"Pharmacies are Everywhere, and You can get it at any Time": Experiences With Pharmacy-Based PrEP Delivery Among Adolescent Girls and Young Women in Kisumu, Kenya.

INTRODUCTION: Many Kenyan adolescent girls and young women (AGYW) with behaviors associated with HIV acquisition access contraception at retail pharmacies. Offering oral pre-exposure prophylaxis (PrEP) in pharmacies could help reach AGYW with PrEP services. METHODS: We piloted PrEP delivery at 3 retail pharmacies in Kisumu, Kenya. AGYW purchasing contraception were offered PrEP by nurses with remote prescriber oversight. AGYW who accepted were provided with a free 1-month supply. We conducted in-depth interviews with AGYW 30 days postobtaining PrEP. Transcripts were analyzed to explore experiences of AGYW accessing PrEP at pharmacies. RESULTS: We conducted 41 interviews. AGYW preferred pharmacies for accessing PrEP and they were willing to pay for PrEP even if available for free at clinics. Reasons for this preference included accessibility, lack of queues, and medication stockouts, privacy, anonymity, autonomy, and high-quality counseling from our study nurses. CONCLUSIONS: Pharmacies may be an important PrEP access option for this population.

Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial.

Youth living with HIV (YLHIV) report that negative interactions with health care workers (HCWs) affects willingness to return to care. This stepped wedge randomized trial evaluated effectiveness of a standardized patient actor (SP) HCW training intervention on adolescent engagement in care in Kenya. HCWs caring for YLHIV at 24 clinics received training on adolescent care, values clarification, communication, and motivational interviewing, with 7 SP encounters followed by facilitated feedback of videotaped interactions. Facilities were randomized to timing of the intervention. The primary outcome was defined as return within 3 months after first visit (engagement) among YLHIV who were either newly enrolled or who returned to care after >3 months out of care. Visit data was abstracted from electronic medical records. Generalized linear mixed models adjusted for time, being newly enrolled, and clustering by facility. YLHIV were surveyed regarding satisfaction with care. Overall, 139 HCWs were trained, and medical records were abstracted for 4,595 YLHIV. Median YLHIV age was 21 (IQR 19-23); 82% were female, 77% were newly enrolled in care, and 75% returned within 3 months. Half (54%) of trained HCWs remained at their clinics 9 months post-training. YLHIV engagement improved over time (global Wald test, p = 0.10). In adjusted models, the intervention showed no significant effect on engagement [adjusted Prevalence Ratio (aPR) = 0.95, 95% Confidence Interval (CI): 0.88-1.02]. Newly enrolled YLHIV had significantly higher engagement than those with prior lapses in care (aPR = 1.18, 95%CI: 1.05-1.33). Continuous satisfaction with care scores were significantly higher by wave 3 compared to baseline (coefficient = 0.38, 95%CI: 0.19-0.58). Despite provider skill improvement, there was no effect of SP training on YLHIV engagement in care. This may be due to temporal improvements or turnover of trained HCWs. Strategies to retain SP-training benefits need to address HCW turnover. YLHIV with prior gaps in care may need more intensive support. Registration CT #: NCT02928900. https://clinicaltrials.gov/ct2/show/NCT02928900.

"They have given you the morale and confidence:" adolescents and young adults want more community-based oral HIV self-testing options in Kenya.

Community-based delivery of oral HIV self-testing (HIVST) may expand access to testing among adolescents and young adults (AYA). Eliciting youth perspectives can help to optimize these services. We conducted nine focus group discussions (FGDs) with HIV negative AYA aged 15-24 who had completed oral HIVST following community-based distribution through homes, pharmacies, and bars. FGDs were stratified by distribution point and age (15-17, 18-24). Participants valued HIVST because it promoted greater autonomy and convenience compared to traditional clinic-based testing. AYA noted how HIVST could encourage positive behavior change, including using condoms to remain HIV negative. Participants recommended that future testing strategies include individualized, ongoing support during and after testing. Support examples included access to trained peer educators, multiple community-based distribution points, and post-test support via phones and websites. Multiple distribution points and trained peer educators' involvement in all steps of distribution, testing, and follow-up can enhance future community-based HIVST programs.

"I Have Actually not Lost any Adolescent Since I Started Engaging Them one on one:" Training Satisfaction and Subsequent Practice among Health Providers Participating in a Standardized Patient Actor Training to Improve Adolescent Engagement in HIV Care.

BACKGROUND: Poor health care worker (HCW) interactions with adolescents negatively influence engagement in HIV care. We assessed the impact of standardized patient actor training on HCW competence in providing adolescent HIV care in Kenya. METHODS: We conducted pre-post cross-sectional surveys and qualitative exit interviews during a stepped wedge randomized trial. Cross-sectional surveys assessed self-rated competence in providing adolescent services before and after the intervention, and training satisfaction. In-depth interviews with a subset of HCW participants one year after training. RESULTS: Over 90% of HCWs reported satisfaction with the training and there was significant improvement in self-rated competence scores (mean = 4.63 [highest possible score of 5] post-training vs 3.86 pre-training, p < 0.001). One-year following training, HCWs reported using skills in patient-centered communication and structuring an adolescent clinical encounter. CONCLUSIONS: This SP training intervention improved self-rated competence and showed sustained perceived impact on HCW skills in adolescent HIV service provision one year later.

High Acceptance and Completion of HIV Self-testing Among Diverse Populations of Young People in Kenya Using a Community-Based Distribution Strategy.

Oral HIV self-testing (HIVST) may expand access to testing among hard-to-reach reach adolescents and young adults (AYA). We evaluated community-based HIVST services for AYA in an urban settlement in Kenya. Peer-mobilizers recruited AYA ages 15-24 through homes, bars/clubs, and pharmacies. Participants were offered oral HIVST, optional assistance and post-test counseling. Outcomes were HIVST acceptance and completion (self-report and returned kits). Surveys were given at enrollment, post-testing, and 4 months. Log-binomial regression evaluated HIVST preferences by venue. Among 315 reached, 87% enrolled. HIVST acceptance was higher in bars/clubs (94%) than homes (86%) or pharmacies (75%). HIVST completion was 97%, with one confirmed positive result. Participants wanted future HIVST at multiple locations, include PrEP, and cost ≤ $5USD. Participants from bars/clubs and pharmacies were more likely to prefer unassisted testing and peer-distributers compared to participants from homes. This differentiated community-based HIVST strategy could facilitate engagement in HIV testing and prevention among AYA.

Modeling the health impact and cost threshold of long-acting ART for adolescents and young adults in Kenya.

BACKGROUND: Despite high efficacy of oral antiretroviral therapy (ART), viral suppression among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa (SSA) remains low. Compared to daily oral ART, bimonthly long-acting injectable ART (LA-ART) may simplify adherence, improve clinical outcomes, and decrease HIV transmission in this priority population. However, LA-ART will likely cost more than oral ART and the cost threshold at which LA-ART will be cost effective in SSA has not been evaluated. METHODS: We adapted a mathematical model of HIV transmission and progression in Kenya to include HIV acquisition and viral suppression among AYA (age 10-24). We projected the population-level health and economic impact of providing LA-ART to AYA over a 10-year time horizon assuming oral ART costs of US$233 annually and a two-month duration of viral suppression per LA-ART injection. We calculated the maximum cost at which switching from oral to LA-ART would be considered cost-effective, using thresholds of $500 and $1,508 per disability-adjusted life year averted (WHO's threshold of HIV treatment interventions and Kenya's gross domestic product per capita). FINDINGS: Assuming 85% of AYA switch from oral to injectable formulations, LA-ART is estimated to prevent 40,540 infections and 20,480 deaths over 10 years. The maximum increase in the annual per-person cost of receiving LA-ART is estimated to be $89 and $236 for LA-ART to be cost-effective under the thresholds of $500 and $1,508 per DALY averted, respectively. The cost threshold was lower when non-adherent oral ART AYA users were assumed to be less likely to switch to LA-ART. INTERPRETATION: Providing LA-ART to AYA can be cost-effective in Kenya if it is less than twice the cost of oral ART. Long-acting injectable ART for priority populations with low viral suppression has the potential to cost-effectively avert disability and death. FUNDING: National Institutes of Health (R01 HD085807; PI: Kohler).

Brief Report: Time to Repeat Viral Load Testing Among Unsuppressed Adolescents and Young Adults Living With HIV in Kenya.

BACKGROUND: Repeat HIV viral load (VL) testing is required after unsuppressed VL to confirm treatment failure. We assessed proportion of adolescents and young adults living with HIV (AYALHIV) in Kenya with a confirmatory VL test and time to repeat testing. DESIGN: A retrospective analysis of longitudinal data abstracted from Kenya's national VL database. METHODS: VL data for AYALHIV who were 10-24 year old between April 2017 and May 2019 were abstracted from 117 HIV care clinics. Records were eligible if at least one VL test was performed ≥6 months after antiretroviral therapy (ART) initiation. The proportion of unsuppressed AYALHIV (≥1000 copies/mL) and time in months between first unsuppressed VL and repeat VL was determined. RESULTS: We abstracted 40,928 VL records for 23,969 AYALHIV; of whom, 17,092 (71%) were eligible for this analysis. Of these, 12,122 (71%) were women, median age of 19 years [interquartile range (IQR): 13-23], and median ART duration of 38 months (IQR: 16-76). Among eligible AYALHIV, 4010 (23%) had an unsuppressed VL at first eligible measurement. Only 316 (8%) of the unsuppressed AYALHIV had a repeat VL within 3 months and 1176 (29%) within 6 months. Among 2311 virally unsuppressed AYALHIV with a repeat VL, the median time between the first and the repeat VL was 6 months (IQR: 4-8), with 1330 (58%) having confirmed treatment failure. CONCLUSIONS: One-quarter of AYALHIV on ART had unsuppressed VL, with less than a third receiving a repeat VL within 6 months. Strategies to improve VL testing practices are needed to improve AYALHIV's outcomes.

High Awareness, Yet Low Uptake, of Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women Within Family Planning Clinics in Kenya.

Adolescent girls and young women (AGYW) are a priority population for HIV prevention in high-burden settings. We evaluated psychosocial characteristics, behavioral risk factors for HIV, and pre-exposure prophylaxis (PrEP) awareness and uptake among AGYW seeking contraceptive services at four public sector family planning (FP) clinics offering integrated PrEP delivery in Kisumu, Kenya. From October 2018 to June 2019, we approached all AGYW (aged 15-24 years) seeking contraception to participate in a survey following receipt of FP services and PrEP screening. Overall, 470 AGYW were screened for PrEP at their FP visit by facility staff and subsequently enrolled in the survey. Median age was 22 years (interquartile range 20-23), 22% of AGYW were in school, and 55% were married. The most frequent forms of contraception were implants and injectables (41% each). Over a third of AGYW (36%) reported low social support, 13% had symptoms of moderate to severe depression, and 3% reported intimate partner violence. Three-quarters (75%) of AGYW reported recent condomless sex and 42% suspected that their primary partner had other sexual partners. Most AGYW (89%) had previously heard of PrEP; 76% had at least one PrEP eligibility criterion as per national guidelines; however, only 4% initiated PrEP at their current FP visit. PrEP initiators more frequently had high HIV risk perception than noninitiators (85% vs. 10%, p < 0.001). Low perceived HIV risk (76%) and pill burden (51%) were common reasons for declining PrEP among AGYW with HIV behavioral risk factors. PrEP counseling should be tailored to AGYW to guide appropriate PrEP decision-making in this important population.

Training Exposure and Self-Rated Competence among HIV Care Providers Working with Adolescents in Kenya.

Lack of health care worker (HCW) training is a barrier to implementing youth-friendly services. We examined training coverage and self-reported competence, defined as knowledge, abilities, and attitudes, of HCWs caring for adolescents living with HIV (ALWH) in Kenya. Surveys were conducted with 24 managers and 142 HCWs. Competence measures were guided by expert input and Kalamazoo II Consensus items. Health care workers had a median of 3 (interquartile range [IQR]: 1-6) years of experience working with ALWH, and 40.1% reported exposure to any ALWH training. Median overall competence was 78.1% (IQR: 68.8-84.4). In multivariable linear regression analyses, more years caring for ALWH and any prior training in adolescent HIV care were associated with significantly higher self-rated competence. Training coverage for adolescent HIV care remains suboptimal. Targeting HCWs with less work experience and training exposure may be a useful and efficient approach to improve quality of youth-friendly HIV services.

Health provider training is associated with improved engagement in HIV care among adolescents and young adults in Kenya.

OBJECTIVES: Adolescents and young adults (AYA) have poorer retention, viral suppression, and survival than other age groups. We evaluated correlates of initial AYA engagement in HIV care at facilities participating in a randomized trial in Kenya. DESIGN: Retrospective cohort study. METHODS: Electronic medical records from AYA ages 10-24 attending 24 HIV care facilities in Kenya were abstracted. Facility surveys assessed provider trainings and services. HIV provider surveys assessed AYA training and work experience. Engagement in care was defined as return for first follow-up visit within 3 months among newly enrolled or recently re-engaged (returning after >3 months out of care) AYA. Multilevel regression estimated risk ratios and 95% confidence intervals (CIs), accounting for clustering by facility. Final models adjusted for AYA individual age and median AYA age and number enrolled per facility. RESULTS: Among 3662 AYA records at first eligible visit, most were female (75.1%), older (20-24 years: 54.5%), and on antiretroviral therapy (79.5%). Overall, 2639 AYA returned for care (72.1%) after enrollment or re-engagement visit. Engagement in care among AYA was significantly higher at facilities offering provider training in adolescent-friendly care (85.5 vs. 67.7%; adjusted risk ratio (aRR) 1.11, 95% CI: 1.01-1.22) and that used the Kenyan government's AYA care checklist (88.9 vs. 69.2%; aRR 1.14, 95% CI: 1.06-1.23). Engagement was also significantly higher at facilities where providers reported being trained in AYA HIV care (aRR 1.56, 95% CI: 1.13-2.16). CONCLUSION: Adolescent-specific health provider training and tools may improve quality of care and subsequent AYA engagement. Health provider interventions are needed to achieve the '95-95-95' targets for AYA.

Distance to HIV and Antenatal Care: A Geospatial Analysis in Siaya County, Kenya.

As maternal child health (MCH) programs expand in the setting of HIV, health systems are challenged to reach those most vulnerable and at the greatest need. Cross-sectional surveys of MCH clinics and recent mothers in the Siaya Health Demographic Surveillance System were conducted to assess correlates of accessing antenatal care and facility delivery. Of 376 recent mothers, 93.4% accessed antenatal care and 41.2% accessed facility delivery. Per-kilometer distance between maternal residence and the nearest facility offering delivery services was associated with 7% decreased probability of uptake of facility delivery. Compared with a reference of less than 1 km between home and clinic, a distance of more than 3 km to the nearest facility was associated with 25% decreased probability of uptake of facility delivery. Distance to care was a factor in accessing facility delivery services. Decentralization or transportation considerations may be useful to optimize MCH and HIV service impact in high-prevalence regions.

Influence and involvement of support people in adolescent and young adult HIV testing.

HIV incidence and mortality are high among adolescents and young adults (AYA) in sub-Saharan Africa, but testing rates are low. Understanding how support people (SP), such as peers, partners, or parents, influence AYA may improve HIV testing uptake. AYA aged 14-24 seeking HIV testing at a referral hospital in Nairobi, Kenya completed a post-test survey assessing the role of SP. Among 1062 AYA, median age was 21. Overall, 12% reported their decision to test was influenced by a parent, 20% by a partner, and 22% by a peer. Young adults (20-24 years old) were more likely than adolescents (14-19 years old) to be influenced to test by partners (23% vs. 12%, p < .001), and less likely by parents (6.6% vs. 27%, p < .001), healthcare workers (11% vs. 16%, p < .05), or counselors (9.4% vs. 19%, p < .001). Half of AYA were accompanied for testing (9.9% with parent, 10% partner, 23% peer, 4.3% others, and 2.1% multiple types). Young adults were more likely than adolescents to present alone (58% vs. 32%, p < .001) or with a partner (12% vs. 6.7%, p < .05), and less likely with a parent (1.6% vs. 31%, p < .001). Similar proportions of adolescents and young adults came with a peer or in a group. Correlates of presenting with SP included: younger age (aRR = 1.55 [95%CI = 1.30-1.85]), female sex (aRR = 1.45 [95%CI = 1.21-1.73]), and school enrollment (aRR = 1.41 [95%CI = 1.05-1.88]). SP play an important role in AYAs' HIV testing and varies with age. Leveraging SP may promote uptake of HIV testing and subsequent linkage care for AYA.

Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial.

BACKGROUND: Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10-24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills. This stepped-wedge randomized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA, resulting in increased retention in care. METHODS/DESIGN: The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment, communication, and empathy skills for AYA HIV care. We will recruit 24 clinics in Kenya with an active electronic medical record (EMR) system and at least 40 adolescents enrolled in HIV care per site. Stratified randomization by county will be used to assign clinics to one of four waves - time periods when they receive the intervention - with each wave including six clinics. From each clinic, up to 10 HCWs will participate in the training intervention. SP training includes didactic sessions in adolescent health, current guidelines, communication skills, and motivational interviewing techniques. HCW participants will rotate through seven standardized SP scenarios, followed by SP feedback, group debriefing, and remote expert evaluation. AYA outcomes will be assessed using routine clinic data. The primary outcome is AYA retention in HIV care, defined as returning for first follow-up visit within 6 months of presenting to care, or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up. Secondary outcomes include HCW competency scores, AYA satisfaction with care, and AYA clinical outcomes including CD4 and viral load. Additional analyses will determine cost-effectiveness of the intervention. DISCUSSION: This trial will contribute valuable information to HIV programs in Kenya and other low-resource settings, providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02928900. Registered 26 August 2016.

"At our age, we would like to do things the way we want: " a qualitative study of adolescent HIV testing services in Kenya.

OBJECTIVES: Adolescents in Africa have low HIV testing rates. Better understanding of adolescent, provider, and caregiver experiences in high-burden countries such as Kenya could improve adolescent HIV testing programs. DESIGN: We conducted 16 qualitative interviews with HIV-positive and HIV-negative adolescents (13-18 years) and six focus group discussions with Healthcare workers (HCWs) and caregivers of adolescents in Nairobi, Kenya. METHODS: Semi-structured interviews and focus groups were recorded and transcribed. Analysis employed a modified constant comparative approach to triangulate findings and identify themes influencing testing experiences and practices. RESULTS: All groups identified that supportive interactions during testing were essential to the adolescent's positive testing experience. HCWs were a primary source of support during testing. HCWs who acted respectful and informed helped adolescents accept results, link to care, or return for repeat testing, whereas HCWs who acted dismissive or judgmental discouraged adolescent testing. Caregivers universally supported adolescent testing, including testing with the adolescent to demonstrate support. Caregivers relied on HCWs to inform and encourage adolescents. Although peers played less significant roles during testing, all groups agreed that school-based outreach could increase peer demand and counteract stigma. All groups recognized tensions around adolescent autonomy in the absence of clear consent guidelines. Adolescents valued support people during testing but wanted autonomy over testing and disclosure decisions. HCWs felt pressured to defer consent to caregivers. Caregivers wanted to know results regardless of adolescents' wishes. CONCLUSION: Findings indicate that strengthening HCW, caregiver, and peer capacities to support adolescents while respecting their autonomy may facilitate attaining '90-90-90' targets for adolescents.

Continuous quality improvement intervention for adolescent and young adult HIV testing services in Kenya improves HIV knowledge.

OBJECTIVES: To determine whether continuous quality improvement (CQI) improves quality of HIV testing services for adolescents and young adults (AYA). DESIGN: CQI was introduced at two HIV testing settings: Youth Centre and Voluntary Counseling and Testing (VCT) Center, at a national referral hospital in Nairobi, Kenya. METHODS: Primary outcomes were AYA satisfaction with HIV testing services, intent to return, and accurate HIV prevention and transmission knowledge. Healthcare worker (HCW) satisfaction assessed staff morale. T tests and interrupted time series analysis using Prais-Winsten regression and generalized estimating equations accounting for temporal trends and autocorrelation were conducted. RESULTS: There were 172 AYA (Youth Centre = 109, VCT = 63) during 6 baseline weeks and 702 (Youth Centre = 454, VCT = 248) during 24 intervention weeks. CQI was associated with an immediate increase in the proportion of AYA with accurate knowledge of HIV transmission at Youth Centre: 18 vs. 63% [adjusted risk difference (aRD) 0.42,95% confidence interval (CI) 0.21 to 0.63], and a trend at VCT: 38 vs. 72% (aRD 0.30, 95% CI -0.04 to 0.63). CQI was associated with an increase in the proportion of AYA with accurate HIV prevention knowledge in VCT: 46 vs. 61% (aRD 0.39, 95% CI 0.02-0.76), but not Youth Centre (P = 0.759). In VCT, CQI showed a trend towards increased intent to retest (4.0 vs. 4.3; aRD 0.78, 95% CI -0.11 to 1.67), but not at Youth Centre (P = 0.19). CQI was not associated with changes in AYA satisfaction, which was high during baseline and intervention at both clinics (P = 0.384, P = 0.755). HCW satisfaction remained high during intervention and baseline (P = 0.746). CONCLUSION: CQI improved AYA knowledge and did not negatively impact HCW satisfaction. Quality improvement interventions may be useful to improve adolescent-friendly service delivery.

A national evaluation using standardised patient actors to assess STI services in public sector clinical sentinel surveillance facilities in South Africa.

OBJECTIVES: Quality concerns in STI service delivery and missed opportunities for integration with HIV testing and prevention services in South Africa have been well documented. This national evaluation aimed to evaluate current utilisation and adherence to national STI guidelines, including partner notification and integration with HIV services, for diagnosis and management of STIs. METHODS: Facility surveys assessed infrastructure and resource availability, and standardised patient (SP) assessments evaluated quality of STI care in 50 public clinics in nine provinces in South Africa. The primary outcome was the proportion of SPs receiving essential STI care, defined as: offered an HIV test, condoms, partner notification counselling and correct syndromic treatment. Weighted proportions were generated, and SP findings were compared by gender using χ2 tests with Rao-Scott correction. RESULTS: More than 80% of facilities reported medications in stock, with the exceptions of oral cefixime (48.3%), oral erythromycin (75.1%) and paediatric syrups. Among 195 SP encounters, 18.7% (95% CI 10.7% to 30.5%) received all hypothesised essential STI services: offered HIV test (67.1%), offered condoms (31.4%), partner notification counselling (70.2%) and recommended syndromic treatment (60.7%). Men were more likely than women to be offered all services (25.1% vs 12.3%, p=0.023), recommended treatment (70.7% vs 50.9%, p=0.013) and partner notification counselling (79.9% vs 60.6%, p=0.020). Only 6.3% of providers discussed male circumcision with male SPs, and 26.3% discussed family planning with female SPs. CONCLUSIONS: This evaluation of STI services across South Africa found gaps in the availability of medications, adherence to STI guidelines, condom provision and prevention messaging. Limited integration with HIV services for this high-risk population was a missed opportunity. Quality of STI care should continue to be monitored, and interventions to improve quality should be prioritised as part of national strategic HIV and primary healthcare agendas.

Systems Mapping of Sexually Transmitted Infection Services at Three Clinical Sentinel Surveillance Sites in South Africa: Opportunities for Integrated Care.

Sexually transmitted infection (STI) service delivery in the context of integrated care and the South African HIV epidemic is complex. We aimed to document STI care and HIV testing processes in public health clinics in South Africa, revealing bottlenecks to patient flow and identifying opportunities for improvement. Clinic mapping, with semi-structured interviews and clinic observation, was conducted with facility representatives at three clinical sentinel surveillance sites. Facility surveys assessed patient volume and staffing. Identified challenges were associated with staffing allocations, and disruptions in patient flow resulted from poor clinic layout, inadequate lighting, and limited allocation of space for HIV testing and physical examination. Recommendations include staffing adjustments, reorganization of space to allow for designated service and waiting areas, sufficient supplies, and improved lighting. The facility reorganization component of South Africa's Ideal Clinic initiative provides a key opportunity for enacting many of these recommendations.

Safety, Feasibility, and Acceptability of the PrePex Device for Adult Male Circumcision in Malawi.

INTRODUCTION: Nonsurgical adult male circumcision devices present an alternative to surgery where health resources are limited. This study aimed to assess the safety, feasibility, and acceptability of the PrePex device for adult male circumcision in Malawi. METHODS: A prospective single-arm cohort study was conducted at 3 sites (1 urban static, 1 rural static, 1 rural tent) in Malawi. Adverse event (AE) outcomes were stratified to include/exclude pain, and confidence intervals (CIs) were corrected for clinic-level clustering. RESULTS: Among 935 men screened, 131 (14.0%) were not eligible, 13 (1.4%) withdrew before placement, and 791 (84.6%) received the device. Moderate and severe AEs totaled 7.1% including pain [95% CI: 3.4-14.7] and 4.0% excluding pain (95% CI: 2.6 to 6.4). Severe AEs included pain (n = 3), insufficient skin removal (n = 4), and early removal (n = 4). Among early removals, 1 had immediate surgical circumcision, 1 had surgery after 48 hours of observation, 1 declined surgery, and 1 did not return to our site although presented at a nearby clinic. More than half of men (51.9%) reported odor; however, few (2.2%) stated they would not recommend the device to others because of odor. Median levels of reported pain (scale, 1-10) were 2 (interquartile range, 2-4) during application and removal, and 0 (interquartile range, 0-2) at all other time points. CONCLUSIONS: Severe AEs were rare and similar to other programs. Immediate provision of surgical services after displacement or early removal proved a challenge. Cases of insufficient skin removal were linked to poor technique, suggesting provider training requires reinforcement and supervision.

Classification and rates of adverse events in a Malawi male circumcision program: impact of quality improvement training.

BACKGROUND: Assessing safety outcomes is critical to inform optimal scale-up of voluntary medical male circumcision (VMMC) programs. Clinical trials demonstrated adverse event (AE) rates from 1.5 to 8 %, but we have limited data on AEs from VMMC programs. METHODS: A group problem-solving, quality improvement (QI) project involving retrospective chart audits, case-conference AE classification, and provider training was conducted at a VMMC clinic in Malawi. For each identified potential AE, the timing, assessment, treatment, and resolution was recorded, then a clinical team classified each event for type and severity. During group discussions, VMMC providers were queried regarding lessons learned and challenges in providing care. After baseline evaluation, clinicians and managers initiated a QI plan to improve AE assessment and management. A repeat audit 6 months later used similar methods to assess the proportions and severity of AEs after the QI intervention. RESULTS: Baseline audits of 3000 charts identified 418 possible AEs (13.9 %), including 152 (5.1 %) excluded after determination of provider misclassification. Of the 266 remaining AEs, the team concluded that 257 were procedure-related (8.6 AEs per 100 VMMC procedures), including 6 (0.2 %) classified as mild, 218 (7.3 %) moderate, and 33 (1.1 %) severe. Structural factors found to contribute to AE rates and misclassification included: provider management of post-operative inflammation was consistent with national guidelines for urethral discharge; available antibiotics were from the STI formulary; providers felt well-trained in surgical skills but insecure in post-operative assessment and care. After implementation of the QI plan, a repeat process evaluating 2540 cases identified 115 procedure-related AEs (4.5 AEs per 100 VMMC procedures), including 67 (2.6 %) classified as mild, 28 (1.1 %) moderate, and 20 (0.8 %) severe. Reports of AEs decreased by 48 % (from 8.6 to 4.5 per 100 VMMC procedures, p < 0.001). Reports of moderate-plus-severe (program-reportable) AEs decreased by 75 % (from 8.4 to 1.9 per 100 VMMC procedures, p < 0.001). CONCLUSIONS: AE rates from our VMMC program implementation site were within the range of clinical trial experiences. A group problem-solving QI intervention improved post-operative assessment, clinical management, and AE reporting. Our QI process significantly improved clinical outcomes and led to more accurate reporting of overall and program-reportable AEs.