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Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.

ABSTRACT: Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.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.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.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.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.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?

SUBMITTER: MacPherson P

PROVIDER: S-EPMC4118051 | biostudies-literature | 2014 Jul 23-30

REPOSITORIES: biostudies-literature

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Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.

MacPherson Peter P Lalloo David G DG Webb Emily L EL Maheswaran Hendramoorthy H Choko Augustine T AT Makombe Simon D SD Butterworth Anthony E AE van Oosterhout Joep J JJ Desmond Nicola N Thindwa Deus D Squire Stephen Bertel SB Hayes Richard J RJ Corbett Elizabeth L EL

JAMA 20140701 4

<h4>Importance</h4>Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>Cluster randomized trial conducted in Blantyre, Malawi, between ...[more]

PMID: 25038356

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Project description:BackgroundUndiagnosed 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 findingsThis 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 boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI -36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome.ConclusionsIn this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope.Trial registrationClinicaltrials.gov NCT03541382.

Project description:BackgroundHuman immunodeficiency virus (HIV) self-testing is an innovative solution to the problem of low HIV testing coverage. It can help in realizing the first "95" of the Joint United Nations Programme on HIV/AIDS targets in the HIV treatment cascade. However, there is limited information to guide how those who self-test and show positive results can successfully be linked to HIV care and treatment. Therefore, this scoping review aimed at synthesizing available evidence of the outcomes of intervention strategies to optimize linkage to HIV care after HIV self-testing.MethodsOur methodology followed Arksey and O'Malley's methodological framework. Two independent reviewers screened and extracted data based on predetermined criteria. The databases searched included PubMed, EBSCOhost, Web of Science, Cochrane Library, Scopus, Mednar, and the International Clinical Trials Registry Platform.ResultsA total of 4809 records were retrieved. After full-text screening, 14 studies met the inclusion criteria for the review. The intervention strategies reported were classified into four main categories: technology-assisted interventions, innovative HIV self-testing kits distribution mechanisms, financial incentive, social entrepreneurship models, and the use of key community opinion leaders and social media influencers. This scoping review found men who have sex with men as the main recipients of the interventions to improve the rate of linkage to HIV care following HIV self-testing. Studies that met the inclusion criteria reported mixed findings on the outcomes of interventions to improve the rate of linkage to HIV care following HIV self-testing. Financial incentives, interventions leveraging technology, and key opinion leaders were the most effective strategies.ConclusionsGiven that the included studies did not employ a uniform system of measurement of effectiveness, there is a need for identification of standardized definitions and clear indicators for evaluating linkage to care and antiretroviral therapy (ART) initiation following HIV self-testing.

Project description:BackgroundPrevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15-19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi.MethodsThe trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15-19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio.DiscussionTo the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities.Trial registrationClinicaltrials.gov registry ( NCT03541382 ) registered 30 May 2018.

Project description:BackgroundHIV testing among the sexual partners of HIV-positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear.Methods and findingsWe conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 PRS arm) and were included in the final analysis (78% female). Testing coverage among sexual partners was 71% (183/257) in the index HIVST arm and 25% (27/107) in the PRS arm (aRR: 2·77, 95% CI [2·56 to 3·00], p ≤ 0.001). Reported HIV positivity rates did not significantly differ by arm (16% (30/183) in HIVST versus 15% (4/27) in PRS; p = 0.99). ART initiation at 12 months was 47% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, index HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to higher HIV testing rates in the HIVST arm (5% partners initiated ART in HVIST versus 3% in PRS). Adverse events including IPV and termination of the relationship did not vary by arm (IPV: 3/257 index HIVST versus 4/10 PRS; p = 0.57). Limitations include reliance on secondary report by ART clients, potential social desirability bias, and not powered for sex disaggregated analyses.ConclusionsIndex HIVST significantly increased HIV testing and the absolute number of partners initiating ART in Malawi, without increased risk of adverse events. Additional research is needed to improve linkage to HIV treatment services after HIVST use.Trial registrationClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

Project description:BackgroundGender disparities exist in the scale-up and uptake of HIV services with men being disproportionately under-represented in the services. In Eastern and Southern Africa, of the people living with HIV infection, more adult women than men were on treatment highlighting the disparities in HIV services. Delayed initiation of antiretroviral treatment creates a missed opportunity to prevent transmission of HIV while increasing HIV and AIDS-associated morbidity and mortality. The main objective of this study was to assess the strategies that men prefer for Antiretroviral Therapy (ART) initiation in Blantyre, Malawi.MethodsThis was a qualitative study conducted in 7 Health facilities in Blantyre from January to July 2017. We selected participants following purposive sampling. We conducted 20 in-depth interviews (IDIs) with men of different HIV statuses, 17 interviews with health care workers (HCWs), and 14 focus group discussions (FGDs) among men of varying HIV statuses. We digitally recorded all the data, transcribed verbatim, managed using NVivo, and analysed it thematically.ResultsRestructuring the delivery of antiretroviral (ARVs) treatment and conduct of ART clinics is key to optimizing early initiation of treatment among heterosexual men in Blantyre. The areas requiring restructuring included: Clinic days by offering ARVs daily; Clinic hours to accommodate schedules of men; Clinic layout and flow that preserves privacy and establishment of male-specific clinics; ARV dispensing procedures where clients receive more pills to last them longer than 3 months. Additionally there is need to improve the packaging of ARVs, invent ARVs with less dosing frequency, and dispense ARVs from the main pharmacy. It was further suggested that the test-and-treat strategy be implemented with fidelity and revising the content in counseling sessions with an emphasis on the benefits of ARVs.ConclusionThe success in ART initiation among men will require a restructuring of the current ART services to make them accessible and available for men to initiate treatment. The inclusion of people-centered approaches will ensure that individual preferences are incorporated into the initiation of ARVs. The type, frequency, distribution, and packaging of ARVs should be aligned with other medicines readily available within a health facility to minimize stigma.

Project description:BackgroundDespite the aging HIV epidemic, increasing age can be associated with hesitancy to test. Addressing this gap is a critical policy concern and highlights the urgent need to identify the underlying factors, to improve knowledge of HIV-related risks as well as uptake of HIV testing and prevention services, in midlife-older adults.MethodsWe conducted five focus group discussions and 12 in-depth interviews between April 2013 and November 2016 among rural and urban Malawian midlife-older (≥30 years) men and women. Using a life-course theoretical framework we explored how age is enacted socially and its implications on HIV testing and sexual risk behaviours. We also explore the potential for HIV self-testing (HIVST) to be part of a broader strategy for engaging midlife-older adults in HIV testing, prevention and care. Thematic analysis was used to identify recurrent themes and variations.ResultsMidlife-older adults (30-74 years of age) associated their age with respectability and identified HIV as "a disease of youth" that would not affect them, with age protecting them against infidelity and sexual risk-taking. HIV testing was felt to be stigmatizing, challenging age norms, threatening social status, and implying "lack of wisdom". These norms drove self-testing preferences at home or other locations deemed age and gender appropriate. Awareness of the potential for long-standing undiagnosed HIV to be carried forward from past relationships was minimal, as was understanding of treatment-as-prevention. These norms led to HIV testing being perceived as a threat to status by older adults, contributing to low levels of recent HIV testing compared to younger adults.ConclusionsCharacteristics associated with age-gender norms and social position encourage self-testing but drive poor HIV-risk perception and unacceptability of conventional HIV testing in midlife-older adults. There is an urgent need to provide targeted messages and services more appropriate to midlife-older adults in sub-Saharan Africa. HIVST which has often been highlighted as a tool for reaching young people, may be a valuable tool for engaging midlife-older age groups who may not otherwise test.

Dataset Information

Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.

Publications

Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial.

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