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Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial

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      Abstract

      BackgroundAchieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.Methods and FindingsWe conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18–39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.ConclusionsProvision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.Trial RegistrationClinicalTrials.gov NCT02386215.

      Abstract

      In a randomized clinical trial, Harsha Thirumurthy and colleagues compare the efficacy of providing HIV self-tests to pregnant and postpartum women to conventional strategies using invitations to clinic-based testing.

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      Why Was This Study Done?Despite progress in recent years, men in sub-Saharan Africa have lower HIV testing rates than women, and nearly half of all HIV-positive individuals remain unaware of their HIV status; this represents a key barrier to meeting the UNAIDS 90-90-90 targets for HIV elimination.Among pregnant and postpartum women, male partner testing has been encouraged for HIV prevention purposes but remains uncommon in many countries.Recent WHO guidelines on HIV testing services have acknowledged the potential of HIV self-testing as a means to increase testing uptake among those not reached by other testing services, and have called for additional research to explore the potential benefits of self-testing.“Secondary distribution” of self-tests by women visiting health facilities has the potential to increase access to testing among their male sexual partners and to promote results disclosure and safer sexual decision-making.What Did the Researchers Do and Find?We conducted a randomized trial among 600 women attending antenatal and postpartum clinics in western Kenya to determine whether providing them multiple HIV self-tests is more effective at promoting partner testing and couples testing than a conventional strategy based on partner invitations to clinic-based testing.In the three months of follow-up, male partner testing was reported to have occurred for 90% of women in the HIV self-testing group but only 52% of women in the comparison group, a difference that was statistically significant.Couples testing was more than twice as likely among women who received multiple HIV self-tests than women who received invitations for their partners (75% in the HIV self-testing group versus 33% in the comparison group).The self-testing intervention was safe and effective at promoting partner HIV testing among women whose partners had not tested in the past 12 months.What Do These Findings Mean?The promising results of this study suggest that secondary distribution of self-tests warrants further consideration as countries develop HIV self-testing policies and seek new ways to promote male partner testing and couples testing.Additional research is recommended to explore uptake of clinic-based confirmatory testing among partners who self-test HIV-positive, which was beyond the scope of this research.The feasibility of secondary distribution strategies among other populations and settings should be explored, along with the potential of HIV self-tests to facilitate safer sexual behaviors.

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      Most cited references 23

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      Prevention of HIV-1 infection with early antiretroviral therapy.

      Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. In nine countries, we enrolled 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1-infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1-related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1-negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death. As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P=0.01). The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 052 ClinicalTrials.gov number, NCT00074581.).
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        A modified poisson regression approach to prospective studies with binary data.

         Guangyong Zou (2004)
        Relative risk is usually the parameter of interest in epidemiologic and medical studies. In this paper, the author proposes a modified Poisson regression approach (i.e., Poisson regression with a robust error variance) to estimate this effect measure directly. A simple 2-by-2 table is used to justify the validity of this approach. Results from a limited simulation study indicate that this approach is very reliable even with total sample sizes as small as 100. The method is illustrated with two data sets.
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          Antenatal couple counseling increases uptake of interventions to prevent HIV-1 transmission.

          To determine effect of partner involvement and couple counseling on uptake of interventions to prevent HIV-1 transmission, women attending a Nairobi antenatal clinic were encouraged to return with partners for voluntary HIV-1 counseling and testing (VCT) and offered individual or couple posttest counseling. Nevirapine was provided to HIV-1-seropositive women and condoms distributed to all participants. Among 2104 women accepting testing, 308 (15%) had partners participate in VCT, of whom 116 (38%) were couple counseled. Thirty-two (10%) of 314 HIV-1-seropositive women came with partners for VCT; these women were 3-fold more likely to return for nevirapine (P = 0.02) and to report administering nevirapine at delivery (P = 0.009). Nevirapine use was reported by 88% of HIV-infected women who were couple counseled, 67% whose partners came but were not couple counseled, and 45%whose partners did not present for VCT (P for trend = 0.006). HIV-1-seropositive women receiving couple counseling were 5-fold more likely to avoid breast-feeding (P = 0.03) compared with those counseled individually. Partner notification of HIV-1-positive results was reported by 138 women (64%) and was associated with 4-fold greater likelihood of condom use (P = 0.004). Partner participation in VCT and couple counseling increased uptake of nevirapine and formula feeding. Antenatal couple counseling may be a useful strategy to promote HIV-1 prevention interventions.
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            Author and article information

            Affiliations
            [1 ]Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
            [2 ]Impact Research and Development Organization, Kisumu, Kenya
            [3 ]RTI International, San Francisco, California, United States of America
            [4 ]Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
            [5 ]Carolina Population Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
            Massachusetts General Hospital, UNITED STATES
            Author notes

            The authors have declared that no competing interests exist.

            • Conceptualization: HT KA.

            • Data curation: SHM.

            • Formal analysis: SHM HT.

            • Funding acquisition: HT.

            • Investigation: SHM HT BO KA.

            • Methodology: SHM KA SNM SM HT.

            • Project administration: HT.

            • Supervision: HT KA.

            • Writing – original draft: SHM HT.

            • Writing – review & editing: SHM HT KA BO SM SNM.

            Contributors
            Role: Academic Editor
            Journal
            PLoS Med
            PLoS Med
            plos
            plosmed
            PLoS Medicine
            Public Library of Science (San Francisco, CA USA )
            1549-1277
            1549-1676
            8 November 2016
            November 2016
            : 13
            : 11
            27824882
            5100966
            10.1371/journal.pmed.1002166
            PMEDICINE-D-16-01951
            (Academic Editor)
            © 2016 Masters et al

            This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

            Counts
            Figures: 1, Tables: 4, Pages: 15
            Product
            Funding
            Funded by: International Initiative for Impact Evaluation
            Award ID: TW2.2.02
            Award Recipient :
            Funded by: funder-id http://dx.doi.org/10.13039/100009633, Eunice Kennedy Shriver National Institute of Child Health and Human Development;
            Award ID: K01HD061605
            Award Recipient :
            The study was funded by the International Initiative for Impact Evaluation (TW2-02-02). HT acknowledges support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (K01HD061605). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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            Custom metadata
            Data from this study are available on the Odum Institute, HIV self-testing Dataverse: http://dx.doi.org/10.15139/S3/12409.

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