Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya

Cluster Randomized Trial of Integration of Family Planning Services Into HIV Care and Treatment in Suba, Kisumu East, Rongo and Migori Districts of Nyanza Province

This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Unintended Pregnancy
• Intervention / Treatment: Procedure: Integrated family planning/HIV care and treatment services

Detailed Description

The study will have three parts. During the first part (3 months), baseline data on contraceptive prevalence and unintended pregnancy will be collected at 18 PSCs that are supported by the FACES program in Suba, Kisumu East, Nyatike, Rongo and Migori Districts. Also during this first part, information about knowledge, attitudes and practices related to family planning will be obtained from patients and from clinicians at the sites. During the second part (3 months), an intervention consisting of integrating family planning services will be designed and implemented at twelve of the 18 FACES-supported PSCs. We aim to utilize a 2:1 integration:control model, with delayed integration so as to gradually expand the integration of FP and HIV services throughout the 18 sites, while maintaining the ability to test hypotheses on the effects of integration on health outcomes. After collecting the baseline data, we plan to stratify the clinics into two categories based on the overall patient volume and differences in the structure of family planning provision, i.e., whether or not there is a specific MCH division providing family planning at the site or not. Randomization of sites will then occur among clinics in each of these strata, with a ratio of two intervention sites (integrated model) to one control site (family planning provided in the standard manner at the site). During the third and last part (12 months), data on prevalence more effective contraception and unintended pregnancy will be collected from each of the 18 sites. At the end of part three, information about knowledge, attitudes and practices related to family planning again will be obtained from patients and from clinicians at the sites. In addition, we will administer questionnaires assessing the acceptability of family planning services to patients, and in addition clinic staff will be answer a questionnaire assessing the feasibility of providing integrated family planning services. After 12 months of data collection, the 6 control sites were integrated and data were collected for an additional 11 months from all 18 sites to assess the sustainability of the intervention under the Ministry of Health.

The study population will primarily consist of HIV-positive men and non-pregnant, HIV-positive women of reproductive age who obtain care at the FACES-supported PSCs in Suba, Kisumu East, Rongo and Migori Districts in Nyanza Province, Kenya. In addition, study subjects will also include clinic staff at the FACES centers included in the study.

• Study Type: Interventional
• Enrollment (Actual): 5040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Migori, Kenya
    • Migori District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

For health facilities:

• Each site must be providing HIV care and treatment services

For participants:

• Women aged 18-45, not pregnant, HIV+, receiving HIV care at that health facility
• Men aged 18 and above, HIV+, receiving HIV care at that health facility

Exclusion Criteria:

For health facilities

• If they do not meet the inclusion criteria listed above
• If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision

For participants:

• Participants are excluded if they do not meet the inclusion criteria listed above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated HIV/FP services; Family planning services are integrated into HIV care and treatment services at this facility.	Procedure: Integrated family planning/HIV care and treatment services; Family planning services will be provided during the patient's HIV care visit.
No Intervention: Standard (non-integrated), referral-based, services; Patients from the HIV care and treatment clinic will be referred for family planning services, and will not receive FP services by the HIV care provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods)	1 year post integration/site initiation and 2 years post integration/site initiation
Pregnancy rate	1 year post integration/study initiation and 2 years post integration/site initiation

Secondary Outcome Measures

Outcome Measure	Time Frame
Knowledge of contraceptive methods among HIV-positive women	baseline (months 1-3); post-intervention (months 9-12)
Knowledge of contraceptive methods among providers	baseline (months 1-3); post-intervention (months 9-12)
Acceptability of family planning services	baseline (months 1-3); post-intervention (months 9-12)
Feasibility of providing family planning services at HIV care and treatment centers	months 9-12
Reproductive intentions of HIV-infected women receiving care and treatment	months 1-3

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Kenya Medical Research Institute; Ibis Reproductive Health; Tides
• Investigators: Principal Investigator: Daniel Grossman, MD, Ibis Reproductive Health; Principal Investigator: Craig Cohen, MD, MPH, University of California, San Francisco; Principal Investigator: Elizabeth Bukusi, MBChB, PhD, Kenya Medical Research Institute; Principal Investigator: Sara Newmann, MD, MPH, University of California, San Francisco

Publications and helpful links

General Publications

• Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Kenya; Family planning; Unintended pregnancy; Integrated services
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: TFR08-02986