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  1. Article ; Online: Assessing the efficacy of an integrated intervention to create demand for fishermen's schistosomiasis and HIV services (FISH) in Mangochi, Malawi

    Donaldson F Conserve / Sekeleghe Kayuni / Moses K Kumwenda / Kathryn L Dovel / Augustine Talumba Choko

    PLoS ONE, Vol 17, Iss 1, p e

    Study protocol for a cluster randomized control trial.

    2022  Volume 0262237

    Abstract: Background Both HIV and schistosomiasis are major public health problems worldwide with 1.8 million new HIV infections, and up to 110 million untreated schistosomiasis cases globally. Although a causal link has not been established, there are strong ... ...

    Abstract Background Both HIV and schistosomiasis are major public health problems worldwide with 1.8 million new HIV infections, and up to 110 million untreated schistosomiasis cases globally. Although a causal link has not been established, there are strong suggestions that having schistosomiasis increases onward transmission of HIV from co-infected men to women. With both HIV and schistosomiasis treatment readily available in Malawi, there is a need to investigate the feasibility, acceptability and health impacts of joint management of these two hazards, with special focus on health education and demand-creation for fishermen. The aim of this project is to identify optimal models of delivering integrated HIV and schistosomiasis services for fishermen, particularly investigating the effect of using social networks, HIV self-test kits and beach clinic services in Mangochi, Malawi. Methods We have mapped 45 boat teams or landing sites for a 3-arm cluster randomized trial using "boat team" as the unit of randomization. The three arms are: 1) Standard of care (SOC) with leaflets explaining the importance of receiving presumptive treatment for schistosomiasis (praziquantel) and HIV services for fishermen, and two intervention arms of 2) SOC + a peer explaining the leaflet to his fellow fishermen in a boat team; and 3) arm 2 with HIV self-test kits delivered to the boat team fishermen by the peer. The primary outcomes measured at 9 months of trial delivery will compare differences between arms in the proportions of boat-team fishermen: 1) who self-report starting antiretroviral therapy or undergoing voluntary medical male circumcision; and 2) who have ≥1 S. haematobium egg seen on light microscopy of the filtrate from 10mls urine ("egg-positive"). Discussion This is the first evaluation of an integrated HIV and schistosomiasis services intervention for fishermen, particularly investigating the effect of using social networks, HIVST kits and beach clinic services. The findings will support future efforts to integrate HIVST with other health services for fishermen in similar settings if found to be efficacious. Trial registration This trial is registered in the ISRCTN registry: ISRCTN14354324; date of registration: 05 October 2020. https://www.isrctn.com/ISRCTN14354324?q=ISRCTN14354324&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search. Linked to protocol version number 1.4 of 11 January 2021.
    Keywords Medicine ; R ; Science ; Q
    Subject code 360
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Socio-cultural and economic barriers, and facilitators influencing men’s involvement in antenatal care including HIV testing

    Doreen Sakala / Moses K. Kumwenda / Donaldson F. Conserve / Bassey Ebenso / Augustine T. Choko

    BMC Public Health, Vol 21, Iss 1, Pp 1-

    a qualitative study from urban Blantyre, Malawi

    2021  Volume 12

    Abstract: Abstract Background Male partner involvement in antenatal care (ANC) is associated with positive maternal and neonatal outcomes. However, only a handful of men attend ANC with their partners. This study aimed to understand the underlying barriers and ... ...

    Abstract Abstract Background Male partner involvement in antenatal care (ANC) is associated with positive maternal and neonatal outcomes. However, only a handful of men attend ANC with their partners. This study aimed to understand the underlying barriers and facilitators influencing men’s ANC attendance including HIV testing in Blantyre, Malawi. Methods Data were collected during a formative qualitative study of a cluster-randomised trial. Six focus group discussions (FGDs) with 42 men and women and 20 in-depth interviews (IDIs) were conducted at three primary health centres in urban Blantyre, Malawi. FGD participants were purposively sampled with IDI participants subsequently sampled after FGD participation. Thematic analysis was used to analyse the data. Results The economic requirement to provide for their families exerted pressure on men and often negatively affected their decision to attend ANC together with their pregnant partners despite obvious benefits. Peer pressure and the fear to be seen by peers queueing for services at ANC, an environment traditionally viewed as a space for women and children made men feel treated as trespassers and with some level of hostility rendering them feeling emasculated when they attend ANC. Health system problems associated with overall organization of the ANC services, which favours women created resistance among men to be involved. An association between ANC and HIV testing services discouraged men from attending ANC because of their fear of testing HIV-positive in the presence of their partners. The availability of a male friendly clinic offering a private, quick, supportive/sensitive and flexible service was considered to be an important incentive that would facilitate men’s ANC attendance. Men described compensation to cover transport and opportunity cost for attending the clinic as a motivator to attending ANC services and accepting an HIV test. Conclusion Peer and economic influences were the most influential barriers of men attending ANC and testing for HIV with their ...
    Keywords Antenatal care ; HIV ; HIV testing ; Male involvement ; Malawi ; Sub-Saharan Africa ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Understanding mechanisms of impact from community-led delivery of HIV self-testing

    Pitchaya P Indravudh / Fern Terris-Prestholt / Melissa Neuman / Moses K Kumwenda / Richard Chilongosi / Cheryl C Johnson / Karin Hatzold / Elizabeth L Corbett / Katherine Fielding

    PLOS Global Public Health, Vol 2, Iss 10, p e

    Mediation analysis of a cluster-randomised trial in Malawi.

    2022  Volume 0001129

    Abstract: Community HIV strategies are important for early diagnosis and treatment, with new self-care technologies expanding the types of services that can be led by communities. We evaluated mechanisms underlying the impact of community-led delivery of HIV self- ... ...

    Abstract Community HIV strategies are important for early diagnosis and treatment, with new self-care technologies expanding the types of services that can be led by communities. We evaluated mechanisms underlying the impact of community-led delivery of HIV self-testing (HIVST) using mediation analysis. We conducted a cluster-randomised trial allocating 30 group village heads and their catchment areas to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention used participatory approaches to engage established community health groups to lead the design and implementation of HIVST campaigns. Potential mediators (individual perceptions of social cohesion, shared HIV concern, critical consciousness, community HIV stigma) and the outcome (HIV testing in the last 3 months) were measured through a post-intervention survey. Analysis used regression-based models to test (i) intervention-mediator effects, (ii) mediator-outcome effects, and (iii) direct and indirect effects. The survey included 972 and 924 participants in the community-led HIVST and SOC clusters, respectively. The community-led HIVST intervention increased uptake of recent HIV testing, with no evidence of indirect effects from changes in hypothesised mediators. However, standardised scores for community cohesion (adjusted mean difference [MD] 0.15, 95% CI -0.03 to 0.32, p = 0.10) and shared concern for HIV (adjusted MD 0.13, 95% CI -0.02 to 0.29, p = 0.09) were slightly higher in the community-led HIVST arm than the SOC arm. Social cohesion, community concern, and critical consciousness also apparently had a quadratic association with recent testing in the community-led HIVST arm, with a positive relationship indicated at lower ranges of each score. We found no evidence of intervention effects on community HIV stigma and its association with recent testing. We conclude that the intervention effect mostly operated directly through community-driven service delivery of a novel HIV technology rather than ...
    Keywords Public aspects of medicine ; RA1-1270
    Subject code 306
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi

    Pitchaya P Indravudh / Katherine Fielding / Moses K Kumwenda / Rebecca Nzawa / Richard Chilongosi / Nicola Desmond / Rose Nyirenda / Melissa Neuman / Cheryl C Johnson / Rachel Baggaley / Karin Hatzold / Fern Terris-Prestholt / Elizabeth L Corbett

    PLoS Medicine, Vol 18, Iss 5, p e

    A cluster-randomised trial.

    2021  Volume 1003608

    Abstract: Background Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of ...

    Abstract Background Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). Methods and findings This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and ...
    Keywords Medicine ; R
    Subject code 306
    Language English
    Publishing date 2021-05-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi

    Hendramoorthy Maheswaran / Elizabeth L Corbett / Katherine Fielding / Cheryl C Johnson / Pitchaya P Indravudh / Richard Chilongosi / Moses K Kumwenda / Rose Nyirenda / Linda A Sande / Saviour Mphande

    BMJ Global Health, Vol 6, Iss Suppl

    2021  Volume 4

    Keywords Medicine (General) ; R5-920 ; Infectious and parasitic diseases ; RC109-216
    Language English
    Publishing date 2021-07-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation

    Miriam Taegtmeyer / Elizabeth L Corbett / Katherine Fielding / Nicola Desmond / Cheryl C Johnson / Pitchaya P Indravudh / Richard Chilongosi / Rebecca Nzawa / Moses K Kumwenda / Rose Nyirenda

    BMJ Global Health, Vol 6, Iss Suppl

    a cluster randomised trial in Malawi

    2021  Volume 4

    Keywords Medicine (General) ; R5-920 ; Infectious and parasitic diseases ; RC109-216
    Language English
    Publishing date 2021-07-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: 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

    Augustine T. Choko / Katherine Fielding / Nigel Stallard / Hendramoorthy Maheswaran / Aurelia Lepine / Nicola Desmond / Moses K. Kumwenda / Elizabeth L. Corbett

    Trials, Vol 18, Iss 1, Pp 1-

    study protocol for a cluster randomised trial

    2017  Volume 10

    Abstract: Abstract Background Despite 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 ... ...

    Abstract Abstract Background Despite 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. Methods A 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. Discussion This 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 ...
    Keywords Adaptive trials ; HIV self-testing ; Cluster randomised trials ; HIV ; Multi-arm multi-stage ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2017-07-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Partner-delivered HIV self-test kits with and without financial incentives in antenatal care and index patients with HIV in Malawi

    Augustine T Choko, PhD / Katherine Fielding, ProfPhD / Cheryl C Johnson, MA / Moses K Kumwenda, PhD / Richard Chilongosi, BSc / Rachel C Baggaley, PhD / Rose Nyirenda, MSc / Linda A Sande, MA / Nicola Desmond, PhD / Karin Hatzold, MD / Melissa Neuman, ScD / Elizabeth L Corbett, ProfPhD

    The Lancet Global Health, Vol 9, Iss 7, Pp e977-e

    a three-arm, cluster-randomised controlled trial

    2021  Volume 988

    Abstract: Summary: Background: Secondary distribution of HIV self-testing (HIVST) kits by patients attending clinic services to their partners could improve the rate of HIV diagnosis. We aimed to investigate whether secondary administration of HIVST kits, with or ... ...

    Abstract Summary: Background: Secondary distribution of HIV self-testing (HIVST) kits by patients attending clinic services to their partners could improve the rate of HIV diagnosis. We aimed to investigate whether secondary administration of HIVST kits, with or without an additional financial incentive, via women receiving antenatal care (ANC) or via people newly diagnosed with HIV (ie, index patients) could improve the proportion of male partners tested or the number of people newly diagnosed with HIV. Methods: We did a three-arm, open-label, pragmatic, cluster-randomised trial of 27 health centres (clusters), eligible if they were a government primary health centre providing ANC, HIV testing, and ART services, across four districts of Malawi. We recruited women (aged ≥18 years) attending their first ANC visit and whose male partner was available, not already taking ART, and not already tested for HIV during this pregnancy (ANC cohort), and people (aged ≥18 years) with newly diagnosed HIV during routine clinic HIV testing who had at least one sexual contact not already known to be HIV-positive (index cohort). Centres were randomly assigned (1:1:1), using a public selection of computer-generated random allocations, to enhanced standard of care (including an invitation for partners to attend HIV testing services), HIVST only, or HIVST plus a US$10 financial incentive for retesting. The primary outcome for the ANC cohort was the proportion of male partners reportedly tested, as ascertained by interview with women in this cohort at day 28. The primary outcome for the index cohort was the geometric mean number of new HIV-positive people identified per facility within 28 days of enrolment, as measured by observed HIV test results. Cluster-level summaries compared intervention with standard of care by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03705611. Findings: Between Sept 8, 2018, and May 2, 2019, nine clusters were assigned to each trial arm, resulting in 4544 eligible women in the ANC ...
    Keywords Public aspects of medicine ; RA1-1270
    Subject code 310
    Language English
    Publishing date 2021-07-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests.

    Augustine T Choko / Miriam Taegtmeyer / Peter MacPherson / Derek Cocker / McEwen Khundi / Deus Thindwa / Rodrick S Sambakunsi / Moses K Kumwenda / Kondwani Chiumya / Owen Malema / Simon D Makombe / Emily L Webb / Elizabeth L Corbett

    PLoS ONE, Vol 11, Iss 6, p e

    2016  Volume 0158107

    Abstract: To evaluate the effect of storing commonly used rapid diagnostic tests above manufacturer-recommended temperature (at 37°C), and the accuracy of delayed reading of oral fluid kits with relevance to HIV self-testing programmes.A quality assurance study of ...

    Abstract To evaluate the effect of storing commonly used rapid diagnostic tests above manufacturer-recommended temperature (at 37°C), and the accuracy of delayed reading of oral fluid kits with relevance to HIV self-testing programmes.A quality assurance study of OraQuick (OraSure), Determine HIV 1/2™ (Alere) and Uni-Gold™ (Recombigen®).Consecutive adults (≥18y) attending Ndirande Health Centre in urban Blantyre, Malawi in January to April 2012 underwent HIV testing with two of each of the three rapid diagnostic test kits stored for 28 days at either 18°C (optimally-stored) or at 37°C (pre-incubated). Used OraQuick test kits were stored in a laboratory for delayed day 1 and subsequent monthly re-reading was undertaken for one year.Of 378 individuals who underwent parallel testing, 5 (1.3%) were dropped from the final analysis due to discordant or missing reference standard results (optimally-stored Determine and Uni-Gold). Compared to the diagnostic reference standard, OraQuick had a sensitivity of 97.2% (95% CI: 93.6-99.6). There were 7 false negative results among all test kits stored at 37°C and three false negatives among optimally stored kits. Excellent agreement between pre-incubated tests and optimally-stored tests with Kappa values of 1.00 for Determine and Uni-Gold; and 0.97 (95% CI: 0.95; 1.00) for OraQuick were observed. There was high visual stability on re-reading of OraQuick, with only 1/375 pre-incubated and 1/371 optimally-stored OraQuick kits changing from the initial result over 12 months.Erroneous results observed during HIV testing in low income settings are likely to be due to factors other than suboptimal storage conditions. Re-reading returned OraQuick kits may offer a convenient and accurate quality assurance approach, including in HIV self-testing programmes.
    Keywords Medicine ; R ; Science ; Q
    Subject code 690
    Language English
    Publishing date 2016-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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