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Original Investigation |

Effect of Optional Home Initiation of HIV Care Following HIV Self-testing on Antiretroviral Therapy Initiation Among Adults in Malawi:  A Randomized Clinical Trial

Peter MacPherson, PhD1,2; David G. Lalloo, MD1; Emily L. Webb, PhD3; Hendramoorthy Maheswaran, MSc2,4; Augustine T. Choko, MSc2; Simon D. Makombe, DipClinMed5; Anthony E. Butterworth, PhD6; Joep J. van Oosterhout, PhD7,8; Nicola Desmond, PhD1,2; Deus Thindwa, MSc2; Stephen Bertel Squire, MD1; Richard J. Hayes, DSc3; Elizabeth L. Corbett, PhD2,6
[+] Author Affiliations
1Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, United Kingdom
2TB and HIV Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi
3MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom
4Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, United Kingdom
5HIV Department, Ministry of Health, Lilongwe, Malawi
6Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom
7Department of Medicine, College of Medicine, University of Malawi, Blantyre, Malawi
8Dignitas International, Zomba, Malawi
JAMA. 2014;312(4):372-379. doi:10.1001/jama.2014.6493.
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Importance  Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.

Objective  To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only.

Design, Setting, and Participants  Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas. Participants were all adult (≥16 years) residents (n = 16 660) who received access to home HIV self-testing through resident volunteers. This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial.

Interventions  Clusters were randomly allocated to facility-based care or optional home initiation of HIV care (including 2 weeks of ART if eligible) for participants reporting positive HIV self-test results.

Main Outcomes and Measures  The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability. Secondary outcomes were uptake of HIV self-testing, reporting of positive HIV self-test results, and rates of loss from ART at 6 months.

Results  A significantly greater proportion of adults in the home group initiated ART (181/8194, 2.2%) compared with the facility group (63/8466, 0.7%; risk ratio [RR], 2.94, 95% CI, 2.10-4.12; P < .001). Uptake of HIV self-testing was high in both the home (5287/8194, 64.9%) and facility groups (4433/8466, 52.7%; RR, 1.23; 95% CI, 0.96-1.58; P = .10). Significantly more adults reported positive HIV self-test results in the home group (490/8194 [6.0%] vs the facility group, 278/8466 [3.3%]; RR, 1.86; 95% CI, 1.16-2.97; P = .006). After 6 months, 52 of 181 ART initiators (28.7%) and 15 of 63 ART initiators (23.8%) in the home and facility groups, respectively, were lost from ART (adjusted incidence rate ratio, 1.18; 95% CI, 0.62-2.25, P = .57).

Conclusions and Relevance  Among Malawian adults offered HIV self-testing, optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART.

Trial Registration  clinicaltrials.gov Identifier: NCT01414413

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Figures

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Figure 1.
Location of Study Clusters and Allocation

Lake Malawi is shown in light blue. CHC indicates Chilomoni Health Center; NDR, Ndirande Health Center; QEH, Queen Elizabeth Central Hospital.

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Figure 2.
Flowchart of HIV Self-testing and ART Initiation in Malawi

ART indicates antiretroviral therapy.

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Figure 3.
Cluster Resident ART Initiations During 6 Months of HIV Self-testing Availability

ART indicates antiretroviral therapy.

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