Abstract
BackgroundAbout 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services.MethodsOur Choice is a comprehensive FP intervention that promotes unbiased childbearing consultations to ensure clients receive SCC or contraception services to achieve their desired reproductive goals. The intervention is theoretically grounded and has demonstrated preliminarily feasibility and acceptance through pilot testing. This three-arm cluster randomized controlled trial compares two implementation strategies for integrating Our Choice into routine FP services vs. usual care. Six sites in Uganda will be randomized to receive either (1) Our Choice intervention with enhanced training and supervision provided by study staff (SCC1), (2) Our Choice intervention implemented by the Ministry of Health’s standard approach to disseminating new services (SCC2), or (3) existing FP services (usual care). Our Choice and usual care FP services will be implemented simultaneously over a 30-month period. Sixty clients in serodiscordant relationships who express childbearing desires will be enrolled by a study coordinator at each site (n = 360) and followed for 12 months or post-pregnancy (once, if applicable). Analysis will compare intervention arms (SCC1 and SCC2) to usual care and then to each other (SCC1 vs. SCC2) on the primary outcome of correct use of either SCM (if trying to conceive) or dual contraception (if pregnancy is not desired). Secondary outcomes (i.e., pregnancy, use of prevention of mother-to-child transmission services, condom use, and partner seroconversion) and cost-effectiveness will also be examined.DiscussionFindings will provide critical information about the success of implementation models of varying intensity for integrating SCC into FP, thereby informing policy and resource allocation within and beyond Uganda.Trial registrationNCT03167879 ClinicalTrials.gov, Registered 30 May, 2017.
Highlights
About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis
Despite the fact that approximately half of their pregnancies are planned [1], people living with HIV (PLHIV) in sub-Saharan Africa rarely receive counseling on established, effective methods for making conception safer
For the 14–73% of PLHIV who desire children [1, 3,4,5,6], many of whom are in serodiscordant relationships, the absence of safer conception counseling (SCC) in family planning (FP) represents a missed opportunity to limit risks of horizontal and vertical transmission associated with childbearing
Summary
About 40% of HIV-positive women in sub-Saharan Africa become pregnant post-diagnosis. Despite about half of their pregnancies being planned, safer conception methods (SCM) are underutilized among serodiscordant couples, partially due to the fact that safer conception counseling (SCC) has not been integrated into routine HIV family planning (FP) services. Despite the fact that approximately half of their pregnancies are planned [1], people living with HIV (PLHIV) in sub-Saharan Africa rarely receive counseling on established, effective methods for making conception safer. Comprehensive FP services can be most effectively positioned to reduce risk of HIV transmission when they help PLHIV and their partners make informed childbearing decisions and use established, effective methods for either safely conceiving and delivering a child or preventing unwanted pregnancies. In Uganda, where up to 50% of PLHIV in relationships have an uninfected partner [7, 8], these services are critically needed
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