Integrating Safer Conception Counseling to Transform HIV Family Planning Services
Condition: Safer Conception Intervention Trial
Study type: Interventional

Summary: 
      This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family
      planning (FP) program that incorporates a structured, multi-component safer conception
      counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2;
      less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new
      services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by
      The AIDS Support Organization (TASO) Uganda.
    

Detailed description: 
      Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned
      pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to
      support safer conception, despite ~40% of HIV+ women in sub-Saharan Africa (SSA) becoming
      pregnant post HIV diagnosis. Antiretroviral therapy (ART) greatly reduces the transmission
      risks associated with childbearing, but many PLHA are either not on ART or not adequately
      adherent; hence the need for using safer conception methods (SCM) such as manual
      self-insemination and timed unprotected intercourse. This cluster RCT will compare (1) a
      comprehensive FP program that incorporates a structured, multi-component SCC intervention
      (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by
      Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at 6 HIV
      clinics operated by TASO Uganda. The 3-arm design, together with the planned
      cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP
      services that differ on level of intensity, thereby informing MoH policy and resource
      allocation. Sixty clients in HIV serodiscordant relationships who express childbearing
      desires at recruitment will be enrolled at each site (n=360) and followed for 12 months or
      completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those
      trying to conceive) or dual contraception (those who decide against pregnancy).
    

Intervention name(s): safer conception counseling
Intervention type(s): Behavioral
Intervention description(s): Multi-component counseling to help HIV-affected couples to make an informed decision about childbearing, and to provide counseling to use contraception or safer conception methods, depending on whether the couples chooses to seek or prevent pregnancy after initial consultation.
Other intervention name(s): SCC
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This 3-arm cluster RCT will compare (1) a multi-component intervention that integrates safer conception counseling (SCC) into existing family planning (FP) services and provides intensive training and supervision (SCC1), (2) the integration of the same intervention as in (1) into FP services but with a less intensive training and supervision model that mimics the Ministry of Health approach, and (3) usual care FP services, at 6 HIV clinics (2 per arm) operated by TASO Uganda. The model is factorial because the two active intervention arms will be combined and compared to usual care in some analyses.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: family planning; safer conception; HIV; serodiscordant couples; Uganda; contraception