The Parasol Protocol: An Implementation Science Study of HIV Continuum of Care Interventions for Gay Men and Transgender Women in Burma/Myanmar

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Abstract

Background

Efforts to improve HIV diagnosis and antiretroviral therapy (ART) initiation among people living with HIV and reduce onward transmission of HIV rely on innovative interventions along multiple steps of the HIV care continuum. These innovative methods are particularly important for key populations, including men who have sex with men (MSM) and transgender women (TW). The HIV epidemic in Myanmar is concentrated among key populations, and national efforts now focus on reducing stigma and improving engagement of MSM and TW in HIV prevention and care.

Objective

This study aims to test the use of several innovations to address losses in the HIV care continuum: (1) use of respondent-driven sampling (RDS) to reach and engage MSM and TW in HIV testing, (2) HIV self-testing (HIVST) to increase HIV testing uptake and aid early diagnosis of infection, (3) community-based CD4 point-of-care (POC) technology to rapidly stage HIV disease for those who are HIV infected, and (4) peer navigation support to increase successful health system navigation for HIV-infected MSM and TW in need of ART or HIV engagement in care.

Methods

To assess the effect of HIVST, we will implement a randomized trial in which MSM and TW adults in the greater Yangon metropolitan area who are HIV uninfected will be recruited via RDS (N=366). Participants will complete a baseline socio-behavioral survey and will be randomized to standard, voluntary counseling and testing (VCT) or to HIVST. Biologic specimens will be collected during this baseline visit for confirmatory testing using dried blood spots. Participants will be asked to return to the study office to complete a second study visit in which they will report their HIV test result and answer questions on the acceptability of the assigned testing method. Aim 1 participants with confirmed HIV infection and who are not engaged in care (N=49) will be offered direct enrollment into Aims 2 and 3, which include immediate CD4 POC and the option for peer navigation, respectively. Aims 2 and 3 participants will be prospectively followed for 12 months with data collection including interviewer-administered sociobehavioral survey, CD4 POC, and viral load testing occurring biannually. Participants who accept peer navigation will be compared to those who decline peer navigation. Analyses will estimate the impact of CD4 POC on engagement in care and the impact of peer navigation on ART adherence and viral load.

Results

Formative qualitative research was conducted in June and September 2015 and led to further refinement of recruitment methods, HIVST instructions and counseling, and peer navigation methods. Aim 1 recruitment began in November 2015 with subsequent enrollment into Aims 2 and 3 and is currently ongoing.

Conclusions

These innovative interventions may resolve gaps in the HIV care continuum among MSM and TW and future implementation may aid in curbing the HIV epidemic among MSM and TW in Myanmar.

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Most cited references 49

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Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel.

Melanie Thompson, Judith Aberg, Pedro Cahn … (2010)

Recent data regarding the consequences of untreated human immunodeficiency virus (HIV) infection and the expansion of treatment choices for antiretroviral-naive and antiretroviral-experienced patients warrant an update of the International AIDS Society-USA guidelines for the use of antiretroviral therapy in adults with HIV infection. To provide updated recommendations for management of HIV-infected adults, using antiretroviral drugs and laboratory monitoring tools available in the international, developed-world setting. This report provides guidelines for when to initiate antiretroviral therapy, selection of appropriate initial regimens, patient monitoring, when to change therapy, and what regimens to use when changing. A panel with expertise in HIV research and clinical care reviewed relevant data published or presented at selected scientific conferences since the last panel report through April 2010. Data were identified through a PubMed search, review of scientific conference abstracts, and requests to antiretroviral drug manufacturers for updated clinical trials and adverse event data. New evidence was reviewed by the panel. Recommendations were drafted by section writing committees and reviewed and edited by the entire panel. The quality and strength of the evidence were rated and recommendations were made by full panel consensus. Patient readiness for treatment should be confirmed before initiation of antiretroviral treatment. Therapy is recommended for asymptomatic patients with a CD4 cell count 500/microL. Components of the initial and subsequent regimens must be individualized, particularly in the context of concurrent conditions. Patients receiving antiretroviral treatment should be monitored regularly; treatment failure should be detected and managed early, with the goal of therapy, even in heavily pretreated patients, being HIV-1 RNA suppression below commercially available assay quantification limits.

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Loss to follow-up of HIV-positive patients before initiation of antiretroviral therapy can exceed 50% in low-income settings and is a challenge to the scale-up of treatment. We implemented point-of-care counting of CD4 cells in Mozambique and assessed the effect on loss to follow-up before immunological staging and treatment initiation. In this observational cohort study, data for enrolment into HIV management and initiation of antiretroviral therapy were extracted retrospectively from patients' records at four primary health clinics providing HIV treatment and point-of-care CD4 services. Loss to follow-up and the duration of each preparatory step before treatment initiation were measured and compared with baseline data from before the introduction of point-of-care CD4 testing. After the introduction of point-of-care CD4 the proportion of patients lost to follow-up before completion of CD4 staging dropped from 57% (278 of 492) to 21% (92 of 437) (adjusted odds ratio [OR] 0·2, 95% CI 0·15-0·27). Total loss to follow-up before initiation of antiretroviral treatment fell from 64% (314 of 492) to 33% (142 of 437) (OR 0·27, 95% CI 0·21-0·36) and the proportion of enrolled patients initiating antiretroviral therapy increased from 12% (57 of 492) to 22% (94 of 437) (OR 2·05, 95% CI 1·42-2·96). The median time from enrolment to antiretroviral therapy initiation reduced from 48 days to 20 days (p<0·0001), primarily because of a reduction in the median time taken to complete CD4 staging, which decreased from 32 days to 3 days (p<0·0001). Loss to follow-up between staging and antiretroviral therapy initiation did not change significantly (OR 0·84, 95% CI 0·49-1·45). Point-of-care CD4 testing enabled clinics to stage patients rapidly on-site after enrolment, which reduced opportunities for pretreatment loss to follow-up. As a result, more patients were identified as eligible for and initiated antiretroviral treatment. Point-of-care testing might therefore be an effective intervention to reduce pretreatment loss to follow-up. Absolute Return for Kids and UNITAID. Copyright © 2011 Elsevier Ltd. All rights reserved.

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Vital signs: HIV prevention through care and treatment--United States.

(2011)

An estimated 1.2 million persons in the United States were living with human immunodeficiency virus (HIV) infection in 2008. Improving survival of persons with HIV and reducing transmission involve a continuum of services that includes diagnosis (HIV testing), linkage to and retention in HIV medical care, and ongoing HIV prevention interventions, including appropriately timed antiretroviral therapy (ART). CDC used three surveillance datasets to estimate recent HIV testing and HIV prevalence among U.S. adults by state, and the percentages of HIV-infected adults receiving HIV care for whom ART was prescribed, who achieved viral suppression, and who received prevention counseling from health-care providers. Published data were used to estimate the numbers of persons in the United States living with and diagnosed with HIV and, based on viral load and CD4 laboratory reports, linked to and retained in HIV care. In 2010, 9.6% of adults had been tested for HIV during the preceding 12 months (range by state: 4.9%-29.8%). Of the estimated 942,000 persons with HIV who were aware of their infection, approximately 77% were linked to care, and 51% remained in care. Among HIV-infected adults in care, 45% received prevention counseling, and 89% were prescribed ART, of whom 77% had viral suppression. Thus, an estimated 28% of all HIV-infected persons in the United States have a suppressed viral load. Prevalence of HIV testing and linkage to care are high but warrant continued effort. Increasing the percentages of HIV-infected persons who remain in HIV care, achieve viral suppression, and receive prevention counseling requires additional effort. Public health officials and HIV care providers should improve engagement at each step in the continuum of HIV care and monitor progress in every community using laboratory reports of viral load and CD4 test results.

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Author and article information

Contributors

Andrea L Wirtz:

Center for Public Health and Human RightsDepartment of EpidemiologyBloomberg School of Public Health, Johns Hopkins University615 N Wolfe St.E7141Baltimore, MD,United States1 410 502 0800awirtz1@jhu.edu

ORCID: http://orcid.org/0000-0002-2063-1534

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: May 2017

Publication date (Electronic): 17 May 2017

Volume: 6

Issue: 5

Electronic Location Identifier: e90

Affiliations

[1] ¹Center for Public Health and Human Rights Department of Epidemiology Bloomberg School of Public Health, Johns Hopkins University Baltimore, MDUnited States

[2] ²International HIV/AIDS Alliance in Myanmar YangonMyanmar

Author notes

Corresponding Author: Andrea L Wirtz awirtz1@ 123456jhu.edu

Author information

Andrea L Wirtz http://orcid.org/0000-0002-2063-1534

Soe Naing http://orcid.org/0000-0003-1863-0572

Emily Clouse http://orcid.org/0000-0002-5740-5936

Kaung Htet Thu http://orcid.org/0000-0003-4423-6333

Sandra Hsu Hnin Mon http://orcid.org/0000-0001-5421-9401

Zin Min Tun http://orcid.org/0000-0002-1192-0609

Stefan Baral http://orcid.org/0000-0002-5482-2419

Aung Zayar Paing http://orcid.org/0000-0003-1310-3378

Chris Beyrer http://orcid.org/0000-0003-0665-9124

Article

Publisher ID: v6i5e90

DOI: 10.2196/resprot.7642

PMC ID: 5451637

PubMed ID: 28526661

SO-VID: 115e95f8-8b97-4baf-a6a7-a10c1a35aa9a

Copyright © ©Andrea L Wirtz, Soe Naing, Emily Clouse, Kaung Htet Thu, Sandra Hsu Hnin Mon, Zin Min Tun, Stefan Baral, Aung Zayar Paing, Chris Beyrer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.05.2017.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 4 March 2017

Date revision requested : 30 March 2017

Date revision received : 12 April 2017

Date accepted : 14 April 2017

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