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BACKGROUND: Assisted partner notification services (APS) are widely implemented throughout sub-Saharan Africa. The effectiveness of APS among persons with previously diagnosed human immunodeficiency virus (HIV) infection is uncertain, and there are few published data on the success of integrating referrals for HIV preexposure prophylaxis (PrEP) into APS. METHODS: Staff in 22 Namibian Ministry of Health and Social Service clinics offered APS to patients newly and previously diagnosed with HIV (index cases [ICs]) between October 2019 and June 2021. Counselors used a structured interview guide to elicit ICs' sex partners and biological children and assisted ICs to arrange testing of contacts. Contacts testing HIV-positive were linked to HIV services and those 14 years or older testing negative were offered PrEP. The primary outcome was the case-finding index (contacts testing HIV-positive ÷ ICs receiving APS). RESULTS: Staff provided APS to 1222 (78%) of 1557 newly diagnosed ICs eliciting 1155 sex partners and 649 biological children. Among 280 previously diagnosed ICs, 279 sex partners and 158 biological children were elicited. The case-finding index was higher among ICs with newly diagnosed HIV compared with previously diagnosed HIV (0.14 vs 0.09, P = 0.46), though this difference was not statistically significant. Most sex partners testing HIV-negative were initiated on PrEP (67% in sex partners from newly diagnosed ICs; 74% in sex partners from previously diagnosed ICs). CONCLUSIONS: Assisted partner notification services successfully identified sex partners and biological children with undiagnosed HIV infection when provided to both newly and previously diagnosed ICs. Integration of referral to PrEP resulted in many HIV-negative partners initiating PrEP.
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Infecções por HIV , Soropositividade para HIV , Criança , Humanos , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , HIV , Busca de Comunicante/métodos , Namíbia/epidemiologia , Parceiros Sexuais , Encaminhamento e ConsultaRESUMO
INTRODUCTION: Across sub-Saharan Africa, ministries of health have proposed integrating pre-exposure prophylaxis (PrEP) for HIV prevention into family planning (FP) services to reach adolescent girls and young women (AGYW); however, evidence on effective implementation strategies is still limited. We conducted a qualitative study of integrated PrEP-FP service implementation at two FP clinics in Kisumu, Kenya. METHODS: From June 2017 to May 2020, the Prevention Options for Women Evaluation Research (POWER) study enrolled 1000 sexually active, HIV-negative AGYW age 16 to 25. Actions taken to implement PrEP were captured prospectively in 214 monitoring and evaluation documents and 15 interviews with PrEP implementers. We analysed data using conventional and directed content analysis, with the latter informed by the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation. RESULTS: POWER deployed a variety of implementation strategies to train and educate stakeholders (e.g., having new providers shadow PrEP providers); develop stakeholder interrelationships (e.g., organizing support teams with protected time to reflect on implementation progress and make refinements); provide technical assistance; and change physical infrastructure and workflow. Although these strategies reportedly influenced contextual factors across four of the five CFIR domains, they primarily interacted with contextual factors relevant to inner setting, especially implementation climate and readiness for implementation. Overall, implementing PrEP proved easier and less labor-intensive at a private, youth-friendly clinic than a public FP clinic, largely because the baseline structural characteristics (e.g., space, workflow) and organizational mission of the former were more conducive to offering AGYW-centered care. Nevertheless, adoption of PrEP delivery among non-study staff at both sites was low, likely due to the widespread perception that PrEP was not within their scope of work. CONCLUSIONS: Some FP clinics may be "lower-hanging fruit" than others for PrEP implementation. Approaching PrEP implementation as a behavioral intervention for FP providers may help ensure that providers have the requisite capability, opportunity, and motivation to adopt the clinical innovation. In particular, PrEP implementers should assess the need for implementation strategies that support providers' clinical decision-making, establish worker expectations and accountability, and address workload constraints. TRIAL REGISTRATION: Clinical Trial Number: NCT03490058 .
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Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Adolescente , Adulto , Fármacos Anti-HIV/uso terapêutico , Serviços de Planejamento Familiar , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Humanos , Quênia , Adulto JovemRESUMO
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.
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Preservativos/estatística & dados numéricos , Infecções por HIV/prevenção & controle , Pessoal de Saúde/psicologia , Profilaxia Pré-Exposição/estatística & dados numéricos , Adulto , Idoso , Feminino , Infecções por HIV/transmissão , Humanos , Entrevistas como Assunto , Quênia , Masculino , Pessoa de Meia-Idade , Profilaxia Pré-Exposição/métodos , Pesquisa Qualitativa , Parceiros SexuaisRESUMO
PURPOSE OF REVIEW: Clinical trials have found that PrEP is highly effective in reducing risk of HIV acquisition across types of exposure, gender, PrEP regimens, and dosing schemes. Evidence is urgently needed to inform scale-up of PrEP to meet the ambitious WHO/UNAIDS prevention target of 3,000,000 individuals on PrEP by 2020. RECENT FINDINGS: Successful models of delivering HIV services at scale evolved from years of formal research and programmatic evidence. These efforts produced lessons-learned relevant for scaling-up PrEP delivery, including the importance of streamlining laboratory tests, expanding prescription and management authority, differentiating medication access points, and reducing stigma and barriers of parental consent for PrEP uptake. Further research is especially needed in areas differentiating PrEP from ART delivery, including repeat HIV testing to ensure HIV negative status and defining and measuring prevention-effective adherence. Evidence from 15 years of ART scale-up could immediately inform a public health approach to PrEP delivery.
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Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/métodos , África Subsaariana , Humanos , Masculino , Programas de Rastreamento , Adesão à Medicação , Consentimento dos Pais , Saúde Pública , Estigma SocialRESUMO
The article "Scaling-up PrEP Delivery in Sub-Saharan Africa: What Can We Learn from the Scale-up of ART?", written by Gabrielle O'Malley, Gena Barnabee and Kenneth Mugwanya, was originally published electronically on the publisher's internet portal.
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BACKGROUND: No established strategy for household tuberculosis (TB) contact investigation (HTCI) exists in Ethiopia. We implemented integrated, active HTCI model into two hospitals and surrounding community health services to determine yield of active HTCI of all forms of TB and explore factors associated with active TB diagnosis in household contacts (HHCs). METHODS: Case managers obtained HHC information from index cases at TB/DOTS clinic and liaised with health extension workers (HEWs) who screened HHCs for TB at household and referred contacts under five and presumptive cases for diagnostic investigation. RESULTS: From 363 all forms TB index cases, 1509 (99%) HHCs were screened and 809 (54%) referred, yielding 19 (1.3%) all forms TB cases. HTCI of sputum smear-positive pulmonary TB (SS + PTB) index cases produced yield of 4.3%. HHCs with active TB were more likely to be malnourished (OR: 3.39, 95%CI: 1.19-9.64), live in households with SS + PTB index case (OR: 7.43, 95%CI: 1.64-33.73) or TB history (OR: 4.18, 95%CI: 1.51-11.55). CONCLUSION: Active HTCI of all forms of TB cases produced comparable or higher yield than reported elsewhere. HTCI contributes to improved and timely case detection of Tuberculosis among population who may not seek health care due to minimal symptoms or access issues. Active HTCI can successfully be implemented through integrated approach with existing community TB programs for better coordination and efficiency. Referral criteria should include factors significantly associated with active disease.
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Busca de Comunicante/métodos , Tuberculose/epidemiologia , Adolescente , Adulto , Instituições de Assistência Ambulatorial/estatística & dados numéricos , Gerentes de Casos , Serviços de Saúde Comunitária , Estudos Transversais , Etiópia/epidemiologia , Saúde da Família/estatística & dados numéricos , Feminino , Pessoal de Saúde/estatística & dados numéricos , Mão de Obra em Saúde , Humanos , Masculino , Saúde Ocupacional/estatística & dados numéricos , Avaliação de Programas e Projetos de Saúde , Encaminhamento e Consulta/estatística & dados numéricos , Tuberculose Pulmonar/epidemiologiaRESUMO
INTRODUCTION: Adolescent girls and young women (AGYW) face barriers in accessing clinic-based HIV pre-exposure prophylaxis (PrEP) services and community-based models are a proposed alternative. Evidence from such models, however, is limited. We evaluated PrEP service coverage, uptake, and early persistence among AGYW receiving services through community and hybrid models in Namibia. METHODS: We analyzed routine data for AGYW aged 15-24 who initiated PrEP within HIV prevention programming. PrEP was delivered via three models: community-concierge (fully community-based services with individually-tailored refill locations), community-fixed (community-based initiation and refills delivered by community providers on a set schedule at fixed sites), and hybrid community-clinic (community-based initiation and referral to clinics for refills delivered by clinic providers). We examined proportions of AGYW engaged in services along a programmatic PrEP cascade, overall and by model, and assessed factors associated with PrEP uptake and early persistence (refill within 15-44 days after initiation) using multivariable generalized estimating equations. RESULTS: Over 10-months, 7593 AGYW participated in HIV prevention programming. Of these, 7516 (99.0%) received PrEP education, 6105 (81.2%) received HIV testing services, 6035 (98.9%) tested HIV-negative, and 2225 (36.9%) initiated PrEP. Of the 2047 AGYW expected for PrEP refill during the study period, 254 (12.4%) persisted with PrEP one-month after initiation. Structural and behavioral HIV risk factors including early school dropout, food insecurity, inconsistent condom use, and transactional sex were associated with PrEP uptake. AGYW who delayed starting PrEP were 2.89 times more likely to persist (95% confidence interval (CI): 1.52-5.46) and those receiving services via the community-concierge model were 8.7 times (95% CI: 5.44-13.9) more likely to persist (compared to the hybrid model). CONCLUSION: Community-based models of PrEP service delivery to AGYW can achieve high PrEP education and HIV testing coverage and moderate PrEP uptake. AGYW-centered approaches to delivering PrEP refills can promote higher persistence.
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Aizoaceae , Infecções por HIV , Humanos , Adolescente , Feminino , Namíbia , Transporte Biológico , Instituições de Assistência Ambulatorial , Infecções por HIV/prevenção & controleRESUMO
BACKGROUND: We synthesize implementation bottlenecks experienced while implementing the DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, an HIV prevention intervention for adolescent girls and young women (AGYW), in Namibia from 2017 to 2019. Bottlenecks were organized into the following 4 AGYW program components. PROGRAM ACCESS: Enrollment was slowed by the time-intensive nature of screening and other baseline data collection requirements, delays in acquiring parental consent, and limited time for after-school activities. Solutions included obtaining advance consent and providing 1-stop service delivery and transportation assistance. HEALTH EDUCATION: We experienced difficulty identifying safe spaces for AGYW to meet. A lack of tailored curricula also impeded activities. Governments, stakeholders, and partners can plan ahead to help DREAMS identify appropriate safe spaces. Curricula should be identified and adapted before implementation. HEALTH SERVICES: Uneven availability of government-provided commodities (e.g., condoms, preexposure prophylaxis [PrEP], family planning products) and lack of AGYW-centered PrEP delivery approaches impacted services. Better forecasting of commodity needs and government commitment to supply chain strengthening will help ensure adequate program stock. SOCIAL SERVICES: The availability of only centralized care following gender-based violence (GBV) and the limited number of government social workers to manage GBV cases constrained service provision. Triaging GBV cases-i.e., referring high-risk cases to government social workers and providing DREAMS-specific social services for other cases-can ensure proper caseload management. CONCLUSION: These bottlenecks highlight practical implementation issues and higher-level considerations for AGYW-centered HIV prevention programs. The critical need for multilayered programming for HIV/GBV prevention in AGYW cannot be addressed simply with additional funds but requires multilevel collaboration and forecasting. The urgency to achieve results must be balanced with the need for adequate implementation preparedness.
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Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Adolescente , Feminino , Humanos , Infecções por HIV/prevenção & controle , Namíbia , Preservativos , Serviços de Planejamento Familiar , QuêniaRESUMO
Introduction: Despite the potential for community-based approaches to increase access to pre-exposure prophylaxis (PrEP) for adolescent girls and young women (AGYW), there is limited evidence of whether and how they improve PrEP persistence. We compared PrEP persistence among AGYW receiving services through community and hybrid models in Namibia to facility-based services. We subsequently identify potential mechanisms to explain how and why community and hybrid models achieved (or not) improved persistence to inform further service delivery innovation. Methods: Data were collected from PrEP service delivery to AGYW over two-years in Namibia's Khomas Region. We used Kaplan-Meier analysis to estimate survival curves for PrEP persistence beyond three-months after initiation and report the cumulative probability of persistence at one- and three-months. Persistence was defined as any PrEP use within three months after initiation followed by a PrEP refill or previously prescribed supply of at least 30 days at the three-month visit. Interviews were conducted with 28 AGYW and 19 providers and analyzed using a deductive-inductive thematic approach. Results: From October 2017 through September 2019, 372 (18.7%) AGYW received services through a facility model, 302 (15.1%) through a community model, and 1,320 (66.2%) through a hybrid model. PrEP persistence at one- and three-months was 41.2% and 34.9% in the community model and 6.2% and 4.8% in the hybrid model compared to 36.8% and 26.7% in the facility model. Within the community and hybrid models, we identified three potential mechanisms related to PrEP persistence. Individualized service delivery offered convenience and simplicity which enabled AGYW to overcome barriers to obtaining refills but did not work as well for highly mobile AGYW. Consistent interactions and shared experiences fostered social connectedness with providers and with peers, building social networks and support systems for PrEP use. PrEP and HIV-related stigma, however, was widely experienced outside of these networks. Community-to-facility referral for PrEP refill triggered apprehension towards unfamiliar PrEP services and providers in AGYW, which discouraged persistence. Conclusion: Service delivery approaches that offer convenience and simplicity and foster social connectedness may reduce access barriers and increase social support enabling AGYW to self-manage their PrEP use and achieve improved PrEP persistence.
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Daily oral pre-exposure prophylaxis (PrEP) is being incorporated into services frequented by adolescent girls and young women (AGYW) in sub-Saharan Africa who are at a significant risk of HIV. In non-PrEP studies, positive provider-client rapport has been shown to improve patient decision-making and use of medication in clinical care. We examined AGYW and healthcare provider (HCP) perspectives on the value of and strategies for building positive provider-client rapport. We conducted in-depth interviews from January 2018 to December 2019 with 38 AGYW and 15 HCPs from two family planning clinics in Kisumu, Kenya where PrEP was being delivered to AGYW as part of the Prevention Options for Women Evaluation Research (POWER) study. We used semi-structured interview guides and audio-recorded interviews with participant consent. Verbatim transcripts were analysed using thematic content analysis. HCPs and AGYW emphasised the importance of positive provider-client rapport to meet AGYW support needs in PrEP service delivery. HCPs described how they employed rapport-building strategies that strengthened AGYW PrEP uptake and continuation, including: (1) using friendly and non-judgmental tones; (2) maintaining client confidentiality (to build client trust); (3) adopting a conversational approach (to enable accurate risk assessment); (4) actively listening and tailoring counselling (to promote client knowledge, skills, and self-efficacy); and (5) supporting client agency. Positive provider-client relationships and negative experiences identified in this analysis have the potential to facilitate/deter AGYW from using PrEP while at risk. The strategies to enhance provider-client rapport identified in this study could be integrated into PrEP provider training and delivery practices.
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Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Adolescente , Fármacos Anti-HIV/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Humanos , Ciência da Implementação , QuêniaRESUMO
INTRODUCTION: HIV incidence remains high among African adolescent girls and young women (AGYW). The primary objective of this study is to assess pre-exposure prophylaxis (PrEP) initiation, use, persistence and HIV acquisition among African AGYW offered PrEP in order to inform PrEP scale-up. METHODS: POWER was a prospective implementation science evaluation of PrEP delivery for sexually active HIV-negative AGYW ages 16-25 in family planning clinics in Kisumu, Kenya and youth and primary healthcare clinics in Cape Town and Johannesburg, South Africa. Follow-up visits occurred at month 1 and quarterly for up to 36 months. PrEP users were defined based on the month 1 refill. PrEP persistence through month 6 was assessed using Kaplan-Meier survival analysis among AGYW with a month 1 visit, defining non-persistence as an ≥15 day gap in PrEP availability for daily dosing. PrEP execution was evaluated in a subset with PrEP supply from the prior visit sufficient for daily dosing by measuring blood tenofovir diphosphate (TFV-DP) levels. RESULTS: From June 2017 to September 2020, 2550 AGYW were enrolled (1000 in Kisumu, 787 in Cape Town and 763 in Johannesburg). Median age was 21 years, 66% had a sexual partner of unknown HIV status, and 29% had chlamydia and 10% gonorrhoea. Overall, 2397 (94%) initiated PrEP and 749 (31%) had a refill at 1 month. Of AGYW who could reach 6 months of post-PrEP initiation follow-up, 128/646 (20%) persisted with PrEP for 6 months and an additional 92/646 (14%) had a gap and restarted PrEP. TFV-DP levels indicated that 47% (91/193) took an average of ≥4 doses/week. Sixteen HIV seroconversions were observed (incidence 2.2 per 100 person-years, 95% CI 1.2, 3.5); 13 (81%) seroconverters either did not have PrEP dispensed in the study interval prior to seroconversion or TFV-DP levels indicated <4 doses/week in the prior 6 weeks. CONCLUSIONS: In this study of PrEP integration with primary care and reproductive health services for African AGYW, demand for PrEP was high. Although PrEP use decreased in the first months, an important fraction used PrEP through 6 months. Strategies are needed to simplify PrEP delivery, support adherence and offer long-acting PrEP options to improve persistence and HIV protection.
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Fármacos Anti-HIV , Infecções por HIV , Soropositividade para HIV , Profilaxia Pré-Exposição , Adolescente , Adulto , Fármacos Anti-HIV/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Soropositividade para HIV/tratamento farmacológico , Humanos , Quênia/epidemiologia , Adesão à Medicação , Estudos Prospectivos , Soroconversão , África do Sul/epidemiologia , Adulto JovemRESUMO
Background: Successful integration of pre-exposure prophylaxis (PrEP) with existing reproductive health services will require iterative learning and adaptation. The interaction between the problem-solving required to implement new interventions and health worker motivation has been well-described in the public health literature. This study describes structural and motivational challenges faced by health care providers delivering PrEP to adolescent girls and young women (AGYW) alongside other SRH services, and the strategies used to overcome them. Methods: We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) with HCWs from two demonstration projects delivering PrEP to AGYW alongside other SRH services. The Prevention Options for the Women Evaluation Research (POWER) is an open label PrEP study with a focus on learning about PrEP delivery in Kenyan and South African family planning, youth mobile services, and public clinics at six facilities. PrIYA focused on PrEP delivery to AGYW via maternal and child health (MCH) and family planning (FP) clinics in Kenya across 37 facilities. IDIs and FGDs were transcribed verbatim and analyzed using a combination of inductive and deductive methods. Results: We conducted IDIs with 36 participants and 8 FGDs with 50 participants. HCW described a dynamic process of operationalizing PrEP delivery to better respond to patient needs, including modifying patient flow, pill packaging, and counseling. HCWs believed the biggest challenge to sustained integration and scaling of PrEP for AGYW would be lack of health care worker motivation, primarily due to a misalignment of personal and professional values and expectations. HCWs frequently described concerns of PrEP provision being seen as condoning or promoting unprotected sex among young unmarried, sexually active women. Persuasive techniques used to overcome these reservations included emphasizing the social realities of HIV risk, health care worker professional identities, and vocational commitments to keeping young women healthy. Conclusion: Sustained scale-up of PrEP will require HCWs to value and prioritize its incorporation into daily practice. As with the provision of other SRH services, HCWs may have moral reservations about providing PrEP to AGYW. Strategies that strengthen alignment of HCW personal values with professional goals will be important for strengthening motivation to overcome delivery challenges.
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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.
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Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/transmissão , Pessoal de Saúde , Profilaxia Pré-Exposição , Parceiros Sexuais , Adulto , Preservativos , Aconselhamento , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Quênia , Masculino , Pessoa de Meia-Idade , Profilaxia Pré-Exposição/métodos , Medição de Risco , Comportamento de Redução do Risco , Carga ViralRESUMO
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 .