Feasibility and Acceptability of the Novel Tu'Washindi Intervention to Increase PrEP Use among Adolescent Girls and Young Women in Siaya County, Kenya.

The Tu'Washindi intervention addressed intimate partner violence (IPV) and relationship dynamics to increase PrEP use among adolescent girls and young women (AGYW) in Siaya County, Kenya. We evaluated feasibility and acceptability in a cluster-randomized trial in six DREAMS Safe Spaces. The multilevel intervention, delivered over 6 months, included three components delivered by DREAMS staff with support from the study team: an 8-session structured support club; community sensitization of male partners; and a couples PrEP education and health fair ("Buddy Day"). Feasibility and acceptability assessments included implementation process measures, questionnaires, and focus group discussions with AGYWs and post-intervention questionnaires with intervention providers. The study included 103 AGYWs aged 17 to 24 (N = 49 intervention), with 97% retention. Median age was 22, 54% were married, and 84% were mothers. At enrollment, 45% used PrEP and 61% reported lifetime IPV. All intervention participants attended at least one support club session (mean = 5.2 of 8) and 90% attended Buddy Day. At 6 months, most participants perceived Tu'Washindi to be effective: all agreed (with 54% reporting "strongly agree") that the intervention improved partner communication and 60% agreed they were better able to gain partner support for their PrEP use. Providers believed the intervention resonated with community values. Tu'Washindi was highly acceptable and feasible and it was perceived by AGYW participants and providers as being effective in improving partner relationships and supporting PrEP use.

How men influence young women taking PrEP: perspectives from young women, male partners, and male peers in Siaya county, Western Kenya.

BACKGROUND: Daily oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention option for those who are most vulnerable to HIV infection, especially young women (YW). Objection by or lack of support from male sexual partners has been shown to impact YW's ability to take PrEP consistently. We explored the views of YW, and male partners and male peers of YW in Siaya County, Western Kenya, to illustrate how men influence, and can support, YW in using PrEP. METHODS: We used Photovoice to capture the views of YW ages 18-24 who were currently or previously enrolled in the DREAMS program and with current or previous experience taking PrEP. We also captured the views of YW's sexual partners and male peers. The YW completed eight photo assignments that focused on identifying factors influencing their PrEP use, and male participants completed four photo assignments focused on identifying ways men support or hinder YW's PrEP use. Photographs were presented and discussed in same- and mixed-gender groups using the SHOWeD method. YW also participated in in-depth interviews. The analysis focused on identifying themes that described men's influence on YW's PrEP adherence and persistence. RESULTS: Among YW, a restricting male influence on PrEP use emerged in the majority of photo assignments such that YW's photographs and discussions revealed that men were more often viewed as barriers than supporters. YW perceived that they had little autonomy over their sexual lives and choice to use PrEP. YW's PrEP use was perceived to be hindered by stigmatizing community narratives that influenced men's support of PrEP use among women. Male participants suggested that men would support YW's PrEP use if PrEP was better promoted in the community and if men were more knowledgeable about its benefits. CONCLUSIONS: A lack of support from male partners and peers and stigmatizing community narratives influence YW's PrEP use. Community-based programs should include education about PrEP specifically for male partners and peers of YW to positively influence PrEP use among YW.

Facility characteristics preferred by older men seeking medical male circumcision services in Kenya: qualitative findings from the 'Tasco' study (May 2014-June 2016).

Primary healthcare facilities are central to the implementation of voluntary medical male circumcision (VMMC) as points of access to integrated health services in line with the Kenya AIDS Strategic Framework II (2020/21-2024/25). Knowledge of factors that explain men's uptake of VMMC and sexual health services at these facilities and preferences of where to get the services remain poorly understood. Using qualitative methodologies, we examined factors that determined facility choice for VMMC services and reasons for preferring the facility among men aged 25-39 years who previously underwent VMMC. The current study draws from focus group discussion interviews with circumcised men and their partners conducted as part of a randomized controlled trial to assess impact of two demand creation interventions in western Kenya. This involved 12 focus group discussions (FGD) with 6-10 participants each. Six FGDs were conducted with circumcised men, and 6 with their sex partners. Thematic issues relevant to a predetermined framework were identified. The themes were organized as follows: service availability, accessibility, affordability, appropriateness and, acceptability. Facility location, physical layout, organization of patient flow, infrastructure, and service provider skills were the outstanding factors affecting the choice of VMMC service outlets by men aged 25-39 years. Additionally, preferences were influenced by individual's disposition, attitudes, knowledge of VMMC services and tacit balance between their own recognized health needs versus desire to conform to social-cultural norms. Facility choice and individual preference are intricate issues, simultaneously involving multiple but largely intra-personal and facility-level factors. The intrapersonal dimensions elicited may also reflect differential responses to strategic communications and demand creation messages with promotion and prevention frames.

Individual-, Interpersonal- and Institutional-Level Factors Associated with HIV Stigma Among Youth in Kenya.

HIV stigma remains a barrier in achieving optimal HIV treatment. We studied the prevalence and predictors of HIV stigma among adolescents and youth with HIV (AYWHIV) ages 15-24 years in Western Kenya. Of 1011 AYWHIV, 69% were female with a median age of 18 years. Most (59%) attended adolescent clinic days, and 40% attended support groups. One-quarter (27%) had experienced physical, 18% emotional, and 7% sexual violence. The majority of AYWHIV (88%) reported disclosure concerns, 48% reported perceived community stigma, 36% experienced, and 24% internalized stigma. Compared to AYWHIV attending adolescent clinics, those in general/adult clinics had higher internalized stigma. Similarly, having dropped out of school was associated with higher internalized stigma. AYWHIV in sexual relationships had higher experienced stigma and disclosure concerns. Lastly, exposure to violence was associated with higher experienced, internalized, perceived community stigma and disclosure concerns. These risk factors can be targeted when developing stigma-prevention interventions.

Integrated Health Care Delivery for Adolescents Living with and at Risk of HIV Infection: A Review of Models and Actions for Implementation.

Integrated service delivery, providing coordinated services in a convenient manner, is important in HIV prevention and treatment for adolescents as they have interconnected health care needs related to HIV care, sexual and reproductive health and disease prevention. This review aimed to (1) identify key components of adolescent-responsive integrated service delivery in low and middle-income countries, (2) describe projects that have implemented integrated models of HIV care for adolescents, and (3) develop action steps to support the implementation of sustainable integrated models. We developed an implementation science-informed conceptual framework for integrated delivery of HIV care to adolescents and applied the framework to summarize key data elements in ten studies or programs across seven countries. Key pillars of the framework included (1) the socioecological perspective, (2) community and health care system linkages, and (3) components of adolescent-focused care. The conceptual framework and action steps outlined can catalyze design, implementation, and optimization of HIV care for adolescents.

Understanding sexual behaviors of youth from the lens of caregivers, teachers, local leaders and youth in Homabay County, Kenya.

In Kenya similar to other countries in Eastern and Southern Africa There is a disproportionately high burden of the global HIV incidence among youth ages 15-24 years, and where adolescent girls and young women account for up to a third of all incident HIV infections and more than double the burden of HIV compared to their male peers. Previous work has shown early sexual debut as entry point into risks to sexual and reproductive health among young people including STI/HIV acquisition. This was a formative assessment of the local context of three sexual risk behaviors among youth ages of 15-24 years: early sexual debut, multiple sexual partnerships, and age-mixing /intergenerational sex for purposes of informing comprehensive combination HIV intervention program design. We conducted a cross-sectional formative qualitative study in four sub-counties within Homabay county a high HIV prevalence region of Kenya. Participants were recruited through youth groups, schools, government offices and, community gatekeepers using approved fliers, referred to a designated venue for focus group discussion (FGD). After oral informed consent, twelve FGDs of 8-10 participants were carried out. Transcripts and field notes were uploaded to Atlas.ti qualitative data analysis and research software (version 8.0, 2017, ATLAS.ti GmbH). Open coding followed by grouping, categorization of code groups, and thematic abstraction was used to draw meaning for the data. A total of 111 youth participated in the FGD, 65 males and 46 females. The main findings were that youth engaged in early sex for fear of being labeled 'odd' by their peers, belief (among both male and female) that 'practice makes perfect', curiosity about sex, media influence, need to prove if one can father a child (among male), the notion that sex equals love with some of the youth using this excuse to coerce their partners into premature sex, and the belief that sex is a human right and parents/guardians should not intervene. Male youth experienced more peer-pressure to have sex earlier. Female youths cited many reasons to delay coitarche that included fear of pregnancy, burden of taking care of a baby, and religious doctrines. Having multiple sexual partners and intergenerational sexual relationships were common among the youth driven by perceived financial gain and increased sexual prowess. HIV prevention strategies need to address gender vulnerabilities, as well as promoting a protective environment, hence application of combination prevention methods is a viable solution to the HIV pandemic.Trial registration number: The study was approved by the KNH/UoN Ethics review committee (KNH/UoN ERC-P73/03/2011) and New York University (NYU Reg no.-00000310).

Early infant male circumcision: Potential for changing adverse gender norms associated with traditional male circumcision among circumcising communities in Kenya.

Introduction: Traditional male circumcision (TMC) inculcates masculine-dominance norms in young men. Early infant male circumcision (EIMC) and medical male circumcision (MMC) can potentially minimise these adverse gender norms. We explored the perceptions about EIMC and MMC among communities practising TMC in Kenya.Method: We conducted focus group discussions with men and women and councils of elders, and key informant interviews with traditional circumcisers. Data were analysed using NVivo 10.Results: Most participants described MC as a rite of passage into adulthood, with the preferred age for MC to occur at 10 to 15 years old. Interestingly, awareness of the advantages of EIMC, especially among younger men and women, was high. Participants acknowledged that TMC reinforces hegemonic masculinity that undermines gender equality. Except among traditional circumcisers and some members of councils of elders, MMC and female providers were largely deemed acceptable.Conclusion: EIMC and MMC are slowly gaining acceptance, providing important tools to challenge adverse gender norms associated with TMC.

VMMC Programmatic Successes and Challenges: Western Kenya Case Study.

PURPOSE OF REVIEW: The Nyanza region of western Kenya is lauded for impressive coverage of voluntary medical male circumcision (VMMC) and remains the bedrock of the VMMC program in Kenya. We conducted literature review on programmatic successes and challenges of implementing VMMC program in the region. RECENT FINDINGS: Responsive stakeholders' engagement, robust policy environment, effective technical working groups, prompt capacity building of health facilities, government support, flexible implementation strategies, and sustained donor funding contributed to the successes of the program that saw circumcision prevalence in Nyanza reach between 75.6 and 85.3% among 15-29-year-olds by 2019. However, the lack of support for early infant circumcision, inadequate domestic financing, and slow pace of service integration into government health facilities continue to undermine the progress towards sustainability. While local ownership of the VMMC program has been demonstrated through its inclusion in county annual health workplans and progressive integration into routine health care, continued dependence on declining external funding threatens its sustainability. Furthermore, Kenya is experiencing a youth bulge with a projected high demand for VMMC which calls for increased resource inputs into the program. Strategies are therefore needed to increase domestic resource inflows into VMMC.

Formative assessment to identify perceived benefits and barriers of HIV oral self-testing among female sex workers, service providers, outreach workers, and peer educators to inform scale-up in Kenya.

In Kenya, HIV prevalence estimates among female sex workers (FSWs) are almost five times higher than among women in the general population. However, only 68% of infected FSWs are aware of their HIV-positive status. We aimed to identify perceived benefits, opportunities, and barriers of HIV self-testing (HIVST) in improving testing coverage among FSWs. Twenty focus group discussions were conducted with 77 service providers, 42 peer educators (PEs) and outreach workers, and 37 FSWs attending drop-in centers (DiCEs) in four regions of Kenya. An additional 8 FSWs with HIV-negative or unknown status-completed in-depth interviews. Data were analyzed thematically. Acceptability of HIVST was high, with cited benefits including confidentiality, convenience, and ease of use. Barriers included absence of counseling, potential for inaccurate results, fear of partner reaction, possible misuse, and fear that HIVST could lead to further stigmatization. PEs and DiCEs were the preferred models for distributing HIVST kits. FSWs wanted kits made available free or at a nominal cost (100 Kenya Shillings or ∼USD 1). Linkage to confirmatory testing, the efficiency of distributing HIVST kits using peers and DiCEs, and the types and content of effective HIVST messaging require further research.

"I didn't support PrEP because I didn't know what it was": Inadequate information undermines male partner support for young women's pre-exposure prophylaxis use in western Kenya.

The HIV infection rate is higher among adolescent girls and young women (AGYW) in Africa than men in the same age range. Pre-exposure prophylaxis (PrEP) can be used by women discreetly; however, for most AGYW, male partner approval is desired. We explored PrEP use in the context of relationship violence and power dynamics through focus group discussions and support club sessions with AGYW, in-depth interviews and male sensitisation sessions with male partners of AGYW, and joint sessions with AGYW and their male partners. Many male partners reported hesitancy in supporting partner's PrEP use without sufficient information; most of these became supportive following their engagement in study activities; and most preferred participation in decisions around PrEP use. For AGYW, male involvement minimised partner violence around their PrEP use. The findings support the need for correct PrEP information to be provided to male partners of AGYW and to involve them early on, in decision-making about PrEP use. This is likely to improve uptake of and adherence to PrEP.

Life in the Balance: Young Female Sex Workers in Kenya Weigh the Risks of COVID-19 and HIV.

The COVID-19 pandemic has had serious health, economic and psychosocial consequences. Marginalized populations including female sex workers face the stark choice of risking exposure to SARS-CoV-2 as they engage with clients or prioritizing their health at the cost of losing a primary source of income. As part of an ongoing open-label, randomized controlled trial providing daily oral pre-exposure prophylaxis and adherence support, we interviewed 193 of 200 enrolled young female sex workers (18-24 years) in Kisumu, Kenya, about COVID-19 awareness and precautions, access to health services, and sex work during Kenya's pandemic-related lockdown. Nearly all participants were aware of COVID-19 and reported taking protective measures, but only half reported concerns about acquiring SARS-CoV-2. Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients. Nearly 15% experienced violence from a client or regular, non-paying sex partner during the lockdown period. Participants' access to healthcare services was not disrupted.

RESUMEN: La pandemia de COVID-19 puede tener graves consecuencias sanitarias, económicas y psicosociales. Poblaciones marginadas como las mujeres trabajadoras sexuales se enfrentan a la dura elección de arriesgarse a exponerse al SARS-CoV-2 mientras interactúan con los clientes o priorizar su salud a riesgo de perder su principal fuente de ingresos. Como parte de un ensayo controlado aleatorio abierto en curso que proporcionaba profilaxis pre-exposición (PrEP) oral diaria y apoyo para la adherencia, entrevistamos a 193 de 200 las mujeres trabajadoras sexuales jóvenes (de 18 a 24 años) en Kisumu, Kenia, sobre su conocimiento y precauciones frente al COVID-19, acceso a servicios de salud, y trabajo sexual durante el confinamiento por la pandemia en Kenia. Casi todas las participantes conocían el COVID-19 y reportaron que tomaron medidas de protección, pero sólo la mitad dijeron estar preocupadas por infectarse con el SARS-CoV-2. Los toques de queda nocturnos y los cierres de bares afectaron negativamente al negocio del trabajo sexual, reduciendo el número de clientes y la cantidad que recibieron de los clientes. Casi el 15% experimentó violencia por parte de un cliente o por una pareja sexual habitual que no paga durante el periodo de confinamiento. El acceso de las participantes a los servicios de salud no se vio interrumpido.

The Psychosocial Effects of the COVID-19 Pandemic on Youth Living with HIV in Western Kenya.

The objective of this study was to assess psychosocial effects of COVID-19 among adolescents living with HIV (ALHIV) in Kenya and to assess the feasibility of conducting behavioral surveys by phone. We adapted our protocol to administer telephone rather than in-person follow-up surveys and included questions about COVID-19. The majority of participants (99%) reported having heard of COVID-19; 23% reported no longer being able to go outside, 17% reported that they could no longer go to their regular clinic for medical care, and 3% reported that they could no longer get medication refills. PHQ-9 screening identified 9% (n = 45) with mild depression symptoms, and 1% (n = 3) with moderate-to-severe depression symptoms. Young adults 20-24 years old had more mild to severe depressive symptoms than the younger age groups (p < 0.001). Offering remote peer-support or mental health care, continuing to offer differentiated care services, and considering financial support will support the health and well-being of ALHIV.

Mapping geographic clusters of new HIV diagnoses to inform granular-level interventions for HIV epidemic control in western Kenya.

BACKGROUND: As countries make progress towards HIV epidemic control, there is increasing need to identify finer geographic areas to target HIV interventions. We mapped geographic clusters of new HIV diagnoses, and described factors associated with HIV-positive diagnosis, in order to inform targeting of HIV interventions to finer geographic areas and sub-populations. METHODS: We analyzed data for clients aged > 15 years who received home-based HIV testing as part of a routine public health program between May 2016 and July 2017 in Siaya County, western Kenya. Geospatial analysis using Kulldorff's spatial scan statistic was used to detect geographic clusters (radius < 5 kilometers) of new HIV diagnoses. Factors associated with new HIV diagnosis were assessed in a spatially-integrated Bayesian hierarchical model. RESULTS: Of 268,153 clients with HIV test results, 2906 (1.1%) were diagnosed HIV-positive. We found spatial variation in the distribution of new HIV diagnoses, and identified nine clusters in which the number of new HIV diagnoses was significantly (1.56 to 2.64 times) higher than expected. Sub-populations with significantly higher HIV-positive yield identified in the multivariable spatially-integrated Bayesian model included: clients aged 20-24 years [adjusted relative risk (aRR) 3.45, 95% Bayesian Credible Intervals (CI) 2.85-4.20], 25-35 years (aRR 4.76, 95% CI 3.92-5.81) and > 35 years (aRR 2.44, 95% CI 1.99-3.00); those in polygamous marriage (aRR 1.84, 95% CI 1.55-2.16), or separated/divorced (aRR 3.36, 95% CI 2.72-4.08); and clients who reported having never been tested for HIV (aRR 2.35, 95% CI 2.02-2.72), or having been tested > 12 months ago (aRR 1.53, 95% CI 1.41-1.66). CONCLUSION: Our study used routine public health program data to identify granular geographic clusters of higher new HIV diagnoses, and sub-populations with higher HIV-positive yield in the setting of a generalized HIV epidemic. In order to target HIV testing and prevention interventions to finer granular geographic areas for maximal epidemiologic impact, integrating geospatial analysis into routine public health programs can be useful.

Correlates of Rectal Douching Practices Among Men Who Have Sex With Men in Kenya.

BACKGROUND: Among men who have sex with men (MSM), rectal douching (RD) has been associated with increased prevalence of human immunodeficiency virus and other sexually transmitted infections. Substances commonly used for RD, especially water-based solutions, could disrupt the rectal epithelium and increase susceptibility to infection. The few existing reports on RD among MSM are primarily in middle- and high-income settings, and to date, no study has focused on RD among MSM in Africa. METHODS: We conducted a secondary data analysis of programmatic data from key population service centers in western Kenya. Data were extracted from records of clients who identified as MSM and accessed services between January 1, 2014, and September 1, 2016. We compared demographic and behavioral characteristics of men who did and did not practice RD. Logistic regression assessed associations with RD. RESULTS: Of the 202 MSM in this analysis, 63% engaged in RD. All who engaged in RD used water-based substances. Those who engaged in receptive anal intercourse in the last 3 months were more likely to report RD (odds ratio, 3.19; 95% confidence interval, 1.67-6.07). Among MSM who engaged in sex work, those who practiced RD reported more regular clients per week (2.8 clients vs. 1.3 clients, P = 0.01). Rectal douching practices did not vary by other sexual risk practices. CONCLUSIONS: Rectal douching is common in this population of Kenyan MSM, especially among those who have recently engaged in receptive anal intercourse, suggesting that a rectal douche that delivers microbicides could be a potential intervention to reduce human immunodeficiency virus/sexually transmitted infection within this population.

Prevalence and Predictors of Uncircumcised, Kenyan Men's Desire for Circumcision for Their Infant Sons.

Men are key decision makers for their son's circumcision, so understanding their beliefs is important for the uptake of early infant male circumcision in countries in sub-Saharan Africa that have high HIV prevalence. We analyzed men's preferences for circumcising their sons using data from a population-representative survey of 1501 uncircumcised men aged 25-49 years in western Kenya. Most men (59%) reported they would "definitely" want their son circumcised if a son was born to them within the next year. However, only 25% intended to become circumcised themselves. In multivariable Poisson regression models to estimate prevalence ratios, key predictors of the desire to circumcise their sons included knowledge that circumcision reduces HIV acquisition, having a supportive partner, discussing circumcision with the partner, altruism, and intention to be circumcised himself. Focusing on partner dynamics may have the greatest capacity to increase demand since 55% had not talked to their partner about circumcision.

Young Women's Ratings of Three Placebo Multipurpose Prevention Technologies for HIV and Pregnancy Prevention in a Randomized, Cross-Over Study in Kenya and South Africa.

End-user input is critical to inform development of multipurpose prevention technology (MPT) products that prevent HIV and pregnancy. The TRIO Study, conducted in Kenya and South Africa, enrolled 277 HIV-negative women aged 18-30 in a randomized cross-over study to use each placebo MPT (daily oral tablets, monthly injections, and monthly vaginal ring) for one month. At the end of each month, participants rated how much they liked using the product on a 5-point Likert scale (5 = liked very much). We compared mean ratings using paired t-tests and examined sociodemographic-, attribute-, and behavior-related characteristics associated with ratings using multivariable linear regression and data from in-depth interviews. After use, mean ratings were significantly higher for injections [4.3 (SD = 1.0)] compared with tablets [3.0 (SD = 1.3)] and rings [3.3 (SD = 1.4)] (p < 0.001); mean ratings for rings were significantly higher than for tablets (p = 0.013). Mean ratings of a hypothetical active MPT increased for all products after the one-month period of use, with the greatest increase for rings, the least familiar product. In multivariable analysis, acceptability of key product attributes (e.g., product look) were associated with a significant increase of ≥ 1 point in the mean rating across all three products (p ≤ 0.001). Perceived ability to use the product without partner knowledge was associated with a higher mean rating for rings (b = 0.50; p = 0.006). The acceptability of product attributes contributed significantly to the rating of all products, highlighting the value of choice in pregnancy and HIV prevention to accommodate diverse users.

End-Users' Product Preference Across Three Multipurpose Prevention Technology Delivery Forms: Baseline Results from Young Women in Kenya and South Africa.

A multipurpose prevention technology (MPT) that combines HIV and pregnancy prevention is a promising women's health intervention, particularly for young women. However, little is known about the drivers of acceptability and product choice for MPTs in this population. This paper explores approval ratings and stated choice across three different MPT delivery forms among potential end-users. The Trio Study was a mixed-methods study in women ages 18-30 that examined acceptability of three MPT delivery forms: oral tablets, injections, and vaginal ring. Approval ratings and stated choice among the products was collected at baseline. Factors influencing stated product choice were explored using multivariable multinomial logistic regression. The majority (62%) of women in Trio stated they would choose injections, 27% would choose tablets and 11% would choose the ring. Significant predictors of choice included past experience with similar contraceptive delivery forms, age, and citing frequency of use as important. Ring choice was higher for older (25-30) women than for younger (18-24) women (aRR = 3.1; p < 0.05). These results highlight the importance of familiarity in MPT product choice of potential for variations in MPT preference by age.

Perspectives on biomedical HIV prevention options among women who inject drugs in Kenya.

Due to heightened vulnerability to HIV from frequent engagement in sex work and overlapping drug-using and sexual networks, women who inject drugs should be a high priority population for pre-exposure prophylaxis (PrEP) and other biomedical HIV prevention tools. Kenya is one of the first African countries to approve oral PrEP for HIV prevention among "key populations," including people who inject drugs and sex workers. The objective of this study was to explore preferences and perceived challenges to PrEP adoption among women who inject drugs in Kisumu, Kenya. We conducted qualitative interviews with nine HIV-uninfected women who inject drugs to assess their perceptions of biomedical HIV interventions, including oral PrEP, microbicide gels, and intravaginal rings. Despite their high risk and multiple biomedical studies in the region, only two women had ever heard of any of these methods. All women were interested in trying at least one biomedical prevention method, primarily to protect themselves from partners who were believed to have multiple other sexual partners. Although women shared concerns about side effects and product efficacy, they did not perceive drug use as a significant deterrent to adopting or adhering to biomedical prevention methods. Beginning immediately and continuing throughout Kenya's planned PrEP rollout, efforts are urgently needed to include the perspectives of high risk women who use drugs in biomedical HIV prevention research and programing.

Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial.

BACKGROUND: Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing. METHODS AND FINDINGS: We conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used. CONCLUSIONS: Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT02386215.

Higher HPV16 and HPV18 Penile Viral Loads Are Associated With Decreased Human Papillomavirus Clearance in Uncircumcised Kenyan Men.

BACKGROUND: Whether higher penile human papillomavirus (HPV) viral load is associated with a lower rate of HPV clearance remains unknown. OBJECTIVES: We examined the association between penile HPV16 and HPV18 viral load and subsequent HPV clearance in uncircumcised Kenyan men. STUDY DESIGN: Participants were human immunodeficiency virus (HIV)-seronegative, sexually active, 18- to 24-year-old men randomized to the control arm of a male circumcision trial in Kisumu, Kenya. Men provided exfoliated penile cells from two anatomical sites (glans/coronal sulcus and shaft) every 6 months for 2 years. GP5+/6+ polymerase chain reaction was used to identify 44 HPV-DNA types. Human papillomavirus viral load testing was conducted using a LightCyler real-time polymerase chain reaction assay; viral load was classified as high (>250 copies/scrape) or low (≤250 copies/scrape), for nonquantifiable values. The Kaplan-Meier method and Cox regression modeling were used to examine the association between HPV viral load and HPV clearance. RESULTS: A total of 1097 men, with 291 HPV16 and 131 HPV18 cumulative infections over 24 months were analyzed. Human papillomavirus clearance at 6 months after first HPV detection was lower for high versus low viral load HPV16 infections in the glans (adjusted hazard ratio [aHR], 0.65; 95% confidence interval [CI], 0.46-0.92)] and shaft (aHR, 0.44; 95% CI, 0.16-0.90), and HPV18 infections in the glans (aHR, 0.05; 95% CI, 0.01-0.17). DISCUSSION: High versus low HPV viral load was associated with a reduced HPV clearance for HPV16 infections in the glans and shaft, and for HPV18 infections in the glans, among young uncircumcised men. Reduced clearance of high viral load HPV16 and HPV18 infections in men may increase HPV transmission to their female partners as well as enhance the development of penile lesions in comparison to men with low viral load HPV infections.