Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
Condition: Unintended Pregnancy; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Integrated family planning/HIV care and treatment services
Intervention type(s): Procedure
Intervention description(s): Family planning services will be provided during the patient's HIV care visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Family planning; HIV; Integrated services; Unintended pregnancy; Kenya