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Trial record 1 of 1 for:    NCT01001507
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Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya

This study has been completed.
Sponsor:
Collaborators:
Ibis Reproductive Health
Kenya Medical Research Institute
Tides
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01001507
First received: October 22, 2009
Last updated: December 6, 2013
Last verified: December 2013

October 22, 2009
December 6, 2013
September 2009
October 2011   (final data collection date for primary outcome measure)
  • Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods) [ Time Frame: 1 year post integration/site initiation and 2 years post integration/site initiation ] [ Designated as safety issue: No ]
  • Pregnancy rate [ Time Frame: 1 year post integration/study initiation and 2 years post integration/site initiation ] [ Designated as safety issue: No ]
  • Contraceptive prevalence [ Time Frame: 1 year post integration/site initiation ] [ Designated as safety issue: No ]
  • Pregnancy rate [ Time Frame: 1 year post integration/study initiation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01001507 on ClinicalTrials.gov Archive Site
  • Knowledge of contraceptive methods among HIV-positive women [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Knowledge of contraceptive methods among providers [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Acceptability of family planning services [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Feasibility of providing family planning services at HIV care and treatment centers [ Time Frame: months 9-12 ] [ Designated as safety issue: No ]
  • Reproductive intentions of HIV-infected women receiving care and treatment [ Time Frame: months 1-3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Unintended Pregnancy
  • HIV Infections
Procedure: Integrated family planning/HIV care and treatment services
Family planning services will be provided during the patient's HIV care visit.
  • Experimental: Integrated HIV/FP services
    Family planning services are integrated into HIV care and treatment services at this facility.
    Intervention: Procedure: Integrated family planning/HIV care and treatment services
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5040
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01001507
TFR08-02986
No
University of California, San Francisco
University of California, San Francisco
  • Ibis Reproductive Health
  • Kenya Medical Research Institute
  • Tides
  • Bill and Melinda Gates Foundation
Principal Investigator: Craig Cohen, MD, MPH University of California, San Francisco
Principal Investigator: Daniel Grossman, MD Ibis Reproductive Health
Principal Investigator: Elizabeth Bukusi, MBChB, PhD Kenya Medical Research Institute
Principal Investigator: Sara Newmann, MD, MPH University of California, San Francisco
University of California, San Francisco
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP