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      Traditional healer-delivered point-of-care HIV testing versus referral to clinical facilities for adults of unknown serostatus in rural Uganda: a mixed-methods, cluster-randomised trial

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          Summary

          Background

          HIV counselling and testing are essential to control the HIV epidemic. However, HIV testing uptake is low in sub-Saharan Africa, where many people use informal health-care resources such as traditional healers. We hypothesised that uptake of HIV tests would increase if provided by traditional healers. We aimed to determine the effectiveness of traditional healers delivering HIV testing at point of care compared with referral to local clinics for HIV testing in rural southwestern Uganda.

          Methods

          We did a mixed-methods study that included a cluster-randomised trial followed by individual qualitative interviews among a sample of participants in Mbarara, Uganda. Traditional healers aged 18 years or older who were located within 8 km of the Mbarara District HIV clinic, were identified in the 2018 population-level census of traditional healers in Mbarara District, and delivered care to at least seven clients per week were randomly assigned (1:1) as clusters to an intervention or a control group. Healers screened their clients for eligibility, and research assistants confirmed eligibility and enrolled clients who were aged 18 years or older, were receiving care from a participating healer, were sexually active (ever had intercourse), self-reported not having received an HIV test in the previous 12 months (and therefore considered to be of unknown serostatus), and had not previously been diagnosed with HIV infection. Intervention group healers provided counselling and offered point-of-care HIV tests to adult clients. Control group healers provided referral for HIV testing at nearby clinics. The primary outcome was the individual receipt of an HIV test within 90 days of study enrolment. Safety and adverse events were recorded and defined on the basis of prespecified criteria. This study is registered with ClinicalTrials.gov, NCT03718871.

          Findings

          Between Aug 2, 2019, and Feb 7, 2020, 17 traditional healers were randomly assigned as clusters (nine to intervention and eight to control), with 500 clients of unknown HIV serostatus enrolled (250 per group). In the intervention group, 250 clients (100%) received an HIV test compared with 57 (23%) in the control group, a 77% (95% CI 73–82) increase in testing uptake, after adjusting for the effect of clustering (p<0·0001). Ten (4%) of 250 clients in the intervention group tested HIV positive, seven of whom self-reported linkage to HIV care. No new HIV cases were identified in the control group. Qualitative interviews revealed that HIV testing delivered by traditional healers was highly acceptable among both providers and clients. No safety or adverse events were reported.

          Interpretation

          Delivery of point-of-care HIV tests by traditional healers to adults of unknown serostatus significantly increased rates of HIV testing in rural Uganda. Given the ubiquity of healers in Africa, this approach holds promise as a new pathway to provide community-based HIV testing, and could have a dramatic effect on uptake of HIV testing in sub-Saharan Africa.

          Funding

          US National Institute of Mental Health, National Institutes of Health.

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          Most cited references24

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          Three approaches to qualitative content analysis.

          Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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            Systematic review and meta-analysis of community and facility-based HIV testing to address linkage to care gaps in sub-Saharan Africa.

            HIV testing and counselling is the first crucial step for linkage to HIV treatment and prevention. However, despite high HIV burden in sub-Saharan Africa, testing coverage is low, particularly among young adults and men. Community-based HIV testing and counselling (testing outside of health facilities) has the potential to reduce coverage gaps, but the relative impact of different modalities is not well assessed. We conducted a systematic review of HIV testing modalities, characterizing community (home, mobile, index, key populations, campaign, workplace and self-testing) and facility approaches by population reached, HIV positivity, CD4 count at diagnosis and linkage. Of 2,520 abstracts screened, 126 met eligibility criteria. Community HIV testing and counselling had high coverage and uptake and identified HIV-positive people at higher CD4 counts than facility testing. Mobile HIV testing reached the highest proportion of men of all modalities examined (50%, 95% confidence interval (CI) = 47-54%) and home with self-testing reached the highest proportion of young adults (66%, 95% CI = 65-67%). Few studies evaluated HIV testing for key populations (commercial sex workers and men who have sex with men), but these interventions yielded high HIV positivity (38%, 95% CI = 19-62%) combined with the highest proportion of first-time testers (78%, 95% CI = 63-88%), indicating service gaps. Community testing with facilitated linkage (for example, counsellor follow-up to support linkage) achieved high linkage to care (95%, 95% CI = 87-98%) and antiretroviral initiation (75%, 95% CI = 68-82%). Expanding home and mobile testing, self-testing and outreach to key populations with facilitated linkage can increase the proportion of men, young adults and high-risk individuals linked to HIV treatment and prevention, and decrease HIV burden.
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              • Article: not found

              Simple sample size calculation for cluster-randomized trials.

              Cluster-randomized trials, in which health interventions are allocated randomly to intact clusters or communities rather than to individual subjects, are increasingly being used to evaluate disease control strategies both in industrialized and in developing countries. Sample size computations for such trials need to take into account between-cluster variation, but field epidemiologists find it difficult to obtain simple guidance on such procedures. In this paper, we provide simple formulae for sample size determination for both unmatched and pair-matched trials. Outcomes considered include rates per person-year, proportions and means. For simplicity, formulae are expressed in terms of the coefficient of variation (SD/mean) of cluster rates, proportions or means. Guidance is also given on the estimation of this value, with or without the use of prior data on between-cluster variation. The methods are illustrated using two case studies: an unmatched trial of the impact of impregnated bednets on child mortality in Kenya, and a pair-matched trial of improved sexually-transmitted disease (STD) treatment services for HIV prevention in Tanzania.
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                Author and article information

                Journal
                101613665
                42402
                Lancet Glob Health
                Lancet Glob Health
                The Lancet. Global health
                2214-109X
                21 October 2021
                November 2021
                02 November 2021
                : 9
                : 11
                : e1579-e1588
                Affiliations
                Department of Emergency Medicine (R Sundararajan MD, M Ponticiello BS) and Center for Global Health (R Sundararajan, M H Lee PhD, D Fitzgerald MD), Weill Cornell Medicine, New York, NY, USA; Department of Medicine, University of California, San Diego, La Jolla, CA, USA (S A Strathdee PhD); Mbarara Regional Referral Hospital, Mbarara, Uganda (W Muyindike MD, D Nansera MD); Mbarara University of Science and Technology, Mbarara, Uganda (W Muyindike, D Nansera, J Mwanga-Amumpaire MD); Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA (R King PhD)
                Author notes

                Contributors

                RS designed this trial with input from JM-A, SAS, and DF. RS secured funding for the study and was primarily responsible for writing of the manuscript. JM-A, WM, DN, and RK contributed to conceptualisation of the project, protocol development, and trial design. JM-A and RS oversaw the trial. RS, MP, and MHL analysed and verified the underlying trial data. MP created the figures. All authors reviewed the draft, provided input, and approve of the final version. All authors confirm access to the data in the study and accept responsibility to submit for publication.

                Correspondence to: Dr Radhika Sundararajan, Department of Emergency Medicine, Weill Cornell Medicine, New York, NY 10065, USA ras9199@ 123456med.cornell.edu
                Article
                NIHMS1749771
                10.1016/S2214-109X(21)00366-1
                8562591
                34678199
                65aebc6a-1ad2-4c3f-82f8-3eaa834719db

                This is an Open Access article under the CC BY 4.0 license.

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