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Abstract
Introduction
Reaching men aged 20–35 years, the group at greatest risk of HIV, with voluntary medical
male circumcision (VMMC) remains a challenge. We assessed the impact of two VMMC demand
creation approaches targeting this age group in a randomised controlled trial (RCT).
Methods
We conducted a 2×2 factorial RCT comparing arms with and without two interventions:
(1) standard demand creation augmented by human-centred design (HCD)-informed approach;
(2) standard demand creation plus offer of HIV self-testing (HIVST). Interpersonal
communication (IPC) agents were the unit of randomisation. We observed implementation
of demand creation over 6 months (1 May to 31 October 2018), with number of men circumcised
assessed over 7 months. The primary outcome was the number of men circumcised per
IPC agent using the as-treated population of actual number of months each IPC agent
worked. We conducted a mixed-methods process evaluation within the RCT.
Results
We randomised 140 IPC agents, 35 in each arm. 132/140 (94.3%) attended study training
and 105/132 (79.5%) reached at least one client during the trial period and were included
in final analysis. There was no evidence that the HCD-informed intervention increased
VMMC uptake versus no HCD-informed intervention (incident rate ratio (IRR) 0.87, 95% CI
0.38 to 2.02; p=0.75). Nor did offering men a HIVST kit at time of VMMC mobilisation
(IRR 0.65, 95% CI 0.28 to 1.50; p=0.31). Among IPC agents that reported reaching at
least one man with demand creation, both the HCD-informed intervention and HIVST were
deemed useful. There were some challenges with trial implementation; <50% of IPC agents
converted any men to VMMC, which undermined our ability to show an effect of demand
creation and may reflect acceptability and feasibility of the interventions.
Conclusion
This RCT did not show evidence of an effect of HCD-informed demand intervention or
HIVST on VMMC uptake. Findings will inform future design and implementation of demand
creation evaluations.
The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience
Abstract Introduction Social, structural and systems barriers inhibit uptake of HIV testing. HIV self‐testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first‐time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale‐up in three African countries. Methods Kit distributors collected individual‐level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community‐based distributor (CBD: door‐to‐door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or public health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re‐read from CBD and IHTS recipients. Results Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community‐based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test‐kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self‐testers (65,577; 22.3%) were first‐time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first‐time testers were in young (16 to 24 years) and older (>50 years) men (country‐ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self‐selection. Conclusions HIVST delivered at scale using several different models reached a high proportion of men, young people and first‐time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility‐and community‐based HIV testing, innovative male‐ and youth‐sensitive approaches like HIVST may be essential to reaching UNAIDS fast‐track targets for 2020.
Background Conventional 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 findings An 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. Conclusions In 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 registration ISRCTN 18421340.
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