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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001507
• Other study ID #: TFR08-02986
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: December 6, 2013
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5040
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections
• Unintended Pregnancy

Intervention

Procedure:
• Integrated family planning/HIV care and treatment services
Family planning services will be provided during the patient's HIV care visit.

Locations

Country	Name	City	State
Kenya	Migori District Hospital	Migori

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Ibis Reproductive Health, Kenya Medical Research Institute, Tides

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Pregnancy rate		1 year post integration/study initiation and 2 years post integration/site initiation	No
Secondary	Knowledge of contraceptive methods among HIV-positive women		baseline (months 1-3); post-intervention (months 9-12)	No
Secondary	Knowledge of contraceptive methods among providers		baseline (months 1-3); post-intervention (months 9-12)	No
Secondary	Acceptability of family planning services		baseline (months 1-3); post-intervention (months 9-12)	No
Secondary	Feasibility of providing family planning services at HIV care and treatment centers		months 9-12	No
Secondary	Reproductive intentions of HIV-infected women receiving care and treatment		months 1-3	No