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General

Study Overview

Title:

Effectiveness Evaluation of the First-Phase of an Integrated Chronic Care Model to Improve Prevention, Care, and Support for People Living with HIV in Côte d’Ivoire

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-5616685dc795d

Initial Registration Date:

10/08/2015

Last Update Date:

04/21/2020

Study Status:

Completed

Change History for Status

Changed On	Previous Value
04/21/2020	Ongoing

Location(s):

Cote Divoire

Abstract:

In Côte d’Ivoire less than half of adults living with HIV meeting the recommendation for ART (CD4 < 350mm3) are on treatment, and only 2/3 of those who start ART are still on treatment at 12 months. This is a quasi-experimental mixed methods study to determine the effectiveness, acceptability and cost-effectiveness of the first phase of implementation of an integrated chronic model of care for people living with HIV in Côte d'Ivoire on patient retention to care and treatment. The quantitative component involves data abstraction from client records at two points in time in intervention and matched comparison facilities: prior to initiation of the model, and after 6 months of implementation. Healthcare provider and patient acceptability and perceived effectiveness of the model to reduce barriers to adherence and retention will be assessed through in-depth interviews and focus group discussions after several months of implementation of the model. The incremental cost-effectiveness of the model will be determined by comparing costs and health effects of the intervention in intervention vs. comparison facilities.

Change History for Abstract

Changed On

Previous Value

04/21/2020

In Côte d’Ivoire less than half of adults living with HIV meeting the recommendation for ART (CD4 < 350mm3) are on treatment, and only 2/3 of those who start ART are still on treatment at 12 months. This is a quasi-experimental mixed methods study to determine the effectiveness, acceptability and cost-effectiveness of the first phase of implementation of an integrated chronic model of care for people living with HIV in Côte d'Ivoire on patient retention to care and treatment. The quantitative component involves data abstraction from client records at two points in time in intervention and matched comparison facilities: prior to initiation of the model, and after 6 months of implementation. Healthcare provider and patient acceptability and perceived effectiveness of the model to reduce barriers to adherence and retention will be assessed through in-depth interviews and focus group discussions after several months of implementation of the model. The incremental cost-effectiveness of the model will be determined by comparing costs and health effects of the intervention in intervention vs. comparison facilities.

Registration Citation:

Stender, S. and Ouattara, K., 2015. Effectiveness Evaluation of the First-Phase of an Integrated Chronic Care Model to Improve Prevention, Care, and Support for People Living with HIV in Côte d’Ivoire. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie071

Categories:

Health, Nutrition, and Population

Additional Keywords:

retention, antiretroviral therapy, chronic care, integration

Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:

Stacie Stender

Affiliation:

Johns Hopkins University School of Public Health & Jhpiego

Name of Second PI:

Kiyali Ouattara

Affiliation:

Jhpiego Côte d'Ivoire

Study Sponsor

Name:

International Initiative for Impact Evaluation

Study Sponsor Location:

United States

Research Partner

Name of Partner Institution:

Direction de la Formation et de la Recherche, Ministère de la Sante et de la Lutte contre le SIDA

Type of Organization:

Government agency (eg., statistics office, Ministry of Health)

Location:

Cote Divoire

Intervention

Intervention Overview

Intervention:

A chronic model of integrated care is being offered in two regions of Côte d'Ivoire focusing on a proactive team approach to care, patient focused care with a strong long-term provider-patient relationship, seamless referral systems, task shifting to enable care closest to the patient as possible, and improved community-health facility linkages. Chronic care teams are being established in facilities and client circulation is being modified to improve quality and scope of services offered at each visit.

Change History for Intervention

Changed On

Previous Value

04/21/2020

A chronic model of integrated care is being offered in two regions of Côte d'Ivoire focusing on a proactive team approach to care, patient focused care with a strong long-term provider-patient relationship, seamless referral systems, task shifting to enable care closest to the patient as possible, and improved community-health facility linkages. Chronic care teams are being established in facilities and client circulation is being modified to improve quality and scope of services offered at each visit.

Private Intervention Details:

Theory of Change:

Theory of Change begins with program inputs: minimum package of integrated care, decentralized care, scheduling system and community engagement through chronic clubs and home visits to provide psychosocial support for PLHIV and/or other chronic diseass.

These core program activities, implemented through the SCI-VIH project, ensure that a package of integrated services is available to all clients in intervention sites, which, in turn, will ensure that PLHIV who come to the health facility will receive these integrated services—or be seamlessly referred to a health facility that offers them. A primary goal of the project is to improve patient-centred care and community support. The focus on the patient and his/her family aims to improve the client-provider relationship. This, in addition to the community components, contributes to change in sociocultural norms, increased self-efficacy, and changes in attitudes and beliefs. This, in turn, contributes to improved health status, as does health seeking behaviour related to perceived severity of the disease and access to health information. Increased adherence and retention to HIV care and treatment are the expected outcome based on these inputs.

Multiple Treatment Arms Evaluated?

No

Implementing Agency

Name of Organization:

Jhpiego in collaboration with the Ministry of Health

Type of Organization:

NGO (International)

Program Funder

Name of Organization:

United States Centers for Disease Control and Prevention

Type of Organization:

Foreign or Multilateral Aid Agency

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Start Date:

09/01/2015

End Date:

03/31/2018

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Natural experiment

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Matching

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

The primary analysis is to compare patients in the intervention and comparison regions during the six-month study period. Our data are at the individual level, but matching was done at the facility level, and the intervention program is being implemented at the regional level with multiple facilities per region. We will use a multi-level analysis to account for clustering in this quasi-experimental design. We are including different types of facilities in two intervention regions, and individually matched clinics in two comparison regions. We chose clinics as matches based on type of facility, clinic size, and services offered. We will examine adherence and retention to ART at specific recommended follow-up intervals based on the standard of care, as well as cumulative retention across the six-month follow-up period. The primary analysis will include generalized estimating equations (GEE) to examine the dichotomous outcome of retention. Cost effectiveness analysis will be conducted from a societal perspective inclusive of all costs and all health effects affected by the intervention, regardless of who bears the costs or receives the effects. Economic costs will include

Change History for Details of Evaluation Approach

Changed On

Previous Value

04/21/2020

The primary analysis is to compare patients in the intervention and comparison regions during the six-month study period. Our data are at the individual level, but matching was done at the facility level, and the intervention program is being implemented at the regional level with multiple facilities per region. We will use a multi-level analysis to account for clustering in this quasi-experimental design. We are including different types of facilities in two intervention regions, and individually matched clinics in two comparison regions. We chose clinics as matches based on type of facility, clinic size, and services offered. We will examine adherence and retention to ART at specific recommended follow-up intervals based on the standard of care, as well as cumulative retention across the six-month follow-up period. The primary analysis will include generalized estimating equations (GEE) to examine the dichotomous outcome of retention. Cost effectiveness analysis will be conducted from a societal perspective inclusive of all costs and all health effects affected by the intervention, regardless of who bears the costs or receives the effects. Economic costs will include

Private Details of Evaluation Approach:

The secondary analysis of primary outcomes is to again compare the intervention and comparison regions by performing an interrupted time series analysis, using an autoregressive integrated moving average (ARIMA) model to assess the impact of the intervention on adherence and retention. Both models allow us to compare the two regions in the quasi-experimental design.

Change History for Private Details of Evaluation Approach

Changed On	Previous Value
04/21/2020	The secondary analysis of primary outcomes is to again compare the intervention and comparison regions by performing an interrupted time series analysis, using an autoregressive integrated moving average (ARIMA) model to assess the impact of the intervention on adherence and retention. Both models allow us to compare the two regions in the quasi-experimental design.

Outcomes (Endpoints):

We focus on two primary outcomes: retention and adherence to care whereby retention is defined as clinic visit for ART refill within 60 days of last scheduled appointment among people living with HIV and adherence is defined as attendance at facility within 3 days of scheduled appointment. Qualitative interviews and a cost effectiveness analysis will provide insight into patient and provider experiences with regards to the implementation of the model.

Change History for Outcomes (Endpoints)

Changed On

Previous Value

04/21/2020

We focus on two primary outcomes: retention and adherence to care whereby retention is defined as clinic visit for ART refill within 60 days of last scheduled appointment among people living with HIV and adherence is defined as attendance at facility within 3 days of scheduled appointment. Qualitative interviews and a cost effectiveness analysis will provide insight into patient and provider experiences with regards to the implementation of the model.

Unit of Analysis:

Individual patient

Hypotheses:

Our primary hypothesis is that both primary outcomes, retention and adherence, will be improved for individuals attending clinics in the intervention region versus the comparison region. We base this on our expectation that implementation of the integrated chronic model of care will result in individuals and families receiving ongoing care, as defined by their own needs, at each visit, with interpersonal, organizational, community and public policy factors addressed systematically.

Change History for Hypotheses

Changed On

Previous Value

04/21/2020

Our primary hypothesis is that both primary outcomes, retention and adherence, will be improved for individuals attending clinics in the intervention region versus the comparison region. We base this on our expectation that implementation of the integrated chronic model of care will result in individuals and families receiving ongoing care, as defined by their own needs, at each visit, with interpersonal, organizational, community and public policy factors addressed systematically.

Unit of Intervention or Assignment:

Healthcare facility

Number of Clusters in Sample:

We have 16 clusters in total: 8 facilities in the intervention region, and 8 matched facilities in the comparison region.

Number of Individuals in Sample:

1809 clinical records of individual patients

Size of Treatment, Control, or Comparison Subsamples:

All clients seeking care at the 8 intervention sites will be exposed to the intervention.

Supplementary Files

Analysis Plan:

Analysis Plan.docx

Other Documents:

Data

Outcomes Data

Description:

Clinical and pharmacy records will be retrospectively reviewed during two time points to evaluate adherence and retention to treatment. The HIV clinical records provide information on clinical measures of health in addition to expected date of next visit and documentation of clinical services provided.

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

10/01/2016

Data Collection Completion Date:

08/30/2016

Unit of Analysis:

PLHIV enrolled in care at facilities in the region of intervention matched to facilities in control region.

Clusters in Final Sample:

8 intervention sites and 8 comparison sites

Total Observations in Final Sample:

In our analysis of data from the clinical record (time period January 2013 to June 2016), we collected a total of 16,135 clinical visits made by 2,519 individuals.

Size of Treatment, Control, or Comparison Subsamples:

For retention, we measured in quarterly cohorts based upon date of ART start date; comparing intervention and control regions.

Findings

Preliminary Report:

No

Preliminary Report URL:

Summary of Findings:

Quantitative data analysed covered cohorts of patients that began treatment between 1 January 2013 and 30 June 2016. In this quasi-experimental study, we conducted a difference-in-difference analysis and propensity score matching to evaluate the intervention impact between the intervention region and the comparison region. Pharmacy registry data and clinical follow-up data suggest that the intervention region N’Zi-Iffou improved relative to Indénie-Djuablin. In many cases it was not statistically significant or consistent. However, in difference-in-difference multivariable models controlling for regional imbalances at baseline, we found a significant interaction between initial CD4 count and intervention status, in that the intervention region showed substantially and significantly better retention than the control region among clients with a higher initial CD4 count. In analyses of propensity score matched datasets, we did not observe significant differences in 30-day, 90-day, or 180-day retention between the two regions. Overall, both the quantitative clinical and pharmacy records data showed that retention in both regions was steadily improving during the study period. Our ability to assess the impact of the intervention will be greater after a longer follow-up period. 

Paper:

No

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Yes--Available now

Date of Data Availability:

Data URL or Contact:

https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/640WKZ

Access procedure:

Other Materials

Survey:

Yes

Survey Instrument Links or Contact:

Contact Stacie Stender at scstender@me.com

Program Files:

No

Program Files Links or Contact:

Contact Stacie Stender at scstender@me.com

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: