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Benefits and Costs of Integrating Sexual-Reproductive Health and HIV Services in Kenya and Swaziland (Integra)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01694862
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : May 16, 2016
Sponsor:
Collaborators:
Population Council
International Planned Parenthood Federation
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Susannah Mayhew, London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Unintended pregnancies [ Time Frame: 24 months ]
Unintended pregnancy measures:
  • percent women who become pregnant (cohort study)
  • percent HIV+/HIV- women reporting planned pregnancy (cohort and client exit interviews)
  • percent clients women with correct knowledge of fertile period (cohort, client exit interviews) Proportion of population who report unintended pregnancy in last 12 months (community survey)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
HIV risk behaviour [ Time Frame: 24 months ]
HIV risk measures:
  • Condom use at last sex (cohort, client exit interviews, community survey)
  • Number of partners in past 12 months (cohort, client exit interviews, community survey)
  • Received STI/HIV counseling (cohort, client exit interviews, community survey) Consistent condom use reported (cohort, client exit interviews, community survey)
  • Use of condoms with another FP method (dual protection )(cohort, client exit interviews, community survey)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2012)
Unit costs [ Time Frame: 24 months ]
Economics measures in 42 study clinics:
  • Cost per eligible client receiving ART,
  • Cost per person-month of receiving ART
  • Cost per client counseled, tested and receiving results
  • Cost per client receiving each service component
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Benefits and Costs of Integrating Sexual-Reproductive Health and HIV Services in Kenya and Swaziland
Official Title  ICMJE Integra Initiative to Assess the Benefits and Costs of Integrating Sexual and Reproductive Health and HIV Services in Kenya and Swaziland
Brief Summary

The overarching aim of the Integra Initiative is to strengthen the evidence base on the impact of integrating family planning (FP), postnatal care (PNC) and HIV services in sub-Saharan Africa. Specifically, in the study the investigators aim to test the following hypotheses:

the provision of integrated services, compared to separate services, will:

  1. lead to increased uptake of a range of SRH services .
  2. attract a greater number and diversity of clients.
  3. lead to increased quality of a range of SRH services
  4. lead to healthier sexual and reproductive behavior.
  5. lead to reduced stigma at health facilities.
  6. lead to the more efficient use of resources, with a lower unit cost of provision of key services.

For the purposes of this study integration is defined as offering clients both HIV and postnatal care (PNC) or HIV and family planning (FP) services in the same visit.

To better understand how services can be integrated in different countries this study focuses on two key models of integration in Kenya and Swaziland.

  • The first model focuses on integration of FP and HIV services (integrated FP model) and entails performing HIV testing, STI screening and management, cervical cancer screening, condom promotion within FP consultations, as well as active referral to antiretroviral (ART) units for HIV-positive clients. The FP model will be evaluated in Kenya only.
  • The second model focuses on integration of PNC and HIV services (integrated PNC model) and will be implemented in both Kenya and Swaziland. The model focuses on the provision of PNC services to mother and baby, FP services, repeat HIV testing for mother, HIV testing for infant and referral to HIV services for HIV positive mothers and infants, as well as referrals for clients requiring other additional services.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Pregnancy
  • HIV
Intervention  ICMJE Procedure: Integrated FP/PNC service delivery
The intervention uses a procedural tool building on existing MoH procedures. It has nine components: strengthening protocols, guidelines and training materials for integrated HIV-SRH care; training, mentorship; developing a mentoring and supervisory package; improving provider capacity; ensuring availability of minimum levels of equipment and supplies for integrated services; support supervision; organizational change (including reviewing use of available rooms) and role clarification; improving availability of IEC/BCC materials on FP and HIV; strengthening the referral system between FP and ART and the data collection and recording systems.
Other Name: BCS+
Study Arms  ICMJE
  • Experimental: Integrated FP /PNC service delivery
    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.
    Intervention: Procedure: Integrated FP/PNC service delivery
  • No Intervention: Non-integrated FP/PNC service delivery
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2012)
4763
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya,   Swaziland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694862
Other Study ID Numbers  ICMJE Integra Initiative
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susannah Mayhew, London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Population Council
  • International Planned Parenthood Federation
  • Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: Susannah H Mayhew, PhD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP