Migori District Hospital
Migori, Kenya
NCT Number: NCT01001507
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Migori, Kenya
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For health facilities:
For participants:
Exclusion criteria
For health facilities
For participants:
Family planning services will be provided during the patient's HIV care visit.
Time frame: 1 year post integration/site initiation and 2 years post integration/site initiation
Time frame: 1 year post integration/study initiation and 2 years post integration/site initiation
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Time frame: months 9-12
Time frame: months 1-3
University of California, San Francisco
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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