Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA.

INTRODUCTION: African American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population. METHODS AND ANALYSIS: The goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA. ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations. TRIAL REGISTRATION NUMBER: NCT04373551.

Factors consistently associated with utilisation of essential maternal and child health services in Nigeria: analysis of the five Nigerian national household surveys (2003-2018).

OBJECTIVE: This study aims to identify the individual and contextual factors consistently associated with utilisation of essential maternal and child health services in Nigeria across time and household geolocation. DESIGN, SETTING AND PARTICIPANTS: Secondary data from five nationally representative household surveys conducted in Nigeria from 2003 to 2018 were used in this study. The study participants are women and children depending on essential maternal and child health (MCH) services. OUTCOME MEASURES: The outcome measures were indicators of whether participants used each of the following essential MCH services: antenatal care, facility-based delivery, modern contraceptive use, childhood immunisations (BCG, diphtheria, tetanus, pertussis/Pentavalent and measles) and treatments of childhood illnesses (fever, cough and diarrhoea). METHODS: We estimated generalised additive models with logit links and smoothing terms for households' geolocation and survey years. RESULTS: Higher maternal education and households' wealth were significantly associated with utilisation of all types of essential MCH services (p<0.05). On the other hand, households with more children under 5 years of age and in poor communities were significantly less likely to use essential MCH services (p<0.05). Except for childhood immunisations, greater access to transport was positively associated with utilisation (p<0.05). Households with longer travel times to the most accessible health facility were less likely to use all types of essential MCH services (p<0.05), except modern contraceptive use and treatment of childhood fever and/or cough. CONCLUSION: This study adds to the evidence that maternal education and household wealth status are consistently associated with utilisation of essential MCH services across time and space. To increase utilisation of essential MCH services across different geolocations, interventions targeting poor communities and households with more children under 5 years of age should be appropriately designed. Moreover, additional interventions should prioritise to reduce inequities of essential MCH service utilisation between the wealth quantiles and between education status.

Implementation science for integration of HIV and non-communicable disease services in sub-Saharan Africa: a systematic review.

OBJECTIVE: As the burden of chronic non-communicable diseases (NCDs) rises across sub-Saharan Africa (SSA), global donors and governments are exploring strategies to integrate HIV and NCD care. Implementation science is an emerging research paradigm that can help such programs achieve health impact at scale. We define implementation science as a systematic, scientific approach to ask and answer questions about how to deliver what works in populations who need it with greater speed, appropriate fidelity, efficiency, and relevant coverage. We identified achievements and gaps in the application of implementation science to HIV/NCD integration, developed an HIV/NCD implementation science research agenda, and detailed opportunities for capacity building and training. DESIGN: We conducted a systematic review of the application of implementation science methods to integrated HIV/NCD programs in SSA. METHODS: We searched PubMed, CINAHL, PsycINFO, and EMBASE for evaluations of integrated programs in SSA reporting at least one implementation outcome. RESULTS: We identified 31 eligible studies. We found that most studies used only qualitative, economic, or impact evaluation methods. Only one study used a theoretical framework for implementation science. Acceptability, feasibility, and penetration were the most frequently reported implementation outcomes. Adoption, appropriateness, cost, and fidelity were rare; sustainability was not evaluated. CONCLUSIONS: Implementation science has a promising role in supporting HIV/NCD integration, although its impact will be limited unless theoretical frameworks, rigorous study designs, and reliable measures are employed. To help support use of implementation science, we need to build sustainable implementation science capacity. Doing so in SSA and supporting implementation science investigators can help expedite HIV/NCD integration.

Quality of HIV care provided by non-physician clinicians and physicians in Mozambique: a retrospective cohort study.

OBJECTIVES: To compare HIV care quality provided by non-physician clinicians (NPC) and physicians. DESIGN: Retrospective cohort study assessing the relationship between provider cadre and HIV care quality among non-pregnant adult patients initiating antiretroviral therapy (ART) in the national HIV care programme. METHODS: Computerized medical records from patients initiating ART between July 2004 and October 2007 at two HIV public HIV clinics in central Mozambique were used to develop multivariate analyses evaluating differences in process and care continuity measures for patients whose initial provider was a NPC or physician. RESULTS: A total of 5892 patients was included in the study, including 4093 (69.5%) with NPC and 1799 (30.5%) with physicians as initial providers. Those whose initial provider was a NPC were more likely to have a CD4 cell count 90-210 days [risk ratio (RR) 1.13, 1.04

Intermittent preventive treatment of malaria during pregnancy in central Mozambique.

PROBLEM: New WHO strategies for control of malaria in pregnancy (MiP) recommend intermittent preventive treatment (IPTp), bednet use and improved case management. APPROACH: A pilot MiP programme in Mozambique was designed to determine requirements for scale-up. LOCAL SETTING: The Ministry of Health worked with a nongovernmental organization and an academic institution to establish and monitor a pilot programme in two impoverished malaria-endemic districts. RELEVANT CHANGES: Implementing the pilot programme required provision of additional sulfadoxine-pyrimethamine (SP), materials for directly observed SP administration, bednets and a modified antenatal card. National-level formulary restrictions on SP needed to be waived. The original protocol required modification because imprecision in estimation of gestational age led to missed SP doses. Multiple incompatibilities with other health initiatives (including programmes for control of syphilis, anaemia and HIV) were discovered and overcome. Key outputs and impacts were measured; 92.5% of 7911 women received at least 1 dose of SP, with the mean number of SP doses received being 2.2. At the second antenatal visit, 13.5% of women used bednets. In subgroups (1167 for laboratory analyses; 2600 births), SP use was significantly associated with higher haemoglobin levels (10.9 g/dL if 3 doses, 10.3 if none), less malaria parasitaemia (prevalence 7.5% if 3 doses, 39.3% if none), and fewer low-birth-weight infants (7.3% if 3 doses, 12.5% if none). LESSONS LEARNED: National-level scale-up will require attention to staffing, supplies, bednet availability, drug policy, gestational-age estimation and harmonization of vertical initiatives.

Using nurses to identify HAART eligible patients in the Republic of Mozambique: results of a time series analysis.

BACKGROUND: The most pressing challenge to achieving universal access to highly active anti-retroviral therapy (HAART) in sub-Saharan Africa is the shortage of trained personnel to handle the increased service requirements of rapid roll-out. Overcoming the human resource challenge requires developing innovative models of care provision that improve efficiency of service delivery and rationalize use of limited resources. METHODS: We conducted a time-series intervention trial in two HIV clinics in central Mozambique to discern whether expanding the role of basic-level nurses to stage HIV-positive patients using CD4 counts and WHO-defined criteria would lead to more rapid information on patient status (including identification of HAART eligible patients), increased efficiency in the use of higher-level clinical staff, and increased capacity to start HAART-eligible patients on treatment. RESULTS: Overall, 1,880 of the HAART-eligible patients were considered in the study of whom 48.5% started HAART, with a median time of 71 days from their initial blood draw. After adjusting for time, expanding the role of nurses to stage patients was associated with more rational use of higher-level clinical staff at one site (Beira OR 1.9, 95% CI 1.1-3.3; Chimoio OR 0.2, 95% CI 0.1-0.5). In multivariate analyses, the rate of starting HAART in patients with CD4 counts of less than 200/mm3 increased over time (HR = 1.07, 95% CI 1.02-1.13), as did the total number of new patients initiating HAART (beta = 7.3, 95% CI 1.3-13.3). However, the intervention was not independently associated with either of these outcomes in multivariate analyses (HR = 0.9, 95% CI 0.7-1.2) for starting HAART in patients with CD4 counts of less than 200/mm3; (beta = -5.2, p = 0.75) for the total number of new patients initiating HAART per month. No effect of the intervention was found in these outcomes when stratifying by site. CONCLUSION: The CD4 nurse intervention, when implemented correctly, was associated with a more rational use of higher-level clinical providers, which may improve overall clinic flow and efficient use of the limited supply of human resources. However, this intervention did not lead to an increase in the number of patients starting HAART or a reduction in the time to HAART initiation. Study month appears to play an important role in all outcomes, suggesting that general improvements in clinic efficiency may have overshadowed the effect of the intervention. The lack of observed effect in these outcomes may be due to additional health systems bottlenecks that delay the initiation of treatment in HAART-eligible patients.

Lessons learned from bednet distribution in Central Mozambique.

INTRODUCTION: Malaria is an important cause of mortality and morbidity in sub-Saharan Africa. Use of insecticide-treated bednets (ITNs) is an important preventive intervention. Selection of the best mechanisms for distribution and promotion of ITNs to vulnerable populations is an important strategic issue. METHODS: Commercial shopkeepers and groups of community leaders were trained to promote and sell ITNs in 19 sites in central Mozambique between 2000 and 2004. Pregnant women and children under 5 years of age comprised the target population. Sales records, household survey results and project experiences were examined to derive 'lessons learned'. PRIMARY OUTCOME: An end-of-project household survey revealed that 40.8% of households owned one or more bednets, but only 19.6% of households owned a net that had been re-treated with insecticide within the preceding 6 months. Higher levels of bednet (treated or untreated) coverage (over 50%) were achieved in urban or peri-urban sites than in rural sites (as low as 15%). Bednet ownership was significantly associated with higher socio-economic status (odds ratios for association with bednet ownership: 5.6 for highest educational level compared with no education, 0.4 for dirt floor compared with cement or other finished flooring, 2.1 for automobile ownership compared with transportation on foot), but was negatively associated with the presence of young children in the household (odds ratio 0.5). Primary output: 23 000 ITNs were sold during the course of the project. Process lessons: Nearly all of the community leader sites failed and were replaced by shopkeepers or Ministry of Health personnel. Sales were most brisk in more prosperous urban and peri-urban sites (up to 147 nets/month) but were significantly slower in poorer, rural sites (as low as three nets/month). Remote rural sites with slow sales were more expensive to serve. Logistical difficulties were related to tariffs, transport, management of cash, warehousing and organization of re-treatment campaigns. CONCLUSIONS: This project failed to achieve adequate or equitable levels of ITN coverage in a timely manner in the programme sites. However, its findings helped support a subsequent Mozambican decision to conduct targeted distribution of long-lasting nets to the neediest populations in the provinces where the project was conducted.