Integrating Counseling to Transform HIV Family Planning Services
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RAND
- Enrollment
- 389
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Used Dual Contraception or Safer Conception Method
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV+ client of TASO
- •Client if of reproductive age (males age 15-60; females age 15-45).
- •Has a partner with whom the client is considering having a child.
- •If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
- •Partner with whom the client is considering having a child is HIV-negative.
- •Client reports that their partner is aware of the client being HIV-positive.
Exclusion Criteria
- •Female client (or partner of male client) is pregnant
Outcomes
Primary Outcomes
Number of Participants Who Used Dual Contraception or Safer Conception Method
Time Frame: Month 12
Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention
Secondary Outcomes
- Number Who Achieved Desired Pregnancy Status(Month 12)
- Partner HIV Status(study end point (Month 12 or when learning of pregnancy))