Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations

Abstract

BackgroundThroughout sub-Saharan Africa HIV-testing rates remain low. Barriers to testing, such as inconvenient service hours and long wait times, lack of privacy, and fear of unwanted disclosure, continue to impede service utilization. HIV self-testing (HIVST) is one strategy that addresses these barriers and has been shown to increase use of HIV-testing when distributed through community-based settings. However, the scalability of HIVST is limited because it has yet to be fully integrated into existing health systems and routine care. To address this gap, we designed a study to test the effect of offering HIVST to routine outpatient department (OPD) clients on uptake of HIV-testing as compared to standard of care and optimized standard of care.Methods/designThis is a non-blinded, multi-site, cluster-randomized control trial. The health facility is the unit of randomization (cluster). Fifteen facilities were randomized to one of three arms: (1) Standard of care using routine provider-initiated testing and counseling (PITC); (2) Optimized standard of care using optimized PITC defined by additional training, job aids, and monitoring of PITC strategies with OPD providers and support staff; and (3) HIVST defined by HIVST demonstrations for OPD clients, HIVST kit distribution, and private spaces for HIVST kit use and/or interpretation. The primary outcome is the proportion of OPD clients tested for HIV on the day that they accessed OPD services. Secondary outcome measures are the proportion of OPD clients newly identified as HIV-positive and antiretroviral therapy (ART) initiation. Costs and cost-effectiveness will be evaluated. Nested studies will determine the acceptability of facility-based HIVST among OPD clients and health care providers, the presence of adverse events, such as coercion to test or unwanted status disclosure, and a process evaluation to determine feasibility and scale-up of facility-based HIVST for the future.DiscussionThis study protocol tests whether facility-based HIVST can positively contribute to HIV-testing among OPD clients in resource-limited settings. This will be one of the first studies to test the integration of HIVST into facility-based, primary health services in sub-Saharan Africa.Trial registrationClinicalTrials.gov, ID: NCT03271307. Registered on 31 August 2017.Pan African Clinical Trials: PACTR201711002697316. Registered on 1 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2878-y) contains supplementary material, which is available to authorized users.

Implementation of community and facility‐based HIV self‐testing under routine conditions in southern Eswatini

“…In Kenya, uptake was 98% among PrEP users offered HIVST, and users cited the confidentiality, ease of use and convenience as reasons why they would opt for this method of testing [12]. As regard to integrating HIVST more broadly into health systems, a randomised controlled trial in 15 health facilities in Malawi plans to evaluate offering oral HIVST to patients waiting for routine services in outpatient departments [33]. Our pilot offered HIVST as an alternative to standard HTS at several entry points (e.g.…”

Economic evaluation of facility‐based HIV self‐testing among adult outpatients in Malawi

“…The HIVST study was a cluster‐randomized controlled trial that examined the integration of HIVST into OPDs in health facilities in Malawi from September 2017 to February 2018 [12,14]. In Malawi, clients wait for outpatient services an average of four hours [15], providing an opportunity for HIVST while waiting to see a provider.…”

“…To evaluate the relative cost and expected impact of HIVST at outpatient departments (OPD) in Malawi for increasing HIV status awareness, we conducted an economic evaluation of an HIVST cluster‐randomized controlled trial [12,14].…”

Acceptability of index partner HIV self-testing among HIV-positive clients in Malawi: A mixed methods analysis

“…Our study was nested within a larger cluster randomized control trial aimed to examine the impact of HIVST on HIV testing uptake among outpatients in high-burden facilities in Malawi (ClinicalTrials.gov identifier NCT03271307 and Pan African Clinical Trials identifier PACTR201711002697316). The trial and its methodology are described in detail elsewhere [23,24]. Fifteen high-burden facilities participated in the study.…”