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

• ClinicalTrials.gov Identifier: NCT01001507
• Recruitment Status: Completed
• First Posted: October 26, 2009
• Last Update Posted: December 9, 2013
• Sponsor: University of California, San Francisco
• Collaborators: Ibis Reproductive Health; Kenya Medical Research Institute; Tides; Bill and Melinda Gates Foundation
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: October 22, 2009
• First Posted Date: October 26, 2009
• Last Update Posted Date: December 9, 2013
• Study Start Date: September 2009
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2013)

• 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 ]
• Pregnancy rate [ Time Frame: 1 year post integration/study initiation and 2 years post integration/site initiation ]

Original Primary Outcome Measures (submitted: October 23, 2009)

• Contraceptive prevalence [ Time Frame: 1 year post integration/site initiation ]
• Pregnancy rate [ Time Frame: 1 year post integration/study initiation ]

Current Secondary Outcome Measures (submitted: October 23, 2009)

• Knowledge of contraceptive methods among HIV-positive women [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
• Knowledge of contraceptive methods among providers [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
• Acceptability of family planning services [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
• Feasibility of providing family planning services at HIV care and treatment centers [ Time Frame: months 9-12 ]
• Reproductive intentions of HIV-infected women receiving care and treatment [ Time Frame: months 1-3 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
• Official Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Unintended Pregnancy
• HIV Infections

Intervention

Procedure: Integrated family planning/HIV care and treatment services

Family planning services will be provided during the patient's HIV care visit.

Study Arms

• 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

• Publications *: Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 23, 2009): 5040
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kenya

Administrative Information

• NCT Number: NCT01001507
• Other Study ID Numbers: TFR08-02986
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

• Ibis Reproductive Health
• Kenya Medical Research Institute
• Tides
• Bill and Melinda Gates Foundation

Investigators

• 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

• PRS Account: University of California, San Francisco
• Verification Date: December 2013