opportunities. Through mechanisms such as professional internships, school re-integration programs, and other government collaborations, young Indigenous women are building the knowledge, skills, and relationships to lead community development efforts and inform inclusive national policies. This brief is part of the Abriendo Oportunidades® Legacy Series, celebrating and highlighting 20 years of impactful program implementation

Developing and validating measures of unintended pregnancy and reasons for contraceptive non-use

This was a prospective cohort study involving follow-up with women to monitor their reproductive outcomes and adoption and continuation of contraceptive use over 18 months in Homa Bay County, Kenya