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

May 13, 2016 updated by: Susannah Mayhew, London School of Hygiene and Tropical Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

4763

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Thika, Nyeri and others, Kenya
        • Multiple MoH facilities in Kenya
  • Swaziland
      • Manzini, Swaziland
        • Multiple MoH locations in Swaziland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • BCS+
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Bill and Melinda Gates Foundation
Population Council
International Planned Parenthood Federation

Investigators

  • Principal Investigator: Susannah H Mayhew, PhD, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (ESTIMATE)

September 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Integra Initiative

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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