True and false positive HIV point of care test results in a prospective multinational study of at-risk African women: implications for large-scale repeat HIV testing in HIV prevention programs.

BACKGROUND: Accurate HIV point of care testing is the cornerstone of prevention and treatment efforts globally, though false (both negative and positive) results are expected to occur. SETTING: We assessed the spectrum of true and false positive HIV results in a large prospective study of HIV incidence in African women using three contraceptive methods tested longitudinally in Eswatini, Kenya, South Africa, and Zambia. METHODS: HIV serologic testing was conducted quarterly using two parallel rapid HIV tests. When one or both tests were positive, additional confirmatory testing was conducted, including HIV enzyme immunoassay (EIA) and ribonucleic acid (RNA). RESULTS: 7730 women contributed 48,234 visits: true positive results occurred at 412 visits (0.9%) and false positives at 96 visits (0.2%). Of 412 women with HIV seroconversion, 10 had discordant (i.e., one negative and one positive) rapid tests and 13 had undetectable HIV RNA levels. Of 62 women with false positive rapid HIV results, most had discordant rapid testing but six (9.7%) had dually-positive rapid results and four (6.5%) had false positive or indeterminate EIA results. The positive predictive value of dual positive rapid results was 98.3%. CONCLUSION: Although the majority of rapid test results were accurate, false positive results were expected and occurred in this population of initially HIV seronegative individuals tested repeatedly and prospectively. When HIV infection occurred, not all cases had textbook laboratory results. Our findings highlight the importance of confirmatory testing, particularly for individuals undergoing repeat testing and in settings where the point prevalence is expected to be low.

Evaluation of person-centered interventions to eliminate perinatal HIV transmission in Kisumu County, Kenya: A repeated cross-sectional study using aggregated registry data.

BACKGROUND: Following a decline in perinatal HIV transmission from 20% to 10% between 2010 and 2017 in Kenya, rates have since plateaued with an estimated 8% transmission rate in 2021. Between October 2016 and September 2021, Family AIDS Care & Education Services (FACES) supported HIV care and treatment services across 61 facilities in Kisumu County, Kenya with an emphasis on service strengthening for pregnant and postpartum women living with HIV to reduce perinatal HIV transmission. This included rigorous implementation of national HIV guidelines and implementation of 3 locally adapted evidence-based interventions targeted to the unique needs of women and their infants. We examined whether these person-centered program enhancements were associated with changes in perinatal HIV transmission at FACES-supported sites over time. METHODS AND FINDINGS: We conducted a repeated cross-sectional study of annually aggregated routinely collected documentation of perinatal HIV transmission risk through the end of breastfeeding at FACES-supported facilities between October 2016 and September 2021. Data included 12,599 women living with HIV with baseline antenatal care metrics, and, a separate data set of 11,879 mother-infant pairs who were followed from birth through the end of breastfeeding (overlapping with those in antenatal care 2 years prior). FACES implemented 3 interventions for pregnant and postpartum women living with HIV in 2019: (1) high-risk clinics; (2) case management; and (3) a mobile app to support treatment engagement. Our primary outcome was infant HIV acquisition by the end of breastfeeding (18 to 24 months). We compared infant HIV acquisition risk in the final year of the FACES program (2021) to the year before intervention scale-up and following implementation of the "Treat All" policy (2018). Mother-infant pair loss to follow-up was a secondary outcome. Program data were aggregated by year and site, thus in multivariable regression, we adjusted for site-level characteristics, including facility type, urban versus rural, number of women with HIV in antenatal care each year, and the proportion among them under 25 years of age. Between October 2016 and September 2021, 81,172 pregnant women received HIV testing at the initiation of antenatal care, among whom 12,599 (15.5%) were living with HIV, with little variation in HIV prevalence over time. The risk of infant HIV acquisition by 24 months of age declined from 4.9% (101/2,072) in 2018 to 2.2% (48/2,156) in 2021 (adjusted risk difference -2.6% [95% confidence interval (CI): -3.7, -1.6]; p < 0.001). Loss to follow-up declined from 9.9% (253/2,556) in 2018 to 2.5% (59/2,393) in 2021 (risk difference -7.5% [95% CI: -8.8, -6.2]; p < 0.001). During the same period, UNAIDS estimated rates of perinatal transmission in the broader Nyanza region and in Kenya as a whole did not decline. The main limitation of this study is that we lacked a comparable control group. CONCLUSIONS: These findings suggest that implementation of person-centered interventions was associated with significant declines in perinatal HIV transmission and loss to follow-up of pregnant and postpartum women.

"We chose PrEP because I wanted to be sure that this child my wife was going to conceive was indeed mine." Factors influencing the choice of safer conception methods and experiences with its use: a qualitative study among HIV sero-discordant couples in Zimbabwe.

BACKGROUND: Safer conception services are needed to minimize HIV transmission among HIV sero-discordant couples desiring pregnancy. Few studies have evaluated the choices couples make when they are offered multiple safer conception methods or real-world method acceptability. This paper addresses an important knowledge gap regarding factors that influence the choice of safer conception methods, couples' actual experiences using safer conception methods, and why some couples switch safer conception methods. METHODS: Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples who exited the SAFER study-a pilot safer conception study for HIV sero-discordant couples in Zimbabwe that offered couples a choice of ART with monthly viral load monitoring (ART/VL), oral PrEP, vaginal insemination, and semen washing. All couples in SAFER had used at least two safer conception methods. RESULTS: We found that safer conception method choice often centered around a desire for intimacy, condomless sex, and certainty in the conception process, particularly for men. Method-related attributes such as familiarity, perceived ease of use, side effects, and perceived level of effectiveness in preventing HIV and achieving pregnancy influenced method choice, switching, and satisfaction. Concerns were expressed about each safer conception method and couples were willing to try different methods until they found method(s) that worked for them. The majority of participants reported having positive experiences using safer conception, especially those using ART/VL + PrEP, citing that they were able to attempt pregnancy for the first time with peace of mind and experienced joy and satisfaction from being able to achieve pregnancy safely. CONCLUSIONS: The differences in method preferences and experiences voiced by participants in this study and in other studies from the region point to the importance of having a variety of safer conception options in the service delivery package and addressing concerns about paternity, intimacy, and method-related attributes to enable HIV sero-discordant couples to safely achieve their reproductive goals.

"First was to sit down and bring our minds together". A qualitative study on safer conception decision-making among HIV sero-different couples in Zimbabwe.

Decision-making on childbearing and safer conception use in HIV sero-different couples involves an intricate balance of individual desires and perceived HIV acquisition risk. This paper addresses an important knowledge gap regarding HIV sero-different couples' considerations and the relationship and power dynamics involved when deciding to use a safer conception method. Between February and June 2019, we conducted semi-structured in-depth interviews among 14 men and 17 women, representing 17 couples, who exited the SAFER study - a pilot study assessing the feasibility, acceptability and cost-effectiveness of a safer conception programme for HIV sero-different couples in Zimbabwe. All couples in SAFER were provided with a choice of safer conception methods and were followed for up to 12 months of pregnancy attempts and 3 months following pregnancy. While couples generally perceived their safer conception discussions to be easy and consensus-driven, the decision-making process also involved complex gender dynamics and trade-offs in relationship power, which resulted in differing interpretations of what constituted a joint or shared couple decision. Participants regarded effective couple communication as an essential component of and precursor to good safer conception conversations and requested additional training in couple communication. Couples relied on information from healthcare providers to kickstart their safer conception discussions. Safer conception programmes should address relationship power imbalances, promote effective couple communication and offer healthcare provider support to enable HIV sero-different couples to make informed choices about conception in a manner that upholds their safety and reproductive autonomy.

Our study explored how HIV sero-different couples in Zimbabwe made decisions on the use of safer conception methods. We interviewed 14 men and 17 women who participated in the SAFER study ­ a pilot study looking at how feasible, acceptable and cost-effective a safer conception programme for HIV sero-different couples is in Zimbabwe. We sought to understand the relationship dynamics, considerations and power trade-offs involved in choosing a safer conception method. Couples reported that their conversations about safer conception were easy and agreeable. At the same time, we found that both gender norms and HIV status shaped the couples' decision-making process, with male gender and partners with an HIV-negative status often having more influence in the final decision of which method to use. Effective couple communication was deemed crucial to support safer conception conversations, with participants requesting additional training in this area. The findings emphasise the importance of providing safer conception methods in a context that addresses power disparities, fosters good communication and includes healthcare providers' support to uphold HIV sero-different couples' reproductive rights and help them achieve their reproductive goals.

"Something Like That": Awareness and Acceptability of HIV PrEP and PEP Among Kenyan Adolescents.

BACKGROUND: Adolescents account for 15% of new HIV cases in Kenya. HIV pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are highly effective prevention tools, but uptake is low among adolescents, particularly in resource-limited settings. We assessed awareness and acceptability of PrEP and PEP among Kenyan adolescents. METHOD: Focus group discussions were conducted with 120 adolescent boys and girls ages 15 to 19 in Kisumu. Data were analyzed using the Framework Approach. RESULTS: Adolescent participants often had not heard of or could not differentiate between PrEP and PEP. They also confused these HIV prevention tools with emergency contraceptives. Taking a daily pill to prevent HIV was perceived as analogous to taking a pill to treat HIV. Boys were aware of and willing to consider using PrEP and PEP due to their dislike for using condoms. Adolescents identified insufficient information, cost, and uncomfortableness speaking with healthcare workers about their HIV prevention needs due to sexuality stigma as barriers to using PrEP and PEP. CONCLUSION: Low awareness and poor understanding of PrEP and PEP among adolescents reveal the need for increased education and sensitization about these HIV prevention options. Expanding access to sexual and reproductive health services that are tailored to the needs of adolescents and staffed with non-judgmental providers could help reduce sexuality stigma as a barrier to accessing care. New HIV prevention approaches such as long-acting injectables or implants, on-demand regimens, and multipurpose prevention technologies may encourage increased uptake of PrEP and PEP by adolescents.

Safety and adherence to self-administered intravaginal 5-fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV-positive women in Kenya: A phase 1 clinical trial.

Objective: To determine the safety, tolerance, and adherence to self-administered intravaginal 5% fluorouracil (5FU) cream as adjuvant therapy following cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3) treatment among women living with HIV (WLWH) in Kenya. Methods: A Phase I Pilot trial was performed among 12 WLWH in Kenya, aged 18-49 years between March 2023-February 2024 (ClinicalTrial.gov NCT05362955). Participants self-administered 2g of 5FU intravaginally every other week for eight applications. Safety was assessed using a standardized grading scale, and adherence was evaluated using self-report, inspection of used applicators, and weighing of the study drug. Results: The mean age and CD4 count were 43.9 years and 781 cells/mm3, respectively. Seven (58%) had an 8th-grade education or less. All 12 reported at least one grade I adverse event (AE), 1 (8%) reported a grade 2 AE, no grade 3 or 4 AEs were reported. Increased vaginal discharge (n=9, 75%) and irritation (n=5, 42%), with a mean duration of 3.2 and 2.8 days, respectively, were the most commonly reported AEs. Provider-observed AEs included grade 1 cervical erythema and superficial abrasions. All participants tolerated all eight 5FU doses, and 96% adherence was demonstrated. Conclusion: Self-administered 5FU following CIN2/3 treatment among WLWH in Kisumu, Kenya, was safe, tolerable, and associated with high adherence. Randomized trials are needed to investigate whether adjuvant 5FU can improve treatment outcomes or serve as primary cervical precancer treatment in sub-Saharan Africa. A self-administered therapy may be transformative in increasing access to treatment and, hence, secondary prevention of cervical cancer.

The influence of an agricultural intervention on social capital and water insecurity coping strategies: Qualitative evidence from female smallholder farmers living with HIV in western Kenya.

Background: Greater social capital is associated with positive health outcomes and better HIV management. The ways by which social capital may influence household water insecurity (HHWI), a critical determinant of health among persons living with HIV, remain underexplored. Further, despite the importance of reliable water access and use for health and agricultural productivity, few studies have described the strategies smallholder farmers living with HIV use to manage water insecurity. Objective: We qualitatively explored how an agricultural intervention (provision of a treadle pump for irrigation) influenced HHWI coping strategies through its impacts on social capital among smallholder farmers living with HIV in western Kenya. Method: In 2018, we purposively recruited participants from the Shamba Maisha study, a randomized agricultural intervention (NCT02815579) that provided irrigation pumps to improve treatment outcomes and food security among smallholder farmers living with HIV in western Kenya (n = 42). Participants shared their experiences with water insecurity through go-along and photo-elicitation interviews. Data were thematically analyzed using inductively developed codes. Results: Participants described diverse strategies for coping with agricultural water insecurity. Dimensions of social capital such as feelings of belonging, connectedness, and trust influenced the use of the treadle water pump and other water access behaviors. For instance, participants reported borrowing or sharing water pumps with friends and neighbors if they felt they had a good rapport. In addition, participants indicated a willingness to engage in collective activities, such as supporting the operation of the irrigation pump during planting, when they felt sufficiently connected to a larger group. Overall, individuals in the intervention arm described greater social cohesion, reciprocity, and community connectedness than those in the control arm. Conclusion: The impact of an agricultural intervention on water access and use was described as being modified by social capital among female smallholder farmers living with HIV. Findings suggest that social capital may create an enabling environment for implementing strategies that improve the management and reduce the burden of HIV. Measuring these strategies and their associations with HIV outcomes may strengthen our understanding of resilience among female smallholder farmers living with HIV. The development of a coping strategies index and its use in a longitudinal study could help to identify pathways through which social capital influences health and the effectiveness of livelihood interventions.

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial.

BACKGROUND: In Kenya, 65% of sexually active unmarried women use modern contraceptives, a population at increased risk of HIV acquisition compared to other populations. Anchoring HIV prevention services, including pre-exposure prophylaxis (PrEP), to trusted contraceptive delivery settings offers opportunities to efficiently reach this important population. In Kenya, almost half (40%) of women accessing contraception services do so outside traditional healthcare facilities, such as retail pharmacies. Thus, integrating PrEP services into retail pharmacies may increase options for reaching adolescent girls and young women (AGYW) who could benefit from PrEP. Efforts are underway to define care pathways for pharmacy-delivered PrEP services in Kenya, including unsupported and supported models with nurse navigators. METHODS: The AGYW Pharmacy PrEP study is an unblinded 2-arm cluster-randomized controlled trial in Kisumu, Kenya. The objective is to determine the effect that unsupported versus supported pharmacy-delivered PrEP services has on PrEP initiation, persistence, and adherence among AGYW seeking contraception. Twenty retail pharmacies offering pharmacy provider-led PrEP delivery will be randomized 1:1 to either receive or not receive a nurse navigator to support PrEP delivery. Eligible AGYW (n = 1900 total, n = 950/arm) will be ≥ 15 years old, purchasing a method of contraception at the pharmacy. Trained pharmacy provider will offer eligible AGYW either daily oral PrEP or the monthly DPV vaginal ring. The primary trial outcomes are PrEP initiation (use of PrEP at 1 month), persistence (use of PrEP at 10 months), and adherence (quantified by levels of TFV or DPV in hair samples). Additionally, several secondary (STI incidence, PrEP method selection, predictors of PrEP adherence) and exploratory outcomes (HIV incidence, quality of care, contraceptive method mix) will be explored. DISCUSSION: We hypothesize pharmacy-delivered PrEP services supported with nurse navigator, versus delivered by pharmacy providers alone, will improve PrEP outcomes among AGYW seeking contraception. Our results will help policy makers better understand how to potentially implement this novel differentiated service model for PrEP and prime pharmacies for the delivery of new PrEP agents in the pipeline (e.g., long-acting injectables and multi-purpose technologies). The study was initiated on May 13, 2023, and is expected to be completed by February 2025. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05467306), with registration on July 20, 2022.

User-informed tailoring of electronic and in-person peer navigation strategies to improve retention in HIV care for adolescents and young adults: a qualitative inquiry.

Poor adherence and retention in HIV care remain a major challenge among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa (SSA). Strategies are urgently required to support AYA to remain in care for better health outcomes. We explored AYA preferences regarding the format and delivery of electronic and in-person peer navigation to improve HIV care outcomes. This formative qualitative study was conducted among AYA enrolled in HIV care at three clinics in western Kenya. We conducted two focus group discussions (FGDs) each with 8-9 participants (n = 17) purposively selected based on age, gender and clinic where they received care. The characteristics desired of a navigator are a person of the same age group and HIV status who has a good memory and is friendly and able to maintain confidentiality. AYA want the content of their interaction with the navigator to center on sharing motivational messages and also educating them on matters of HIV care, sexual and reproductive health and mental health. The preferred navigation formats for electronic communication are platforms considered confidential. AYA preferred interventions delivered through secure communication platforms by navigators with whom they have commonalities. The navigation interventions that prioritize confidentiality and holistic content will likely be most highly valued by AYA. Furthermore, electronic mechanisms can help support the relationship building that is at the core of our navigation approach and a fundamental aspect of social work in general.

Equivalence between physicians and associate clinicians in the frequency of iatrogenic urogenital fistula following cesarean section in Tanzania and Malawi.

BACKGROUND: Physicians and associate (non-physician) clinicians conduct cesarean sections in Tanzania and Malawi. Urogenital fistulas may occur as complications of cesarean section. Location and circumstances can indicate iatrogenic origin as opposed to ischemic injury following prolonged, obstructed labor. METHODS: This retrospective review assessed the frequency of iatrogenic urogenital fistulas following cesarean sections conducted by either associate clinicians or physicians in Tanzania and Malawi. It focuses on 325 women with iatrogenic fistulas among 1290 women who had fistulas after cesarean birth in Tanzania and Malawi between 1994 and 2017. An equivalence test compared the proportion of iatrogenic fistulas after cesarean sections performed by associate clinicians and physicians (equivalence margin = 0.135). Logistic regression was used to model the occurrence of iatrogenic fistula after cesarean section, controlling for cadre, date, maternal age, previous abdominal surgery and parity. RESULTS: Associate clinicians attended 1119/1290 (86.7%) cesarean births leading to fistulas, while physicians attended 171/1290 (13.3%). Iatrogenic fistulas occurred in 275/1119 (24.6%) cesarean births by associate clinicians and in 50/171 (29.2%) cesarean births by physicians. The risk difference and 90% confidence interval were entirely contained within an equivalence margin of 13.5%, supporting a conclusion of equivalence between the two cadres. The odds of iatrogenic fistula after cesarean section were not statistically significantly different between associate clinicians and physicians (aOR 0.90; 95% CI 0.61-1.33). CONCLUSIONS: Associate clinicians appear equivalent to physicians performing cesarean sections in terms of iatrogenic fistula risk. Lower iatrogenic proportions for associate clinicians could reflect different caseloads. The occurrence of iatrogenic fistulas illustrates the importance of appropriate labor management and cesarean section decision-making, irrespective of health provider cadre. Given the noninferior performance and lower costs of employing associate clinicians, other countries with insufficient and/or unequally distributed health workforces could consider task-shifting cesarean sections to associate clinicians.

Exploring HIV risk perception mechanisms among youth in a test-and-treat trial in Kenya and Uganda.

Understanding risk perception and risk-taking among youth can inform targeted prevention efforts. Using a health beliefs model-informed framework, we analysed 8 semi-structured, gender-specific focus group discussions with 93 youth 15-24 years old (48% male, 52% female), drawn from the SEARCH trial in rural Kenya and Uganda in 2017-2018, coinciding with the widespread introduction of PrEP. Highly connected social networks and widespread uptake of antiretrovirals shaped youth HIV risk perception. Amid conflicting information about HIV prevention methods, youth felt exposed to multiple HIV risk factors like the high prevalence of HIV, belief that people with HIV(PWH) purposefully infect others, dislike of condoms, and doubts about PrEP efficacy. Young women also reported minimal sexual autonomy in the context of economic disadvantages, the ubiquity of intergenerational and transactional sex, and peer pressure from other women to have many boyfriends. Young men likewise reported vulnerability to intergenerational sex, but also adopted a sexual conquest mentality. Comprehensive sexuality education and economic empowerment, through credible and trusted sources, may moderate risk-taking. Messaging should leverage youth's social networks to spread fact-based, gender- and age-appropriate information. PrEP should be offered alongside other reproductive health services to address both pregnancy concerns and reduce HIV risk.

An agricultural livelihood intervention is associated with reduced HIV stigma among people with HIV.

OBJECTIVE: HIV stigma undermines antiretroviral treatment (ART) adherence and viral suppression. Livelihood interventions may target drivers of negative attitudes towards people with HIV (PWH) by improving their health and strengthening their economic contributions. We examined the effects of a multisectoral agricultural livelihood intervention on HIV stigma among PWH in western Kenya. DESIGN: Sixteen health facilities were randomly allocated (1 : 1) to intervention or control arms in Shamba Maisha , a cluster randomized controlled trial that aimed to improve HIV-related health through behavioral, mental health, and nutritional pathways. METHODS: The intervention included a farming loan and agricultural and financial training. Participants had access to farmland and surface water and were at least 18 years old, on ART for more than 6 months, and moderately-to-severely food insecure. We measured internalized, anticipated, and enacted HIV stigma semiannually over 2 years using validated scales. In blinded intent-to-treat analyses, we compared changes in scores over 24 months by study arm, using longitudinal multilevel difference-in-differences linear regression models that accounted for clustering. RESULTS: Of 720 enrolled participants (354 intervention), 55% were women, and the median age was 40 years [interquartile range 34-47 years]. Two-year retention was 94%. Compared with the control arm, the intervention resulted in significant decreases ( P  < 0.001) of 0.42 points [95% confidence interval (CI) -0.52 to -0.31) in internalized stigma, 0.43 points (95% CI -0.51 to -0.34) in anticipated stigma, and 0.13 points (95% CI -0.16 to -0.09) in enacted stigma over 24 months. CONCLUSION: The agricultural livelihood intervention reduced HIV stigma among PWH. Poverty-reduction approaches may be a novel strategy for reducing HIV stigma.

The impact of Covid-19 pandemic on the research portfolio and approval turnaround time at the Kenya Medical Research Institute.

BACKGROUND: The Covid-19 pandemic led to an unprecedented impact on many sectors globally including research. We assessed the impact of the Covid-19 pandemic on the research portfolio, and on the approval turnaround time for research protocols submitted to the Scientific and Ethics Review Unit (SERU), at the Kenya Medical Research Institute (KEMRI). METHODS: We compared research protocols submitted between October 01, 2019 and March 31, 2020 (Period 1), to those submitted between April 1 and September 30, 2020 (Period 2). A document review tool was used to extract data from the 198 research protocols reviewed and approved over the two periods. RESULTS: In the two periods under review, the single largest percentage of protocols (89/198, 45.4%) involved infectious and parasitic diseases, and the single largest percentage of study designs was cross-sectional (75/198, 38%). Before the pandemic, the median time taken to review KEMRI-linked protocols was 87 days and for non-KEMRI linked protocols it was 121 days. During the pandemic, approval turnaround time dropped for both KEMRI and non-KEMRI protocols to 66 days and 92 days, respectively, due to the streamlined processes at the KEMRI SERU. CONCLUSION: The research portfolio was minimally affected by the pandemic. The adoption of email submission, and faster-than-usual processing and review protocols during the pandemic reduced the approval turnaround time.

Priorities for contraceptive method and service delivery attributes among adolescent girls and young women in Kenya: a qualitative study.

Introduction: Despite increasing global commitment to meeting the family planning needs of adolescent girls and young women (AGYW), there is limited research on how they prioritize contraceptive method and service delivery characteristics. In this qualitative study, we examine the specific elements that drive the contraceptive choices of Kenyan AGYW, and apply our findings to the development of attributes and levels for a discrete choice experiment (DCE). Methods: Our four-stage approach included data collection, data reduction, removing inappropriate attributes, and optimizing wording. Between June-October 2021, we conducted in-depth interviews with 30 sexually-active 15-24 year-old AGYW in Kisumu county, Kenya who were non-pregnant and desired to delay pregnancy. Interviews focused on priorities for contraceptive attributes, how AGYW make trade-offs between among these attributes, and the influences of preferences on contraceptive choice. Translated transcripts were qualitatively coded and analyzed with a constant comparative approach to identify key concepts. We developed and iteratively revised a list of attributes and levels, and pre-tested draft DCE choice tasks using cognitive interviews with an additional 15 AGYW to optimize comprehension and relevance. Results: In-depth interview participants' median age was 18, 70% were current students, and 93% had a primary sexual partner. AGYW named a variety of priorities and preferences related to choosing and accessing contraceptive methods, which we distilled into six key themes: side effects; effectiveness; user control; privacy; source of services; and cost. Bleeding pattern was top of mind for participants; amenorrhea was generally considered an intolerable side effect. Many participants felt more strongly about privacy than effectiveness, though some prioritized duration of use and minimizing chance of pregnancy above other contraceptive characteristics. Most AGYW preferred a clinic setting for access, as they desired contraceptive counseling from a provider, but pharmacies were considered preferable for reasons of privacy. We selected, refined, and pre-tested 7 DCE attributes, each with 2-4 levels. Conclusions: Identifying AGYW preferences for contraceptive method and service delivery characteristics is essential to developing innovative strategies to meet their unique SRH needs. DCE methods may provide valuable quantitative perspectives to guide and tailor contraceptive counseling and service delivery interventions for AGYW who want to use contraception.

Confirmatory Factor Analysis and Validation of the Sexual and Reproductive Empowerment Scale for Adolescents and Young Adults in Kenya.

Understanding the levels of power that adolescent girls and young women exercise in their sexual and reproductive lives is imperative to inform interventions to help them meet their goals. We implemented an adapted version of the Sexual and Reproductive Health Empowerment (SRE) Scale for Adolescents and Young Adults among 500 adolescent girls and young women aged 15-20 in Kisumu, Kenya. We used confirmatory factor analysis (CFA) to assess factor structure, and logistic regression to examine construct validity through the relationship between empowerment scores and ability to mitigate risk of undesired pregnancy through consistent contraceptive use. Participants had a mean age of 17.5, and most were students (61 percent), were currently partnered (94 percent), and reported having sex in the past 3 months (70 percent). The final, 26-item CFA model had acceptable fit. All subscales had Cronbach's alpha scores >0.7, and all items had rotated factor loadings >0.5, indicating good internal consistency and robust factor-variable associations. The total SRE-Kenya (SRE-K) score was associated with increased odds of the consistent method used in the past three months (adjusted odds ratio: 1.98, 95 percent CI: 1.29-3.10). The SRE-K scale is a newly adapted and valid measure of sexual and reproductive empowerment specific to adolescent girls and young women in an East African setting.

Getting HIV Pre-exposure Prophylaxis (PrEP) into Private Pharmacies: Global Delivery Models and Research Directions.

PURPOSE OF REVIEW: To provide an overview of the current state of HIV pre-exposure prophylaxis (PrEP) delivery via private sector pharmacies globally, to discuss the context-specific factors that have influenced the design and implementation of different pharmacy-based PrEP delivery models in three example settings, and to identify future research directions. RECENT FINDINGS: Multiple high- and low-income countries are implementing or pilot testing PrEP delivery via private pharmacies using a variety of delivery models, tailored to the context. Current evidence indicates that pharmacy-based PrEP services are in demand and generally acceptable to clients and pharmacy providers. Additionally, the evidence suggests that with proper training and oversight, pharmacy providers are capable of safely initiating and managing clients on PrEP. The delivery of PrEP services at private pharmacies also achieves similar levels of PrEP initiation and continuation as traditional health clinics, but additionally reach individuals underserved by such clinics (e.g., young men; minorities), making pharmacies well-positioned to increase overall PrEP coverage. Implementation of pharmacy-based PrEP services will look different in each context and depend not only on the state of the private pharmacy sector, but also on the extent to which key needs related to governance, financing, and regulation are addressed. Private pharmacies are a promising delivery channel for PrEP in diverse settings. Countries with robust private pharmacy sectors and populations at HIV risk should focus on aligning key areas related to governance, financing, and regulation that have proven critical to pharmacy-based PrEP delivery while pursuing an ambitious research agenda to generate information for decision-making. Additionally, the nascency of pharmacy-based PrEP delivery in both high- and low-and-middle-income settings presents a prime opportunity for shared learning and innovation.

The Effect of Stigma on Family Planning and HIV Pre-exposure Prophylaxis Decisions of Young Women Accessing Post-Abortion Care in Kenya.

Adolescent girls and young women (AGYW) in Eastern and Southern Africa face parallel epidemics of unintended pregnancy and HIV. Their sexual health decisions are often dominated by intersecting stigmas. In an implementation science project integrating delivery of daily, oral pre-exposure prophylaxis (PrEP) for HIV prevention into 14 post-abortion care (PAC) clinics in Kenya, we enrolled a subset of PrEP initiating AGYW (aged 15 to 30 years) into a research cohort. Utilizing log binomial models, we estimated the effect of PrEP stigma on PrEP continuation (measured via self-report and urine assay for tenofovir) and abortion stigma on contraceptive initiation. Between April 2022 and February 2023, 401 AGYW were enrolled after initiating PrEP through their PAC provider, of which 120 (29.9%) initiated highly-effective contraception. Overall, abortion and PrEP stigmas were high in this cohort. Abortion stigma was more prevalent among those that were adolescents, unmarried, and reported social harm. Among 114 AGYW returning for the month 1 follow-up visit, 83.5% reported continuing PrEP and 52.5% had tenofovir detected. In this subset, higher levels of PrEP stigma were significantly associated with greater likelihood of PrEP adherence, but not PrEP continuation. For abortion stigma, greater scores in the subdomain of isolation were significantly associated with greater likelihood of initiating a highly-effective contraception, while greater scores in the subdomain of community condemnation were significantly associated with reduced likelihood of initiating a highly-effective contraception. Given the burden of stigma documented by our work, PAC settings are a pivotal space to integrate stigma-informed counseling and to empower young women to optimize contraceptive and PrEP decisions.

Adaptation of the Client Diagnostic Questionnaire for East Africa.

Research increasingly involves cross-cultural work with non-English-speaking populations, necessitating translation and cultural validation of research tools. This paper describes the process of translating and criterion validation of the Client Diagnostic Questionnaire (CDQ) for use in a multisite study in Kenya and Uganda. The English CDQ was translated into Swahili, Dholuo (Kenya) and Runyankole/Rukiga (Uganda) by expert translators. The translated documents underwent face validation by a bilingual committee, who resolved unclear statements, agreed on final translations and reviewed back translations to English. A diagnostic interview by a mental health specialist was used for criterion validation, and Kappa statistics assessed the strength of agreement between non-specialist scores and mental health professionals' diagnoses. Achieving semantic equivalence between translations was a challenge. Validation analysis was done with 30 participants at each site (median age 32.3 years (IQR = (26.5, 36.3)); 58 (64.4%) female). The sensitivity was 86.7%, specificity 64.4%, positive predictive value 70.9% and negative predictive value 82.9%. Diagnostic accuracy by the non-specialist was 75.6%. Agreement was substantial for major depressive episode and positive alcohol (past 6 months) and alcohol abuse (past 30 days). Agreement was moderate for other depressive disorders, panic disorder and psychosis screen; fair for generalized anxiety, drug abuse (past 6 months) and Post Traumatic Stress Disorder (PTSD); and poor for drug abuse (past 30 days). Variability of agreement between sites was seen for drug use (past 6 months) and PTSD. Our study successfully adapted the CDQ for use among people living with HIV in East Africa. We established that trained non-specialists can use the CDQ to screen for common mental health and substance use disorders with reasonable accuracy. Its use has the potential to increase case identification, improve linkage to mental healthcare, and improve outcomes. We recommend further studies to establish the psychometric properties of the translated tool.