Terminé

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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Ce qui est testé

Integrated FP/PNC service delivery

Procédure
Qui peut participer

De 15 à 49 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude sur les services de santé

Interventionnel
Date de début : janvier 2009
Voir le détail du protocole

Résumé

Sponsor principalLondon School of Hygiene and Tropical Medicine
Dernière mise à jour : 16 mai 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 janvier 2009

Date à laquelle le premier participant a commencé l'étude.

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.

Sponsor principalLondon School of Hygiene and Tropical Medicine
Dernière mise à jour : 16 mai 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

4763 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche sur les services de santé

Cette étude s'intéresse à la manière dont les soins de santé sont organisés et délivrés, et évalue l'efficacité de différents systèmes ou modèles de prise en charge.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Femme

Le sexe biologique des participants éligibles à s'inscrire.

De 15 à 49 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

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.

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
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.

Groupe II

Pas d'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.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 2 sites

Multiple MoH locations in Swaziland

Manzini, EswatiniOuvrir Multiple MoH locations in Swaziland dans Google Maps

Multiple MoH facilities in Kenya

Thika, Nyeri and Others, Kenya
Terminé2 Centres d'Étude