Abstract
BackgroundGlobally, men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings.Methods/DesignThis cluster-randomized trial (conducted from June 2012 to June 2017), evaluates whether single-venue, integrated delivery of core HIV services to vulnerable high-risk populations improves service utilization and consequently, HIV testing and other outcomes along the HIV care continuum. Core services include: HIV counseling and testing, information, education and communication, condom distribution, needle and syringe exchange programs, opioid agonist therapy, management of sexually transmitted infections, tuberculosis screening, diagnosis, and treatment, and antiretroviral therapy. Stratified restricted randomization was used to allocate 22 Indian cities (10 men who have sex with men and 12 people who inject drugs sites) at a 1:1 ratio to either the intervention or control condition. Integrated care centers were scaled-up and implemented in the 11 intervention cities and outcomes will be assessed by pre- and post-intervention surveys at intervention and control sites. As men who have sex with men and people who inject drugs are hidden populations, with no sampling frame, respondent-driven sampling will be used to accrue samples for the two independent cross-sectional surveys.DiscussionFor an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection. There is a clear gap in access to services among men who have sex with men and people who inject drugs. Trials need to be designed to optimize utilization of services in these populations.Trial registrationClinicalTrials.gov Identifier: NCT01686750 Date of Registration: September 13, 2012Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1905-5) contains supplementary material, which is available to authorized users.
Highlights
Men who have sex with men and people who inject drugs remain disproportionately affected by HIV, but they have not been the focus of prevention and treatment interventions in many resource-limited settings
For an AIDS-free generation to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection
We propose to leverage men who have sex with men (MSM) and people who inject drugs (PWID) social networks to disseminate information about the Integrated care centers (ICC) to improve ICC utilization [47]
Summary
Dramatic progress has been made in the management and prevention of HIV since the first report in 1981. Resurgence in reports of both STIs and high-risk behavior have been noted globally among MSM [57] These two populations are difficult to target because a large majority of them remain hidden and no sampling frame exists making achieving a representative sample challenging. Conversations about the end of AIDS and an AIDSfree generation have begun [59, 60] For this goal to be realized, prevention, care and treatment services need to reach all populations at risk for HIV infection those that are hardest-to-reach. Trials need to be designed to optimize utilization of services in these populations We believe that this represents one of the first trials aimed at improving the HIV care continuum among MSM and PWID populations.
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