Intervention for Sustainable Testing and Retention (iSTAR)

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The objective of the study is to evaluate the effectiveness of iSTAR, an integrated community and clinic based intervention that is designed to test, link, engage and sustain HIV-infected women in care. Using a cluster randomized comparative effectiveness trial of iSTAR versus a clinic-based approach (Control Group or CG), the study will assess linkage, engagement, retention and viral suppression among 400 HIV-infected women. Based on the EPIS framework, it will use social network intervention methods to facilitate implementation and also assess implementation leadership and context. Fifty churches in Benue state Nigeria will be randomly assigned (1:1) to iSTAR or CG. The iSTAR intervention provides: confidential, onsite integrated laboratory testing during baby showers; a network of church-based health advisors; clinic based teams trained in motivational interviewing; quality improvement skills to engage and support HIV-infected women; and integrated case management to reduce loss to follow-up. Primary outcomes are difference in linkage and engagement rates between iSTAR and CG. Secondary outcomes are difference in retention and viral suppression rate. The findings will yield data that will be used to facilitate program scale-up, and sustainability planning for transition to the local community.

The iSTAR study is designed as a multiple principal investigator (MPI) plan. The study is being implemented through the collaboration of University of Nevada, Las Vegas (UNLV), University of Nigeria Nsukka (UNN), Sunrise Foundation, and Catholic Caritas Foundation of Nigeria (CCFN) and Centre for Clinical Care & Clinical Research Nigeria (CCCRN). Dr. Echezona Ezeanolue from UNLV and Dr. Chima Onoka from UNN serve as Principal investigator (PI) on this study.

The UNLV team consists of the PI and his assistants (Dr. Rohan Jadhav, Tami Bruno, Aaron Hunt, Dina Patel, and Semiu Gbadamosi). The UNLV team prepared and submitted the proposal for this study to the funding agency in collaboration with implementing partners in Nigeria. The team oversees all aspects of study including site selection, randomization of churches, baby shower screenings, referral of HIV-infected pregnant women to healthcare facilities, and data collection. They also prepared guidelines for operationalization of this study on the ground.

The UNN team consist of the PI, a program manager, a compliance officer and a research manager. The UNN team supervise the onsite implementation of the study. The team receives participant data, research activities, and outcome measures from the CCFN team and shares it with UNLV. The CCCFN team includes a research manager, an existing state-level study coordinator, 7 research assistants (1 for each LGA), a lab coordinator, and 18 clinic-based facilitators (CBFs). The state-level coordinator oversees the study, and the 7 research assistants (RAs) supervise between 12-18 church-based health advisors (CHAs) in each LGA. Teams of church-based health advisors from selected churches (CHTs) organize baby showers. Baby showers include screening for HIV, hepatitis B, and sickle cell disease. Church-based health advisers (CHAs) draw blood and transport specimens to the CCFN-supported laboratories located at health facilities that conduct diagnostic and clinical activities for the study. Results of the clinical activities and testing will be communicated through the state-level study coordinator back to the research assistants of each LGA.

To effectively carry out their duties and functions effectively the RAs, CHAs and CBFs receive ongoing training and mentorship on retention strategies from a team lead by CCCRN. A general training was done for the research team at the beginning of the project. Onsite training and direct mentorship will continuously by carried out by the CCCRN lead team all throughout the study.

Adolescent Coordinated Transition to Improve Outcomes among Nigerian HIV+ Youth (ACT STUDY)

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The ACT Study award is a five – year NIH research grant to University of Las Vegas (UNLV) and the collaborating Nigeria Implementing Partners (IPs) including Institute of Human Virology, Nigeria (IHVN); AIDS Prevention Initiative, Nigeria (APIN); Center for Clinical Care and Research, Nigeria (CCCRN); Center for Integrated Health Programmes (CIHP) and Family Health International (FHI360)

Background

ACT Study is National, multi – region, multi – center Cluster Randomized study premised on the background of high mortality (50%) among HIV infected, high HIV burden among adolescents in Nigeria, poor health outcomes for adolescents living with HIV in Nigeria, the need for a coordinated multidisciplinary and culturally appropriate approaches that are necessary to successfully transition patients from paediatric to adult care, identified several educational, logistic and psychosocial barriers that impair successful transition of care for ALHIV, and less developed transition models for ALHIV compared to other chronic diseases. Other background support for the study include need to have elements for a successful transition from paediatric to adult care like psychosocial support, provision of information on social issues to the adolescents etc., need for a feasible, acceptable and sustainable model of transition of care for ALHIV in resource – limited settings such as Nigeria.

ACT Study aims are:

  1. Determine the impact of ACT on retention in care among ALHIV.
  2. Evaluate the impact of ACT on viral suppression rates among ALHIV.
  3. Examine the impact of the planned ACT intervention on the psychosocial wellbeing of adolescents.

Significance of the Study
ACT Study is significant because: (1) Nigeria is a high – burden country with the second largest population of ALHIV worldwide. Successful interventions in Nigeria will have significant impact on health outcomes indicators among ALHIV globally. 2) Ineffective transfer from paediatric to adult care is associated with poor health outcomes and can be reduced with a successful transition process to adult care leading to higher post – transition retention in care, viral suppression and wellbeing among adolescents. Well – designed implementation science studies demonstrating successful models of transition of care for ALHIV in resource – limited settings are scarce. Feasible, acceptable, low cost and sustainable transition approaches remain crucial especially in resource – limited settings. (4) Implementation research that utilize the large PEPFAR investment and existing program infrastructure in resource – limited countries are more likely to be feasible and sustainable.

Inclusion criteria for ACT Study
ACT Study is being conducted in PEPFAR supported comprehensive ART sites with both paediatric and adult HIV services established for at least 12 months to increase feasibility of intervention.
ACT Study outcomes include:
1) Retention, defined as proportion of patients known to be alive and receiving highly active ART at the end of a follow – up period at 12 and 24 months post – transfer respectively
2) HIV Viral Load suppression, defined according to the Nigerian guidelines as plasma viral load (VL) of <400 copies/ml after ≥24 weeks of ART
3) We will evaluate psychosocial health with respect to successful transitioning

Building and Strengthening Infection Control Strategies for TB (TB BASIC)

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CDC has developed multiple resources for helping countries to assess and improve TBIC practices in health facilities. In this program CDC awarded a research grant that required CCCRN to conduct a pilot implementation of this package at inpatient and outpatient facilities in seven CCCRN supported health care facilities in Enugu, Ebonyi and Abia States across two levels of health facility in Nigeria. Given the high burden of TB, risk of transmission of TB to healthcare workers and patients – especially those with HIV, and the concern for MDR TB, improving TBIC measures is key to reducing morbidity and mortality in these settings. The information gained from this study was used to provide Ministry of Health (MOH) valuable insights as to the strengths and weaknesses of their current TBIC program and areas for potential improvement within health facilities in Nigeria. The primary intent of this evaluation is TBIC program improvement. The long term intent is to decrease and eventually eliminate TB transmission within health care facilities.

  1. To rapidly assess key TBIC measures in the selected facilities.
  2. To identify programmatic areas for potential strengthening, using tools for developing an intervention plan and monitoring programmatic activities, training materials, and visual aids.
  3. To support local and state public health officials and facility staff in developing the expertise needed to strengthen, scale-up and conduct ongoing monitoring of TBIC practices in local health facilities.
  4. To evaluate TBIC practices after the intervention to determine if there are any changes and/or improvements in comparison with the baseline assessment.
  5. To assess healthcare worker knowledge, attitudes, and practices regarding TBIC, before and after implementation of the interventions and then annually thereafter.
  6. To identify challenges to and strategies for implementation of TBIC measures and describe lessons learned.

At the end of the implementation years there was institution of improved TBIC practices in all facilities of implementation with significant improvement in all the indices assessed. (Link to dash board Possible). Lessons learnt are presently been replicated across other supported sites, as dissemination to state government and other stakeholders have been completed.

TB REACH

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In May 2014 WHO awarded CCCRN the WHO TB REACH grant.

The aim is to increase TB case detection among itinerant Fulani in Kwara and Niger State using community volunteers. The project screened 96,000 Fulani herdsmen for Tuberculosis and helped build community structures for sustainable screening using modified clinical tools. All capacity developed, tools and equipment deployed were handed over to the state government through the national TB program for sustainability and ownership

Partnership for Medical Education and Training-PMET (Pre-Service PMET 1 and In-service PMET 2)

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In 2012 CCCRN became the only PEPFAR implementing partner to secure a 5 year CDC funded in-service training award Called Partnership for Medical Education and Training.

The Nigerian health workforce falls critically below the World Health Organization (WHO) threshold of 2.5 health care providers per 1,000 people required for effective service provision. Recognizing this deficiency and its implications on access to HIV service, CCCRN implement the 2 awards for pre service and in service trainings.

From 2012 till date, CCCRN supported training regulatory bodies (Nursing and Midwifery Council of Nigeria, Community Health Practice Registration Board of Nigeria, West African Postgraduate Medical College) and 13 pre service training institutions to review and adapt new curricula for medical training. In addition, trainings for master tutors and infrastructural and tool upgrades were provided for these institutions to improve quality of training for students.

Since inception of the project, more than 400 health care workers (including 28 post graduate physicians) graduated with an enhanced capacity for managing HIV care centers.

Through the PMET 2 award, CCCRN is institutionalizing training structures in a sustainable manner that will enable increased government investment in capacity building. CCCRN has developed ten training centers in Federal capital territory, Gombe, Nassarawa, Benue, Ekiti, Lagos Enugu, Imo, Ebonyi, Kaduna, in tertiary health facilities in collaboration with hospital management and the Government of Nigeria. This strategy of domiciling trainings within government structures serves the purpose of integrating HIV trainings within existing service delivery structures, minimizing costs of space or facilitators, while strengthening human capacity and infrastructure at these institutions. Engagement of trainers within these institutions enables trainings to be conducted by a stable work force of experience hands that derive their remuneration from the Government. To date, through this grant, over 4500 numbers of health care workers have received in-service trainings according to National guidelines in Adult ART, Paediatric ART, PMTCT, HCT and TB/HIV, and over 130 national trainers have been certified by the Federal ministry of health to provide training for health care workers across different program areas for HIV. A segment of these trainees are followed up longitudinally under a Training Impact Evaluation process using a set of field tested tools and check list to access the level of knowledge and skills retained from trainings received and its direct and indirect impact of work outcome.

To ensure sustainability CCCRN is currently engaging facility management on the establishment of a training unit under the hospital management (a department or an institute) as well as expanding the training menu to include other non HIV related training programs for other health care workers and interests. CCCRN is supporting the faculties to register with corporate affairs commission of Nigeria as an independent business entity capable of meeting human resource for health development needs in the catchment areas they operate. The scope of training interest is been expanded beyond the HIV curriculum and in partnership with the Kaduna business school, business development plans are been developed for the training faculty.

This award mechanism also provides support and close collaboration with the FMOH in the review and revision of National HIV curriculum into an Integrated Curriculum based on new national guidelines.

This award has also established a web based virtual learning platform to enhance capacity building for health care work force .This is an online training platform managed by CCCRN with accreditation by relevant health regulatory bodies to provide CME points on completion of stipulated modules. And it provides additional learning resource other than those covered in the didactic sessions. These modules will extend beyond the National curriculum to include more detailed learning topics on HIV management, co-morbidities and clinical case managements. Upon completion of a module, users are scored and certificates generated automatically for successful participants. CME points are awarded based on guidance from MDCN on the weighted assessment of time required to complete the module. In other to keep track of trainings, the award established Train-Smart, a data based software customized to serve as the monitoring and reporting tool as well as data base for all in-service trainings supported by CCCRN. The database captures the training date, training venue, health workers names, facility, pre & post test results and facilitator information. Access to this database is provided for health administrators at the state government level for the purpose of staff deployment and redeployment

Service Expansion and Early Detection for Sustainable HIV Care Project (SEEDS)

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In 2012, the United States Government through the Center for Disease Control awarded CCCRN a five years cooperative agreement funded by The U.S. President’s Emergency Plan for AIDS Relief.(CDC GH 12-1210) Through this SEEDS project, CCCRN with its partner organizations are building strategic partnerships with the public and private sector to support Nigerian health institutions in developing, implementing, monitoring, evaluating and managing HIV/AIDS prevention, and care and treatment programs. In Imo, Ebonyi and Enugu States, the projects has strengthened 763 health facilities and currently provided care and treatment to more than 30,000 HIV infected Nigerians. These includes targeted population like 3321 female sex workers and 635 MSM. Applying technology for improving care delivery, CCCRN has deployed electronic medical record (EMR) systems in all the 33 secondary and tertiary health facilities in this pool with xx % of the primary level facilities also operating on the EMR.
The ultimate goal of SEEDS is to reduce mortality and morbidity from HIV in assigned states of Nigeria by ensuring that the

  1. Incidence of HIV infections in the target population is reduced.
  2. Target population persons living with HIV (PLHIV) and their families receive quality HIV care and treatment services.
  3. Service Delivery Facilities (SDFs) have strengthened organizational and technical capacity to provide and support the provision of high quality HIV and AIDS care and treatment services.
  4. Service Delivery Partners collaborate with government authorities to sustain HIV and AIDS care and treatment programs. CCCRN is supporting host government by instituting a state transition team charged with the responsibility of providing transition plans for supported facilities to ensure sustainability of care at the end of the supported projects.