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

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

Finding women in fishing communities around Lake Victoria: "Feasibility and acceptability of using phones and tracking devices".

INTRODUCTION: Women in fishing communities have both high HIV prevalence and incidence, hence they are a priority population for HIV prevention and treatment interventions. However, their mobility is likely to compromise the effectiveness of interventions. We assessed the acceptability, feasibility and of using phones and global positioning system (GPS) devices for tracking mobility, to inform future health research innovations. METHODS: A mult-site formative qualitative study was conducted in six purposively selected Fishing Communities on the shores of Lake Victoria in Kenya, Tanzania, and Uganda. Participants were selected based on duration of stay in the community and frequency of movement. Sixty-four (64) women participated in the study (16 per fishing community). Twenty-four (24) participants were given a study phone; 24 were asked to use their own phones and 16 were provided with a portable GPS device to understand what is most preferred. Women were interviewed about their experiences and recommendations on carrying GPS devices or phones. Twenty four (24) Focus Group Discussions with 8-12 participants were conducted with community members to generate data on community perceptions regarding GPS devices and phones acceptability among women. Data were analyzed thematically and compared across sites/countries. RESULTS: Women reported being willing to use tracking devices (both phones and GPS) because they are easy to carry. Their own phone was preferred compared to a study phone and GPS device because they were not required to carry an additional device, worry about losing it or be questioned about the extra device by their sexual partner. Women who carried GPS devices suggested more sensitization in communities to avoid domestic conflicts and public concern. Women suggested changing the GPS colour from white to a darker colour and, design to look like a commonly used object such as a telephone Subscriber Identity Module (SIM) card, a rosary/necklace or a ring for easy and safe storage. CONCLUSION: Women in the study communities were willing to have their movements tracked, embraced the use of phones and GPS devices for mobility tracking. Devices need to be redesigned to be more discrete, but they could be valuable tools to understanding movement patterns and inform design of interventions for these mobile populations.

Many Cooks in the Kitchen: Iterating a Qualitative Analysis Process Across Multiple Countries, Sites, and Teams.

Establishing and proving methodological rigor has long been a challenge for qualitative researchers where quantitative methods prevail, but much published literature on qualitative analysis assumes a relatively small number of researchers working in relative proximity. This is particularly true for research conducted with a grounded theory approach. Different versions of grounded theory are commonly used, but this methodology was originally developed for a single researcher collecting and analyzing data in isolation. Although grounded theory has evolved since its development, little has been done to reconcile this approach with the changing nature and composition of international research teams. Advances in technology and an increased emphasis on transnational collaboration have facilitated a shift wherein qualitative datasets have been getting larger and the teams collecting and analyzing them more diverse and diffuse. New processes and systems are therefore required to respond to these conditions. Data for this article are drawn from the experiences of the Innovations for Choice and Autonomy (ICAN) Research Consortium. ICAN aims to understand how self-injectable contraceptives can be implemented in ways that best meet women's needs in Kenya, Uganda, Malawi, and Nigeria. We found that taking a structured approach to analysis was important for maintaining consistency and making the process more manageable across countries. However, it was equally important to allow for flexibility within this structured approach so that teams could adapt more easily to local conditions, making data collection and accompanying analysis more feasible. Meaningfully including all interested researchers in the analysis process and providing support for learning also increased rigor. However, competing priorities in a complex study made it difficult to adhere to planned timelines. We conclude with recommendations for both funders and study teams to design and conduct global health studies that ensure more equitable contributions to analysis while remaining logistically feasible and methodologically sound.

A youth-centred approach to improving engagement in HIV services: human-centred design methods and outcomes in a research trial in Kisumu County, Kenya.

IntroductionInnovative interventions are needed to improve HIV outcomes among adolescents and young adults (AYAs) living with HIV. Engaging AYAs in intervention development could increase effectiveness and youth acceptance, yet research is limited. We applied human-centred design (HCD) to refine adherence-support interventions pretrial and assessed HCD workshop acceptability. METHODS: We applied an iterative, four-phased HCD process in Kenya that included: (1) systematic review of extant knowledge, (2) prioritisation of design challenges, (3) a co-creation workshop and (4) translation tables to pair insights with trial intervention adaptations. The co-creation workshop was co-led by youth facilitators employing participatory activities to inform intervention adaptations. Iterative data analysis included rapid thematic analysis of visualised workshop outputs and notes using affinity mapping and dialogue to identify key themes. We conducted a survey to assess workshop acceptability among participants. RESULTS: Twenty-two participants engaged in the 4-day workshop. Co-creation activities yielded recommendations for improving planned interventions (eg, message frequency and content; strategies to engage hard-to-reach participants), critical principles to employ across interventions (eg, personalisation, AYA empowerment) and identification of unanticipated AYA HIV treatment priorities (eg, drug holidays, transition from adolescent to adult services). We revised intervention content, peer navigator training materials and study inclusion criteria in response to findings. The youth-led HCD workshop was highly acceptable to participants. CONCLUSIONS: Research employing HCD among youth can improve interventions preimplementation through empathy, youth-led inquiry and real-time problem solving. Peer navigation may be most influential in improving retention when engagement with young people is based on mutual trust, respect, privacy and extends beyond HIV-specific support. Identifying opportunities for personalisation and adaptation within intervention delivery is important for AYAs. Patient engagement interventions that target young people should prioritise improved transition between youth and adult services, youth HIV status disclosure, AYA empowerment and healthcare worker responsiveness in interactions and episodic adherence interruptions.

Clinic presentation delay and tuberculosis treatment outcomes in the Lake Victoria region of East Africa: A multi-site prospective cohort study.

In the Lake Victoria region of East Africa, little is known about delays between tuberculosis (TB) symptom onset and presentation at a clinic. Associations between clinic presentation delay and TB treatment outcomes are also poorly understood. In 2019, we abstracted data from routine TB treatment records for all adults (n = 776) initiating TB treatment in a 6-month period across 12 health facilities near Lake Victoria. We interviewed 301 cohort members and assessed whether they experienced a clinic presentation delay longer than 6 weeks. We investigated potential clinical and demographic correlates of clinic presentation delay and examined the association between clinic presentation delay and an unfavorable TB treatment outcome (death, loss to follow-up, or treatment failure). Clinic presentation delay was common, occurring among an estimated 54.7% (95% CI: 48.9%, 61.2%) of cohort members, though no specific correlates were identified. Clinic presentation delay was slightly associated with unfavorable TB treatment outcomes. The 180-day risk of an unfavorable outcome was 14.2% (95% CI: 8.0%, 20.4%) among those with clinic presentation delay, compared to 12.7% (95% CI: 5.1%, 20.3%) among those presenting earlier. Multi-level community-based interventions may be necessary to reduce clinic presentation delays in communities near Lake Victoria.

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.

Geographic mobility and treatment outcomes among people in care for tuberculosis in the Lake Victoria region of East Africa: A multi-site prospective cohort study.

Geographic mobility may disrupt continuity of care and contribute to poor clinical outcomes among people receiving treatment for tuberculosis (TB). This may occur especially where health services are not well coordinated across international borders, particularly in lower and middle income country settings. In this work, we describe mobility and the relationship between mobility and unfavorable TB treatment outcomes (i.e., death, loss to follow-up, or treatment failure) among a cohort of adults who initiated TB treatment at one of 12 health facilities near Lake Victoria. We abstracted data from health facility records for all 776 adults initiating TB treatment during a 6-month period at the selected facilities in Kenya, Tanzania, and Uganda. We interviewed 301 cohort members to assess overnight travel outside one's residential district/sub-county. In our analyses, we estimated the proportion of cohort members traveling in 2 and 6 months following initiation of TB treatment, explored correlates of mobility, and examined the association between mobility and an unfavorable TB treatment outcome. We estimated that 40.7% (95% CI: 33.3%, 49.6%) of people on treatment for TB traveled overnight at least once in the 6 months following treatment initiation. Mobility was more common among people who worked in the fishing industry and among those with extra-pulmonary TB. Mobility was not strongly associated with other characteristics examined, however, suggesting that efforts to improve TB care for mobile populations should be broad ranging. We found that in this cohort, people who were mobile were not at increased risk of an unfavorable TB treatment outcome. Findings from this study can help inform development and implementation of mobility-competent health services for people with TB in East Africa.

Adapt for Adolescents: Protocol for a sequential multiple assignment randomized trial to improve retention and viral suppression among adolescents and young adults living with HIV in Kenya.

BACKGROUND: Adolescents and young adults living with HIV (AYAH) aged 14-24 years in Africa experience substantially higher rates of virological failure and HIV-related mortality than adults. We propose to utilize developmentally appropriate interventions with high potential for effectiveness, tailored by AYAH pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYAH in Kenya. METHODS: Using a SMART design, we will randomize 880 AYAH in Kisumu, Kenya to either youth-centered education and counseling (standard of care) or electronic peer navigation in which a peer provides support, information, and counseling via phone and automated monthly text messages. Those with a lapse in engagement (defined as either a missed clinic visit by ≥14 days or HIV viral load ≥1000 copies/ml) will be randomized a second time to one of three higher-intensity re-engagement interventions: This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYAH at 24 months post-enrollment and assess the cost-effectiveness of successful strategies. DISCUSSION: The study utilizes promising interventions tailored to AYAH while optimizing resources by intensifying services only for those AYAH who need more support. Findings from this innovative study will offer evidence for public health programming to end the HIV epidemic as a public health threat for AYAH in Africa. TRIAL REGISTRATION: Clinicaltrials.govNCT04432571, registered June 16, 2020.

Acceptability and applicability of biometric iris scanning for the identification and follow up of highly mobile research participants living in fishing communities along the shores of Lake Victoria in Kenya, Tanzania, and Uganda.

BACKGROUND: Recruitment and retention of participants in research studies conducted in fishing communities remain a challenge because of population mobility. Reliable and acceptable methods for identifying and tracking participants taking part in HIV prevention and treatment research are needed. The study aims to assess the acceptability, and technical feasibility of iris scans as a biometric identification method for research participants in fishing communities. METHODS: This was a cross-sectional study conducted in eight fishing communities in Kenya, Tanzania, and Uganda, with follow-up after one month in a randomly selected subset of participants. All consenting participants had their iris scanned and then responded to the survey. RESULTS: 1,199 participants were recruited. The median age was 33 [Interquartile range (IQR) 24-42] years; 56% were women. The overall acceptability of iris scanning was 99%, and the success rate was 98%. Eighty one percent (n = 949) had a successful scan on first attempt, 116 (10%) on second and 113 (9%) after more than two attempts. A month later, 30% (n = 341) of participants were followed up. The acceptability of repeat iris scanning was 99% (n = 340). All participants who accepted repeat iris scanning had successful scans, with 307 (90%) scans succeeding on first attempt; 25 (7%) on second attempt, and 8 (2%) after several attempts. The main reason for refusing iris scanning was fear of possible side effects of the scan on the eyes or body. CONCLUSION: The acceptability and applicability of biometric iris scan as a technique for unique identification of research participants is high in fishing communities. However, successful use of the iris scanning technology in research will require education regarding the safety of the procedure.

Analyzing fast and slow: Combining traditional and rapid qualitative analysis to meet multiple objectives of a complex transnational study.

Much of the methodological literature on rapid qualitative analysis describes processes used by a relatively small number of researchers focusing on one study site and using rapid analysis to replace a traditional analytical approach. In this paper, we describe the experiences of a transnational research consortium integrating both rapid and traditional qualitative analysis approaches to develop social theory while also informing program design. Research was conducted by the Innovations for Choice and Autonomy (ICAN) consortium, which seeks to understand how self-injection of the contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) can be implemented in a way that best meets women's needs, as defined by women themselves. Consortium members are based in Kenya, Uganda, Malawi, Nigeria, and the United States. Data for the ICAN study was collected in all four countries in sub-Saharan Africa. In order to both illuminate social phenomena across study sites and inform the program design component of the study, researchers developed tools meant to gather both in-depth information about women's contraceptive decision-making and data targeted specifically to program design during the formative qualitative phase of the study. Using these two bodies of data, researchers then simultaneously conducted both a traditional qualitative and rapid analysis to meet multiple study objectives. To complete the traditional analysis, researchers coded interview transcripts and kept analytical memos, while also drawing on data collected by tools developed for the rapid analysis. Rapid analysis consisted of simultaneously collecting data and reviewing notes developed specifically for this analysis. We conclude that integrating traditional and rapid qualitative analysis enabled us to meet the needs of a complex transnational study with the added benefit of grounding our program design work in more robust primary data than normally is available for studies using a human-centered design approach to intervention development. However, the realities of conducting a multi-faceted study across multiple countries and contexts made truly "rapid" analysis challenging.

Cost of Home-Based Couples Human Immunodeficiency Virus Counseling and Testing and Human Immunodeficiency Virus Self-Testing During Pregnancy and Postpartum in Southwestern Kenya.

OBJECTIVE: Home-based couples HIV testing and counseling and HIV self-testing (HIVST) for pregnant women can promote HIV status disclosure and male partner testing; however, cost data are lacking. We examined a home-based couples intervention (HBCI) and HIVST intervention costs per couple (unit cost) during pregnancy and postpartum in Kenya. METHODS: This randomized controlled trial is comparing HBCI and HIVST for couples among pregnant women attending antenatal care clinics in two counties in southwestern Kenya. We used micro-costing to estimate the unit cost per couple receiving the intervention as the total of direct and indirect costs for each study arm in 2019 US$. We used a one-month window to conduct a time and motion study to determine personnel effort and resources. We then compared the unit cost by arm, identified key cost drivers, and conducted sensitivity analyses for cost uncertainties. RESULTS: At base-case, the unit cost was $129.01 and $41.99, respectively, for HBCI and HIVST. Personnel comprised half of the unit cost for both arms. Staff spent more time on activities related to participant engagement in HBCI (accounting for 6.4% of the unit cost) than in HIVST (2.3%). Staff training was another key cost driver in HBCI (20.1% of the unit cost compared to 12.5% in HIVST). Sensitivity analyses revealed that the unit cost ranges were $104.64-$154.54 for HBCI and $30.49-$56.59 for HIVST. CONCLUSIONS: Our findings may guide spending decisions for future HIV prevention and treatment programs for pregnant couples in resource-limited settings such as Kenya.

Factors Associated with Short and Long Term Mobility and HIV Risk of Women Living in Fishing Communities Around Lake Victoria in Kenya, Tanzania, and Uganda: A Cross Sectional Survey.

Mobility is linked to negative HIV care continuum outcomes. We sought to understand factors associated with short and long term mobility among women in fishing communities in Kenya, Tanzania, and Uganda. From 2018 through 2019 we conducted a cross-sectional survey of women aged 15 years and above, randomly selected from a census of six fishing villages, around Lake Victoria. Data collected included: demographics, risky sexual behaviour on the most recent trip, and travel behaviour in the previous 4 months. Mobility was recorded as any overnight trip outside the participant's village. A two-level multinomial logistic regression model was used to determine the associated factors. A total of 901 participants were enrolled, of whom 645 (71.6%) reported travelling (53.4%; short and 18.2% long term trips). Five factors were associated with long term travel: age, travel purpose, frequency of travel, sexual behaviour while travelling, and destination. Trips made by women aged 46-75 years were less likely to be long term. Long term trips were more common if the trip was to visit, rather than to trade, and more common for women who reported one or two trips rather than three or more trips. Women who made long term trips were more likely to engage in unprotected sex while on a trip. Women who travelled to a regional town/district or another town/district were more likely to take long term trips. The factors associated with travel duration among women living in fishing communities could inform planning of future health care interventions in these communities.

Social networks, mobility, and HIV risk among women in the fishing communities of Lake Victoria.

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.

Preferences for accessing sexual and reproductive health services among adolescents and young adults living with HIV/AIDs in Western Kenya: A qualitative study.

Despite the need, adolescents and young adults (AYAs) in resource-limited settings have limited access to sexual and reproductive health (SRH) care services for improved health outcomes. This is worse for AYAs living with HIV in resource-limited settings where much is unknown about contexts and issues inhibiting access to SRHs. We explored adolescents', healthcare workers, and caregivers' preferences for access to sexual and reproductive health services for adolescents and young adults living with HIV. We conducted 30 in-depth interviews and 8 focus group discussions among a subset of AYA aged 14-24 living with HIV, healthcare workers, and caregivers/parents. We recruited participants from Lumumba Sub-County Hospital (KLM) and Kisumu County Referral Hospitals in Kisumu County (KCH). Trained and experienced qualitative research assistants 5-10 years older than the adolescents conducted interviews and facilitated discussions using guides designed to elicit detailed views and perspectives on sex and sexuality, access to SRH services, challenges of AYA living with HIV, and potential interventions to improve access to SRH services. Audio files were transcribed verbatim and translated to English where necessary before coding and analysis. We applied constant comparative analysis for theme and content to arrive at our conclusions. Our analysis yielded two main themes: preferences for a venue for SRH services and choices for qualities of an SRH counsellor. We found that AYAs generally preferred receiving SRH services to be co-situated within clinical facilities. We also observed gender differences in the qualities of SRH providers, with male AYAs preferring older male service providers compared to females who preferred younger female providers close to their age. The study highlighted the preferences of AYAs for accessing SRH, which need to be considered when designing their health programs. Further, AYAs seem to endite health systems to individualize access to SRH for AYAs living with HIV by providing a combination of attributes that meet individual preferences.

Adolescent and young adult preferences for financial incentives to support adherence to antiretroviral therapy in Kenya: a mixed methods study.

INTRODUCTION: To develop a patient-centred financial incentive delivery strategy to improve antiretroviral treatment adherence in adolescents and young adults (AYA) living with HIV in Kisumu, Kenya, we conducted a mixed methods study exploring preferences. METHODS: A discrete choice experiment (DCE) and focus group discussion (FGD) were conducted simultaneously to identify preferences for five incentive delivery strategy features: value, eligibility, recipient, format and disbursement frequency. We used consecutive sampling to recruit AYA (14-24 years) living with HIV attending three health facilities in Kisumu, Kenya. We calculated mean preferences, willingness to trade, latent class membership and predictors of latent class membership. The FGD explored preferred incentive features, and, after deductive and inductive coding, qualitative findings were triangulated with DCE results. RESULTS: Two hundred and seven AYA living with HIV (46% 14-17 years, 54% 18-24 years; 33% male sex, 89% viral load <50 copies/ml) were recruited to the study (28 October-16 November 2020). Two distinct preference phenotypes emerged from the DCE analysis (N = 199), 44.8% of the population fell into an "immediate reward" group, who wanted higher value cash or mobile money distributed at each clinic visit, and 55.2% fell into a "moderate spender" group, who were willing to accept lower value incentives in the form of cash or shopping vouchers, and accrued payments. The immediate reward group were willing to trade up to 200 Kenyan Shillings (KSH)-approximately 2 US dollars (USD)-of their 500 KSH (∼5 USD) incentive to get monthly as opposed to accrued yearly payments. The strongest predictor of latent class membership was age (RR 1.45; 95% CI: 1.08-1.95; p = 0.006). Qualitative data highlighted the unique needs of those attending boarding school and confirmed an overwhelming preference for cash incentives which appeared to provide the greatest versatility for use. CONCLUSIONS: Providing small financial incentives as cash was well-aligned with AYA preferences in this setting. AYA should additionally be offered a choice of other incentive delivery features (such as mobile money, recipient and disbursement frequency) to optimally align with the specific needs of their age group and life stage.

Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at Lake Victoria: study protocol for the Owete cluster randomized controlled trial.

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 .

Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial.

BACKGROUND: Women in Africa face disproportionate risk of human immunodeficiency virus (HIV) acquisition, accounting for more than half of new infections in Africa and similarly face a disproportionate burden of sexually transmitted infections (STIs). Very high STI prevalence is being observed globally, especially among people taking pre-exposure prophylaxis (PrEP) for HIV prevention. Doxycycline post-exposure prophylaxis (dPEP) has been proposed as an STI prevention strategy to reduce chlamydia, syphilis, and possibly gonorrhea, and trials are ongoing among cisgender men who have sex with men (MSM) and transgender women who are taking PrEP in high-income settings. We designed and describe here the first open-label trial to determine the effectiveness of dPEP to reduce STI incidence among cisgender women. METHODS: We are conducting an open-label 1:1 randomized trial of dPEP versus standard of care (STI screening and treatment and risk-reduction counseling without dPEP) among 446 Kenyan women aged ≥ 18 and ≤ 30 years old women taking PrEP. Women are followed for 12 months, with quarterly STI testing, treatment, and adherence counseling. The primary trial outcome will be the combined incidence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Treponema pallidum, compared between the randomized groups. We will also assess dPEP acceptability, tolerability, safety, impact on sexual behavior, adherence, and occurrence of antimicrobial resistance (AMR) in N. gonorrhoeae and C. trachomatis isolates. Finally, we will estimate cost per incident STI case and complications averted accounting for nonadherence and benefits relative AMR or side effects. DISCUSSION: The results of this trial may have immediate implications for the global epidemic of STIs and sexual health. If effective, dPEP could put STI prevention into women's hands. While dPEP may be able to prevent STIs, it carries important risks that could counter its benefits; global debate about the balance of these potential risks and benefits requires data to inform policy and implementation and our study aims to fill this gap. TRIAL REGISTRATION: ClinicalTrials.gov NCT04050540 .

Effects of the Waya Intervention on Marital Satisfaction and HIV Risk Behaviors in Western Kenya: A Pre-Post Study Design.

Poor marital satisfaction is associated with high-risk sexual behavior and HIV transmission. We tested whether a counselor-led couple education and counseling intervention dubbed Waya (paternal aunt) would improve marital satisfaction and reduce HIV risk behavior among married couples in Kisumu County, western Kenya. In a pre-post design, we enrolled 60 heterosexual married couples at high risk for HIV to undergo five 1-h couple education and counseling sessions over 56 days. We collected self-reported data on marital satisfaction, the number of sex partners, and condom use with extramarital partners at pre- and post-intervention visits. We used Wilcoxon and McNemar tests to examine the association of our intervention with marital relationship satisfaction and reduction in HIV risk sexual behavior. The intervention was associated with marital relationship satisfaction score improvement from a median of 5 (interquartile range [IQR], 4-5) to 6 (IQR, 6-7) among men and 4 (IQR, 3-5) to 6 (IQR, 5-6) among women (p < .01). The intervention was also associated with reducing HIV risk sexual behaviors depicted by a reduction in the number of sex partners in the past one month and an increase in consistent extramarital condom use. The number of sex partners reduced from a median of 2 (IQR, 1-2) to 1 (IQR, 1-2) and consistent extramarital condom use increased from 4% at baseline to 56% among men. Our intervention was associated with improvements in marital relationship satisfaction and reductions in HIV high-risk behaviors necessary for achieving epidemic control in HIV hotspots such as fishing communities in western Kenya.

Couple Efficacy and Communal Coping for HIV Prevention Among Kenyan Pregnant Couples.

Involving both partners of a couple in HIV prevention can improve maternal and child health outcomes in sub-Saharan Africa. Using data from 96 couples, we explored the actor and partner effects of perceived relationship dynamics on a couple's confidence and ability to reduce HIV risk together. Perceived relationship quality altered perceived confidence and ability to reduce HIV threat. One's own ability to confidently act together with their spouse appeared to be stronger for husbands than wives with respect to relationship commitment. A partner's confidence to communicate with their spouse about HIV risk reduction appeared to be stronger from husbands to wives for relationship satisfaction and trust. Gender differences in perceived relationship quality and effects on communal coping may exist and requires further study for applicability in intervention development in this setting. Efficacious couple-oriented interventions for HIV prevention should incorporate evidence on how partners mutually influence each other's health beliefs and behaviors.

Social, economic, and health effects of the COVID-19 pandemic on adolescents retained in or recently disengaged from HIV care in Kenya.

INTRODUCTION: Adolescents living with HIV (ALHIV, ages 10-19) experience complex challenges to adhere to antiretroviral therapy (ART) and remain in care, and may be vulnerable to wide-scale disruptions during the COVID-19 pandemic. We assessed for a range of effects of the pandemic on ALHIV in western Kenya, and whether effects were greater for ALHIV with recent histories of being lost to program (LTP). METHODS: ALHIV were recruited from an ongoing prospective study at 3 sites in western Kenya. The parent study enrolled participants from February 2019-September 2020, into groups of ALHIV either 1) retained in care or 2) LTP and traced in the community. Phone interviews from July 2020-January 2021 assessed effects of the pandemic on financial and food security, healthcare access and behaviors, and mental health. Responses were compared among the parent study groups. RESULTS: Phone surveys were completed with 334 ALHIV or their caregivers, including 275/308 (89.3%) in the retained group and 59/70 (84.3%) among those LTP at initial enrollment. During the pandemic, a greater proportion of LTP adolescents were no longer engaged in school (45.8% vs. 36.4%, p = 0.017). Over a third (120, 35.9%) of adolescents reported lost income for someone they relied on. In total, 135 (40.4%) did not have enough food either some (121, 36.2%) or most (14, 4.2%) of the time. More LTP adolescents (4/59, 6.8% vs. 2/275, 0.7%, p = 0.010) reported increased difficulties refilling ART. Adolescent PHQ-2 and GAD-2 scores were ≥3 for 5.6% and 5.2%, respectively. CONCLUSIONS: The COVID-19 pandemic has had devastating socioeconomic effects for Kenyan ALHIV and their households. ALHIV with recent care disengagement may be especially vulnerable. Meanwhile, sustained ART access and adherence potentially signal resilience and strengths of ALHIV and their care programs. Findings from this survey indicate the critical need for support to ALHIV during this crisis.