2014 Articles

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation
science study

Elul, Batya O.; Lahuerta, Maria; Abacassamo, Fatima R.; Lamb, Matthew R.; Ahoua, Laurence; McNairy, Margaret L.; Tomo, Maria; Horowitz, Deborah; Sutton, Roberta; Mussa, Antonio; Gurr, Danielle; Jani, Ilesh

Background: Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan
Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high
levels of attrition across the HIV care continuum. Data from “real-life” settings are needed on the effectiveness of an
easy to deliver package of services that can improve overall performance of the HIV care continuum.
Methods/Design: We are conducting an implementation science study using a two-arm cluster site-randomized
design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based,
and practical interventions—including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral
therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care—as compared
to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV
diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental
effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes.
Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from
the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC
arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average
of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a
combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test.
Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted.
Discussion: Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of
a CIS + FI in a “real-life” service delivery system in a SSA country severely impacted by HIV.