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

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

Abstract

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.

Trial registration: Clinicaltrials.gov, NCT01930084.

Figures

Figure 1
Figure 1
The HIV care continuum[[5]].
Figure 2
Figure 2
Overview of study design.

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