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

Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona, Risa Hoffman, Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona, Risa Hoffman

Abstract

Background: Throughout 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/design: This 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.

Discussion: This 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 registration: ClinicalTrials.gov, ID: NCT03271307 . Registered on 31 August 2017. Pan African Clinical Trials: PACTR201711002697316 . Registered on 1 November 2017.

Keywords: Cost-effectiveness; HIV; HIV self-testing; HIV testing; Randomized control trial; Sub-Saharan Africa.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been reviewed and approved by the Institutional Review Board (IRB) at the University of California, Los Angeles (UCLA) and the National Health Sciences Research Council (NHSRC) in Malawi. Any protocol modifications will be submitted to the IRB Committees for review, and participants will be informed if warranted. Informed consent will be obtained from all study participants prior to enrollment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial design
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure. *Only for the HIV self-testing (HIVST) arm

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