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

Not Applicable

Completed

• Conditions: Unintended Pregnancy; HIV Infections
• Interventions: Procedure: Integrated family planning/HIV care and treatment services

• Registration Number: NCT01001507
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5040

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated HIV/FP services	Integrated family planning/HIV care and treatment services	Family planning services are integrated into HIV care and treatment services at this facility.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Reproductive intentions of HIV-infected women receiving care and treatment	months 1-3
Feasibility of providing family planning services at HIV care and treatment centers	months 9-12

Trial Locations

Locations (1)

Migori District Hospital; 🇰🇪 Migori, Kenya