Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trialReport as inadecuate




Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 18:349

First Online: 24 July 2017Received: 09 November 2016Accepted: 02 July 2017

Abstract

BackgroundDespite large-scale efforts to diagnose people living with HIV, 54% remain undiagnosed in sub-Saharan Africa. The gap in knowledge of HIV status and uptake of follow-on services remains wide with much lower rates of HIV testing among men compared to women. Here, we design a study to investigate the effect on uptake of HIV testing and linkage into care or prevention of partner-delivered HIV self-testing alone or with an additional intervention among male partners of pregnant women.

MethodsA phase II, adaptive, multi-arm, multi-stage cluster randomised trial, randomising antenatal clinic ANC days to six different trial arms. Pregnant women accessing ANC in urban Malawi for the first time will be recruited into either the standard of care SOC arm invitation letter to the male partner offering HIV testing or one of five intervention arms offering oral HIV self-test kits. Three of the five intervention arms will additionally offer the male partner a financial incentive fixed or lottery amount conditional on linkage after self-testing with one arm testing phone call reminders.

Assuming that 25% of male partners link to care or prevention in the SOC arm, six clinic days, with a harmonic mean of 21 eligible participants, per arm will provide 80% power to detect a 0.15 absolute difference in the primary outcome. Cluster proportions will be analysed by a cluster summaries approach with adjustment for clustering and multiplicity.

DiscussionThis trial applies adaptive methods which are novel and efficient designs. The methodology and lessons learned here will be important as proof of concept of how to design and conduct similar studies in the future. Although small, this trial will potentially present good evidence on the type of effective interventions for improving linkage into ART or prevention. The trial results will also have important policy implications on how to implement HIVST targeting male partners of pregnant women who are accessing ANC for the first time while paying particular attention to safety concerns. Contamination may occur if women in the intervention arms share their self-test kits with women in the SOC arm.

Trial registrationISRCTN, ID: 18421340. Registered on 31 March 2016.

KeywordsAdaptive trials HIV self-testing Cluster randomised trials HIV Multi-arm multi-stage AbbreviationsACASIAudio computer-assisted self-interview

ANCAntenatal clinic

ARTAntiretroviral treatment

CIConfidence interval

COMRECCollege of Medicine Research and Ethics Committee

CRTCluster randomised trial

DSMBData Safety and Monitoring Board

FIFinancial incentive

FWERFamily wise error rate

HIVHuman immunodeficiency virus

HIVSTHIV self-testing

HTSHIV-testing services

IQRInterquartile range

LSHTMLondon School of Hygiene and Tropical Medicine

MAMSMulti-arm multi-stage

MFCMale-friendly clinic

MLWMalawi Liverpool Wellcome Trust Clinical Research Programme

PHCPrimary health centre

PITCProvider-initiated testing and counselling

RRRisk ratio

SAEsSerious adverse events

SDStandard deviation

SMSShort messaging service

SOCStandard of care

SSASub-Saharan Africa

VMMCVoluntary male medical circumcision

WINWeighted inverse normal

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-2093-2 contains supplementary material, which is available to authorized users.

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Author: Augustine T. Choko - Katherine Fielding - Nigel Stallard - Hendramoorthy Maheswaran - Aurelia Lepine - Nicola Desmond - Mos

Source: https://link.springer.com/







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