NCT01001507

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,040 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unintended Pregnancy
• HIV Infections

Interventions

Type	Name	Description
PROCEDURE	Integrated family planning/HIV care and treatment services	Family planning services will be provided during the patient's HIV care visit.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-10-26
• Last updated: 2013-12-09

Locations

1 site across 1 country: Kenya