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Introduction With recent approvals of long‐acting (LA) HIV pre‐exposure prophylaxis (PrEP) in the form of injectable cabotegravir and the dapivirine ring, programmes need to consider how to optimize the delivery of PrEP methods, including by leveraging lessons from the past decade of oral PrEP delivery. Discussion Framed around differentiated service delivery building blocks, the major considerations for the delivery of LA PrEP are how to reach the populations who would most benefit from PrEP, where to locate PrEP services, how to reduce the user burden of accessing and continuing with PrEP, and how to integrate PrEP with other services. Demand creation for LA PrEP and education about new LA PrEP options should be co‐developed with communities and be positively framed. Client‐facing clinical decision support tools provide information about HIV prevention and PrEP options in non‐technical ways and can support their informed decision‐making about PrEP. Training for providers is needed to increase their ability to ask about sexual and drug use behaviours in a non‐judgmental and comfortable manner as part of risk assessment, discuss harm reduction strategies and counsel about available PrEP options that fit clients’ circumstances and needs. PrEP adherence support should include supportive counselling and be tailored to address an individual's particular barriers and needs. Reminders through text messaging or calls can foster PrEP persistence, given the narrow the window around dosing for injectable cabotegravir. Strategies are needed to expand PrEP delivery options, including telePrEP, pharmacy‐based PrEP, key population‐led services and mobile venues. Integrated delivery models are needed which include sexually transmitted infection testing and treatment, contraception for cis‐women not desiring to become pregnant, PrEP for pregnant women in high HIV prevalence settings, and gender‐affirming hormones and support for transgender persons. Conclusions The outcome of expanding PrEP options through LA PrEP formulations is to increase PrEP coverage, adherence, persistence and effectiveness by offering a choice of PrEP that meets the needs of persons who would benefit from PrEP. The lessons learned from the delivery of oral PrEP about demand creation, informed client decision‐making, provider training, adherence support and service delivery model are relevant to the delivery of LA PrEP and integration with other services.

The interconnectedness of the global HIV and sexually transmitted infection (STI) epidemics necessitates integrated strategies to address both. This Series paper highlights the biological link between HIV and STIs, and describes the successful progress in HIV response versus STI response over the past decades. The concept of undetectable=untransmissible (U=U) in HIV treatment has revolutionised HIV prevention by reducing stigma and promoting early treatment. In line with this approach, we discuss the role of chronic suppressive therapy for herpes simplex virus type 2 and the importance of the accurate diagnosis and treatment of curable STIs to prevent transmission between sexual partners. This Series paper explores the potential of pre-exposure prophylaxis (PrEP) for HIV in different forms (eg, daily oral PrEP, event-driven PrEP, and long-acting injectable PrEP), and highlights the challenges of adherence to daily regimens and the promise of longer-acting agents, such as cabotegravir and lenacapavir. The potential of doxycycline post-exposure prophylaxis for the prevention of bacterial STIs is also discussed, with concerns about antimicrobial resistance. Although vaccine development for HIV and STIs is a key biomedical advance, we discuss the challenges and possibilities of developing effective vaccines, including lessons learnt from previous HIV vaccine trials, the potential of mRNA-based vaccines for herpes simplex virus, ongoing trials for gonorrhoea and chlamydia vaccines, and the impact of existing human papillomavirus and mpox vaccines. Diagnostic innovations emphasise the importance of point-of-care tests for HIV and STIs. This Series paper discusses the benefits, landscape, and pipeline of rapid diagnostic tests (eg, lateral flow tests and molecular assays) and the challenges of implementing these tests in low-resource settings, particularly the need for rapid results to inform clinical decisions, promote convenience, and reduce cost. This Series paper also addresses innovations in service delivery and advocates for integrated and person-centred approaches (eg, differentiated services) that combine HIV and STI services, and highlights the potential of community-based and home-based models to improve access and reduce stigma.

Hormonal contraceptives are used widely but their effects on HIV-1 risk are unclear. We aimed to assess the association between hormonal contraceptive use and risk of HIV-1 acquisition by women and HIV-1 transmission from HIV-1-infected women to their male partners. In this prospective study, we followed up 3790 heterosexual HIV-1-serodiscordant couples participating in two longitudinal studies of HIV-1 incidence in seven African countries. Among injectable and oral hormonal contraceptive users and non-users, we compared rates of HIV-1 acquisition by women and HIV-1 transmission from women to men. The primary outcome measure was HIV-1 seroconversion. We used Cox proportional hazards regression and marginal structural modelling to assess the effect of contraceptive use on HIV-1 risk. Among 1314 couples in which the HIV-1-seronegative partner was female (median follow-up 18·0 [IQR 12·6–24·2] months), rates of HIV-1 acquisition were 6·61 per 100 person-years in women who used hormonal contraception and 3·78 per 100 person-years in those who did not (adjusted hazard ratio 1·98, 95% CI 1·06–3·68, p=0·03). Among 2476 couples in which the HIV-1-seronegative partner was male (median follow-up 18·7 [IQR 12·8–24·2] months), rates of HIV-1 transmission from women to men were 2·61 per 100 person-years in couples in which women used hormonal contraception and 1·51 per 100 person-years in couples in which women did not use hormonal contraception (adjusted hazard ratio 1·97, 95% CI 1·12–3·45, p=0·02). Marginal structural model analyses generated much the same results to the Cox proportional hazards regression. Women should be counselled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception, especially injectable methods, and about the importance of dual protection with condoms to decrease HIV-1 risk. Non-hormonal or low-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1. US National Institutes of Health and the Bill & Melinda Gates Foundation.

In Sub Saharan Africa, there is a growing burden of non-communicable diseases, which poses a big challenge to the resource-limited health system in these settings. The aim of this study was to determine the feasibility and preliminary efficacy of a community health workers (CHWs) home-based lifestyle interventions to improve blood pressure (BP) control and body composition among hypertensive patients in low-income populations of Kiambu County, Kenya. This was a randomized controlled trial (RCT) involving 80 patients with uncontrolled high BP (systolic BP (SBP) ≥140mmHg and/or diastolic BP (DBP) ≥90) randomized to either a CHW homebased intervention or a usual care (control) arm and followed up for 6 months. The intervention involved monthly CHW home-visits for health education and audits on behavioral risk factors that affect BP. An adapted WHO stepwise questionnaire and international physical activity questionnaire was used to collect data on behavioral cardiovascular risk factors. To assess the main outcomes of BP, body mass index (BMI) and waist-height-ratio (WHtR), a survey was conducted at baseline, 3 months, and 6 months. Data regarding univariate, bivariate and multivariate (repeated measurements between and within groups) analysis at 5% level of significance were analyzed using STATA 18. Generalized estimating equations (GEE) for repeated measures were used to estimate changes in BP, BMI and WHtR, and to examine the association between the CHW intervention and BP control. The study revealed that 77.5% and 92.5% of the participants in usual care and intervention groups completed the follow-up, respectively. After 6 months of follow-up, there was a reduction in the mean SBP and DBP for both arms, and reductions in BMI and WHtR only in the intervention arm. The adjusted mean reduction in SBP (-8.4 mm Hg; 95% CI, -13.4 to -3.3; P = 0.001) and DBP (-5.2 mm Hg 95% CI, -8.3 to -2.0; P<0.001) were significantly higher in the intervention group compared to the control group. The proportion of participants who achieved the controlled BP target of <140/90 mm Hg was 62.2% and 25.8% for the intervention and usual care arm, respectively. The proportion with controlled BP was significantly higher in the intervention arm compared to the usual care arm after adjusting for baseline covariates (AOR 2.8, 95% CI 1.3-6.0, p = 0.008). There was no significant effect of the intervention on BMI and WHtR. A home-based CHW intervention was significantly associated with reduction in BP among hypertensive patients compared to usual care. Future fully powered RCTs to test the effectiveness of such interventions among low-income populations are recommended. Trial registration number: PACTR202309530525257.

Little data is available on the long-term psychosocial effects of disclosure of HIV status that may occur in late adolescence, even when disclosure is timely. Moreover, few studies have described the post-disclosure psychosocial needs of older adolescents who experience delayed disclosure. This study sought to address existing knowledge gaps in the post-disclosure experiences and psychosocial needs of older adolescents living with HIV (ALWHIV). We conducted focus group discussions (FGDs) and in-depth interviews (IDIs) among older perinatally infected adolescents aged 16-19 years We collected socio-demographic data and baseline viral load (copies/ml) results for the preceding six months using interviewer-administered questionnaires and clinical notes abstraction. We analysed data inductively and deductively to identify themes related to the experiences and expectations of adolescents with the disclosure and post-disclosure period. Adolescents who reported having received timely disclosure expressed that as they grew older, they began to comprehend the lifelong repercussions of an HIV diagnosis and experienced a re-emergence of the negative feelings similar to those experienced during the post-disclosure period. Those who received the knowledge of their HIV status during late adolescence experienced prolonged periods of negative self-perception and anger at not receiving their HIV status earlier. They also expressed a need for more information during the disclosure process on the prevention of onward transmission of the virus, safe conception practices resulting in HIV negative children, and information on how to disclose their HIV status to sexual partners or peers. Anticipated stigma was experienced universally by these older adolescents and was a major barrier towards adherence and coping with an HIV status. Caregivers or siblings with a similar HIV status were a source of social support. Adolescents felt that the support of peers (ALWHIV) helped them to accept their HIV status and to learn how to develop a positive outlook on life. Provision of psychosocial care in late adolescence during the transition to adult care is critical in ensuring the resolution of re-emergent negative emotions. Comprehensive information on HIV prevention and sexual reproductive health should be a crucial component of post-disclosure care for older adolescents. HIV Disclosure and adolescent transition guidelines should include these components to optimize psychosocial care for older adolescents.

Despite significant public health emphasis on unintended pregnancy prevention among adolescent girls and young women in Sub-Saharan Africa, there is a gap in understanding how adolescents' own reproductive priorities and the social influences on their decision-making align and compete. We examined the social context of contraceptive decision-making among Kenyan female adolescents. Using community-based sampling, we conducted 40 in-depth interviews and 6 focus group discussions among sexually-active or partnered adolescent girls and young women aged 15-19 in the Nyanza region of Kenya. We analyzed the data in Dedoose using an inductive, grounded theory approach, and developed a conceptual model from the data illustrating social influences on adolescent contraceptive decision-making. Participants viewed adolescent pregnancy as unacceptable, and described severe social, financial, and health consequences of unintended pregnancy, including abortion under unsafe conditions. Yet, their contraceptive behaviors often did not reflect their desire to delay pregnancy. Contraceptive decision-making was influenced by multiple social factors, centering on the intersecting stigmas of adolescent female sexuality, pregnancy, and contraceptive use, as well as unequal power in sexual relationships. To prioritize pregnancy prevention, adolescents must navigate conflicting social norms and power dynamics, and put their perceived future fertility at risk. Contraceptive decision-making among Kenyan female adolescents is strongly influenced by opposing social norms within families, communities, and sexual relationships, which compel them to risk stigma whether they use a contraceptive method or become pregnant as adolescents. These findings put into perspective adolescents' seemingly incongruent pregnancy preferences and contraceptive behaviors. Interventions to address adolescent unintended pregnancy should focus on supporting adolescent decision-making agency, addressing fertility-related contraceptive concerns, and promoting innovative contraceptive access points rather than increasing contraceptive prevalence.

Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings. Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP. Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Introduction Effective PrEP use is critical for impact, but data are limited on common patterns of continuation and coverage among persons using PrEP in real‐world settings. Methods Data are from the Partners Scale‐Up Project, a programmatic stepped‐wedge cluster‐randomized trial to integrate PrEP delivery in 25 Kenyan public health facilities conducted between February 2017 and December 2021. We evaluated PrEP continuation using visit attendance and pharmacy refill records, and computed medication possession ratio to define coverage during the first year of use. Latent class mixture models were used to identify and characterize membership to different PrEP continuation patterns. Multinomial logistic regression was used to examine the association between group trajectories and demographic and behaviour characteristics. Results Overall, 4898 persons initiated PrEP, 54% (2640) were female, mean age was 33 years (standard deviation 11) and 84% (4092) had partners living with HIV. PrEP continuation was 57%, 44%, and 34% at 1, 3, and 6 months, respectively. Four unique trajectories of PrEP coverage were identified: (1) one‐fourth (1154) exhibited consistent high coverage throughout the year with 93%, 94%, 96%, and 67% continuing PrEP at months 1, 3, 6, and 12, respectively; (2) 13% (682) showed high coverage trajectory throughout 6 months but coverage rapidly declined thereafter (94%, 93%, 63%, and 10% continued at months 1, 3, 6, and 12, respectively); (3) 18.9% (918) exhibited moderate coverage trajectory with 91% of clients refilling PrEP at month 1 but nearly all dropped‐off thereafter (37%, 5%, and 4% continued at months 3, 6, and 12, respectively); and (4) 43.8% (2144) exhibited immediate discontinuation trajectory, in which nearly all did not have any subsequent PrEP refill. Overall, being female, older age, having partners living with HIV or of unknown HIV status were statistically associated with better PrEP continuation trajectories compared to the immediate discontinuation trajectory (p <0.05 for all). Conclusions In this analysis of a real‐world PrEP implementation programme in Kenya, we found four distinct patterns of PrEP continuation, with one‐third of users exhibiting consistent high continuation throughout 12 months and two‐fifths with immediate discontinuation patterns. These data may help guide tailored interventions to support PrEP continuation in this setting.

With new pre-exposure prophylaxis (PrEP) modalities for HIV prevention becoming available, understanding how adolescent girls and young women (AGYW) navigate through PrEP options is essential, including factors underlying their choice. Through 16 focus group discussions (FGDs) and 52 in-depth interviews (IDIs) from REACH, an open-label crossover study in which AGYW were allocated 1:1 (between 06 February 2019 and 18 March 2020) to receive oral PrEP for six months and the dapivirine ring for six months, in a randomized sequence, followed by a 6-month period where either product (or neither) could be chosen, we explored decision-making process and product choice, using a mixed inductive-deductive analytical approach. Key themes included the desire to remain HIV-negative and weighing product attributes through experiential learning. Product triability appeared important in informing product choice as individual circumstances changed or assuaging side effects with a given product. Approved biomedical prevention innovations may also benefit from hands-on experience to help with adoption and use during real-world implementation. Furthermore, support from trusted providers will remain critical as AGYW contemplate navigating through PrEP options and choice.

The application of discrete choice experiments (DCEs) is gaining popularity as a means of exploring preferences on health-related issues. The quality and validity of DCEs largely depend on the formative phase of attribute development. This paper documents a systematic attribute development process for a DCE assessing preferences for long-acting HIV prevention products among pregnant and breastfeeding women (PBFW) in Kenya. We applied the Helter and Boehler four-stage attribute development framework, comprising raw data collection, data reduction, removal of inappropriate attributes, and appropriate wording. Through literature review and qualitative approaches, we identified twelve attributes for products formulated as oral tablets, injections, vaginal rings, and implants. Six of the twelve attributes were considered plausible, salient, and capable of being traded, namely dosing frequency, effectiveness in HIV prevention, ability to prevent pregnancy, ability to prevent sexually transmitted infections, product access location, and product cost. A pilot among thirty PBFW confirmed the clarity and relevance of the six attributes, informing their inclusion in the DCE. Documenting this transparent step-by-step process improves transparency and facilitates objective evaluation of the DCE’s formative phase. These findings contribute to methodological rigour in DCE design and provide empirical evidence for expanding preference-based HIV prevention strategies that will benefit PBFW.