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

NCT01694862 | Completed

• 1 other identifier: Integra Initiative
• Study Type: interventional
• Target: 4,763
• Locations: 2 countries
• Sites: 2

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:

• 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.

Conditions

Pregnancy; HIV

Keywords

quasi experimental; evaluation; intervention; service integration; cost analysis; HIV; FP; PNC; Sub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months

Secondary Outcomes (1)

• HIV risk behaviour

  24 months

Other Outcomes (1)

• Unit costs

  24 months

Study Arms (2)

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.

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.

Interventions

Integrated FP/PNC service delivery PROCEDURE

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.

Also known as: BCS+

Integrated FP /PNC service delivery

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Population Council: collaborator
• International Planned Parenthood Federation: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (2)

Multiple MoH locations in Swaziland

Manzini, Eswatini

Location

Multiple MoH facilities in Kenya

Thika, Nyeri and Others, Kenya

Location

Related Publications (9)

• 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.

  PMID: 30245866 DERIVED

• Wekesa 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.

  PMID: 29315327 DERIVED

• Mayhew 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.

  PMID: 28679389 DERIVED

• Kimani 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.

  PMID: 26563220 DERIVED

• Obure 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.

  PMID: 26438349 DERIVED

• Kimani 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.

  PMID: 26381120 DERIVED

• Mulrenan 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.

  PMID: 25976760 DERIVED

• Birdthistle 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.

  PMID: 24607560 DERIVED

• Warren 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.

  PMID: 23148456 DERIVED

Related Links

• Project website

Study Officials

• Susannah H Mayhew, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader (Professor)

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 27, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

KE (1); ES (1)