Abstract
Background In recent years, safer conception strategies have been developed to help HIV-serodiscordant couples conceive a child without transmitting HIV to the seronegative partner. The SAFER clinical trial is assessing implementation of these strategies in low-resource settings, including Zimbabwe.Methods As a part of the SAFER study, we estimated the costs associated with individual and combination strategies, in the trial setting and in real-world practice. Safer conception strategies included: 1) ART with frequent viral load testing until achieving undetectable viral load (ART-VL); 2) daily oral pre-exposure prophylaxis (PrEP); 3) semen-washing with intrauterine insemination; and 4) manual self-insemination at home. For costs in the trial, we used a micro-costing approach, including a time and motion study to quantify personnel effort, and estimated the cost per couple for individual and combination strategies for a mean of 6 months of safer conception service delivery. For real-world practice, we modeled costs for three implementation scenarios, representing differences from the trial in input prices, intervention intensity, and increments to current HIV prevention and treatment practices and guidelines. We used one-way sensitivity analyses to assess the impact of uncertainty in input variables.Results Individual strategy costs were $769-$1,615 per couple in the trial; $185-$563 if using Ministry of Health (MoH) prices. Under the target intervention intensity and using MoH prices, individual strategy costs were $73-$360 per couple over and above the cost of current HIV clinical practices. The cost of delivering the most commonly selected combination strategy, ART-VL plus PrEP, ranged from $166-$517 per couple under the three real-world implementation scenarios. Highest costs were for personnel, lab tests, and strategy-specific consumables, in variable proportions by clinical strategy and analysis scenario. Total costs were most affected by uncertainty in the price of PrEP, number of semen-washing attempts, and scale-up of semen-washing capacity.Conclusions Safer conception methods have costs that may be affordable in many low-resource settings. These cost data will help implementers and policymakers add safer conception services. Cost-effectiveness analysis is needed to assess value for money for safer conception services overall and for specific combinations of safer conception strategies.Trial Registration:· Registry Name: Clinicaltrials.gov· Trial registration number: NCT03049176· Registration date: February 9, 2017· https://clinicaltrials.gov/ct2/show/NCT03049176
Real-world implementation challenges in low-resource settings