Adis Abbaba, Ethiopia

Decentralization of Hepatitis B Care in Sub-Saharan Africa: a Pilot Program in Ethiopia

Chronic hepatitis B (CHB) is a major health problem globally, and in Ethiopia 5-10 % of the general population are infected with hepatitis B. In the absence of treatment, 15-40 % of these will die from its complications. Antiviral therapy effectively prevents disease progression and death in CHB. However, In low-income countries antiviral treatment is rarely available due to complex treatment guidelines, poor laboratory capacity, restrictions on antiviral treatment and lack of public funding. In 2015, we set up a pilot treatment program for CHB at a tertiary hospital in Addis Ababa, Ethiopia. In 2021/22, this program was extended to four regional secondary hospitals to study simplified CHB care in a low-income country. With the present study we aim to decentralize CHB therapy to rural settings, which will be essential to achieve universal access to antiviral therapy in Africa. We will study different treatment models, each of which has its theoretical pros and cons: i) standard model ("treat only if..."), ii) inclusive model ("treat all except..."), and iii) test-and-treat ("treat all"). The primary endpoint will be death or liver decompensation, and secondary endpoints will be programmatic and laboratory success indicators. Moreover, we will study the cost-effectiveness of these decentralized models and compare with the tertiary/secondary hospital-based model. Implementation research, such as our study, is of vital importance to respond to the research gaps identified by the World Health Organization in hepatitis B care. Our study is expected to directly inform international hepatitis B guidelines and will be a major contribution to the efforts to eliminate viral hepatitis as a public health threat by 2030.

Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

This study aims to evaluate the impact of the "Doing What Matters in Times of Stress Guided" self-help manual on mental distress, business performance, and intimate partner violence experienced by women entrepreneurs in Ethiopia. The study will be conducted in four cities - Addis Ababa, Hawassa, Bahir Dar, and Adama - using a randomized controlled trial (RCT) design. The investigators will screen 5000 potential participants via phone and enroll 1200 eligible women, who will be equally distributed across the four cities. After an in-person baseline survey, the women will be stratified by marital status and city and randomized into the intervention or waitlist control group using a computer-generated random assignment. The intervention group will receive seven phone-based sessions over ten weeks to review the self-help manual materials with a lay helper. Two follow-up surveys will be conducted after the intervention, the first one a month after the completion of the intervention, and the second one twelve months after completion. This study is a continuation of a pilot study conducted between July 2021 and August 2022 (PRS registration ID - NCT05208723). The current study seeks to build on the pilot study in the following dimensions: 1. Increase the sample size to 1200 women entrepreneurs to improve the power of the study to detect the impact of the intervention on business performance outcomes, 2. Widen the geographical and contextual coverage, 3. Allow entrepreneurs to invite a household member to attend the self-help phone sessions with them, 4. Capture the impact on intimate partner violence, 5. Introduce a short conflict module to capture the direct and indirect effects of conflict on mental health outcomes, business performance, and intimate partner violence.

Evaluation of Prototype Solutions for Optimizing Maternal Health Behaviors

With funding and support from the Bill and Melinda Gate Foundation (BMGF), a three-year implementation research project will be conducted to develop and test the effectiveness and acceptability of interventions to promote three outcomes: institutional delivery, antenatal care (ANC) and iron folic acid (IFA) supplementation among pregnant women. The project applies a Human-Centered-Design (HCD) to develop prototype solutions that optimize the uptake of and adherence to maternal and child health services by pregnant women. Initial and high-fidelity prototype solutions that come out from a sprint workshop (rapid HCD) and an extended HCD process will be implemented in two phases. Phase 1: The investigators will conduct a design sprint workshop and develop prototype solutions focusing on ANC and institutional delivery and the high-fidelity prototypes will be implemented for four months. The prototype solutions may include but are not limited to social and behavior change communication campaigns, including print media, mass media, social media, and community-based educational events. Specific content and format of the prototypes will be determined based on participant needs and preferences identified from the workshop. Baseline and midline assessments will be conducted to evaluate the effectiveness of the prototypes. Phase 2: The investigators will conduct extended HCD to refine prototype solutions for design challenges around ANC and institutional delivery that are not addressed by the design sprint. The prototype solutions may include but are not limited to social and behavior change communication campaigns, including print media, mass media, social media, and community-based educational events. Specific content and format of the prototypes will be determined based on participant needs and preferences identified from the workshops in Phases 1 and 2. High-fidelity prototypes designed in the two phases will be implemented in the two intervention Woredas (geographical areas in Ethiopia roughly equivalent to counties in the US) for another four months. Another round of baseline and end-line evaluations will be conducted to evaluate the effectiveness of the prototypes. Hence, the following four research activities will occur throughout the study: (1) baseline in Year 1 and (2) midline in Year 1, possibly bleeding into Year 2. These two waves will involve the same pregnant women recruited at baseline. (3) Baseline and (4) end-line in Year 2 and Year 3; these two waves will recruit and retain the same women from the Year 2 baseline. Both rounds of evaluations (four data waves in total) have the objective of assessing the effectiveness of the intervention in improving (a) institutional delivery and (b) uptake of ANC services. In addition, qualitative interviews will assess psychosocial and intermediate outcomes among pregnant women as well as implementation research outcomes of the intervention.

BEP Targeting Strategies in Ethiopia

Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients

Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Poor adherence decreases the benefits of ART as well as chances of prolonged survival. An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.

Ifaa Effectiveness Evaluation on Food Security and Nutrition

The Ifaa Project will deliver multi-sectoral programming in 241 kebeles (sub-districts) in nine woredas (districts) of East Hararghe Zone, however, intervention packages vary by location. The three Ifaa intervention packages that will be delivered to PSNP beneficiaries based on the beneficiaries residence location include: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. The proposed effectiveness evaluation will quantify the impacts of three different intervention packages in terms of key project indicators in the areas of household food security, diet, and child nutrition. As the Ifaa consortium learning partner, Johns Hopkins School of Public Health (JHSPH) has been requested to design an effectiveness evaluation of the different intervention packages to compare their outcomes among beneficiary households. To align the evaluation with project aims, key project indicators are used as study outcome measures. The specific objectives of the evaluation are to quantify the impact of Ifaa interventions as follows: 1. At the household level, Poor or Borderline Food Consumption Score (FCS) 2. at the individual level, change in minimum dietary diversity among children <5 years A secondary objective is to examine Ifaa impacts on child nutrition indicators, including measures of both acute and chronic malnutrition. A longitudinal cohort design will be used to compare the effectiveness of three Ifaa intervention packages among PSNP beneficiaries in Eastern Hararghe: 1) the Ifaa basic package; 2) enhanced package without livelihoods; and 3) enhanced package with livelihoods. Under this approach, the enrolled households will have either a pregnant woman or children <24 months of age. Households will be followed over a two-year period, with the baseline and endline survey conducted at a similar time in the calendar year to avoid seasonal changes in food security. The magnitude of change in key indicators over time will be assessed for each group; if needed, adjusted models will be used to account for baseline differences between groups.

Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia

AIM: The overall aim of the MMS evaluation is to evaluate the programme effectiveness on birthweight of providing MMS as part of routine antenatal care, relative to providing IFA. STUDY DESIGN: This program effectiveness study involves a cluster randomized trial to estimate the effect of MMS on the primary outcome, birthweight, with embedded cost and process evaluations to measure the secondary objectives. The overall study design is built around a two-arm, facility-based, cluster randomized trial with district as the unit of randomization (the cluster), whereby districts are randomized to a comparison arm that continues to deliver iron-folic acid supplementation (IFA) as part of the standard antenatal care package, or to an intervention arm where IFA is removed from the standard antenatal care package and replaced with multi-micronutrient supplementation (MMS). STUDY PERIOD: The entire MMS evaluation will continue for 42 months, starting in March 2022. During 2022, permissions will be obtained and protocols written. In January 2023, a system will be implemented for continuous recording of birth weights in all enrolled health facilities, running until end December 2024 (ie for 24 months). A facility survey will be implemented to collect process data for the secondary objectives at baseline (January 2023), midline (February 2024) and endline (February 2025). Data on costs will be collected alongside the midline facility survey. Primary analysis will be conducted during April 2025. LOCATION: The evaluation will be done in 42 districts in five regions of Ethiopia. The districts were selected by the Ethiopian Ministry of Health as a pilot area to implement the switch from MMS to IFA as part of routine care, with the intention of also permitting the RCT evaluation of that switch. 42 Districts in detail: Gambella Region (2 districts): Itang especial woreda; Godere; Somali Region (4 districts): Kebribaya; Ararso; Awbare; Aware; Oromia Region (20 districts): Gursum; Deder; Goba Koricha; Bele Gesgar; Rayitu; Dodola; Wondo; Kersa; Ejere; Gimbichu; Gemechis; Adami Tulu Jido; Sire; Guna; Medawelabu; Dire; Arero; Becho; Jimma Arjo; Ejersa Lafoo; Southern Nations Nationalities, and People's Region (12 districts): Sodo; Enemor; Shahsego; Chencha Zuria; Atote Ulo; South Ari; Duguna Fango; Kachabira Bira; Silti; Wonago; Zala; Karat Zuria; Sidama Region (4 districts): Shebedino; Dara; Aleta chuko; Bona Zuria; PRIMARY OBJECTIVE: The primary objective is to estimate the effect of MMS implementation on the mean birthweight of babies born in government health facilities to women living in areas where MMS is implemented, relative to the mean birthweight of babies born in government health facilities to women living in areas where standard antenatal IFA supplementation is implemented. PRIMARY OUTCOME: Birthweight measured as part of routine maternity care will be collected for all live births in enrolled health facilities in intervention and comparison areas. The protocol for recording the primary outcome, birthweight, will align with routine practices in health facility maternity wards whereby midwives routinely document birthweight. Digital scales will be provided to facilities for this purpose, replacing manual scales. The study team will work with midwives to ensure training in appropriate use of digital scales, accurate recording of birthweight in grammes to four digits, and continuous quality control measures including scale calibration. SECONDARY OBJECTIVES: - To estimate the cost and cost-effectiveness of the MMS intervention - To investigate the processes of MMS implementation including addressing questions about how delivery is achieved and what is actually delivered (fidelity, dose, adaptations, reach and context) and the mechanisms of impact (how providers and clients respond to MMS and any unanticipated pathways or consequences) - To assess the acceptability and adherence of MMS SECONDARY ANALYSES AND OBJECTIVES: During the baseline, midline and endline facility surveys data collection tools include: (i) a structured tool to capture detailed information about the antenatal care received by women; (ii) a structured tool to collect data on costs of implementing MMS or IFA; (iii) a structured facility readiness assessment to collect data on availability of services, supplies and trained staff (iv) semi-structured interviews with facility staff on their experience of providing antenatal care services. The need for additional qualitative interviews with health care users and health care providers to explore emerging topics regarding adherence and acceptability will be reviewed together with the implementation team when implementation has begun and after analysis of baseline data collection. STUDY POPULATION: For the primary outcome, the study population are mother/infant dyads who are resident in study districts and who access childbirth care in the health centres of those districts. For the secondary objectives there are two study populations: (i) the health staff providing antenatal care services in health centres and (ii) women accessing antenatal care there.

iCaReMe Global Registry

The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world.

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

This is a double blind randomized controlled trial (RCT) to test the efficacy of MTX for managing ENL. Patients diagnosed with moderate or severe ENL at ENLIST Group centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal will be randomly allocated to receive a 15 or 20 mg of oral MTX each week for 48 weeks and prednisolone 40 mg per day reducing to zero over 20 weeks. The control group will receive an identical prednisolone scheme. The participants will be stratified into two groups, those with acute ENL, those with chronic/recurrent ENL. The interventions for both populations are the same, although analysed separately. Adverse effects (AE) will be closely monitored clinically and using laboratory tests. Participants will receive folic acid, 5mg daily for 52 weeks except on the day of MTX to prevent AEs, and nausea will be managed with ondansetron.

Kebele Elimination of Trachoma for Ocular Health

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.