Differentiated service delivery (DSD) models are used increasingly to deliver ART in high-burden settings but there are few data on DSD models for postpartum women, who are at high risk of non-adherence and elevated viral load (VL).
From Jan’16 to Sept’17 we enrolled consecutive postpartum women who initiated ART (TFV+XTC+EFV) during pregnancy and met local DSD eligibility (clinically stable with VL<400 c/mL) at a large urban primary care antenatal clinic (NCT03200054). Women were randomised to be referred to (i) a community-based “Adherence Club” (AC, the local DSD model: lay health worker-led groups of 20-30 patients with 2-4 monthly ART dispensing at a community venue) or (ii) routine primary health care clinics (PHC; the local standard with nurse/doctor-led care). Outcomes were measured through Nov’19 with study visits and batched VL separate from care in either arm at 3, 6, 12, 18 and 24m postpartum. Endpoints were time to VL>1000 c/mL (primary) and >50 c/mL (secondary) by intention-to-treat; per protocol analyses were restricted to women who attended the allocated service within 3m of referral.
Overall 412 women were randomised at a median of 10d postpartum (IQR, 6-20d; at enrolment median age 27y; median duration of prenatal ART 21w; 100% VL<1000 and 88% <50 c/mL); baseline characteristics did not differ by arm. Attendance at the allocated service within 3m of referral per protocol was higher in AC (77%) vs PHC (68%); 90% completed the final study visit at 24m postpartum with no difference by arm. For the primary endpoint, 16% and 29% of women in AC experienced a cumulative incidence of VL>1000 c/mL by 12m and 24m, compared to 23% and 37% in PHC, respectively (HR=0.71; 95%CI=0.50-1.01; p=0.056; Figure). For the secondary endpoint, 32% and 44% of women in AC had VL>50 c/mL by 12m and 24m, compared to 42% and 56% in PHC, respectively (HR=0.69; 95%CI=0.52-0.92; p=0.009). Findings were unchanged in per protocol analyses and across a priori demographic and clinical subgroups. Infant HIV testing, MTCT, breastfeeding duration, family planning use, and other outcomes were similar between AC and PHC arms.
Postpartum referral to DSD models such as “Adherence Clubs” is associated with an approximately 30% reduction in elevated VL and may be an important part of strategies to improve women’s virologic outcomes on ART.