Access to Oral Fluid-Based Human Immunodeficiency Virus Self-Tests Increases Testing Among Male Partners of Adolescent Girls in Kenya: A Randomized Controlled Trial.

PURPOSE: The risk of human immunodeficiency virus (HIV) among adolescent girls (AGs) may be reduced if they know the HIV status of their male partners. We assessed the ability of AGs in Siaya County, Kenya, to offer HIV self-tests to their partners to promote partner and couples testing. METHODS: Eligible AGs were 15-19 years old, self-tested HIV-negative, and had a male partner not tested in the past 6 months. Participants were randomly assigned to receive two oral fluid-based self-tests (intervention arm) or a referral coupon for facility-based testing (comparison arm). The intervention included counseling on ways to safely introduce self-tests to partners. Follow-up surveys were conducted within 3 months. RESULTS: Among 349 AGs enrolled, median age was 17 years (interquartile range 16-18), 88.3% of primary partners were noncohabiting boyfriends, and 37.5% were unaware if their partner had ever tested. At 3 months, 93.9% of the intervention arm and 73.9% of the comparison arm reported that partner testing occurred. Compared to the comparison arm, partner testing was more likely in the intervention arm (risk ratio = 1.27; 95% confidence interval 1.15-1.40; p < .001). Among participants whose partners got tested, 94.1% and 81.5% in the intervention and comparison arms, respectively, reported that couples testing occurred; couples testing was more likely in the intervention than comparison arm (risk ratio = 1.15; 95% confidence interval 1.15-1.27; p = .003). Five participants reported partner violence, one study-related. DISCUSSION: Provision of multiple self-tests to AGs for the purpose of promoting partner and couples testing should be considered in Kenya and other settings where AGs face a high risk of HIV acquisition.

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.

'When I have these kits I have confidence' - HIV self-testing provides agency for women in their sexual decision-making.

Oral fluid-based HIV self-testing (HIVST) has emerged as a promising approach to increasing HIV testing coverage, particularly among high-risk populations. Understanding the experiences of women using self-tests and offering them to their sexual partners (secondary distribution) is crucial for determining the potential of HIVST. Qualitative in-depth interviews were conducted among 32 women at high risk of HIV infection, including women who engage in transactional sex, who participated in a cluster randomised trial of a secondary distribution strategy in western Kenya. Interviews explored how women used self-tests within relationships and how this affected their sexual decision-making. Three key themes emerged: women used HIVST to assess risk prior to engaging in sex with partners; HIVST provided women with increased agency to engage in or end relationships; and women appreciated these benefits and urged expanded access to self-tests. HIVST has the potential to support HIV prevention objectives in settings with high prevalence of HIV.Trial registration: ClinicalTrials.gov identifier: NCT03135067.

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.

Male Circumcision Reduces Penile HPV Incidence and Persistence: A Randomized Controlled Trial in Kenya.

BACKGROUND: Male circumcision reduces the risk of human immunodeficiency virus infection in men. We assessed the effect of male circumcision on the incidence and natural history of human papillomavirus (HPV) in a randomized clinical trial in Kisumu, Kenya. METHODS: Sexually active, 18- to 24-year-old men provided penile exfoliated cells for HPV DNA testing every 6 months for 2 years. HPV DNA was detected via GP5+/6+ PCR in glans/coronal sulcus and in shaft samples. HPV incidence and persistence were assessed by intent-to-treat analyses. RESULTS: A total of 2,193 men participated (1,096 randomized to circumcision; 1,097 controls). HPV prevalence was 50% at baseline for both groups and dropped to 23.7% at 24 months in the circumcision group, and 41.0% in control group. Incident infection of any HPV type over 24 months was lower among men in the circumcision group than in the control group [HR = 0.61; 95% confidence interval (CI), 0.52-0.72]. Clearance rate of any HPV infection over 24 months was higher in the circumcision group than in the control group (HR = 1.87; 95% CI, 1.49-2.34). Lower HPV point-prevalence, lower HPV incidence, and higher HPV clearance in the circumcision group were observed in glans but not in shaft samples. CONCLUSION: Male circumcision reduced the risk of HPV acquisition and reinfection, and increased HPV clearance in the glans. IMPACT: Providing voluntary, safe, and affordable male circumcision should help reduce HPV infections in men, and consequently, HPV-associated disease in their partners.

HIV testing approaches to reach the first UNAIDS 95% target in sub-Saharan Africa.

HIV testing is a crucial first step to accessing HIV prevention and treatment services and to achieving the UNAIDS target of 95% of people living with HIV being aware of their status by 2030. Combined implementation of facility-based and community-based approaches has helped to achieve high levels of HIV testing coverage in many countries including those in sub-Saharan Africa. Approaches such as index testing and self-testing help to reach individuals at higher risk of acquiring HIV, men, and those less likely to use health facilities or community-based services. However, as the proportion of people living with HIV who are aware of their HIV status has risen, the challenge of reaching those who remain undiagnosed or those who are at high risk of acquiring HIV has grown. Demand generation and novel testing approaches will be necessary to reach undiagnosed people living with HIV and to promote frequent retesting among key and priority populations.

Incidence and clearance of penile human papillomavirus infection among circumcised Kenyan men.

Prospective data are limited on human papillomavirus (HPV) acquisition and clearance among circumcised men from resource-limited geographical regions, particularly Africa. The goal of this study was to estimate incidence and clearance of type-specific genital HPV infection in men. Penile exfoliated cell specimens were collected from the glans/coronal sulcus and shaft of 1,037 circumcised Kenyan men at baseline and 6-, 12- and 18-month follow-up visits between 2003-2007. Specimens were tested with GP5+/6+ PCR to detect 44 HPV types. The median age of participants at baseline was 21 years (range 18-28). The 12- and 18-month incidence rates (IRs) for any HPV were 34.9/100 person-years (95% confidence interval [CI]: 31.2-39.0) and 36.4/100 person-years (95% CI: 32.9-40.2), respectively. The 18-month cumulative risk for high-risk HPV was 30% compared to 16% for low-risk HPV. Cumulative risk was not associated with age or anatomical site. The estimated probability of any HPV infection clearing by 12 months was 0.92. Time until HPV clearance was not associated with age, anatomical site, or whether HPV infection type was high-risk or low-risk. HPV IRs among circumcised men in this study were comparable to other circumcised populations.

HIV Self-Testing Can Be Liberating to HIV-Positive Women and Their Sexual Partners: A Qualitative Study in Kisumu, Western Kenya.

BACKGROUND: Nearly half of Kenyan men with HIV-positive partners do not know their partner's status. We carried out a qualitative substudy to explore the experiences of a sample of HIV-positive women when distributing HIV self-tests (HIVST) to their sexual partners. METHODS: HIV-positive women were invited for in-depth interviews to share their experiences in offering HIVST to their partners and how self-testing impacted their relationships. RESULTS: Two hundred ninety-seven women were randomized to HIVST, 12 of whom self-reported being HIV positive and 11 participated in the interview. Self-testing procedures and interpretation of results were well understood. Participants were strategic in approaching their partners, thus avoided partner violence. Couple testing was high, which strengthened relationships, improved condom use, and empowered women to make joint decisions concerning their health. CONCLUSIONS: Giving HIV-positive women HIVST kits to distribute to their male partners is feasible and safe. Providers who have challenges reaching male partners with testing should consider HIVST.

Rollout of ShangRing circumcision with active surveillance for adverse events and monitoring for uptake in Kenya.

INTRODUCTION: Since 2011, Kenya has been evaluating ShangRing device for use in its voluntary medical male circumcision (VMMC) program according to World Health Organization (WHO) guidelines. Compared to conventional surgical circumcision, the ShangRing procedure is shorter, does not require suturing and gives better cosmetic outcomes. After a pilot evaluation of ShangRing in 2011, Kenya conducted an active surveillance for adverse events associated with its use from 2016-2018 to further assess its safety, uptake and to identify any operational bottlenecks to its widespread use based on data from a larger pool of procedures in routine health care settings. METHODS: From December 2017 to August 2018, HIV-negative VMMC clients aged 13 years or older seeking VMMC at six sites across five counties in Kenya were offered ShangRing under injectable local anesthetic as an alternative to conventional surgical circumcision. Providers described both procedures to clients before letting them make a choice. Outcome measures recorded for clients who chose ShangRing included the proportions who were clinically eligible, had successful device placement, experienced adverse events (AEs), or failed to return for device removal. Clients failing to return for follow up were sought through phone calls, text messages or home visits to ensure removal and complete information on adverse events. RESULTS: Out of 3,692 eligible clients 1,079 (29.2%) chose ShangRing; of these, 11 (1.0%) were excluded due to ongoing clinical conditions, 17 (1.6%) underwent conventional surgery due to lack of appropriate device size at the time of the procedure, 97.3% (1051/1079) had ShangRing placement. Uptake of ShangRing varied from 11% to 97% across different sites. There was one severe AE, a failed ShangRing placement (0.1%) managed by conventional wound suturing, plus two moderate AEs (0.2%), post removal wound dehiscence and bleeding, that resolved without sequelae. The overall AE rate was 0.3%. All clients returned for device removal from fifth to eleventh day after placement. CONCLUSION: ShangRing circumcision is effective and safe in the Kenyan context but its uptake varies widely in different settings. It should be rolled out under programmatic implementation for eligible males to take advantage of its unique benefits and the freedom of choice beyond conventional surgical MMC. Public education on its availability and unique advantages is necessary to optimize its uptake and to actualize the benefit of its inclusion in VMMC programs.

You can't do this job when you are sober: Heroin use among female sex workers and the need for comprehensive drug treatment programming in Kenya.

AIMS: Globally, women who use drugs often practice sex work and experience multiple health and social harms that complicate their drug treatment needs. In East Africa, understanding the emergence of heroin use among women is critical in efforts to build effective drug treatment programming, including the ongoing scale-up of medication-assisted treatment (MAT). We explored heroin use among women engaged in sex work in Kenya to inform services. METHODS: In a qualitative study of 45 female sex workers reporting substance use in Kisumu, Kenya, 32 reported lifetime heroin use and comprise the focus of this analysis. Semi-structured interviews explored histories of substance use and sex work and health programming needs. Thematic analysis focused on the contexts and meanings of heroin use. RESULTS: Among 32 women, median age was 28 (range: 18-37). Women commonly smoked cocktails containing heroin while using alcohol and other drugs prior to sex work. Most women perceived heroin to engender "morale" and "courage" to engage in sex work and "fight" potentially abusive clients. Sex work reinforced drug use in ways that both managed and created new risks. CONCLUSIONS: Drawing on the concept of "paradoxical autonomy," we suggest that heroin use engenders new forms of autonomy allowing women to support themselves in conditions of uncertainty, yet does not enable them to entirely overcome their vulnerabilities. Drug treatment programs for sex workers should address the situated logics of substance use in contexts of sexual risk, including patterns of poly-substance use that may render MAT inappropriate for some women who use heroin.

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.

Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study.

BACKGROUND: Increased uptake of HIV testing by men in sub-Saharan Africa is essential for the success of combination prevention. Self-testing is an emerging approach with high acceptability, but little evidence exists on the best strategies for test distribution. We assessed an approach of providing multiple self-tests to women at high risk of HIV acquisition to promote partner HIV testing and to facilitate safer sexual decision making. METHODS: In this cohort study, HIV-negative women aged 18-39 years were recruited at two sites in Kisumu, Kenya: a health facility with antenatal and post-partum clinics and a drop-in centre for female sex workers. Participants gave informed consent and were instructed on use of oral fluid based rapid HIV tests. Participants enrolled at the health facility received three self-tests and those at the drop-in centre received five self-tests. Structured interviews were conducted with participants at enrolment and over 3 months to determine how self-tests were used. Outcomes included the number of self-tests distributed by participants, the proportion of participants whose sexual partners used a self-test, couples testing, and sexual behaviour after self-testing. FINDINGS: Between Jan 14, 2015, and March 13, 2015, 280 participants were enrolled (61 in antenatal care, 117 in post-partum care, and 102 female sex workers); follow-up interviews were completed for 265 (96%). Most participants with primary sexual partners distributed self-tests to partners: 53 (91%) of 58 participants in antenatal care, 91 (86%) of 106 in post-partum care, and 64 (75%) of 85 female sex workers. 82 (81%) of 101 female sex workers distributed more than one self-test to commercial sex clients. Among self-tests distributed to and used by primary sexual partners of participants, couples testing occurred in 27 (51%) of 53 in antenatal care, 62 (68%) of 91 from post-partum care, and 53 (83%) of 64 female sex workers. Among tests received by primary and non-primary sexual partners, two (4%) of 53 tests from participants in antenatal care, two (2%) of 91 in post-partum care, and 41 (14%) of 298 from female sex workers had positive results. Participants reported sexual intercourse with 235 (62%) of 380 sexual partners who tested HIV-negative, compared with eight (18%) of 45 who tested HIV-positive (p<0·0001); condoms were used in all eight intercourse events after positive results compared with 104 (44%) after of negative results (p<0·0018). Four participants reported intimate partner violence as a result of self-test distribution: two in the post-partum care group and two female sex workers. No other adverse events were reported. INTERPRETATION: Provision of multiple HIV self-tests to women at high risk of HIV infection was successful in promoting HIV testing among their sexual partners and in facilitating safer sexual decisions. This novel strategy warrants further consideration as countries develop self-testing policies and programmes. FUNDING: Bill & Melinda Gates Foundation.

Evidence of injection drug use in Kisumu, Kenya: Implications for HIV prevention.

BACKGROUND: Injection drug use is increasingly contributing to the HIV epidemic across sub-Saharan Africa. This paper provides the first descriptive analysis of injection drug use in western Kenya, where HIV prevalence is already highest in the nation at 15.1%. METHODS: We draw on quantitative data from a study of injection drug use in Kisumu, Kenya. We generated descriptive statistics on socio-demographics, sexual characteristics, and drug-related behaviors. Logistic regression models were adjusted for sex to identify correlates of self-reported HIV positive status. RESULTS: Of 151 participants, mean age was 28.8 years, 84% (n = 127) were male, and overall self-reported HIV prevalence reached 19.4%. Women had greater than four times the odds of being HIV positive relative to men (Odds Ratio [OR] 4.5, CI: 1.7, 11.8, p = .003). Controlling for sex, ever experiencing STI symptoms (Adjusted Odds ratio [AOR] 4.6, 95% CI 1.7, 12.0, p = .002) and sharing needles or syringes due to lack of access (AOR 3.6, 95% CI 1.2, 10.5, p = .02) were significantly associated with HIV positive status. Lower education (AOR 2.3, 95% CI 0.9, 5.6, p=.08), trading sex for drugs (AOR 2.8, 95% CI 0.9, 8.8, p = .08), being injected by a peddler (AOR 2.9, 95% CI 1.0, 8.5, p = .05), and injecting heroin (AOR 2.3, 95% CI 1.0, 5.7, p = .06), were marginally associated with HIV. CONCLUSIONS: This exploratory study identified patterns of unsafe drug injection and concurrent sexual risk in western Kenya, yet few resources are currently available to address addiction or injection-related harm. Expanded research, surveillance, and gender sensitive programming are needed.

Acquisition and persistence of human papillomavirus 16 (HPV-16) and HPV-18 among men with high-HPV viral load infections in a circumcision trial in Kisumu, Kenya.

BACKGROUND: Circumcision and lower human papillomavirus (HPV) viral loads in men are possibly associated with a reduced risk of HPV transmission to women. However, the association between male circumcision and HPV viral load remains unclear. METHODS: Swab specimens from the glans and shaft of the penis were collected from men enrolled in a circumcision trial in Kisumu, Kenya. GP5+/6+ polymerase chain reaction (PCR) was used to identify HPV DNA types. HPV-16 and HPV-18 loads were measured with a LightCycler real-time PCR and classified as high (>250 copies/scrape) or low (≤250 copies/scrape). RESULTS: A total of 1159 men were randomly assigned to undergo immediate circumcision, and 1140 men were randomly assigned to the control arm (these individuals were asked to remain uncircumcised until the study ended). The hazard of acquisition of high-viral load infections in the glans was lower in the circumcision arm, compared with the control arm, for HPV-16 (hazard ratio [HR], 0.32 [95% confidence interval {CI}, .20-.49]) and HPV-18 (HR, 0.34 [95% CI, .21-.54]). The 6-month risk of HPV persistence among men with high-viral load infections in the glans at baseline was lower in the circumcision arm, compared with the control arm, for HPV-16 (risk ratio [RR], 0.36 [95% CI, .18-.72]) and HPV-18 (RR 0.34 [95% CI, .13-.86]). Weaker and less precise results were obtained for shaft samples. CONCLUSIONS: Male circumcision could potentially reduce the risk of HPV transmission to women by reducing the hazard of acquisition, and the risk of persistence of high-HPV viral load infections in the glans in men.

Perception of HIV risk and adherence to a daily, investigational pill for HIV prevention in FEM-PrEP.

BACKGROUND: FEM-PrEP was unable to demonstrate the effectiveness of oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis for HIV prevention because of low adherence. We hypothesized that one reason for the poor adherence was low perceived HIV risk. METHODS: At enrollment and at quarterly follow-up visits, we assessed participants' perceived HIV risk for the subsequent 4 weeks. We used logistic regression to assess factors associated with some (small, moderate, or high) perceived HIV risk. We also used logistic regression with robust variance estimation to assess the association between risk perceptions (none versus some) reported at enrollment and at weeks 12, 24, and 36 and good adherence based on drug concentrations of plasma tenofovir and intracellular tenofovir diphosphate in specimens collected 4 weeks later (at weeks 4, 16, 28, and 40) among 150 randomly selected participants assigned FTC/TDF. RESULTS: Multiple factors were statistically associated with having some perceived risk, including having sex without a condom, having multiple partners, and not knowing if a partner has HIV. We observed a significant association between having some risk perception and good adherence (odds ratio: 2.0; 95% confidence interval: 1.1 to 3.5; P = 0.016). CONCLUSIONS: Data suggest that participants are likely knowledgeable about factors that increase their HIV risk. Perceived risk seemed to have influenced some participants' decisions to adhere to the study pill within the context of a placebo-controlled clinical trial. Future research can explore the role of risk perception in the uptake of and adherence to pre-exposure prophylaxis, now that FTC/TDF has been shown efficacious.

Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Barriers and facilitators to pre-exposure prophylaxis (PrEP) eligibility screening and ongoing HIV testing among target populations in Bondo and Rarieda, Kenya: results of a consultation with community stakeholders.

BACKGROUND: As pre-exposure prophylaxis (PrEP) moves closer to availability in developing countries, practical considerations for implementation become important. We conducted a consultation with district-level community stakeholders experienced in HIV-prevention interventions with at-risk populations in Bondo and Rarieda, Kenya to generate locally grounded approaches to the future rollout of oral PrEP to four populations: fishermen, widows, female sex workers, and serodiscordant couples. METHODS: The 20 consultation participants represented the Ministry of Health, faith- and community-based organizations, health facilities, community groups, and nongovernmental organizations. Participants divided into breakout groups and followed a structured discussion guide asking them to identify barriers to implementing HIV-prevention interventions (including PrEP) with each population. Questions also solicited solutions for addressing these barriers, as well as other facilitators for PrEP implementation. In particular, questions focused on how to encourage people to screen for PrEP eligibility by having HIV and other blood tests and how to encourage compliance with ongoing HIV testing. RESULTS: The barriers and facilitators/solutions discussants provided were frequently population-specific, but there were also broad-level similarities across populations. Service delivery barriers to HIV-prevention interventions concerned the need for staff trained to address the needs of particular populations. Service delivery facilitators to provision of ongoing HIV testing consisted of offering testing options besides facility-based testing. Stigma was the main community-level barrier for all groups, whereas barriers at the level of target populations included mobility; lifestyle and life circumstances, especially cultural norms among fishermen and widows; and fears, lack of awareness, and misinformation. Proposed facilitators and strategies for addressing community- and population-level barriers included topic-specific education within the populations and community, involvement of partners and family members, mass HIV testing, and peer educators. Barriers to PrEP uptake included non-adherence to pill taking and missing clinic visits. For drug adherence, facilitators were counselling and involving family members. Discussants suggested that client reminders, e.g., home visits, were needed to encourage clients to keep their clinic appointments. CONCLUSIONS: Strategies for encouraging eligibility screening and ongoing HIV testing will have local and population-specific aspects. Our results nonetheless apply to similar populations throughout sub-Saharan Africa and reach beyond oral PrEP to other ARV-based PrEP formulations.