Using an on-site modular training approach to amplify prep service delivery in public health facilities in Kenya.

Delivery of oral PrEP, a potent HIV prevention intervention, has begun within public health systems in many countries in Africa. Training as many health providers as possible expeditiously is necessary to efficiently and rapidly scale up PrEP delivery among at risk populations and thereby realize the greatest impact of PrEP. We designed and implemented an innovative on-site modular training approach delivered in five two-hour modules. The modules could be covered in two consecutive days or be broken across several days enabling flexibility to accommodate health provider work schedules. We assessed knowledge gain comparing pre-and post-training test scores and determined monthly PrEP uptake for six months following the training intervention. We also evaluated the cost of this training approach and conducted key informant interviews to explore acceptability among health providers. Between January 2019 and December 2020, 2111 health providers from 104 health facilities were trained on PrEP. Of 1821 (83%) providers who completed both pre- and post-tests, 505 (28%) were nurses, 333 (18%) were HIV counsellors, 276 (15%) were clinical officers and 255 (14%) were lay providers. The mean score prior to and after training was 58% and 82% respectively (p <0.001). On average, health facilities initiated an average of 2.7 (SD 4.7) people on PrEP each month after the training, a number that did not decline over six months post-training (p = 0.62). Assuming Ministry of Health costs, the costs per provider trained was $16.27. Health providers expressed satisfaction with this training approach because it enabled many providers within a facility receive training. On-site modular training is an effective approach for improving PrEP education for health workers in public health facilities, It is also acceptable and low-cost. This method of training can be scaled up to rapidly amplify the number of health workers able to offer PrEP services.

Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial.

BACKGROUND: Successful and sustainable models for HIV pre-exposure prophylaxis (PrEP) delivery in public health systems in Africa are needed. We aimed to evaluate the implementation of PrEP delivery integrated in public HIV care clinics in Kenya. METHODS: As part of Kenya's national PrEP roll-out, we conducted a stepped-wedge cluster-randomised pragmatic trial to catalyse scale-up of PrEP delivery integrated in 25 public HIV care clinics. We selected high-volume clinics in these regions (ie, those with a high number of people living with HIV enrolled in HIV care and treatment). Clinics (each representing a cluster) were stratified by region and randomly assigned to the order in which clinic staff would receive PrEP training and ongoing technical support using numbered opaque balls picked from a bag. There was no masking. PrEP provision was done by clinic staff without additional financial support. Data were abstracted from records of individuals initiating PrEP. The primary outcome was the number of people initiating PrEP per clinic per month comparing intervention to control periods. Other outcomes included PrEP continuation, adherence, and incident HIV infections. This trial is registered with ClinicalTrials.gov, NCT03052010. FINDINGS: After the baseline period, which started in January, 2017, every month two to six HIV care clinics crossed over from control to intervention, until August, 2017, when all clinics were implementing the intervention. Of 4898 individuals initiating PrEP (27 during the control period and 4871 during the intervention period), 2640 (54%) were women, the median age was 31 years (IQR 25-39), and 4092 (84%) reported having a partner living with HIV. The mean monthly number of PrEP initiations per clinic was 0·1 (SD 0·5) before the intervention and 7·5 (2·7) after intervention introduction (rate ratio 23·7, 95% CI 14·2-39·5, p<0·0001). PrEP continuation was 57% at 1 month, 44% at 3 months, and 34% at 6 months, and 12% of those who missed a refill returned later for PrEP re-initiation. Tenofovir diphosphate was detected in 68 (96%) of 71 blood samples collected from a randomly selected subset of participants. Six HIV infections were observed over 2531 person-years of observation (incidence 0·24 cases per 100 person-years), three of which occurred at the first visit after PrEP initiation. INTERPRETATION: We observed high uptake, reasonable continuation with high adherence, frequent PrEP restarts, and low HIV incidence. Integration of PrEP services within public HIV care clinics in Africa is feasible. FUNDING: National Institute of Mental Health and Bill & Melinda Gates Foundation.

Process evaluation of PrEP implementation in Kenya: adaptation of practices and contextual modifications in public HIV care clinics.

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

Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya's public sector.

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

"I Just Decided to Stop:" Understanding PrEP Discontinuation Among Individuals Initiating PrEP in HIV Care Centers in Kenya.

BACKGROUND: Preexposure prophylaxis (PrEP) discontinuation rates in clinical trials and demonstration projects have been well characterized; however, little is known about discontinuation in routine public health settings in sub-Saharan Africa. Understanding discontinuation in nonstudy settings is important for establishing expectations for PrEP continuation in national programs and for facilitating effective PrEP scale-up. METHODS: We conducted in-depth interviews with 46 individuals who had initiated PrEP at 25 HIV comprehensive care clinics (CCCs) in central and western Kenya and whose clinic records indicated they had discontinued. RESULTS: Many of our study participants discontinued PrEP when their perceived risk decreased (eg, hiatus or end of a sexual relationship or partner known to be living with HIV became virally suppressed). Others reported discontinuation due to side effects, daily pill burden, preference for condoms, or their partner's insistence. Participant narratives frequently described facility level factors such as stigma-related discomforts with accessing PrEP at CCCs, inconvenient clinic location or operating hours, long wait times, and short refill dates as discouraging factors, suggesting actionable areas for improving PrEP access and continuation. CONCLUSION: Clients frequently make intentional decisions to discontinue PrEP as they weigh different prevention options within the context of complex lives. Many clients will decide to discontinue PrEP when perceiving themselves to be at reduced risk and PrEP counseling must include provisions for addressing seasons of risk. PrEP will not be the right prevention method for everyone, or forever. Expanding PrEP access points and increasing sex-positive messaging may facilitate PrEP being a better option for many.

"Now that PrEP is reducing the risk of transmission of HIV, why then do you still insist that we use condoms?" the condom quandary among PrEP users and health care providers in Kenya.

Communication around condom use in the context of PrEP services presents a potential conundrum for patients and providers. Within the Partners Scale-Up Project, which supports integration of PrEP delivery in HIV care clinics, we interviewed 41 providers and 61 PrEP users and identified themes relating to condom messaging and use. Most providers counselled PrEP initiators to always use both PrEP and condoms, except when trying to conceive. However, others reported contexts and rationales for not emphasizing condom use. Providers reported that PrEP users were sometimes confused, even frustrated, with their insistence on using condoms in addition to PrEP. PrEP users generally regarded PrEP as a more feasible and desirable HIV prevention method than condoms, enabling increased sexual pleasure and conception, and reducing the conflict and stigma associated with condom use. Innovative approaches to condom counselling in PrEP programs are needed.

"I just believe there is a risk" understanding of undetectable equals untransmissible (U = U) among health providers and HIV-negative partners in serodiscordant relationships in Kenya.

INTRODUCTION: Sustained HIV viral suppression resulting from antiretroviral therapy (ART) eliminates the risk of HIV transmission, a concept popularly framed as Undetectable = Untransmittable (U = U). We explored knowledge and acceptance of information around the elimination of HIV transmission risk with ART (U = U) in Kenya. METHODS: Our qualitative study was conducted within a project evaluating the use of pre-exposure prophylaxis (PrEP) integrated into ART care for HIV serodiscordant couples in public clinics in Kenya (the Partners Scale Up Project). From February 2017 to April 2019, we conducted semi-structured key informant interviews with 83 health providers and in-depth interviews with 61 HIV-negative people in serodiscordant relationships receiving PrEP services. Transcripts were coded using thematic analysis. RESULTS: Health providers reported being aware of reduced risk of HIV transmission as a result of consistent ART use and used words such as "very low," "minimal" and "like zero" to describe HIV transmission risk after viral suppression. Providers reported finding viral load results helpful when counselling clients about the risk of HIV transmission. Many lacked confidence in U = U and counselled on consistent condom use even after viral suppression while some expressed concerns that communicating this message to people living with HIV (PLHIV) would lead them to engage in multiple sexual relationships. Other providers reported that they did not counsel about the reduced risk of HIV transmission after viral suppression for fear of being blamed if HIV transmission occurred. HIV-negative partners reported being informed about U = U by providers but they did not believe nor trust the message. Even after their partners achieved viral suppression, some HIV-negative partners were unwilling to stop PrEP, while others indicated that they would use condoms if they stopped PrEP to be sure that they were protected from HIV. CONCLUSIONS: Despite awareness that effective ART use eliminates HIV transmission risk, there is both a lack of in-depth knowledge and conviction about the strategy among health providers and HIV-negative partners in serodiscordant relationships. New strategies that go beyond communicating the science of U = U to consider the local social and clinical environments could maximize the effectiveness of U = U.

Training health care providers to provide PrEP for HIV serodiscordant couples attending public health facilities in Kenya.

To catalyse national scale up of PrEP for HIV serodiscordant couples in public health facilities in Kenya, the Partners Scale-Up Project, using a two-day case-based interactive curriculum, trained health care providers working in 24 high volume facilities in central and western Kenya on PrEP service delivery. Using a standardised test with questions about PrEP and antiretroviral-based HIV prevention we assessed gain in knowledge and confidence gain by comparing pre-and post-training test scores. We explored experiences of the training through key informant interviews after clinics started delivering PrEP. Of 716 health care providers trained, 235 (32.9%) were nurses, 144 (20.2%) were clinical officers and 155 (21.7%) were HIV counsellors. There was a significant improvement between the means of pre-test and post-test scores (61.7% (SD 17.4) vs 86.4% (SD 12.7) p < 0.001). The proportion of those who reported being 'very comfortable' providing care to HIV serodiscordant couples increased from 22.8% to 67.3% (p < 0.001). Key themes that training increasing both knowledge of PrEP and confidence to deliver PrEP to HIV serodiscordant couples emerged from interviews. This short, standardised training resulted in a substantial increase in knowledge of PrEP and in the confidence of the health providers to provide PrEP to HIV serodiscordant couples. Trial registration ClinicalTrials.gov NCT03052010.

Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya.

BACKGROUND: Antiretroviral therapy (ART) for HIV-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons are extraordinarily effective strategies for HIV prevention. In Africa, the region which shoulders the highest HIV burden, HIV care is principally delivered through public health HIV care clinics, offering an existing platform to incorporate PrEP delivery and maximize ART and PrEP synergies. However, successfully bringing this integrated approach to scale requires an implementation science evaluation in public health settings. METHODS: The Partners Scale Up Project is a prospective, pragmatic implementation evaluation, designed as a stepped-wedge, cluster-randomized trial, operating at 24 clinics in Kenya. In collaboration with the Kenya Ministry of Health, we are catalyzing scaled implementation of PrEP delivery integrated in HIV care clinics. The intervention package includes staff training, clinic streamlined access to PrEP commodity from the Kenya Medical Supply Authority, and ongoing intensive technical assistance to rigorously assess how PrEP delivery is implemented. PrEP service delivery including retention efforts are conducted by the clinic staff with no additional resources from the project. Guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and Consolidated Framework for Implementation Science Research, project progress and learning are documented through ongoing monitoring and process evaluations, including chart abstraction and individual and key informant interviews, to evaluate pragmatic rollout and understand barriers and facilitators for successful PrEP delivery in this setting. In this staged rollout design, each step provides data for both pre-implementation (baseline) and implementation periods, and we will compare time points across steps in the baseline versus implementation periods. DISCUSSION: Cost-effective delivery models are urgently needed to maximize the public health impact of PrEP and ART. The Partners Scale Up Project will set the stage for full-scale PrEP implementation fully run and owned by the Kenya Ministry of Health. The work combines nationally sponsored PrEP delivery with technical support and implementation science from academic partners, defining a new but sustainable paradigm for public health collaboration. TRIAL REGISTRATION: Registered with ClinicalTrials.gov on February 14, 2017: NCT03052010 .