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Abstract Background Mobile health (mHealth) has become an increasingly popular strategy to improve healthcare delivery and health outcomes. Communicating results and health education via text may facilitate program planning and promote better engagement in care for women undergoing human papillomavirus (HPV) screening. We sought to develop and evaluate an mHealth strategy with enhanced text messaging to improve follow-up throughout the cervical cancer screening cascade. Methods Women aged 25–65 participated in HPV testing in six community health campaigns (CHCs) in western Kenya as part of a single arm of a cluster-randomized trial. Women received their HPV results via text message, phone call, or home visit. Those who opted for text in the first four communities received “standard” texts. After completing the fourth CHC, we conducted two semi-structured focus group discussions with women to develop an “enhanced” text strategy, including modifying the content, number, and timing of texts, for the subsequent two communities. We compared the overall receipt of results and follow-up for treatment evaluation among women in standard and enhanced text groups. Results Among 2368 women who were screened in the first four communities, 566 (23.9%) received results via text, 1170 (49.4%) via phone call, and 632 (26.7%) via home visit. In the communities where enhanced text notification was offered, 264 of the 935 screened women (28.2%) opted for text, 474 (51.2%) opted for phone call, and 192 (20.5%) for home visit. Among 555 women (16.8%) who tested HPV-positive, 257 (46.3%) accessed treatment, with no difference in treatment uptake between the standard text group (48/90, 53.3%) and the enhanced text group (22/41, 53.7%). More women in the enhanced text group had prior cervical cancer screening (25.8% vs. 18.4%; p

IntroductionDespite 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).MethodsOur 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.ResultsIn-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.ConclusionsIdentifying 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.

IntroductionHIV self-testing (HIVST) is highly sensitive and specific, addresses known barriers to HIV testing (such as stigma), and is recommended by the World Health Organization as a testing option for the delivery of HIV pre-exposure prophylaxis (PrEP). Nevertheless, HIVST remains underutilized as a diagnostic tool in community-based, differentiated HIV service delivery models, possibly due to concerns about result misinterpretation, which could lead to inadvertent onward transmission of HIV, delays in antiretroviral therapy (ART) initiation, and incorrect initiation on PrEP. Ensuring that HIVST results are accurately interpreted for correct clinical decisions will be critical to maximizing HIVST's potential. Early evidence from a few small pilot studies suggests that artificial intelligence (AI) computer vision and machine learning could potentially assist with this task. As part of a broader study that task-shifted HIV testing to a new setting and cadre of healthcare provider (pharmaceutical technologists at private pharmacies) in Kenya, we sought to understand how well AI technology performed at interpreting HIVST results.MethodsAt 20 private pharmacies in Kisumu, Kenya, we offered free blood-based HIVST to clients ≥18 years purchasing products indicative of sexual activity (e.g., condoms). Trained pharmacy providers assisted clients with HIVST (as needed), photographed the completed HIVST, and uploaded the photo to a web-based platform. In real time, each self-test was interpreted independently by the (1) client and (2) pharmacy provider, with the HIVST images subsequently interpreted by (3) an AI algorithm (trained on lab-captured images of HIVST results) and (4) an expert panel of three HIVST readers. Using the expert panel's determination as the ground truth, we calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for HIVST result interpretation for the AI algorithm as well as for pharmacy clients and providers, for comparison.ResultsFrom March to June 2022, we screened 1,691 pharmacy clients and enrolled 1,500 in the study. All clients completed HIVST. Among 854 clients whose HIVST images were of sufficient quality to be interpretable by the AI algorithm, 63% (540/854) were female, median age was 26 years (interquartile range: 22–31), and 39% (335/855) reported casual sexual partners. The expert panel identified 94.9% (808/854) of HIVST images as HIV-negative, 5.1% (44/854) as HIV-positive, and 0.2% (2/854) as indeterminant. The AI algorithm demonstrated perfect sensitivity (100%), perfect NPV (100%), and 98.8% specificity, and 81.5% PPV (81.5%) due to seven false-positive results. By comparison, pharmacy clients and providers demonstrated lower sensitivity (93.2% and 97.7% respectively) and NPV (99.6% and 99.9% respectively) but perfect specificity (100%) and perfect PPV (100%).ConclusionsAI computer vision technology shows promise as a tool for providing additional quality assurance of HIV testing, particularly for catching Type II error (false-negative test interpretations) committed by human end-users. We discuss possible use cases for this technology to support differentiated HIV service delivery and identify areas for future research that is needed to assess the potential impacts—both positive and negative—of deploying this technology in real-world HIV service delivery settings.

Abstract Introduction Young women in sub‐Saharan Africa are a priority population for HIV prevention, yet challenges with adherence and persistence to HIV pre‐exposure prophylaxis (PrEP) are common. This study involved the development and pilot testing of My Way—a novel delivery system for PrEP and co‐packaged sexual health services. Methods My Way was developed in Kisumu, Kenya through a user‐centred design process (2020). The intervention involves peer‐delivery and support for HIV testing and PrEP use, self‐collected vaginal swabs for sexually transmitted infection (STI) testing, pregnancy testing, oral contraceptive pills, self‐injectable medroxyprogesterone and/or condoms. My Way was assessed among 16‐ to 24‐year‐old sexually active women in a randomized controlled trial versus standard of care (SoC; 2021–2022). Use of PrEP and other sexual health services were tracked at 1, 3 and 6 months for feasibility. Acceptability was determined by questionnaire. The effect of the intervention on tenofovir diphosphate (TFV‐DP) levels was assessed by chi‐square test (primary outcome); other predictors were explored with regression analysis. Results Among 150 women, the median age was 22 years and the median number of sexual partners was 2. Moderate/severe depression was common (60%). In the intervention arm, peers made 88% (198/225) of possible kit deliveries (177 with PrEP) and 49 STIs were diagnosed. In the SoC arm, 24% (55/225) of expected clinic visits occurred (53 with PrEP); no STI testing was performed. TVF‐DP was detected in 16 participants at 6 months: 16% (12/75) in the intervention arm versus 5% (4/75) in the SoC arm (p = 0.03). Persistence among those with ongoing HIV prevention needs (i.e. prevention‐effective persistence) was 18% (12/67) versus 7% (4/56; p = 0.08). No women acquired HIV. The intervention was significantly associated with detectable TFV‐DP (OR 3.5, 1.1‐11.4; p = 0.04); moderate/severe depression trended towards an association with TFV‐DP (OR 0.2, 0.03–1.6; p = 0.13). Conclusions My Way is a promising delivery system for PrEP and other sexual health services among young women in Western Kenya. We found high feasibility and acceptability. PrEP use was modest, but higher with My Way compared to SoC. Long‐acting PrEP formulations may overcome important barriers to PrEP use and should be explored in combination with the My Way delivery model.

AbstractMen’s adherence to constraining male gender norms can lead them to resist contraceptive use. Very few interventions have attempted to transform masculine norms to encourage greater contraceptive acceptance and gender equality. We designed and evaluated a small-scale community-based intervention targeting the masculine norms tied to contraceptive resistance among partnered men (N = 150) in two western Kenya communities (intervention vs. control). Pre–post survey data fit to linear and logistic regression models evaluated differences in post-intervention outcomes, accounting for pre-intervention differences. Intervention participation was associated with increases in contraceptive acceptance scores (adjusted coefficient (aβ) 1.04; 95% confidence interval (CI) 0.16, 1.91; p = 0.02) and contraceptive knowledge scores (aβ 0.22; 95% CI 0.13, 0.31; p

Abstract Background Population mobility is a demonstrated barrier to reducing HIV incidence. A clear understanding of social networks and their influence on mobility among women in the fishing communities of Lake Victoria may contribute to tailoring effective interventions that suit the needs of these mobile women. Methods A cross-sectional qualitative methods study was conducted to understand mobility patterns among women resident and or working in fishing communities of Lake Victoria in Kenya, Tanzania, and Uganda. The study was conducted in six fishing communities from March 2018 to June 2019. The communities were purposively selected, based on population size (1000 people or more) and HIV prevalence of > 15% among women aged 18 years or older who had lived in the fishing community for at least six months. In-depth interviews were conducted with 24 key informants and 72 women from the sites in the three countries. Questions focused on women’s social networks and other factors that fuelled or facilitated women’s mobility as well as challenges they faced due to mobility. Data analysis followed a thematic framework approach. Results Different social groupings/networks existed among women in the fishing communities of Lake Victoria. These included female sex workers, women fish processors/traders, women bar workers/owners, restaurant workers, and family networks. Networks encouraged mobility, supporting finding work opportunities, but also increased sexual risks through partner changes. The benefits of networks included information sharing, financial support, and group protection, especially against violence. Conclusion Social networks and groupings among women in the fishing communities of Lake Victoria could be useful in tailoring HIV prevention and HIV care interventions to suit the needs of these highly mobile populations.

Abstract Introduction HIV self‐testing (HIVST) has the potential to support daily oral pre‐exposure prophylaxis (PrEP) delivery in private pharmacies, but many national guidelines have not approved HIVST for PrEP dispensing. In Kenya, pharmacy providers are permitted to deliver HIVST, but often do not have the required certification to deliver rapid diagnostic testing (RDT). We estimated the performance of provider‐delivered HIVST compared to RDT, the standard of care for PrEP delivery, at private pharmacies in Kenya to inform decisions on the use of HIVST for PrEP scale‐up. Methods At 20 pharmacies in Kisumu County, we trained pharmacy providers (pharmacists and pharmaceutical technologists) on blood‐based HIVST use and client assistance (if requested). We recruited pharmacy clients purchasing sexual and reproductive health‐related products (e.g. condoms) and enrolled those ≥18 years with self‐reported behaviours associated with HIV risk. Enrolled clients received HIVST with associated provider counselling, followed by RDT by a certified HIV testing services (HTS) counsellor. Pharmacy providers and clients independently interpreted HIVST results prior to RDT (results interpreted only by the HTS counsellor). We calculated the sensitivity and specificity of pharmacy provider‐delivered HIVST compared to HTS counsellor‐administered RDT. Results Between March and June 2022, we screened 1691 clients and enrolled 1500; 64% (954/1500) were female and the median age was 26 years (IQR 22–31). We additionally enrolled 40 providers; 42% (17/40) were pharmacy owners and their median years of experience was 6 (IQR 4–10). The majority (79%, 1190/1500) of clients requested provider assistance with HIVST and providers spent a median of 20 minutes (IQR 15–43) with each HIVST client. The sensitivity of provider‐delivered HIVST at the pharmacy was high when interpreted by providers (98.5%, 95% CI 97.8%, 99.1%) and clients (98.8%, 95% CI 98.0%, 99.3%), as was the specificity of HIVST in this setting (provider‐interpretation: 96.9%, 95% CI 89.2%, 99.6%; client‐interpretation: 93.8%, 95% CI 84.8%, 98.3%). Conclusions When compared to the national HIV testing algorithm, provider‐delivered blood‐based HIVST at private pharmacies in Kenya performed well. These findings suggest that blood‐based HIVST may be a useful tool to support PrEP initiation and continuation at private pharmacies and potentially other community‐based delivery settings.

Abstract Introduction Person‐centred HIV prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. However, data are lacking on the actual uptake of choices among persons at risk of HIV in southern Africa. In an ongoing randomized study (SEARCH; NCT04810650) in rural East Africa, we evaluated the uptake of choices made when offered in a person‐centred, dynamic choice model for HIV prevention. Methods Using the PRECEDE framework, we developed a persont‐centred, Dynamic Choice HIV Prevention (DCP) intervention for persons at risk of HIV in three settings in rural Kenya and Uganda: antenatal clinic (ANC), outpatient department (OPD) and in the community. Components include: provider training on product choice (predisposing); flexibility and responsiveness to client desires and choices (pre‐exposure prophylaxis [PrEP]/post‐exposure prophylaxis [PEP], clinic vs. off‐site visits and self‐ or clinician‐based HIV testing) (enabling); and client and staff feedback (reinforcing). All clients received a structured assessment of barriers with personalized plans to address them, mobile phone access to clinicians (24 hours/7 days/week) and integrated reproductive health services. In this interim analysis, we describe the uptake of choices of product, location and testing during the first 24 weeks of follow‐up (April 2021−March 2022). Results A total of 612 (203 ANC, 197 OPD and 212 community) participants were randomized to the person‐centred DCP intervention. We delivered the DCP intervention in all three settings with diverse populations: ANC: 39% pregnant; median age: 24 years; OPD: 39% male, median age 27 years; and community: 42% male, median age: 29 years. Baseline choice of PrEP was highest in ANC (98%) vs. OPD (84%) and community (40%); whereas the proportion of adults selecting PEP was higher in the community (46%) vs. OPD (8%) and ANC (1%). Personal preference for off‐site visits increased over time (65% at week 24 vs. 35% at baseline). Interest in alternative HIV testing modalities grew over time (38% baseline self‐testing vs. 58% at week 24). Conclusions A person‐centred model incorporating structured choice in biomedical prevention and care delivery options in settings with demographically diverse groups, in rural Kenya and Uganda, was responsive to varying personal preferences over time in HIV prevention programmes.

Abstract Introduction The delivery of daily, oral HIV pre‐exposure prophylaxis (PrEP) at private pharmacies may overcome barriers to PrEP delivery at public healthcare facilities, including HIV‐associated stigma, long wait times and overcrowding. Methods At five private, community‐based pharmacies in Kenya, a care pathway for PrEP delivery (ClinicalTrials.gov: NCT04558554) was piloted—the first of its kind in Africa. Pharmacy providers screened clients interested in PrEP for HIV risk, then used a prescribing checklist to identify clients without medical conditions that might contraindicate PrEP safety, counsel them on PrEP use and safety, conduct provider‐assisted HIV self‐testing and dispense PrEP. For complex clinical cases, a remote clinician was available for consultation. Clients who did not meet the checklist criteria were referred to public facilities for free services delivered by clinicians. Pharmacy providers dispensed a 1‐month PrEP supply at initiation and a 3‐month supply thereafter at a client fee of 300 KES (∼$3 USD) per visit. Results From November 2020 to October 2021, pharmacy providers screened 575 clients, identified 476 who met the prescribing checklist criteria and initiated 287 (60%) on PrEP. Among pharmacy PrEP clients, the median age was 26 years (IQR 22–33) and 57% (163/287) were male. The prevalence of behaviours associated with HIV risk among clients was high; 84% (240/287) reported sexual partners with unknown HIV status and 53% (151/287) reported multiple sexual partners (past 6 months). PrEP continuation among clients was 53% (153/287) at 1 month, 36% (103/287) at 4 months and 21% (51/242) at 7 months. During the pilot observation period, 21% (61/287) of clients stopped and restarted PrEP and overall pill coverage was 40% (IQR 10%–70%). Nearly, all pharmacy PrEP clients (≥96%) agreed or strongly agreed with statements regarding the acceptability and appropriateness of pharmacy‐delivered PrEP services. Conclusions Findings from this pilot suggest that populations at HIV risk frequently visit private pharmacies and PrEP initiation and continuation at pharmacies is similar to or exceeds that at public healthcare facilities. Private pharmacy‐based PrEP delivery, conducted entirely by private‐sector pharmacy staff, is a promising new delivery model that has the potential to expand PrEP reach in Kenya and similar settings.

ABSTRACT: Objectives: We examined sex-specific associations of partner age disparity and relationship concurrency with Neisseria gonorrhoeae and/or Chlamydia trachomatis (NG/CT) infection, higher-risk relationships, and condom use as proxies for HIV risk. Methods: Data were collected in 2016 from 2179 adults in 12 communities in Uganda and Kenya. Logistic regression models examined associations of age disparity and relationship concurrency with NG/CT infection, condom use, and higher-risk (commercial sex and other higher-risk) relationships in the past 6 months, controlling for covariates. Results: Partner age and relationship concurrency were associated with NG/CT infection in women but not men. Relative to women in age-disparate relationships, women in both age-disparate and age-homogeneous relationships had higher odds of NG/CT infection (adjusted odds ratio [aOR]=3.82, 95% confidence interval [CI]: 1.46–9.98). Among men and women, partnership concurrency was associated with higher-risk partnerships. In addition, relative to those with a single age-homogeneous partner, those with concurrent age-homogeneous partners had higher odds of condom use (men: aOR=2.85, 95% CI: 1.89–4.31; women: aOR=2.99, 95% CI: 1.52–5.89). Concurrent age-disparate partnerships were associated with condom use among men only (aOR=4.02, 95% CI: 2.54–6.37). Conclusion: Findings underscore the importance of targeted HIV prevention efforts for couples in age-disparate and concurrent relationships.

Abstract Background Nearly 50% of men living with HIV in many countries are unaware of their HIV status; men also have lower uptake of HIV treatment and pre-exposure prophylaxis (PrEP). In SSA, highly mobile men such as those working in fishing communities alongside Lake Victoria have low uptake of HIV testing and low rates of linkage to HIV treatment and PrEP, despite increasing availability of these services. HIV self-testing (HIVST) kits hold promise for overcoming barriers to HIV testing and linkage to services for HIV-positive and HIV-negative men. We describe here a protocol for an HIV status-neutral, social network-based approach to promote HIV testing, linkage to care and prevention, and better health outcomes, including adherence, in fishermen around Lake Victoria. Methods Utilizing beach management unit (BMU) registries of fishermen operating in three Lake Victoria fishing communities in Siaya County, Kenya, we completed a census and social network mapping to identify close social networks of men. Network clusters identified by a socially-central lead (“promotor”) and selected to ensure maximal separation between treatment and control will be randomized. Promotors in both arms will receive basic HIV training; intervention promotors are further trained in HIVST to distribute kits to their cluster, while control promotors will distribute to their cluster vouchers for free HIVST at nearby clinics. We will test whether these promoters can enhance linkage to ART and PrEP after self-testing, thereby addressing a key limitation of HIVST. We will also measure 6- and 12-month viral load in those living with HIV and PrEP adherence among those without HIV via urine tenofovir levels as objective markers of adherence. Discussion This study has the potential to improve HIV health and promote HIV prevention among a hard to reach, at-risk, and highly mobile population of men in Western Kenya—a critical population in Kenya’s HIV prevention and treatment program. Further, if successful, this innovative social networks-based model could be scaled at the regional level to address HIV prevention and care among similarly at-risk populations of men in eastern Africa and inland fisheries settings across the continent. Trial registration Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men, registered on February 26, 2021, registration # NCT04772469 .

Vaccine coverage for the human papillomavirus (HPV) remains low globally, and differentiated models of vaccine delivery are needed to expand access. Pharmacy-based models of the HPV vaccination may engage women who could benefit. We assessed the acceptability of such a model among pharmacy clients and providers at 20 private pharmacies in Kisumu County, Kenya. In questionnaires, participants (≥18 years) were asked the extent they agreed (5-point scale) with statements that assessed different acceptability component constructs outlined in the Theoretical Framework of Acceptability (TFA). From March to June 2022, 1500 pharmacy clients and 40 providers were enrolled and completed questionnaires. Most clients liked the intervention (TFA: affective attitude; 96%, 1435/1500) and did not think it would be hard to obtain (TFA: burden; 93%, 1399/1500). All providers agreed the intervention could reduce HPV infection (TFA: perceived effectiveness) and felt confident they could deliver it (TFA: self-efficacy). Among the clients who had received or were planning to receive the HPV vaccine in the future, half (50%, 178/358) preferred a pharmacy-based HPV vaccination. In this study, most Kenyan pharmacy clients and providers perceived a pharmacy-delivered HPV vaccination as highly acceptable; however, more research is needed to test the feasibility and effectiveness of this novel vaccine delivery model in Africa.

Abstract Introduction Despite the increased risk of cervical cancer among HIV-positive women, many HIV-care programs do not offer integrated cervical cancer screening. Incorporating self-collected Human Papillomavirus (HPV) testing into HIV programs is a potential strategy to identify women at higher risk for cervical cancer while leveraging the staffing, infrastructure and referral systems for existing services. Community-based HIV and HPV testing has been effective and efficient when offered in single-disease settings. Methods This cross-sectional study was conducted within a community outreach and multi-disease screening campaigns organized by the Family AIDS Care and Education Services in Kisumu County, Kenya. In addition to HIV testing, the campaigns provided screening for TB, malaria, hypertension, diabetes, and referrals for voluntary medical male circumcision. After these services, women aged 25–65 were offered self-collected HPV testing. Rates and predictors of cervical cancer screening uptake and of HPV positivity were analyzed using tabular analysis and Fisher’s Exact Test. Logistic regression was performed to explore multivariate associations with screening uptake. Results Among the 2016 women of screening age who attended the outreach campaigns, 749 women (35.6%) were screened, and 134 women (18.7%) were HPV-positive. In bivariate analysis, women who had no children (p

Abstract Introduction Across sub-Saharan Africa, ministries of health have proposed integrating pre-exposure prophylaxis (PrEP) for HIV prevention into family planning (FP) services to reach adolescent girls and young women (AGYW); however, evidence on effective implementation strategies is still limited. We conducted a qualitative study of integrated PrEP-FP service implementation at two FP clinics in Kisumu, Kenya. Methods From June 2017 to May 2020, the Prevention Options for Women Evaluation Research (POWER) study enrolled 1000 sexually active, HIV-negative AGYW age 16 to 25. Actions taken to implement PrEP were captured prospectively in 214 monitoring and evaluation documents and 15 interviews with PrEP implementers. We analysed data using conventional and directed content analysis, with the latter informed by the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation. Results POWER deployed a variety of implementation strategies to train and educate stakeholders (e.g., having new providers shadow PrEP providers); develop stakeholder interrelationships (e.g., organizing support teams with protected time to reflect on implementation progress and make refinements); provide technical assistance; and change physical infrastructure and workflow. Although these strategies reportedly influenced contextual factors across four of the five CFIR domains, they primarily interacted with contextual factors relevant to inner setting, especially implementation climate and readiness for implementation. Overall, implementing PrEP proved easier and less labor-intensive at a private, youth-friendly clinic than a public FP clinic, largely because the baseline structural characteristics (e.g., space, workflow) and organizational mission of the former were more conducive to offering AGYW-centered care. Nevertheless, adoption of PrEP delivery among non-study staff at both sites was low, likely due to the widespread perception that PrEP was not within their scope of work. Conclusions Some FP clinics may be “lower-hanging fruit” than others for PrEP implementation. Approaching PrEP implementation as a behavioral intervention for FP providers may help ensure that providers have the requisite capability, opportunity, and motivation to adopt the clinical innovation. In particular, PrEP implementers should assess the need for implementation strategies that support providers’ clinical decision-making, establish worker expectations and accountability, and address workload constraints. Trial registration Clinical Trial Number: NCT03490058 .

Abstract Background Despite a high prevalence of human papillomavirus (HPV) and cervical cancer in low and middle-income countries, stigma remains an issue. Addressing HPV and cervical cancer stigma could significantly improve health outcomes for these conditions. The objective of this study was to identify the manifestations of stigma and their potential impacts on health-seeking behavior. Methods Twenty-six in-depth interviews were conducted with women living with HIV, HIV-negative women, community health volunteers, and health care providers in Kisumu, Kenya in 2019. The interviews were designed to draw out existing attitudes or experiences related to stigma within the community. We conducted a thematic analysis of the interviews to identify internalized, anticipated, and discriminatory attitudes. Results Within internalized attitudes, a prominent observed theme was a fear of death associated with a positive HPV test. This stemmed from a lack of understanding of differences between HPV and cervical cancer and posed a significant barrier for women deciding to seek screening or to continue with treatment. Discriminatory attitudes of community members, including assumptions of promiscuity, infidelity, or HIV status, were perceived to prevent women from accessing screening and treatment opportunities. The interviews also exhibited a limited awareness of HPV in this region, which may have contributed to a lack of enacted stigma towards people living with HPV or cervical cancer. Conclusion Stigma has the potential to lead to decreased screening and treatment uptake through its drivers. This includes a decreased perception of personal risk due to a lack of knowledge, which results in increased HPV-risk behaviors. Future research must focus on creating and integrating stigma-reducing interventions, primarily to encourage women to seek out primary and secondary preventative measures.

Abstract Introduction HIV pre‐exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID‐19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID‐19 pandemic. Methods Since 2017, the Partners Scale‐Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May–Aug 2020) and again after some decline in COVID‐19 rates (Nov–Jan 2021). We analysed data using inductive memo‐writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME). Results We interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n = 20) and Western (n = 20) Kenya. About half (n = 19) were female, with a median age of 32 (IQR: 29–34) and 2.3 years of experience delivering PrEP (IQR: 2–3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple‐month PrEP refills, intensifying phone‐based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical‐room PrEP dispensing, pre‐packing PrEP and task‐shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides. Conclusions COVID‐19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post‐pandemic.

Daily oral pre-exposure prophylaxis (PrEP) is being incorporated into services frequented by adolescent girls and young women (AGYW) in sub-Saharan Africa who are at a significant risk of HIV. In non-PrEP studies, positive provider–client rapport has been shown to improve patient decision-making and use of medication in clinical care. We examined AGYW and healthcare provider (HCP) perspectives on the value of and strategies for building positive provider–client rapport. We conducted in-depth interviews from January 2018 to December 2019 with 38 AGYW and 15 HCPs from two family planning clinics in Kisumu, Kenya where PrEP was being delivered to AGYW as part of the Prevention Options for Women Evaluation Research (POWER) study. We used semi-structured interview guides and audio-recorded interviews with participant consent. Verbatim transcripts were analysed using thematic content analysis. HCPs and AGYW emphasised the importance of positive provider–client rapport to meet AGYW support needs in PrEP service delivery. HCPs described how they employed rapport-building strategies that strengthened AGYW PrEP uptake and continuation, including: (1) using friendly and non-judgmental tones; (2) maintaining client confidentiality (to build client trust); (3) adopting a conversational approach (to enable accurate risk assessment); (4) actively listening and tailoring counselling (to promote client knowledge, skills, and self-efficacy); and (5) supporting client agency. Positive provider–client relationships and negative experiences identified in this analysis have the potential to facilitate/deter AGYW from using PrEP while at risk. The strategies to enhance provider–client rapport identified in this study could be integrated into PrEP provider training and delivery practices.

Introduction: Human mobility is a critical aspect of existence and survival, but may compromise care engagement among people living with HIV (PLHIV). We examined the association between various forms of human mobility with retention in HIV care and antiretroviral treatment (ART) interruptions. Methods: In a cohort of adult PLHIV in Kenya and Uganda, we collected surveys in 2016 about past 6-month travel and lifetime migration histories, including reasons and locations, and engagement in HIV care defined as (1) discontinuation of care, and (2) history of a treatment interruption among those who remained in care. We estimated associations between mobility and these care engagement outcomes via logistic regression, adjusted for sex, prior mobility, age, region, marital status, household wealth, and education. Results: Among 1081 participants, 56 (5%) reported having discontinued care; among those in care, 104 (10%) reported treatment interruption. Past-year migration was associated with a higher risk of discontinuation of care (adjusted odds ratio [aOR] 1.98, 95% CI 1.08–3.63). In sex-stratified models, the association was somewhat attenuated in women, but remained robust among men. Past-year migration was associated with reduced odds of having a treatment interruption among men (aOR 0.51, 95% CI 0.34–0.77) but not among women (aOR 2.67, 95% CI 0.78, 9.16). Travel in the past 6 months was not associated with discontinuation of care or treatment interruptions. Conclusions: We observed both negative and protective effects of recent migration on care engagement and ART use that were most pronounced among men in this cohort. Migration can break ties to ongoing care, but for men, who have more agency in the decision to migrate, may foster new care and treatment strategies. Strategies that enable health facilities to support individuals throughout the process of transferring care could alleviate the risk of care disengagement.

Abstract Background Food insecurity is an important underlying driver of HIV risk and vulnerability among adolescents in sub-Saharan Africa. In this region, adolescents account for 80% of all new HIV infections. The primary purpose of this analysis is to understand perceived mechanisms for how a multisectoral agricultural intervention influenced sexual risk taking among HIV-affected adolescents in southwestern Kenya. Methods We conducted semi-structured, individual interviews with 34 adolescent-caregiver dyads who were participants in Adolescent Shamba Maisha (NCT03741634), a sub-study of adolescent girls and caregivers with a household member participating in the Shamba Maisha trial (NCT01548599), a multi-sectoral agricultural and microfinance intervention. Interviews were audiotaped, transcribed, translated, and analyzed using framework and interpretive description analysis methods. Results Adolescents receiving the Shamba Maisha intervention described no longer needing to engage in transactional sex or have multiple concurrent sexual partners as a way to meet their basic needs, including food. Key mechanisms for these effects include greater sexual agency among adolescent girls, and increased confidence and self-efficacy in overcoming existing reciprocity norms and sexual relationship power inequity; as well as staying in school. The intervention also increased caregiver confidence in talking about adolescent sexual reproductive health issues. In contrast, driven primarily by the need for food and basic needs, girls in the control arms described engaging in transactional sex, having multiple sexual partners, being unable to focus in school, getting pregnant or becoming HIV infected. Conclusion These findings emphasize the need to address food insecurity as a part of structural interventions targeting adolescent HIV risk in low-resource countries. We recommend that future interventions build upon the Shamba Maisha model by combining sustainable agricultural production, with household level interventions that deliberately target gender norms that contribute to unequal power dynamics.

Abstract Background HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule. Methods We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15–20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models. Discussion This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery. Trial registration ClinicalTrials.gov NCT03675256 . Registered on September 18, 2018

Abstract Background Preventing unintended pregnancies is paramount for women living with HIV (WLHIV). Previous studies have suggested that efavirenz-containing antiretroviral therapy (ART) reduces contraceptive effectiveness of implants, but there are uncertainties regarding the quality of the electronic medical record (EMR) data used in these prior studies. Methods We conducted a retrospective, cohort study of EMR data from 2011 to 2015 among WLHIV of reproductive age accessing HIV care in public facilities in western Kenya. We validated a large subsample of records with manual chart review and telephone interviews. We estimated adjusted incidence rate ratios (aIRRs) with Poisson regression accounting for the validation sampling using inverse probability weighting and generalized raking. Results A total of 85,324 women contributed a total of 170,845 women-years (w-y) of observation time; a subset of 5080 women had their charts reviewed, and 1285 underwent interviews. Among implant users, the aIRR of pregnancy for efavirenz- vs. nevirapine-containing ART was 1.9 (95% CI 1.6, 2.4) using EMR data only and 3.2 (95% CI 1.8, 5.7) when additionally using both chart review and interview validated data. Among efavirenz users, the aIRR of pregnancy for depomedroxyprogesterone acetate (DMPA) vs. implant use was 1.8 (95% CI 1.5, 2.1) in EMR only and 2.4 (95% CI 1.0, 6.1) using validated data. Conclusion Pregnancy rates are higher when contraceptive implants are concomitantly used with efavirenz-containing ART, though rates were similar to leading alternative contraceptive methods such as DMPA. Our data provides policymakers, program staff, and WLHIV greater confidence in guiding their decision-making around contraceptive and ART options. Our novel, 3-phase validation sampling provides an innovative tool for using routine EMR data to improve the robustness of data quality.

Abstract Background In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya. Methods We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya’s public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics. Results In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counselling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups). Conclusions Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities. Trial registration ClinicalTrials.gov registration NCT03052010 . Retrospectively registered on February 14, 2017.

Background: Pregnant and postpartum women in high HIV prevalent regions are at increased HIV risk. Oral pre-exposure prophylaxis (PrEP) can decrease HIV incidence reducing infant HIV infections. Understanding healthcare worker (HCW) beliefs about PrEP prior to national roll-out is critical to supporting PrEP scale-up. Methods: We conducted 45 semi-structured interviews among a range of HCW cadres with and without PrEP provision experience purposively recruited from four clinics in Kenya to compare their views on prescribing PrEP during pregnancy and postpartum. Interviews were analysed using a conventional content analysis approach to identify key influences on PrEP acceptability and feasibility. Results: All HCWs perceived PrEP as an acceptable and feasible HIV prevention strategy for pregnant and postpartum women. They believed PrEP meets women’s needs as an on-demand, female-controlled prevention strategy that empowers women to take control of their HIV risk. HCWs highlighted their role in PrEP delivery success while acknowledging how their knowledge gaps, concerns and perceived PrEP implementation challenges may hinder optimal PrEP delivery. Conclusion: HCWs supported PrEP provision to pregnant and postpartum women. However, counseling tools to address risk perceptions in this population and strategies to reduce HCW knowledge gaps, concerns and perceived implementation barriers are required.

Abstract Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739 . Registered on May 9, 2018

IntroductionUnderstanding interests in and preferences for multipurpose technology (MPT) for the co-administration of contraception and antiretroviral therapy (ART) and alternative, non-oral ART methods among women living with HIV (WLHIV) is vital to successful implementation of future treatment options, such as long-acting injectable ART.MethodsBetween May 2016 and March 2017 we conducted a cross-sectional telephone survey of 1,132 WLHIV of reproductive potential with prior experience using intermediate- or long-acting contraceptive methods in western Kenya. We present descriptive statistics and multinomial logistic regression to evaluate predictors of interest in specific MPT and non-oral ART methods.ResultsTwo-thirds (67%) reported interest in MPT, with the most common reason for interest being ease of using a single medication for both purposes of HIV treatment and pregnancy prevention (26%). Main reasons for lack of interest in MPT were need to stop/not use contraception while continuing ART (21%) and risk of side effects (16%). Important characteristics of MPT were effectiveness for pregnancy prevention (26%) and HIV treatment (24%) and less than daily dosing (19%). Important characteristics of non-oral ART methods were less than daily dosing (47%), saving time accessing ART (16%), and effectiveness of HIV treatment (15%). The leading preferred methods for both MPT and non-oral ART were injectables (50 and 54%) and implants (32 and 31%). Prior use of a contraceptive implant or injectable predicted interest in similar methods for both MPT and non-oral ART methods, while this relationship did not appear to vary between younger vs. older WLHIV.DiscussionMost WLHIV in western Kenya are interested in MPT for HIV treatment and contraception. Prior exposure to contraceptive implants or injectables appears to predict interest in similar methods of MPT and non-oral ART. Developers of MPT and non-oral ART methods should strongly consider WLHIV's preferences, including their changing reproductive desires.

Novel “differentiated service delivery” models for HIV treatment that reduce clinic visit frequency, minimize waiting time, and deliver treatment in the community promise retention improvement for HIV treatment in Sub-Saharan Africa. Quantitative assessments of differentiated service delivery (DSD) feature most preferred by patient populations do not widely exist but could inform selection and prioritization of different DSD models. We used a discrete choice experiment (DCE) to elicit patient preferences of HIV treatment services and how they differ across DSD models. We surveyed 18+year-olds, enrolled in HIV care for ≥6 months between February-March, 2019 at four facilities in Kisumu County, Kenya. DCE offered patients a series of comparisons between three treatment models, each varying across seven attributes: ART refill location, quantity of dispensed ART at each refill, medication pick-up hours, type of adherence support, clinical visit frequency, staff attitude, and professional cadre of person providing ART refills. We used hierarchical Bayesian model to estimate attribute importance and relative desirability of care characteristics, latent class analysis (LCA) for groups of preferences and mixed logit model for willingness to trade analysis. Of 242 patients, 128 (53.8%) were females and 150 (62.8%) lived in rural areas. Patients placed greatest importance on ART refill location [19.5% (95% CI 18.4, 10.6) and adherence support [19.5% (95% CI 18.17, 20.3)], followed by staff attitude [16.1% (95% CI 15.1, 17.2)]. In the mixed logit, patients preferred nice attitude of staff (coefficient = 1.60), refill ART health center (Coeff = 1.58) and individual adherence support (Coeff = 1.54), 3 or 6 months for ART refill (Coeff = 0.95 and 0.80, respectively) and pharmacists (instead of lay health workers) providing ART refill (Coeff = 0.64). No differences were observed by gender or urbanicity. LCA revealed two distinct groups (59.5% vs. 40.5%). Participants preferred 3 to 6-month refill interval or clinic visit spacing, which DSD offers stable patients. While DSD has encouraged community ART group options, our results suggest strong preferences for ART refills from health-centers or pharmacists over lay-caregivers or community members. These preferences held across gender&urban/rural subpopulations.

The Sustainable East Africa Research in Community Health (SEARCH), a universal test and treat (UTT) trial, implemented ‘Streamlined Care’—a multicomponent strategy including rapid linkage to care and antiretroviral therapy (ART) start, 3-monthly refills, viral load counseling, and accessible, patient-centered care provision. To understand patient and provider experiences of Streamlined Care to inform future care innovations, we conducted in-depth interviews with patients ( n = 18) and providers ( n = 28) at baseline (2014) and follow-up (2015) ( n = 17 patients; n = 21 providers). Audio recordings were transcribed, translated, and deductively and inductively coded. Streamlined Care helped to decongest clinic spaces and de-stigmatize human immunodeficiency virus (HIV) care. Patients credited the individualized counselling, provider-assisted HIV status disclosure, and providers’ knowledge of patient's drug schedules, availability, and phone call reminders for their care engagement. However, for some, denial (repeated testing to disprove HIV+ results), feeling healthy, limited understanding of the benefits of early ART, and anticipated side-effects, and mistrust of researchers hindered rapid ART initiation. Patients’ short and long-term mobility proved challenging for both patients and providers. Providers viewed viral load counselling as a powerful tool to convince otherwise healthy and high-CD4 patients to initiate ART. Patient-centered HIV care models should build on the successes of Streamlined Care, while addressing persistent barriers. #NCT01864683— https://clinicaltrials.gov/ct2/show/NCT01864603

Abstract Introduction In Africa, oral pre‐exposure prophylaxis (PrEP) is largely provided via over‐burdened public HIV care clinics. Successfully incorporating PrEP services into these clinics may require adaptations to practices outlined in national implementation guidelines and modifications to routine existing service delivery. We aimed to describe adaptations made by public HIV clinics in Kenya to integrate PrEP delivery into existing services. Methods The Partners Scale‐Up Project aimed to catalyse integration of PrEP in 25 public HIV care clinics. Between May and December 2018, we conducted qualitative interviews with health providers and documented clinic observations in technical assistance (TA) reports to understand the process of PrEP service integration. We analysed 36 health provider interview transcripts and 25 TA reports to identify clinic‐level adaptations to activities outlined in Kenyan Ministry of Health PrEP guidelines and modifications made to existing service delivery practices to successfully incorporate PrEP services. Identified adaptations were reported using the expanded framework for reporting adaptations and modifications (FRAME). Results All clinics (n = 25) performed HIV testing, HIV risk assessment, PrEP education and adherence counselling as stipulated in the guidelines. Most clinics initiated clients on PrEP without creatinine testing if otherwise healthy. While monthly refill appointments are recommended, a majority of clinics issued PrEP users two to three months of pills at a time. Clinics also implemented practices that had not been specified in the guidelines including incorporating PrEP‐related topics into routine health talks, calling clients with missed PrEP appointments, discussing PrEP service delivery in regular staff meetings, ‘fast‐tracking’ PrEP clients and dispensing PrEP in clinic rooms rather than at clinic‐based pharmacies. PrEP initiation numbers were highest among clinics that did not require creatinine testing, conducted peer on‐the‐job PrEP training and those that discussed PrEP delivery in their routine meetings. Above‐average continuation was observed among clinics that discussed PrEP in their routine meetings, dispensed PrEP in clinic rooms and offered PrEP at nonregular hours. Conclusions Health providers in public HIV care clinics instituted practices and made innovative adaptations to PrEP delivery to reduce barriers for clients and staff. Encouraging clinic level adaptations to national implementation guidelines will facilitate scale‐up of PrEP delivery.

Abstract Background Option B+ is a comprehensive antiretroviral treatment (ART) designed for HIV-infected pregnant/ postpartum women. However, barriers to implementing Option B+ and establishing long-term ART adherence while facilitating retention in prevention of mother to child transmission of HIV (PMTCT) services remain. Community-based mentor mothers (cMMs) who can provide home-based support for PMTCT services may address some of the barriers to successful adoption and retention in Option B+. Thus, we evaluated the acceptability of using cMMs as home-based support for PMTCT services. Methods Gender-matched in-depth interviews were conducted between September–November 2014 for HIV-infected pregnant/postpartum women and their male partners living in southwestern Kenya (n = 40); additionally, we conducted four focus groups involving 30 health workers (n = 70) within four health facilities. Audio-recordings were transcribed, translated, and then coded using a thematic analytical approach in which data were deductively and inductively coded with support from prior literature, identified themes within the interview guides, and emerging themes from the transcripts utilizing Dedoose software. Results Overall, the study results suggest high acceptability of cMMs among individual participants and health workers. Stigma reduction, improvement of utilization of health care services, as well as ART adherence were most frequently discussed potential benefits of cMMs. Participants pictured a cMM as someone acting as a role model and confidant, and who was over 30 years old. Many respondents raised concerns about breaches of confidentiality and inadvertent disclosure. Respondent suggestions to overcome these issues included the cMM working in different communities than where she lives and attending home-visits with no identifying clothing as an HIV-related health worker. Conclusions The home-based cMM approach may be a beneficial and acceptable strategy for promoting ART adherence and retention within PMTCT services for pregnant/postpartum women living with HIV. Considering the risks of inadvertent disclosure of HIV-infected status and related negative consequences for pregnant/postpartum women living with HIV, similar cMM program designs may benefit from recognizing and addressing these risks. Trial registration The MOTIVATE! study was registered on July 7, 2015 at the ClinicalTrials.gov (NCT02491177).

Abstract Background Despite cervical cancer being preventable with effective screening programs, it is the most common cancer and the leading cause of cancer-related death among women in many countries in Africa. Screening involving pelvic examination may not be feasible or acceptable in limited-resource settings. We sought to evaluate women’s perspectives on human papillomavirus (HPV) self-sampling as part of a larger trial on cervical cancer prevention implementation strategies in rural western Kenya. Methods We invited 120 women participating in a cluster randomized trial of cervical cancer screening implementation strategies in Migori County, Kenya for in-depth interviews. We explored reasons for testing, experience with and ability to complete HPV self-sampling, importance of clinician involvement during screening, factors and people contributing to screening decision-making, and ways to encourage other women to come for screening. We used validated theoretical frameworks to analyze the qualitative data. Results Women reported having positive experiences with the HPV self-sampling strategy. The factors facilitating uptake included knowledge and beliefs such as prior awareness of HPV, personal perception of cervical cancer risk, desire for improved health outcomes, and peer and partner encouragement. Logistical and screening facilitators included confidence in the ability to complete HPV self-sampling strategy, proximity to screening sites and feelings of privacy and comfort conducting the HPV self- sampling. The barriers to screening included fear of need for a pelvic exam, fear of disease and death associated with cervical cancer. We classified these findings as capabilities, opportunities and motivations for health behavior using the COM-B framework. Conclusions Overall, HPV self-sampling was an acceptable cervical cancer screening strategy that seemed to meet the needs of the women in this community. These findings will further inform aspects of implementation, including outreach messaging, health education, screening sites and emphasis on availability and effectiveness of preventative treatment for women who screen positive.

Purpose: Human papillomavirus (HPV) testing is being more widely used in simplified cervical cancer screening protocols in low-resource settings. One challenge to successful implementation is the multiple visits necessary to provide results and follow-up. mHealth strategies may reduce visit burden by providing information through text message. Methods: As part of a cluster-randomized trial to compare HPV testing in clinics and community health campaigns in western Kenya, we carried out a mixed-methods study to assess women’s preferences and experiences with different strategies to receive their results. Women could opt to receive their HPV results via text message, cell phone call, home visit, or return clinic visit. We examined overall receipt of results, follow-up rates, and acceptability by notification method. Results: Among the 4,947 women who underwent HPV-based cervical cancer screening, 1,596 (32%) received results via text message, 1,181 (24%) via cell phone call, 1,563 (32%) via clinic visit, and 605 (12%) via home visit. Women opting for texts or calls were younger and had higher rates of prior cervical cancer screening, HIV testing, and modern contraceptive use (P < .001 for all). Home visits were associated with a significantly higher rate of treatment acquisition (45%) than texts (38%), cell phone calls (38%), and clinic visits (23%; P < .001). In a model controlling for age, prior screening, HIV testing, and contraceptive use, clinic visits remained significantly associated with decreased odds of treatment (adjusted odds ratio, 0.45; 95% CI, 0.29 to 0.69) compared with texts. Among treated women, there was no difference in time to treatment by notification method. Conclusion: Cell phone–based results notification strategies were preferred by women with greater health-seeking behavior; however, HPV-positive women who received results via home visit were more likely to pursue for treatment.

Background: In Kenya and elsewhere in sub-Saharan Africa, young women are disproportionately affected by the HIV epidemic compared to young men. The extent to which young women's self-perceptions about risk of HIV acquisition influence their sexual behaviors and use of HIV prevention methods remains unclear. We therefore conducted a qualitative study to explore these issues among young women enrolled in a pre-exposure prophylaxis (PrEP) trial.Methods: From January 2017 to January 2020, we conducted serial semi-structured in-depth interviews 50 purposively selected young women (18–24 years old) who were participating in the MPYA (Monitoring PrEP for Young Adult women) study—a randomized controlled trial in Thika and Kisumu, Kenya, assessing the impact of SMS reminders on PrEP adherence. Interviews were conducted at three time points (~1 week, 3, and 12 months after initiating PrEP). We used an inductive, content analytic approach to identify key themes related to risk perceptions, sexual behavior, and use of HIV prevention tools.Results: Around the time of enrollment, most of the 50 women interviewed reported being at high risk of HIV because of their own sexual behaviors, such as inconsistent condom use, multiple sexual partners, and transactional sex. Additionally, high risk perception was based on the behavior of their partners, such as refusing to use condoms and being unsure of their partner's HIV status. Young women's perceived risk of HIV acquisition was a key motivator for PrEP initiation and continuation. During PrEP use, participants reported feeling protected and at less risk compared to peers who were not taking PrEP. Some reported no longer using condoms because they were confident that PrEP provided enough protection. Over time, many young women reported reducing risky sexual behaviors because of the regular counseling and HIV testing they received as part of their PrEP services. This lowered risk perception was in most cases accompanied by discontinuation of PrEP.Conclusions: HIV risk perception among young women in Kenya was dynamic and influenced their use of PrEP and condoms over time, suggesting an often-deliberate approach to HIV prevention and sexual health.

Background: Successful integration of pre-exposure prophylaxis (PrEP) with existing reproductive health services will require iterative learning and adaptation. The interaction between the problem-solving required to implement new interventions and health worker motivation has been well-described in the public health literature. This study describes structural and motivational challenges faced by health care providers delivering PrEP to adolescent girls and young women (AGYW) alongside other SRH services, and the strategies used to overcome them.Methods: We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) with HCWs from two demonstration projects delivering PrEP to AGYW alongside other SRH services. The Prevention Options for the Women Evaluation Research (POWER) is an open label PrEP study with a focus on learning about PrEP delivery in Kenyan and South African family planning, youth mobile services, and public clinics at six facilities. PrIYA focused on PrEP delivery to AGYW via maternal and child health (MCH) and family planning (FP) clinics in Kenya across 37 facilities. IDIs and FGDs were transcribed verbatim and analyzed using a combination of inductive and deductive methods.Results: We conducted IDIs with 36 participants and 8 FGDs with 50 participants. HCW described a dynamic process of operationalizing PrEP delivery to better respond to patient needs, including modifying patient flow, pill packaging, and counseling. HCWs believed the biggest challenge to sustained integration and scaling of PrEP for AGYW would be lack of health care worker motivation, primarily due to a misalignment of personal and professional values and expectations. HCWs frequently described concerns of PrEP provision being seen as condoning or promoting unprotected sex among young unmarried, sexually active women. Persuasive techniques used to overcome these reservations included emphasizing the social realities of HIV risk, health care worker professional identities, and vocational commitments to keeping young women healthy.Conclusion: Sustained scale-up of PrEP will require HCWs to value and prioritize its incorporation into daily practice. As with the provision of other SRH services, HCWs may have moral reservations about providing PrEP to AGYW. Strategies that strengthen alignment of HCW personal values with professional goals will be important for strengthening motivation to overcome delivery challenges.

Background: Reducing tuberculosis (TB) deaths among children requires a better understanding of the gaps in the care cascade from TB diagnosis to treatment completion. We sought to assess the child TB care cascade in 32 rural communities in Uganda and Kenya using programmatic data. Methods: This is a retrospective cohort study of 160,851 children (agesâ¯

Background Approximately one in every five adolescent girls in Kenya has either had a live birth or is pregnant with her first child. There is an urgent need to understand the language and symbols used to represent adolescent pregnancy, if the current trend in adolescent pregnancy is to be reversed. Agreement on the definition of a societal problem is an important precursor to a social issue’s political prioritization and priority setting. Methods We apply the Public Arenas Model to appraise the environments, definitions, competition dynamics, principles of selection and current actors involved in problem-solving and prioritizing adolescent pregnancy as a policy issue. Using a focused ethnographic approach, we undertook semi-structured interviews with 14 members of adolescent sexual reproductive health networks at the national level and conducted thematic analysis of the interviews. Findings We found that existing definitions center around adolescent pregnancy as a “disease” that needs prevention and treatment, socially deviant behaviour that requires individual agency, and a national social concern that drains public resources and therefore needs to be regulated. These competing definitions contribute to the rarity of the topic achieving traction within the political agenda and contribute to conflicting solutions, such as lowering the legal age of consenting to sex, while limiting access to contraceptive information and services to minors. Conclusion This paper provides a timely theoretical approach to draw attention to the different competing definitions and subsequent divergent interpretations of the problem of adolescent pregnancy in Kenya. Adolescent reproductive health stakeholders need to be familiar with the existing definitions and deliberately reframe this important social problem for better political prioritization and resource allocation. We recommend a definition of adolescent pregnancy that cuts across different arenas, and leverages already existing dominant and concurrent social and economic issues that are already on the agenda table.

Background: Controlled pharmacokinetic (PK) studies in United States populations have defined categories of tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) for various pre-exposure prophylaxis (PrEP) adherence targets. It is unknown how these categories perform in other populations. Therefore, we evaluated the sensitivity and specificity of these PK-derived categories compared to daily medication electronic adherence monitoring (MEMS) data among East African men and women using daily PrEP.Methods: Participants were enrolled as members of HIV serodiscordant couples as part of an open-label PrEP study in Kenya and Uganda. Blood samples were taken at quarterly visits and stored as DBS, which were analyzed for TFV-DP concentrations.Results: Among 150 samples from 103 participants, MEMs data indicated that 87 (58%) took ≥4 doses and 62 (41%) took ≥6 per week consistently over the 4 weeks prior to sample collection. Sensitivities of DBS TFV-DP levels were 62% for the ≥4 doses/week category (≥700 fmol/punch TFV-DP) and 44% for the ≥6 doses/week category (≥1050 fmol/punch TFV-DP); specificities were 86 and 94%, respectively. There were no statistically significant differences in these sensitivities and specificities by gender.Conclusion: In this sample of East African PrEP users, categories of TFV-DP concentrations developed from directly observed PrEP use among United States populations had high specificity but lower than expected sensitivity. Sensitivity was lowest when MEMS data indicated high adherence (i.e., ≥6 doses/week). PrEP studies and implementation programs should carefully consider the sensitivity and specificity of the TFV-DP levels used for adherence feedback.

BackgroundDespite the high burden of adverse adolescent sexual and reproductive health (SRH) outcomes, it has remained a low political priority in Kenya. We examined factors that have shaped the lack of current political prioritization of adolescent SRH service provision.MethodsWe used the Shiffman and Smith policy framework consisting of four categories-actor power, ideas, political contexts, and issue characteristics-to analyse factors that have shaped political prioritization of adolescent SRH. We undertook semi-structured interviews with 14 members of adolescent SRH networks between February and April 2019 at the national level and conducted thematic analysis of the interviews.FindingsSeveral factors hinder the attainment of political priority for adolescent SRH in Kenya. On actor power, the adolescent SRH community was diverse and united in adoption of international norms and policies, but lacked policy entrepreneurs to provide strong leadership, and policy windows were often missed. Regarding ideas, community members lacked consensus on a cohesive public positioning of the problem. On issue characteristics, the perception of adolescents as lacking political power made politicians reluctant to act on the existing data on the severity of adolescent SRH. There was also a lack of consensus on the nature of interventions to be implemented. Pertaining to political contexts, sectoral funding by donors and government treasury brought about tension within the different government ministries resulting in siloed approaches, lack of coordination and overall inefficiency. However, the SRH community has several strengths that augur well for future political support. These include the diverse multi-sectoral background of its members, commitment to improving adolescent SRH, and the potential to link with other health priorities such as maternal health and HIV/AIDS.ConclusionIn order to increase political attention to adolescent SRH in Kenya, there is an urgent need for policy actors to: 1) create a more cohesive community of advocates across sectors, 2) develop a clearer public positioning of adolescent SRH, 3) agree on a set of precise approaches that will resonate with the political system, and 4) identify and nurture policy entrepreneurs to facilitate the coupling of adolescent SRH with potential solutions when windows of opportunity arise.

[This corrects the article DOI: 10.1371/journal.pone.0200242.].

BACKGROUND:Access to routine virologic monitoring, critical to ensuring treatment success, remains limited in low- and middle-income countries. We report on implementation of routine viral load (VL) monitoring and risk factors for virologic failure among HIV-infected children on antiretroviral treatment (ART) in Western Kenya. METHODS:Routine VL testing was introduced in western Kenya in November 2013. We performed a case-control study among 1190 HIV-infected children ≤15 years on ART who underwent routine VL testing June 2014-May 2015. A random sample of 98 cases (virologic failure define as VL >1000 cps/mL) and 201 controls (VL

Background. Kenyan antiretroviral (ART) guidelines encourage treatment buddies (TBy) to maximize treatment adherence. This study examined the effect of TBys on clinic attendance in men and women on ART. Methods. This retrospective cohort study included all adult patients initiating ART from August 2007 to December 2011 at four health facilities in Kenya. Data were abstracted from electronic medical records and analyzed using Poisson regression. Results. Of 2,430 patients, 2,199 (91%) had a TBy. Relationship between TBy and clinic attendance differed in females and males (interaction p=0.09). After demographic and clinic factor adjustment, females with a TBy were 28% more likely to adhere to all appointments than those without (adjusted aRR = 1.28; 95% CI 1.08–1.53), whereas males were no more likely to adhere (aRR = 1.01; 95% CI 0.76–1.32). Males reported partner/spouse (33%) or brother (11%) as the TBy while females reported sister (17%), partner/spouse (14%), or another family member (12%). Multivariable analysis found no association between clinic attendance and TBy relationship in either gender. Conclusion. Clinic attendance was higher among women with TBys but not men. Results support TBys to help women achieve ART success; alternate strategies to bolster TBy benefits are needed for men.

Visual inspection with Acetic Acid (VIA) and Visual Inspection with Lugol’s Iodine (VILI) are increasingly recommended in various cervical cancer screening protocols in low-resource settings. Although VIA is more widely used, VILI has been advocated as an easier and more specific screening test. VILI has not been well-validated as a stand-alone screening test, compared to VIA or validated for use in HIV-infected women. We carried out a randomized clinical trial to compare the diagnostic accuracy of VIA and VILI among HIV-infected women. Women attending the Family AIDS Care and Education Services (FACES) clinic in western Kenya were enrolled and randomized to undergo either VIA or VILI with colposcopy. Lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Between October 2011 and June 2012, 654 were randomized to undergo VIA or VILI. The test positivity rates were 26.2% for VIA and 30.6% for VILI (p = 0.22). The rate of detection of CIN2+ was 7.7% in the VIA arm and 11.5% in the VILI arm (p = 0.10). There was no significant difference in the diagnostic performance of VIA and VILI for the detection of CIN2+. Sensitivity and specificity were 84.0% and 78.6%, respectively, for VIA and 84.2% and 76.4% for VILI. The positive and negative predictive values were 24.7% and 98.3% for VIA, and 31.7% and 97.4% for VILI. Among women with CD4+ count < 350, VILI had a significantly decreased specificity (66.2%) compared to VIA in the same group (83.9%, p = 0.02) and compared to VILI performed among women with CD4+ count ≥ 350 (79.7%, p = 0.02). VIA and VILI had similar diagnostic accuracy and rates of CIN2+ detection among HIV-infected women.

Objective. Pregnant women are especially vulnerable to adverse outcomes related to HIV infection and gender-based violence (GBV). We aimed at developing a program for prevention and mitigation of the effects of GBV among pregnant women at an antenatal clinic in rural Kenya. Methods. Based on formative research with pregnant women, male partners, and service providers, we developed a GBV program including comprehensive clinic training, risk assessments in the clinic, referrals supported by community volunteers, and community mobilization. To evaluate the program, we analyzed data from risk assessment forms and conducted focus groups (n=2 groups) and in-depth interviews (n=25) with healthcare workers and community members. Results. A total of 134 pregnant women were assessed during a 5-month period: 49 (37%) reported violence and of those 53% accepted referrals to local support resources. Qualitative findings suggested that the program was acceptable and feasible, as it aided pregnant women in accessing GBV services and raised awareness of GBV. Community collaboration was crucial in this low-resource setting. Conclusion. Integrating GBV programs into rural antenatal clinics has potential to contribute to both primary and secondary GBV prevention. Following further evaluation, this model may be deemed applicable for rural communities in Kenya and elsewhere in East Africa.

Most HIV-1 transmission in Africa occurs among HIV-1-discordant couples (one partner HIV-1 infected and one uninfected) who are unaware of their discordant HIV-1 serostatus. Given the high HIV-1 incidence among HIV-1 discordant couples and to assess efficacy of interventions for reducing HIV-1 transmission, HIV-1 discordant couples represent a critical target population for HIV-1 prevention interventions and prevention trials. Substantial regional differences exist in HIV-1 prevalence in Africa, but regional differences in HIV-1 discordance among African couples, has not previously been reported.The Partners in Prevention HSV-2/HIV-1 Transmission Trial ("Partners HSV-2 Study"), the first large HIV-1 prevention trial in Africa involving HIV-1 discordant couples, completed enrollment in May 2007. Partners HSV-2 Study recruitment data from 12 sites from East and Southern Africa were used to assess HIV-1 discordance among couples accessing couples HIV-1 counseling and testing, and to correlate with enrollment of HIV-1 discordant couples. HIV-1 discordance at Partners HSV-2 Study sites ranged from 8-31% of couples tested from the community. Across all study sites and, among all couples with one HIV-1 infected partner, almost half (49%) of couples were HIV-1 discordant. Site-specific monthly enrollment of HIV-1 discordant couples into the clinical trial was not directly associated with prevalence of HIV-1 discordance, but was modestly correlated with national HIV-1 counseling and testing rates and access to palliative care/basic health care (r = 0.74, p = 0.09).HIV-1 discordant couples are a critical target for HIV-1 prevention in Africa. In addition to community prevalence of HIV-1 discordance, national infrastructure for HIV-1 testing and healthcare delivery and effective community outreach strategies impact recruitment of HIV-1 discordant couples into HIV-1 prevention trials.