Antibodies from chlamydia-infected individuals facilitate phagocytosis via Fc receptors.

Non-neutralizing functions of antibodies, including phagocytosis, may play a role in Chlamydia trachomatis (CT) infection, but these functions have not been studied and assays are lacking. We utilized a flow-cytometry-based assay to determine whether serum samples from a well-characterized cohort of CT-infected and naïve control individuals enhanced phagocytosis via Fc-receptor-expressing THP-1 cells, and whether this activity correlated with antibody titers. Fc-receptor-mediated phagocytosis was detected only in CT+ donors. Phagocytosis generally did not correlate well with antibody titer. In addition, we found that complement from both CT+ and negative individuals enhanced phagocytosis of CT into primary neutrophils. These results suggest that anti-CT antibodies can have functions that are not reflected by titer. This method could be used to quantitively measure Fc-receptor-mediated function of anti-CT antibodies or complement activity and could reveal new immune correlates of protection.

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.

Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial.

We evaluated correlates of adherence to PrEP, including daily oral tenofovir disoproxil fumarate in combination emtricitabine (oral FTC/TDF) and the monthly dapivirine ring (ring)among adolescent girls and young women (AGYW) in the MTN-034/REACH study. We enrolled 247 AGYW aged 16-21 years in South Africa, Uganda and Zimbabwe (ClinicalTrials.gov: NCT03074786). Participants were randomized to the order of oral FTC/TDF or ring use for 6 months each in a crossover period, followed by a 6-month choice period. We assessed potential adherence correlates-individual, interpersonal, community, study, and product-related factors-quarterly via self-report. We measured biomarkers of adherence monthly; high adherence was defined as > 4 mg dapivirine released from returned rings or intracellular tenofovir diphosphate levels ≥ 700 fmol/punch from dried blood spots (DBS). We tested associations between correlates and objective measures of high adherence using generalized estimating equations. High adherence to oral FTC/TDF was significantly associated with having an older primary partner (p = 0.04), not having exchanged sex in the past 3 months (p = 0.02), and rating oral FTC/TDF as highly acceptable (p = 0.003). High ring adherence was significantly associated with unstable housing (p = 0.01), disclosing ring use to a male family member (p = 0.01), and noting a social benefit from study participation (p = 0.03). All associations were moderate, corresponding to about 6%-10% difference in the proportion with high adherence. In our multinational study, correlates of adherence among African AGYW differed for oral FTC/TDF and the ring, highlighting the benefit of offering multiple PrEP options.

Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya.

BACKGROUND: In Africa, the delivery of HIV pre-exposure prophylaxis (PrEP) at public healthcare clinics is challenged by understaffing, overcrowding, and HIV-associated stigma, often resulting in low PrEP uptake and continuation among clients. Giving clients the option to refill PrEP at nearby private pharmacies, which are often more convenient and have shorter wait times, may address these challenges and improve PrEP continuation. METHODS: This mixed methods study used an explanatory sequential design. At two public clinics in Kiambu County, Kenya, clients ≥ 18 years initiating PrEP were given the option to refill PrEP at the clinic where they initiated for free or at one of three nearby private pharmacies for 300 Kenyan Shillings (~ $3 US Dollars). The providers at these pharmacies (pharmacists and pharmaceutical technologists) were trained in PrEP service delivery using a prescribing checklist and provider-assisted HIV self-testing, both with remote clinician oversight. Clients were followed up to seven months, with scheduled refill visits at one, four, and seven months. The primary outcomes were selection of pharmacy-based PrEP refills and PrEP continuation. Following pilot completion, 15 in-depth interviews (IDIs) with clients who refilled PrEP were completed. We used descriptive statistics and thematic analysis to assess study outcomes. RESULTS: From November 2020 to November 2021, 125 PrEP clients were screened and 106 enrolled. The majority (59%, 63/106) of clients were women and the median age was 31 years (IQR 26-38 years). Over 292 client-months of follow-up, 41 clients (39%) refilled PrEP; only three (3%) at a participating pharmacy. All clients who completed IDIs refilled PrEP at clinics. The reasons why clients did not refill PrEP at pharmacies included: a preference for clinic-delivered PrEP services (i.e., pre-existing relationships, access to other services), concerns about pharmacy-delivered PrEP services (i.e., mistrust, lower quality care, costs), and lack of knowledge of this refill location. CONCLUSIONS: These findings suggest that clients who initiate PrEP at public clinics in Kenya may have already overcome barriers to clinic-delivered PrEP services and prefer PrEP access there. To reach new populations that could benefit from PrEP, a stand-alone model of pharmacy-delivered PrEP services may be needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04558554 [registered: June 5, 2020].

Low prevalence of bacterial vaginosis in Kenyan adolescent girls and rapid incidence after first sex.

BACKGROUND: Bacterial vaginosis is a risk factor for sexually transmitted infections, including HIV. Adult African women have a high prevalence of bacterial vaginosis, but it is not known when first bacterial vaginosis occurs. OBJECTIVE: This study aimed to describe bacterial vaginosis in younger African women, before and after first sex, and to determine the incidence of bacterial vaginosis and significant correlates of bacterial vaginosis incidence and recurrence. STUDY DESIGN: In a prospective observational cohort study enrolling adolescents with limited sexual experience, young women aged 16 to 21 years were recruited in Thika, Kenya. Eligible participants were HIV and herpes simplex virus 2 seronegative and reported 0 or 1 lifetime sexual partner. The Nugent score was determined at quarterly visits from vaginal Gram stains. The trends in bacterial vaginosis were described over time; hazard ratios were calculated using Cox regression, and relative risk of bacterial vaginosis was estimated using generalized estimating equations and Poisson regression. RESULTS: A total of 400 participants with a median age of 18.6 years (interquartile range, 16-21) were enrolled. Of note, 322 participants (80.5%) reported no history of sex, whereas 78 participants (19.5%) reported sex with 1 partner. At enrollment, bacterial vaginosis (Nugent score of ≥7) was uncommon (21/375 [5.6%]). Overall, 144 participants had bacterial vaginosis at least once, for an incidence rate of 16.5 cases per 100 person-years. Before first sex, bacterial vaginosis was present at 2.8% of visits, compared with 13.7% of visits after first sex. An adjusted model of bacterial vaginosis incidence observed that first sex was associated with more than a 2-fold increased bacterial vaginosis risk (adjusted hazard ratio, 2.44; 95% confidence interval, 1.25-4.76; P=.009). Chlamydia diagnosis (adjusted hazard ratio, 1.73; 95% confidence interval, 1.1-2.8; P=.02), and herpes simplex virus 2 seropositivity (adjusted hazard ratio, 2.88; 95% confidence interval, 1.17-7.09; P=.021) were both associated with incident bacterial vaginosis. A multivariate generalized estimating equation model, including all episodes of bacterial vaginosis, demonstrated risk factors, including first sex, sexually transmitted infections, urban residence, recent sex, and no income; the most important risk factor was first sex (adjusted relative risk, 1.92; 95% confidence interval, 1.12-3.31; P=.018). The probability of bacterial vaginosis increased with each subsequent episode; mean Nugent scores increased after each bacterial vaginosis episode. CONCLUSION: Using detailed longitudinal observation, this study found that Kenyan adolescents have almost no bacterial vaginosis before first sex and that initiation of sexual activity was the strongest risk factor for both prevalent bacterial vaginosis and incident bacterial vaginosis.

Intersectional Stigma and Implementation of HIV Prevention and Treatment Services for Adolescents Living with and at Risk for HIV: Opportunities for Improvement in the HIV Continuum in Sub-Saharan Africa.

Adolescents in sub-Saharan Africa, specifically adolescent girls and young women, young men who have sex with men, transgender persons, persons who use substances, and adolescents experiencing homelessness experience intersectional stigma, have a high incidence of HIV and are less likely to be engaged in HIV prevention and care. We conducted a thematic analysis informed by the Health and Discrimination Framework using a multiple case study design with five case studies in 3 sub-Saharan African countries. Our analysis found commonalities in adolescents' intersectional stigma experiences across cases, despite different contexts. We characterize how intersectional stigma impacts the uptake and implementation of HIV prevention and treatment services along the continuum for adolescents. Findings reveal how intersectional stigma operates across social-ecological levels and worsens HIV-related outcomes for adolescents. We identify opportunities for implementation science research to address stigma-related barriers to the uptake and delivery of HIV services for adolescents in sub-Saharan Africa.

Performance of Multiple Adherence Measures for pre-exposure Prophylaxis (PrEP) Among Young Women in Kenya.

Understanding PrEP adherence is key in the formulation of HIV prevention strategies; however, measurement of adherence can be challenging. We compared multiple adherence measures in a two-year study of young Kenyan women at high risk of HIV acquisition. Among 289 participants, concordance between electronic adherence monitoring (EAM) and tenofovir diphosphate (TFV-DP) in dried blood spots ranged from 57 to 72% depending on selected thresholds. Using area under the receiver operating curve, discrimination of quantifiable TFV-DP was high at 0.85 with EAM and low at 0.49-0.54 for multiple self-reported measures. Correlation between EAM and self-reported measures was low (r < 0.11) although correlation within self-reported measures was moderate (r > 0.69). These findings indicate that both TFV-DP and EAM are useful PrEP adherence tools. Adherence would benefit from better availability of less expensive versions of both measurement tools. Additionally, further research on TFV-DP thresholds is needed to inform interpretation and use in understanding PrEP adherence in this population.

RESUMEN: Comprender la adherencia a la PrEP es importante en la formulación de estrategias de prevención del VIH; sin embargo, la medición de la adherencia puede ser difícil. Comparamos múltiples medidas de adherencia en un estudio de dos años de mujeres jóvenes kenianas con alto riesgo de contraer el VIH. Entre 289 participantes, la concordancia entre la monitorización electrónica de la adherencia (EAM) y el tenofovir difosfato (TFV-DP) en las manchas de sangre seca varió del 57% al 72% dependiendo de los umbrales seleccionados. Utilizando el área bajo la curva operativa del receptor, la discriminación de TFV-DP cuantificable fue alta en 0.85 con EAM y baja en 0.49­0.54 para múltiples medidas autoinformadas. La correlación entre la EAM y las medidas autoinformadas fue baja (r < 0,11), aunque la correlación entre de las medidas autoinformadas fue moderada (r > 0,69). Estos resultados indican que tanto TFV-DP como EAM son herramientas útiles de adherencia a la PrEP. La adherencia se beneficiaría de una mejor disponibilidad de versiones menos costosas de ambas herramientas de medición. Además, se necesita más investigación sobre los umbrales TFV-DP para informar la interpretación y el uso en la comprensión de la adherencia a la PrEP en esta población.

Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis.

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW's experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW's disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led most key influencers to support product use through reminders and encouragement. While disclosure yielded positive support from influencers, further community awareness of both PrEP products is essential to reduce potential opposition and perceived stigma.Clinical Trial Number: NCT03593655.

"Yes, I'm reminded, but it doesn't mean I'm taking them": Experiences with Short Message Service Reminder Use in Real-time Monitoring of HIV PrEP among Young Women in Kenya.

Adherence to oral pre-exposure prophylaxis (PrEP) is challenging, and cellular technology offers a promising opportunity for support. However, a recent randomized controlled trial found that SMS reminders did not improve PrEP adherence. We used qualitative methods to explore the trial participants' experiences with the SMS intervention. We conducted serial in-depth interviews with 54 young Kenyan women, using inductive and deductive content analysis . Initially, SMS reminders were highly acceptable. Participants expressed enthusiasm with receiving the reminders because of the coded nature of the SMS reminders; they also helped in 'habit forming' with daily adherence. However, overtime, participants reported growing concerns about privacy, self-efficacy, and responsibility and SMS fatigue. Participants also reported other challenges, including phone loss, poor telephone network, and lack of electricity. Further research to explore if SMS reminders in alternative formats or with different frequency is needed, in addition to identification of alternate adherence support strategies.

Multi-level Factors Driving Pre-exposure Prophylaxis Non-initiation Among Young Women at High Risk for HIV in Kenya.

Few studies have focused on understanding pre-exposure prophylaxis (PrEP) non-initiation among young, high-risk women in sub-Saharan Africa. This study aimed to qualitatively explore why young women in Kenya at high-risk for HIV chose not to enroll in a PrEP adherence trial. We performed 40 semi-structured interviews with young high-risk women assessing concerns about PrEP and/or study participation. We also assessed community-level factors influencing decision-making around PrEP through 10 focus groups involving peers, young men, caregivers, and community leaders. Our qualitative data reflect the complexity of navigating barriers preventing PrEP initiation in settings where taking PrEP may be perceived as immoral behavior. Framed within the context of risk perception, the decision to start PrEP may run counter to the potential risk of losing support from one's community. Our findings suggest that approaches addressing social norms, while de-medicalizing HIV prevention services, are needed to further increase PrEP uptake among young Kenyan women.

"I was just concerned about getting pregnant": Attitudes toward pregnancy and contraceptive use among adolescent girls and young women in Thika, Kenya.

BACKGROUND: Adolescent girls and young women (AGYW) have a high incidence of unplanned pregnancies, especially in low-resource settings. AGYW assess the overlapping risks of pregnancy, contraception, and STIs as they navigate relationships. Few studies have examined how AGYW consider the comparative risks of their decisions around sexual and reproductive health in this context or how risk perception influences contraceptive use. METHODS: Twenty in-depth interviews (IDIs) and 5 focus group discussions (FGDs) were conducted with a subset of sexually active AGYW enrolled in the Girls Health Study (GHS), a longitudinal cohort study in Thika, Kenya, assessing HSV-2 incidence in a cohort of AGYW aged 16-20. Interview questions were focused on perspectives and decision-making around sexual and reproductive health. Interviews were conducted in both English and Kiswahili, transcribed, and coded using inductive and deductive approaches to identify emerging themes. RESULTS: Misconceptions about long-acting reversible contraceptives (LARCs), injectables, and daily oral contraceptive pills strongly disincentivized their use among AGYW. Participants described pregnancy as undesirable, and AGYW reported prioritizing contraceptive methods that were effective and reliable in pregnancy prevention, even if not effective in preventing STI/HIV infection. Participants reported that AGYW relied heavily on emergency contraceptive (EC) pills for pregnancy prevention. CONCLUSIONS: Though the goal of avoiding unintended pregnancy was common, this did not suffice to motivate the uptake of long-term contraceptives among AGYWs. Given the convenience, cost-effectiveness, and lower perceived risk of side effects, EC pills were more likely to be accepted as a form of contraception. Understanding the reasons for AGYW's acceptance of certain contraceptive methods over others can help future interventions better target communication and counseling about contraception and influence key drivers of AGYW behavior and decision-making around sexual and reproductive health.

Cultural considerations and beliefs surrounding preterm birth in Kenya and South Africa.

BACKGROUND: Preterm birth (PTB) is a global health epidemic, sub-Saharan Africa is severely impacted due to its limited healthcare resources. Pregnancy knowledge, cultural beliefs and practices play a role in the identification of risk and management of PTB. This study explored knowledge, understandings, cultural beliefs and attitudes to pregnancy and PTB, as well as cultural considerations for the introduction of an intravaginal device which could be used to identify PTB risk. METHODS: Qualitative research was conducted in South Africa and Kenya. In-depth interviews were conducted using semi-structured guides with women with a history of PTB (n = 10), healthcare providers (n = 16) and health systems experts (n = 10); and 26 focus group discussions with pregnant women seeking antenatal care (n = 132) and community male partners/fathers (n = 54). Interviews/discussions were transcribed, translated, and analysed thematically. RESULTS: Pregnancy knowledge, especially for first time pregnancies was poor, with many reporting late entry to antenatal care. Knowledge about PTB was understood in terms of gestational age, weight or small size of baby, with concerns about long term health and stigma. Various risk factors for PTB were described, including those related to traditions and beliefs of witchcraft/curses. Cultural practices, such as the use of traditional medicines and pica, and religion and its impact on health seeking behaviour were also viewed as risk factors. Although insertion of intravaginal devices was not widely acceptable in traditional communities, especially during pregnancy, it was felt that the use of one to detect risk of PTB would be accepted if proven effective in reducing PTB risk. CONCLUSIONS: Various culturally-informed beliefs exist which explain understandings of and attitudes toward pregnancy, pregnancy risk, and PTB. An inclusive exploratory process is critical to facilitate an understanding of the beliefs and traditions which could impact the introduction and design of a product to detect the risk of PTB.

Barriers to linkage and retention in HIV care still persist among adolescent girls and young women in western Kenya.

Adolescent girls and young women (AGYW) in sub-Saharan Africa experience delayed linkage to and poor retention in HIV care. Identifying and addressing specific barriers in HIV care programming is important to achieving the upgraded UNAIDS 95-95-95 targets and epidemic control. We examined these challenges among 103 HIV-positive AGYW in and out of HIV care in communities around Lake Victoria in western Kenya as part of a larger qualitative study to identify drivers of HIV testing and HIV care utilisation in key populations. We used the social-ecological model to guide development of interview guides. Individual-level barriers included denial and forgetfulness and gendered household responsibilities, medication side effects, especially if taken without food, pills being too big and difficult to swallow and the burden of a daily medication-taking regimen. Interpersonal barriers included troubled family relationships and pervasive fears of stigma and discrimination by friends and family. Communitylevel barriers were stigmatising attitudes toward people living with HIV. Health-system barriers included negative provider attitudes and confidentiality breaches. At the structural level, participants noted high costs due to long travel times to facilities, long clinic waiting times, household food insecurity and school and work commitments. AGYW's limited decision-making autonomy due to age and gender norms, including their reliance on the authority of older adults, makes these barriers especially troubling. Innovative treatment approaches that take into account the unique vulnerabilities of AGYW are urgently needed.

Examining the Use of HIV Self-Testing to Support PrEP Delivery: a Systematic Literature Review.

PURPOSE OF REVIEW: HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. RECENT FINDINGS: After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.

Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring.

In the Phase IIIB MTN-025/HOPE open label extension trial, participants were offered the dapivirine vaginal ring as HIV prophylaxis, and those who accepted the ring received semi real-time individual adherence feedback, based on residual drug level (RDL) from returned rings, during Motivational Interviewing-based counseling. Counseling messages, based on the best knowledge at the time, framed RDL results in terms of ring use and HIV protection, from no use /no protection (0 RDL) to high use /high protection (3 RDL). At six HOPE sites, in-depth-Interviews (IDIs) about RDL were conducted with 64 participants who had received at least one RDL result. We found mixed interpretations of what the RDL meant and strong emotional reactions with a focus on the external validation of the level itself. Counseling was critical to help participants process their reactions to the RDL and make decisions accordingly (i.e., persistence, adherence improvement, and/or switching to another HIV prevention method). Providing drug adherence feedback was complex to implement yet proved useful as a component of a multi-pronged adherence support strategy.

Toward an intravaginal device to detect risk of preterm labor: a user-centered design approach in Sub-Saharan Africa.

BACKGROUND: Prematurity and its complications are the leading cause of death and disability in children under five in Africa and North America, affecting as many as one in ten pregnancies. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. In parallel with early-stage U.S.-based testing of a novel self-placed intravaginal device to predict PTB risk, we elicited key stakeholder input from two sub-Saharan African countries to ensure local contextual factors inform future development of the device and its acceptability. METHODS: A qualitative study was conducted in Kiambu County, Kenya and KwaZulu-Natal Province, South Africa. We conducted 26 focus group discussions with pregnant women (n = 132) and males from the community (n = 54); in-depth interviews with women who had a history of PTB (n = 10), healthcare providers (n = 16), and health system experts (n = 10). Interviews were transcribed and thematic analysis was performed using an iterative coding technique. In addition, we facilitated user-centered design sessions to generate prototype preferences. RESULTS: Women with a personal history of PTB were almost unanimous in support of the proposed device, whereas those with no experience of PTB expressed the greatest degree of reservation. Healthcare providers anticipated that women with a history of PTB would accept the device. However, various potential challenges were identified, including potential discomfort with device insertion, hygiene, and sexual activity, as well as need for provider training, and attention to country-specific regulatory processes. Both community participants and providers expressed a preference for a provider inserted device. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal. CONCLUSIONS: Use of an intravaginal device to detect risk of PTB was generally acceptable, however stakeholders expressed a notable preference for insertion by providers. This reflects the significance of end-user consultation in device design and use. Recommended device modifications as well as educational messaging and provider technical assistance may facilitate utilization.

Prematurity and its complications are the leading cause of death and disability in children under 5 years of age. Up to ten percent of pregnancies in North America and Africa are affected. Screening tests to predict preterm birth (PTB) are insensitive, costly, and often unavailable in low resource settings. A U.S.-based study has developed an intravaginal device to detect preterm labor. In order to assess acceptability and guide development for a low-resource setting, a qualitative study was conducted in Kenya and South Africa. We conducted focus group discussions and interviews with pregnant women, male community members, health care providers and health systems experts. Participants with a personal history of PTB were almost unanimous in support of the proposed device; women with no experience of PTB expressed the greatest degree of reservation. Various potential challenges were identified: discomfort, hygiene, and sexual activity, the need for provider training and attention to country-specific regulatory processes. Design recommendations included preference for a small, soft, pliable device, with a shape that could facilitate easy removal. Stakeholders expressed a strong preference for insertion by providers. These findings reflect the significance of end-user consultation in device design and use.

Differences in Vaginal Microbiota, Host Transcriptome, and Proteins in Women With Bacterial Vaginosis Are Associated With Metronidazole Treatment Response.

BACKGROUND: Bacterial vaginosis (BV) treatment failures and recurrences are common. To identify features associated with treatment response, we compared vaginal microbiota and host ectocervical transcriptome before and after oral metronidazole therapy. METHODS: Women with BV (Bronx, New York and Thika, Kenya) received 7 days of oral metronidazole at enrollment (day 0) and underwent genital tract sampling of microbiome (16S ribosomal RNA gene sequencing), transcriptome (RNAseq), and immune mediator concentrations on day 0, 15, and 35. RESULTS: Bronx participants were more likely than Thika participants to clinically respond to metronidazole (19/20 vs 10/18, respectively, P = .0067) and by changes in microbiota composition and diversity. After dichotomizing the cohort into responders and nonresponders by change in α-diversity between day 35 and day 0, we identified that transcription differences associated with chemokine signaling (q = 0.002) and immune system process (q = 2.5 × 10-8) that differentiated responders from nonresponders were present at enrollment. Responders had significantly lower levels of CXCL9 in cervicovaginal lavage on day 0 (P < .007), and concentrations of CXCL9, CXCL10, and monocyte chemoattractant protein 1 increased significantly between day 0 and day 35 in responders vs nonresponders. CONCLUSIONS: Response to metronidazole is characterized by significant changes in chemokines and related transcripts, suggesting that treatments that promote these pathways may prove beneficial.

Point-of-Care Test for Assessing Tenofovir Adherence: Feasibility and Recommendations from Women in an Oral PrEP Program in Kenya and Their Healthcare Providers.

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention modality when taken as recommended. Women in sub-Saharan Africa may have adherence challenges that remain undisclosed to providers. Real-time measures that identify non-adherence can allow for immediate exploration of adherence challenges, counseling and interventions. We conducted a formative qualitative study in Kenya to explore oral PrEP experiences and reactions to a point-of-care urine test (UT) identifying recent (past 4 days) non-adherence to tenofovir-based PrEP among female PrEP users (25 in-depth interviews; 4 focus groups) and health care provider (10 key informant interviews). Findings indicate that use of the UT would be highly feasible in the context of regular PrEP care, largely acceptable to clients and providers, and could improve adherence. Clients emphasized the need for transparent client-centered strategies in delivering results. This formative study informs the development of tools to implement this point-of-care UT in future interventional studies and clinical settings.

Acceptability and Feasibility of Pharmacy-Based Delivery of Pre-Exposure Prophylaxis in Kenya: A Qualitative Study of Client and Provider Perspectives.

As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.

RESUMEN: Ya que varios países están ampliando sus programas de profilaxis previa a la exposición al VIH (PrEP, por sus siglas en inglés), se necesitan modelos diversos para ampliar el acceso a poblaciones que no están dispuestos a acceder, o que no pueden acceder, a los servicios de PrEP que se ofrecen en las instalaciones de salud. Para identificar los factores que pueden influir en la prestación de servicios de PrEP a través de farmacias privadas, realizamos entrevistas en profundidad con 40 clientes de farmacia, 16 proveedores de servicios de farmacia, 16 usuarios de PrEP, y 10 proveedores de PrEP. La mayoría de los participantes manifestó su firme apoyo a la propuesta de expandir la provisión de PrEP a las farmacias privadas, aunque condicionó su aceptación a la garantía de que la atención sea privada, respetuosa, segura, y asequible. Según los participantes, los factores determinantes de la viabilidad de ofrecer PrEP en las farmacias privadas se centran en asegurar de que la intervención sea compatible con las operaciones de las farmacias privadas (p. ej., el número de personal, los requisitos de documentación). Se necesitan investigaciones adicionales para desarrollar y evaluar diferentes paquetes de estrategias de implementación para descubrir cuáles son los más eficaces para integrar los servicios de PrEP en la prestación rutinaria de servicios de farmacia tanto en Kenia como en otros lugares de alta prevalencia del VIH.