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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Unintended Pregnancy, HIV Infections

Intervention / Treatment
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* Procedure: Integrated family planning/HIV care and treatment services


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated HIV/FP services<br>Family planning services are integrated into HIV care and treatment services at this facility. | Procedure: Integrated family planning/HIV care and treatment services<br>* Family planning services will be provided during the patient's HIV care visit.<br>|
| No Intervention: Standard (non-integrated), referral-based, services<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family planning, HIV, Integrated services, Unintended pregnancy, Kenya