PregnancyIntegraNCT01694862
Benefits and Costs of Integrating Sexual-Reproductive Health and HIV Services in Kenya and Swaziland
A study testing Integrated FP/PNC service delivery in people with Pregnancy and HIV, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- What is being tested?
- Integrated FP/PNC service delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,763 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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:
Read more
- lead to increased uptake of a range of SRH services .
- attract a greater number and diversity of clients.
- lead to increased quality of a range of SRH services
- lead to healthier sexual and reproductive behavior.
- lead to reduced stigma at health facilities.
- 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.
Read the 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.
- Being tested
- Integrated FP/PNC service delivery
- Keywords
- quasi experimental, evaluation, intervention, service integration, cost analysis, HIV, FP, PNC, Sub-Saharan Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated FP/PNC service deliveryProcedure or surgery
Also called BCS+
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated FP /PNC service delivery | 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. Receives: Procedure: Integrated FP/PNC service delivery |
| Non-integrated FP/PNC service delivery | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintended pregnancies
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)
Measured: 24 months
Secondary outcomes (1)
HIV risk behaviour
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,763 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council, International Planned Parenthood Federation, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Susannah Mayhew, London School of Hygiene and Tropical Medicine
- Investigators
- Susannah H Mayhew, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694862
- Sponsor's protocol ID
- Integra Initiative
- Acronym
- Integra
- Status last verified
- May 2016
- First submitted
- 21 Sep 2012
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Birdthistle IJ, Fenty J, Collumbien M, Warren C, Kimani J, Ndwiga C, Mayhew S; Integra Initiative. Integration of HIV and reproductive health services in public sector facilities: analysis of client flow data over time in Kenya. BMJ Glob Health. 2018 Sep 14;3(5):e000867. doi: 10.1136/bmjgh-2018-000867. eCollection 2018.
PubMed 30245866Wekesa E, Askew I, Abuya T. Ambivalence in pregnancy intentions: The effect of quality of care and context among a cohort of women attending family planning clinics in Kenya. PLoS One. 2018 Jan 9;13(1):e0190473. doi: 10.1371/journal.pone.0190473. eCollection 2018.
PubMed 29315327Mayhew SH, Colombini M, Kimani JK, Tomlin K, Warren CE; Integra Initiative; Mutemwa R. Fertility intentions and contraceptive practices among clinic-users living with HIV in Kenya: a mixed methods study. BMC Public Health. 2017 Jul 5;17(1):626. doi: 10.1186/s12889-017-4514-2.
PubMed 28679389Kimani J, Warren CE, Abuya T, Ndwiga C, Mayhew S, Vassall A, Mutemwa R, Askew I. Use of HIV counseling and testing and family planning services among postpartum women in Kenya: a multicentre, non-randomised trial. BMC Womens Health. 2015 Nov 13;15:104. doi: 10.1186/s12905-015-0262-6.
PubMed 26563220Obure CD, Guinness L, Sweeney S, Initiative I, Vassall A. Does integration of HIV and SRH services achieve economies of scale and scope in practice? A cost function analysis of the Integra Initiative. Sex Transm Infect. 2016 Mar;92(2):130-4. doi: 10.1136/sextrans-2015-052039. Epub 2015 Oct 5.
PubMed 26438349Kimani J, Warren C, Abuya T, Mutemwa R; Integra Initiative; Mayhew S, Askew I. Family planning use and fertility desires among women living with HIV in Kenya. BMC Public Health. 2015 Sep 17;15:909. doi: 10.1186/s12889-015-2218-z.
PubMed 26381120Mulrenan C, Colombini M, Howard N, Kikuvi J, Mayhew SH; Integra Initiative. Exploring risk of experiencing intimate partner violence after HIV infection: a qualitative study among women with HIV attending postnatal services in Swaziland. BMJ Open. 2015 May 14;5(5):e006907. doi: 10.1136/bmjopen-2014-006907.
PubMed 25976760Birdthistle IJ, Mayhew SH, Kikuvi J, Zhou W, Church K, Warren CE, Nkambule R, Fenty J; Integra Initiative. Integration of HIV and maternal healthcare in a high HIV-prevalence setting: analysis of client flow data over time in Swaziland. BMJ Open. 2014 Mar 7;4(3):e003715. doi: 10.1136/bmjopen-2013-003715.
PubMed 24607560Warren CE, Mayhew SH, Vassall A, Kimani JK, Church K, Obure CD, du-Preez NF, Abuya T, Mutemwa R, Colombini M, Birdthistle I, Askew I, Watts C. Study protocol for the Integra Initiative to assess the benefits and costs of integrating sexual and reproductive health and HIV services in Kenya and Swaziland. BMC Public Health. 2012 Nov 13;12:973. doi: 10.1186/1471-2458-12-973.
PubMed 23148456
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integra Initiative to Assess the Benefits and Costs of Integrating Sexual and Reproductive Health and HIV Services in Kenya and Swaziland
- ClinicalTrials.gov ID
- NCT01694862
- Acronym / sponsor ID
- Integra / Integra Initiative
- Keywords
- quasi experimental, evaluation, intervention, service integration, cost analysis, HIV, FP, PNC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,763 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Population Council, International Planned Parenthood Federation, Bill and Melinda Gates Foundation
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- lead to increased uptake of a range of SRH services .
- attract a greater number and diversity of clients.
- lead to increased quality of a range of SRH services
- lead to healthier sexual and reproductive behavior.
- lead to reduced stigma at health facilities.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated FP /PNC service delivery | Experimental | Procedure: Integrated FP/PNC service deliveryClinic 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. |
| Non-integrated FP/PNC service delivery | 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
- women aged 15 years and over,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated FP/PNC service deliveryAlso: BCS+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. | Procedure or surgery | Integrated FP /PNC service delivery |
Primary outcome
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)
1 secondary outcome
HIV risk behaviour
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 30245866Birdthistle IJ, Fenty J, Collumbien M, Warren C, Kimani J, Ndwiga C, Mayhew S; Integra Initiative. Integration of HIV and reproductive health services in public sector facilities: analysis of client flow data over time in Kenya. BMJ Glob Health. 2018 Sep 14;3(5):e000867. doi: 10.1136/bmjgh-2018-000867. eCollection 2018.
- Derived from this study: PubMed 29315327Wekesa E, Askew I, Abuya T. Ambivalence in pregnancy intentions: The effect of quality of care and context among a cohort of women attending family planning clinics in Kenya. PLoS One. 2018 Jan 9;13(1):e0190473. doi: 10.1371/journal.pone.0190473. eCollection 2018.
- Derived from this study: PubMed 28679389Mayhew SH, Colombini M, Kimani JK, Tomlin K, Warren CE; Integra Initiative; Mutemwa R. Fertility intentions and contraceptive practices among clinic-users living with HIV in Kenya: a mixed methods study. BMC Public Health. 2017 Jul 5;17(1):626. doi: 10.1186/s12889-017-4514-2.
- Derived from this study: PubMed 26563220Kimani J, Warren CE, Abuya T, Ndwiga C, Mayhew S, Vassall A, Mutemwa R, Askew I. Use of HIV counseling and testing and family planning services among postpartum women in Kenya: a multicentre, non-randomised trial. BMC Womens Health. 2015 Nov 13;15:104. doi: 10.1186/s12905-015-0262-6.
- Derived from this study: PubMed 26438349Obure CD, Guinness L, Sweeney S, Initiative I, Vassall A. Does integration of HIV and SRH services achieve economies of scale and scope in practice? A cost function analysis of the Integra Initiative. Sex Transm Infect. 2016 Mar;92(2):130-4. doi: 10.1136/sextrans-2015-052039. Epub 2015 Oct 5.
- Derived from this study: PubMed 26381120Kimani J, Warren C, Abuya T, Mutemwa R; Integra Initiative; Mayhew S, Askew I. Family planning use and fertility desires among women living with HIV in Kenya. BMC Public Health. 2015 Sep 17;15:909. doi: 10.1186/s12889-015-2218-z.
- Derived from this study: PubMed 25976760Mulrenan C, Colombini M, Howard N, Kikuvi J, Mayhew SH; Integra Initiative. Exploring risk of experiencing intimate partner violence after HIV infection: a qualitative study among women with HIV attending postnatal services in Swaziland. BMJ Open. 2015 May 14;5(5):e006907. doi: 10.1136/bmjopen-2014-006907.
- Derived from this study: PubMed 24607560Birdthistle IJ, Mayhew SH, Kikuvi J, Zhou W, Church K, Warren CE, Nkambule R, Fenty J; Integra Initiative. Integration of HIV and maternal healthcare in a high HIV-prevalence setting: analysis of client flow data over time in Swaziland. BMJ Open. 2014 Mar 7;4(3):e003715. doi: 10.1136/bmjopen-2013-003715.
- Derived from this study: PubMed 23148456Warren CE, Mayhew SH, Vassall A, Kimani JK, Church K, Obure CD, du-Preez NF, Abuya T, Mutemwa R, Colombini M, Birdthistle I, Askew I, Watts C. Study protocol for the Integra Initiative to assess the benefits and costs of integrating sexual and reproductive health and HIV services in Kenya and Swaziland. BMC Public Health. 2012 Nov 13;12:973. doi: 10.1186/1471-2458-12-973.
- Project websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susannah H Mayhew, PhD principal investigator
London School of Hygiene and Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated FP/PNC service delivery in people with Pregnancy and HIV, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Eswatini, Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unintended pregnancies (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694862, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.