Research Article: HIV self-testing alone or with additional interventions, including financial incentives, and linkage to care or prevention among male partners of antenatal care clinic attendees in Malawi: An adaptive multi-arm, multi-stage cluster randomised trial

Date Published: January 2, 2019

Publisher: Public Library of Science

Author(s): Augustine T. Choko, Elizabeth L. Corbett, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Cheryl C. Johnson, Doreen Sakala, Thokozani Kalua, Moses Kumwenda, Richard Hayes, Katherine Fielding, Elvin H. Geng

Abstract: BackgroundConventional HIV testing services have been less comprehensive in reaching men than in reaching women globally, but HIV self-testing (HIVST) appears to be an acceptable alternative. Measurement of linkage to post-test services following HIVST remains the biggest challenge, yet is the biggest driver of cost-effectiveness. We investigated the impact of HIVST alone or with additional interventions on the uptake of testing and linkage to care or prevention among male partners of antenatal care clinic attendees in a novel adaptive trial.Methods and findingsAn adaptive multi-arm, 2-stage cluster randomised trial was conducted between 8 August 2016 and 30 June 2017, with antenatal care clinic (ANC) days (i.e., clusters of women attending on a single day) as the unit of randomisation. Recruitment was from Ndirande, Bangwe, and Zingwangwa primary health clinics in urban Blantyre, Malawi. Women attending an ANC for the first time for their current pregnancy (regardless of trimester), 18 years and older, with a primary male partner not known to be on ART were enrolled in the trial after giving consent. Randomisation was to either the standard of care (SOC; with a clinic invitation letter to the male partner) or 1 of 5 intervention arms: the first arm provided women with 2 HIVST kits for their partners; the second and third arms provided 2 HIVST kits along with a conditional fixed financial incentive of $3 or $10; the fourth arm provided 2 HIVST kits and a 10% chance of receiving $30 in a lottery; and the fifth arm provided 2 HIVST kits and a phone call reminder for the women’s partners. The primary outcome was the proportion of male partners who were reported to have tested for HIV and linked into care or prevention within 28 days, with referral for antiretroviral therapy (ART) or circumcision accordingly. Women were interviewed at 28 days about partner testing and adverse events. Cluster-level summaries compared each intervention versus SOC using eligible women as the denominator (intention-to-treat). Risk ratios were adjusted for male partner testing history and recruitment clinic. A total of 2,349/3,137 (74.9%) women participated (71 ANC days), with a mean age of 24.8 years (SD: 5.4). The majority (2,201/2,233; 98.6%) of women were married, 254/2,107 (12.3%) were unable to read and write, and 1,505/2,247 (67.0%) were not employed. The mean age for male partners was 29.6 years (SD: 7.5), only 88/2,200 (4.0%) were unemployed, and 966/2,210 (43.7%) had never tested for HIV before. Women in the SOC arm reported that 17.4% (71/408) of their partners tested for HIV, whereas a much higher proportion of partners were reported to have tested for HIV in all intervention arms (87.0%–95.4%, p < 0.001 in all 5 intervention arms). As compared with those who tested in the SOC arm (geometric mean 13.0%), higher proportions of partners met the primary endpoint in the HIVST + $3 (geometric mean 40.9%, adjusted risk ratio [aRR] 3.01 [95% CI 1.63–5.57], p < 0.001), HIVST + $10 (51.7%, aRR 3.72 [95% CI 1.85–7.48], p < 0.001), and phone reminder (22.3%, aRR 1.58 [95% CI 1.07–2.33], p = 0.021) arms. In contrast, there was no significant increase in partners meeting the primary endpoint in the HIVST alone (geometric mean 17.5%, aRR 1.45 [95% CI 0.99–2.13], p = 0.130) or lottery (18.6%, aRR 1.43 [95% CI 0.96–2.13], p = 0.211) arms. The lottery arm was dropped at interim analysis. Overall, 46 male partners were confirmed to be HIV positive, 42 (91.3%) of whom initiated ART within 28 days; 222 tested HIV negative and were not already circumcised, of whom 135 (60.8%) were circumcised as part of the trial. No serious adverse events were reported. Costs per male partner who attended the clinic with a confirmed HIV test result were $23.73 and $28.08 for the HIVST + $3 and HIVST + $10 arms, respectively. Notable limitations of the trial included the relatively small number of clusters randomised to each arm, proxy reporting of the male partner testing outcome, and being unable to evaluate retention in care.ConclusionsIn this study, the odds of men’s linkage to care or prevention increased substantially using conditional fixed financial incentives plus partner-delivered HIVST; combinations were potentially affordable.Trial registrationISRCTN 18421340.

Partial Text: In 2016, 1.0 million people died of diseases associated with HIV infection, and 1.8 million were newly infected [1]. Eastern and southern Africa have been disproportionately affected by the epidemic, and face challenges in reaching men: regionally, only 52% of men living with HIV are aware of their infection [2], whilst deaths from AIDS-related illnesses are 27% higher amongst men than women [1]. Achieving the 2020 UN targets of having 90% of all people living with HIV diagnosed, 90% of those diagnosed on antiretroviral therapy (ART), and 90% of those on treatment virally suppressed [1] should bring major reductions in HIV incidence and mortality, but may also require novel service delivery approaches [1].

Recruitment and follow-up was completed between 8 August 2016 and 30 June 2017. In total, 3,137 pregnant women (71 clusters [ANC days]: 36 in stage 1 and 35 in stage 2) were screened, of whom 2,349 (74.9%) were eligible and consented (Fig 1). Baseline characteristics of male partners, as reported by the women, were reasonably balanced across trial arms except for male partner HIV testing history. Recruitment clinic was also imbalanced by trial arm (Table 1). All analyses were adjusted for these 2 covariates.

The main findings of this trial were that, in Blantyre, Malawi, secondary distribution of HIVST kits to male partners by women attending antenatal care greatly increased the proportion of male partners who had an HIV test and, if combined with conditional financial incentives or a phone call reminder, significantly increased male linkage into post-test HIV care and prevention services. With self-testing recently recommended by WHO [3]—and several low-cost products, including 1 WHO prequalified self-test and 4 others approved for procurement through major donors—national strategies based on HIVST such as the one described here are becoming highly feasible.

Source:

http://doi.org/10.1371/journal.pmed.1002719

 

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