Completed

IntegraIntegra Initiative to Assess the Benefits and Costs of Integrating Sexual and Reproductive Health and HIV Services in Kenya and Swaziland

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What is being tested

Integrated FP/PNC service delivery

Procedure
Who is being recruted

From 15 to 49 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorLondon School of Hygiene and Tropical Medicine
Last updated: May 16, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

There are many well-established reasons that support the rationale for integrating or linking sexual and reproductive health (SRH) and HIV services in developing countries with generalized HIV epidemics - primarily in sub-Saharan Africa. Yet the evidence base for the impact of integrated service delivery on health outcomes and costs remains weak. Partly this is a result of methodological difficulties. There is an emerging body of literature addressing the challenges of using randomized controlled trials to assess the impact of public health interventions. Particularly in cases such as the Integra Initiative, where the causal chain (between intervention and outcome) is long, and where there are is a broad range of outcomes that need to be explored, and where there is already some a degree of integration occurring in some clinic settings, attempting to conduct a randomized controlled trial is not appropriate. Consistent with evaluation designs described by Habicht and colleagues, the Integra design includes evaluation of performance and impact to try to make two types of causal inference: adequacy and plausibility. Evaluation of adequacy will assess whether the expected changes in provision, service utilisation and cost-effectiveness have occurred in intervention facilities. Evaluation of impact will assess the plausibility that changes in service, health and behavioral outcomes are due to the Integra Initiative. The case for such plausibility will be built from the following strands of evidence: Comparing findings in 'intervention' facilities with those in facilities chosen as 'comparison' sites prior to the evaluation Exploring a dose-response relationship between the measured extent of integration and the study outcomes Measuring changes in performance over time, to demonstrate a logical sequence between the intervention (integration) and outcomes. Measuring change in each step of the logic model - a prerequisite for any attribution to the intervention Triangulating findings from a mix of research methods to capture a range of perspectives and insights from different disciplines. The study will employ a controlled pre- and post-test quasi-experimental, or non-randomised, design and utilises multiple research methods (cohort study, community survey, clinic assessments, costing tools and qualitative interviews). Since the research is being conducted in real-life health delivery settings where programmatic contamination is possible due to ongoing health programme interventions over the study period, the control group will be referred to as a 'comparison group', for which outcomes will be compared over time up to two years after implementation.

Principal SponsorLondon School of Hygiene and Tropical Medicine
Last updated: May 16, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4763 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 15 to 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria for FP-HIV study: women aged 15 years and over, be revisit FP clients, be living in the catchment area of the health facility, and willing to give their informed consent to be interviewed. Inclusion Criteria for PNC-HIV study: women aged 15 years and over, be postnatal clients attending a postnatal check for themselves and/or their infant (0-10 weeks), living in the catchment area of the health facility, and willing to give their informed consent to be interviewed.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Clinic or district identified as 'intervention' in which FP and PNC services are (theoretically) being provided together with HIV services (counselling, testing, treatment etc.) and in which the procedural intervention has been applied.

Group II

No Intervention
Clinic or district where FP and PNC services are not (theoretically) being provided together with HIV services, and in which no procedural intervention has been applied.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Multiple MoH locations in Swaziland

Manzini, EswatiniOpen Multiple MoH locations in Swaziland in Google Maps

Multiple MoH facilities in Kenya

Thika, Nyeri and Others, Kenya
Completed2 Study Centers